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Exelixis and Sanofi-aventis Sign Global License Agreement to Launch Broad Collaboration for Discovery of PI3K Inhibitors

 

Exelixis to Receive $140 Million Upfront Payment and Guaranteed Research Funding

 

SOUTH SAN FRANCISCO, Calif-- Sanofi-aventis and and Exelixis, Inc. announced a global license agreement for XL147 and XL765 and a broad collaboration for the discovery of inhibitors of phosphoinositide-3 kinase (PI3K) for the treatment of cancer. Activation of the PI3K pathway is a frequent event in human tumors, promoting cell proliferation, survival and resistance to chemotherapy and radiotherapy. Under the license, sanofi-aventis will have a worldwide exclusive license to XL147 and XL765, which are currently in phase 1 and phase 1b/2 clinical trials, and will have sole responsibility for all subsequent clinical, regulatory, commercial and manufacturing activities. Exelixis will participate in conducting ongoing and potential future clinical trials and manufacturing activities.

 

Under the discovery collaboration, Exelixis and sanofi-aventis will combine efforts in establishing several pre-clinical PI3K programs and jointly share responsibility for research and preclinical activities related to isoform-selective inhibitors of PI3K. Sanofi-aventis will have sole responsibility for all subsequent clinical, regulatory, commercial and manufacturing activities of any products arising from the collaboration; however, Exelixis may be responsible for conducting certain clinical trials.

 

Sanofi-aventis will pay Exelixis aggregate upfront cash payments of $140 million under the license and collaboration. Exelixis will also receive guaranteed research funding of $21 million over a three year research term under the collaboration. For the license and the collaboration, Exelixis will be eligible to receive development, regulatory and commercial milestones of over $1 billion in the aggregate, as well as royalties on sales of any products commercialized under the license or collaboration.

 

“Sanofi-aventis has a track record of success in commercializing innovative cancer therapies and is deeply committed to advancing the care of cancer patients,” said George A. Scangos, Ph.D., president and chief executive officer of Exelixis. “We believe that their expertise and resources will enable us to move aggressively in advancing the development of XL147 and XL765 and other potential PI3K inhibitors. The data generated to date in the XL147 and XL765 clinical programs suggest that these compounds may have utility in treating diverse cancers. Sanofi-aventis and Exelixis are committed to realizing the full potential of these compounds and other PI3K inhibitors to provide cancer patients with new treatment options.”

 

The effectiveness of the license and collaboration is subject to antitrust clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary regulatory approvals.

 

 

About Exelixis

Exelixis, Inc. is a development-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics for the treatment of cancer and other serious diseases. The company is leveraging its fully integrated drug discovery platform to fuel the growth of its development pipeline, which is primarily focused on cancer. Currently, Exelixis’ broad product pipeline includes investigational compounds in phase 3, phase 2, and phase 1 clinical development. Exelixis has established strategic corporate alliances with major pharmaceutical and biotechnology companies, including Bristol-Myers Squibb, GlaxoSmithKline, Genentech, Boehringer Ingelheim, Wyeth Pharmaceuticals, and Daiichi-Sankyo. For more information, please visit the company’s web site at www.exelixis.com.



Sanofi-aventis Acquires Laboratorios Kendrick, a Generic Drug Maker in Mexico

 

- Acquisition Advances Emerging Markets Strategy -

 

Paris, France - April 2, 2009 - Sanofi-aventis announced  that its subsidiary sanofi-aventis Mexico has acquired Laboratorios Kendrick (“Kendrick”) in a move to accelerate sales growth and further extend its pharmaceutical portfolio in emerging markets.

 

Kendrick is a leading generic company in Mexico and one of the most dynamic in this market, with sales amounting to around 500 million Mexican pesos (around 26 million euros) in 2008. Kendrick’s portfolio incorporates more than 50 active ingredients in the following therapeutic areas: analgesics, antihistamines, anti-infectives, antirheumatics, cardiovascular and central nervous system drugs.

 

Kendrick’s market share in the Mexican generic market is estimated at 15% (IMS MAT January 2009).

 

Nicolas Cartier, General Manager of sanofi-aventis Mexico said: “The Kendrick acquisition represents an exceptional opportunity to accelerate our growth in the generic market in Mexico. Sanofi-aventis proves once again its leadership and its commitment to offering quality medicines that satisfy the patient needs with one of the most comprehensive portfolios in the industry.”

 

Kendrick will enable sanofi-aventis to reinforce its leadership in Mexico and further extend the range of its pharmaceutical portfolio. This acquisition is one more step in the path to transform sanofi-aventis into a global healthcare leader.

 

About Laboratorios Kendrick

Founded in 1946, Kendrick is one of the companies that actively participate within both the Private Market - pharmacies, chain outlets - and Government Tender market segments in Mexico. Kendrick is a fully-integrated pharmaceutical company that develops, manufactures, markets and distributes unbranded and branded generic products in Mexico.

 

About sanofi-aventis Mexico

With 2,500 employees and sales amounting to around 600 million euros in 2008, sanofi-aventis is the market leader in Mexico, with strong positions in diabetes, oncology, thrombosis, pain and vaccines. In 2007, sanofi-aventis launched its own generic division in Mexico which already ranks 8th among the generic companies in Mexico. Sanofi-aventis has a manufacturing plant in Mexico and has developed a significant presence in terms of clinical research. Recently, sanofi-aventis announced the signing of an agreement to build a 100 million euro facility to manufacture pandemic influenza vaccine in Mexico.



Sanofi-aventis and Novozymes Announce a Development and Commercialization Collaboration for an Innovative Antibiotic

 

- The drug candidate targets severe infections such as Pneumonia and Septicaemia -

 

Paris, France - December 22, 2008 - Sanofi-aventis announced today the signature of a global licensing and collaboration agreement with Novozymes for the development and marketing of a potential new antibiotic.

 

The drug candidate is an antimicrobial peptide named plectasin NZ2114 that targets the treatment of severe infections, such as pneumonia and septicaemia, caused by bacteria like Staphylococcus and Streptococcus.

 

Under the terms of the agreement sanofi-aventis has been granted an exclusive worldwide license for the development, registration and commercialization of the drug. The two companies will jointly work to develop and implement commercial-scale manufacturing of the plectasin NZ2114 drug substance, with the goal of introducing a recombinant process building on Novozymes’ proprietary expression technology.

 

“Plectasin NZ2114 is the first drug candidate that Novozymes has out-licensed for further preclinical and clinical development. Teaming up with one of the largest pharmaceutical companies in the world is the type of collaborations we were looking for” said Per Falholt, Executive Vice President, Research & Development, Novozymes.

 

“The innovative mechanism of action of plectasin NZ2114 makes it potentially active against bacteria resistant to currently available treatments. We are looking forward to developing plectasin NZ2114 for the treatment of severe infections such as pneumonia, septicaemia, and complicated skin and soft tissue infections” declared Dr. Marc Cluzel, Senior Vice President, Research & Development, sanofi-aventis.

 

About Plectasin NZ2114

Plectasin NZ2114 is a variant of plectasin, a novel class of antimicrobials, active against resistant and sensitive Gram-positive bacteria like Staphylococcus and Streptococcus.

 

About Novozymes

Novozymes is the world leader in bioinnovation. Together with customers across a broad array of industries we create tomorrow’s industrial biosolutions, improving our customers' business and the use of our planet's resources. Read more at www.novozymes.com.

 

About Sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY).

 



GlaxoSmithKline to Acquire Genelabs Technologies for $57 Million to Increase Focus on Novel Small Molecule Therapies for Hepatitis C

 

GlaxoSmithKline and Genelabs Technologies, Inc. announced that they have entered into a definitive agreement pursuant to which GSK will acquire Genelabs for approximately $57 million (£35 million) through a tender offer of $1.30 per share in cash. This strategic acquisition will strengthen GSK’s effort to develop and deliver novel therapies against the hepatitis C virus (HCV).

 

Under the terms of the agreement, a subsidiary of GSK will commence a tender offer to acquire all of the outstanding shares of Genelabs common stock. The board of directors of Genelabs has unanimously recommended that shareholders tender their shares in the offer.

 

“Genelabs has demonstrated a strong track record in HCV drug discovery and identified numerous novel classes of inhibitors that target unprecedented mechanisms in the virus’s life cycle,” stated Zhi Hong, SVP of the Infectious Diseases Centre for Excellence in Drug Discovery (ID CEDD) at GSK. “This arrangement, combined with our other collaborations, will give GSK a broad HCV drug discovery platform addressing novel targets and innovative therapeutic approaches.”

 

Genelabs will become part of GSK’s Drug Discovery organisation and its HCV programmes will be consolidated into the broad therapeutic approaches already underway internally and through external collaborations. This acquisition continues GSK’s strategy of pursuing the best science, internally or externally, to bring new medicines to patients and value to the GSK pipeline.

 

Fred Driscoll, President & CEO of Genelabs said, “This transaction provides our shareholders with certain value at a substantial premium to our stock price. Through the efforts of our experienced scientific staff and other employees, we have generated highly differentiated compounds with the potential to address unmet medical needs of people with the HCV infection. GSK’s world-class research and development organisation will allow us to accelerate our strategic vision of providing novel treatments that deliver tremendous value for patients.”

 

There is a high unmet need for new drugs to treat HCV infection. The current gold standard therapy comprises pegylated-alpha interferon (IFN) plus ribavirin (RBV). The efficacy rate of this combination is relatively low (approximately 50%) and both drugs are associated with significant side effects that often lead to treatment discontinuation. Several new antiviral drugs targeting multiple virus and host targets are currently in development. Rapidly emerging drug resistance suggest that combination therapies with multiple classes of drugs will be required to achieve sustained virological response.

 

The tender offer is subject to customary conditions and is expected to close in December 2008.

 

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

 

About the ID CEDD

The ID CEDD is a global research unit within GSK Drug Discovery dedicated to discovering therapies for infectious diseases. It is designed to integrate and better coordinate the progression of infectious diseases medicines from therapeutic hypothesis to clinical proof of concept. While drawing from the broader resources of GSK's R&D organisation, the ID CEDD bridges the conventional gap between discovery and development, brings scientists and physicians together in an entrepreneurial environment and size of small biotechnology companies. The ID CEDD currently consists of three discovery units for antivirals, antibacterials and medicines against diseases of the developing world. It focuses on building an innovative pipeline through both internal efforts and external alliances with other companies and research institutions. Its Infectious Diseases Centre of Excellence for External Drug Discovery (ID CEEDD) will focus on 'virtualising' a portion of the infectious diseases pipeline by forming multiple risk-sharing/reward-sharing alliances.

 

About Genelabs Technologies

Genelabs is a biopharmaceutical company focused on the discovery and development of novel compounds for infectious diseases. In addition to a late-stage drug candidate for hepatitis E partnered with GSK, the company is advancing multiple partnered and proprietary compounds designed to selectively inhibit replication of the hepatitis C virus. For more information, please visit www.genelabs.com.

 

Source: GSK Press Release



 

Pfizer Shows Accelerating Pipeline with Significant Growth in Late-Stage Clinical Development

 

Phase 3 Cohort Now Includes 25 Programs; Additions in Key Disease Areas Including Cancer and Heart Disease

Pfizer Inc provided the latest update to its development pipeline, showing significant progress in achieving the company’s growth, productivity and performance goals.

The pipeline now includes 114 programs, from Phase 1 through Registration. The number in late-stage (Phase 3) development has grown from 16 to 25 over the past six months.

In total, 31 programs advanced to the next stage of development; 13 were discontinued; and one was withdrawn from registration. The majority (19) of the advances were in Pfizer’s identified high-potential disease areas, including oncology, pain, inflammation, diabetes, Alzheimer’s disease and schizophrenia.

“We are making significant operational improvements and driving our strategies to accelerate development, refocus investments and further improve execution, including trial design and cycle times,” said Martin Mackay, President of Pfizer Global Research & Development. “We are investing in the most promising disease areas, where there is strong unmet medical need, favorable markets and an opportunity to advance medical science.”

Pfizer’s pipeline acceleration is ahead of projections given to investors in March 2008. At that time, the company announced the goal to grow its Phase 3 pipeline to at least 24 – and as many as 28 new molecular entities or new indications – by December 2009. The company is targeting 15-20 regulatory submissions in the period 2010-2012.

The company is vigorously driving its biotechnology investments and has 16 biotherapeutics in development, including CP-751871, a fully humanized monoclonal antibody which works against the Insulin-like Growth Factor 1 (IGF1-R). CP-751871 recently began Phase 3 testing against non-small-cell lung cancer, the leading cause of cancer death in the U.S.

The company has seven other cancer programs in Phase 3, including two potential new indications for Sutent in hepatocellular and prostate cancer. Sutent is taken orally and is a highly selective, multi-targeted tyrosine kinase inhibitor that starves tumors of blood and nutrients needed for growth and simultaneously kills cancer cells that make up tumors. It is also being tested in Phase 3 against breast, lung, and colorectal cancers.

Also advancing to Phase 3 is a potential new renal cell carcinoma indication for axitinib. This is an oral, selective inhibitor of VEGFR (vascular endothelial growth factor receptors 1, 2 and 3), which has been shown to induce tumor regression.

Pfizer’s updated pipeline is posted at www.pfizer.com and shows each compound name with the relevant disease area. The mechanism of action is also shown for late-stage programs.

Source: Pfizer Press Release

 



Pfizer and Medivation Enter into Global Agreement to Co-Develop and Market Dimebon for the Treatment of Alzheimer’s and Huntington’s Diseases

 

--Medivation Receives $225 Million Upfront and $500 Million Upon Subsequent Milestones--

 

 NEW YORK & SAN FRANCISCO—Sep 3--Pfizer Inc. and Medivation, Inc. announced that they have entered into an agreement to develop and commercialize Dimebon, Medivation’s investigational drug for treatment of Alzheimer’s disease and Huntington’s disease. Dimebon currently is being evaluated in an international, confirmatory Phase III trial in patients with mild-to-moderate Alzheimer’s disease (www.connectionstudy.com).

 

Under the terms of the agreement, Medivation will receive an up-front cash payment of $225 million. Medivation also is eligible to receive payments of up to $500 million upon the attainment of development and regulatory milestones plus additional undisclosed commercial milestone payments. Medivation and Pfizer will collaborate on the Phase III program in Alzheimer’s disease, Huntington’s disease development and regulatory filings in the United States. The companies will share all U.S. development and commercialization expenses along with U.S. profits/losses on a 60 percent/40 percent basis, with Pfizer assuming the larger share of both expenses and profit/losses. In addition, Medivation will co-promote Dimebon to specialty physicians in the U.S.

 

Pfizer will have responsibility for development, regulatory and commercialization outside the U.S. and will pay Medivation tiered royalties on commercial sales outside of the U.S. The agreement is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. J.P. Morgan served as financial advisor, and Cooley Godward Kronish LLP served as legal advisor, to Medivation on this transaction.

 

Alzheimer’s disease leads to the death of brain cells and the loss of nerve connections in areas of the brain that govern memory, thinking and behavior. Alzheimer’s disease gradually destroys a person’s memory and ability to learn, reason, make judgments, communicate and carry-out daily activities. No currently marketed Alzheimer’s disease drug appears to stop brain cell death and prevent or restore lost nerve connections.

 

Dimebon is an orally-available, small molecule that has been shown to inhibit brain cell death in preclinical models relevant to Alzheimer’s disease and Huntington’s disease, making it a potential treatment for these and other neurodegenerative conditions. Based on preclinical data generated to date, Dimebon appears to improve the function of mitochondria, the energy generators in cells that play a vital role in governing brain cell health, growth and overall function. Dimebon also has been shown to stimulate the outgrowth of nerves from brain cells, or neurites, a process that is believed to play an important role in restoring or generating new brain cell connections.

 

“With more than 18 million people worldwide suffering from the debilitating and ultimately fatal effects of Alzheimer’s disease, Pfizer has made this devastating illness one of our highest priorities,” said Dr. Martin Mackay, president, Pfizer Global Research and Development. “We are working to develop new medicines that improve memory and halt or significantly slow the disease’s progression. We look forward to collaborating with Medivation to bring Dimebon to patients as rapidly as possible.”

 

“After a rigorous process that garnered substantial interest, we believe that Pfizer is the ideal partner, sharing our vision for Dimebon and capable of maximizing its potential globally," said Dr. David Hung, president and chief executive officer of Medivation. "As one of the leaders in Alzheimer’s disease, Pfizer is an optimal partner because of its extensive experience developing new medicines; its marketing and commercialization track record; and, its significant global capability to effectively reach primary care physicians, who today prescribe the vast majority of Alzheimer’s disease medications in the U.S.”

 

About Dimebon’s Clinical Program

Results from the first pivotal trial of Dimebon in Alzheimer’s disease showed that patients treated with Dimebon experienced statistically significant improvements compared to placebo in key aspects of the disease -- memory and thinking, activities of daily living, behavior and overall function. Dimebon’s benefit over placebo continued to increase throughout the 12-month treatment period. At the end of 12 months, Dimebon-treated patients were on average functioning as well or better than they had been at the start of the study on each of 5 clinical endpoints. These results were published in the July 19, 2008 issue of The Lancet, and are noteworthy as untreated Alzheimer's patients progressively deteriorate over time in these areas.

 

On July 7, 2008, Medivation announced positive safety and efficacy results from its Phase 2 trial of Dimebon in Huntington’s disease, which was conducted in collaboration with the Huntington Study Group. Dimebon appeared to be well tolerated and showed statistically significant benefit versus placebo in cognition as measured by the Mini-Mental State Examination, a secondary endpoint in the study.

 

 

About Pfizer Inc

Founded in 1849, Pfizer is the world's largest research-based pharmaceutical company. Pfizer is taking new approaches to advancing better health as it discovers, develops, manufactures and delivers quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. Pfizer also partners with healthcare providers, governments and local communities around the world to expand access to medicines and to provide better quality health care and health system support. For more information visit www.pfizer.com

 

About Medivation

Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options.

 

Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. The Company's current clinical development program includes a pivotal and confirmatory Phase 3 trial of Dimebon in Alzheimer's disease and a Phase 1-2 clinical trial of MDV3100 in patients with castration-resistant (also known as hormone-refractory) prostate cancer. Medivation recently announced that it plans to continue further development of Dimebon in patients with mild-to-moderate Huntington's disease based on the positive results seen in its Phase 2 trial. For more information, please visit us at http://www.medivation.com.

 

Source: Pfizer Press Release



Bristol-Myers Squibb and PDL BioPharma Enter Global Alliance to Develop Novel Treatment for Multiple Myeloma

 

-Elotuzumab Antibody Designed to Target Highly Expressed Cell Surface Protein and Selectively Kill Multiple Myeloma Cells-

 

Bristol-Myers Squibb Company and PDL BioPharma, Inc. announced an agreement for the global development and commercialization of PDL BioPharma’s anti-CS1 antibody, elotuzumab, previously known as HuLuc63, currently in Phase I development for multiple myeloma.

 

Elotuzumab provides a novel approach to treating multiple myeloma because it is an antibody that binds to the CS1 glycoprotein, allowing the immune system to selectively kill myeloma cells with minimal effects on other cell types. CS1 is a cell surface glycoprotein that is widely expressed on multiple myeloma cells but is minimally expressed on normal cells. Elotuzumab is currently being investigated in Phase I studies as a monotherapy and in combination with other therapies. There are currently no approved monoclonal antibodies on the market to treat multiple myeloma.

 

Under the terms of the collaboration, Bristol-Myers Squibb would pay PDL BioPharma an upfront cash payment of $30 million for the development and marketing rights to elotuzumab and for an option to expand the collaboration to include PDL241, another anti-CS1 antibody, upon completion of pre-agreed preclinical studies. PDL BioPharma could receive additional payments of up to $480 million based on pre-defined development and regulatory milestones and up to $200 million based on pre-defined sales-based milestones for elotuzumab in multiple myeloma and other potential oncology indications.

 

The companies will share development costs, with Bristol-Myers Squibb providing 80 percent of the funding and PDL BioPharma providing 20 percent. Bristol-Myers Squibb will lead global development activities, and PDL BioPharma will complete the ongoing Phase I program and provide support for Phase II studies. The companies would share profits on sales of elozutumab in the U.S. PDL BioPharma would receive royalties on net sales of elotuzumab outside the U.S.

 

If Bristol-Myers Squibb exercises its option to expand the collaboration to include PDL241, PDL BioPharma would receive an additional cash payment of $15 million and could receive additional payments of up to $230 million based on pre-defined development and regulatory milestones and up to $200 million based on pre-defined sales-based milestones. The same division of development costs and profit sharing that apply to elotuzumab would apply to PDL241.

 

The closing of the transaction is subject to antitrust clearance under the Hart-Scott-Rodino Act and other customary regulatory approvals.

 

“Elotuzumab provides us with the opportunity to develop and market an innovative therapy that has the potential to meaningfully address the significant unmet medical need in multiple myeloma,” said Francis Cuss, MD, senior vice president, Discovery and Exploratory Clinical Research, Bristol-Myers Squibb. “Consistent with our company’s strategy to integrate external innovation and to expand our capabilities, this collaboration will further strengthen our pipeline of agents targeting hematologic malignancies, which includes SPRYCEL(R) and tanespimycin, an Hsp90 inhibitor from our recent acquisition of Kosan Biosciences.”

 

“We are delighted to enter this global alliance with Bristol-Myers Squibb, which we believe will maximize the potential benefit of elotuzumab to patients, and highlight the value of our scientific discoveries and antibody technologies to the field,” said Mark McCamish, MD, PhD, PDL’s senior vice president and chief medical officer. “In addition, Bristol-Myers Squibb brings extensive oncology development experience and resources and we look forward to collaborating with them to increase the scope of the elotuzumab development program moving forward.”

 

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information visit www.bms.com

 

About PDL BioPharma

PDL BioPharma, Inc. is a biotechnology company focused on the discovery and development of novel antibodies in oncology and immunologic diseases. For more information, please visit www.pdl.com.

 

Source: BMS Press Release



Bristol-Myers Squibb Proposes to Acquire ImClone Systems for $60.00 Per Share in Cash or approximately $4.5 Billion

 

--Combination Is Natural Development in Companies’ Successful, Seven-Year-Long Relationship around ERBITUX®--

 

NEW YORK, July 31, 2008 - Bristol-Myers Squibb Company today announced that it has proposed to enter into an agreement to acquire ImClone Systems Incorporated, a global leader in the development and commercialization of novel antibodies to treat cancer, for $60.00 per share in cash, or a total payment of approximately $4.5 billion, to equity holders of ImClone, other than Bristol-Myers Squibb. Bristol-Myers Squibb currently owns approximately 17 percent of all outstanding shares of ImClone.

 

Bristol-Myers Squibb’s all-cash offer, which is not conditioned on the receipt of financing or on the conduct of due diligence, represents a premium of approximately 30 percent over ImClone’s closing stock price on July 30, 2008, the last trading day before Bristol-Myers Squibb sent its proposal to ImClone’s Board of Directors, a premium of approximately 40 percent over the average closing price of ImClone’s stock during the most recent one-month period and a premium in excess of 40 percent for the average closing stock prices of ImClone stock during each of the most recent three-month and 12-month periods.

 

James M. Cornelius, chairman and chief executive officer, Bristol-Myers Squibb, said, “Our proposed acquisition of ImClone represents an evolutionary development in our companies’ seven-year-long relationship, and is in the best interests of Bristol-Myers Squibb and ImClone shareholders and employees, and the patients we serve together. Bristol-Myers Squibb is the natural partner for ImClone as we possess the knowledge base and resources to advance the company’s growth over the long-term, not only with respect to ERBITUX®, the important cancer therapy we jointly commercialize, but also in terms of developing ImClone’s pipeline assets. Our current contractual relationship with ImClone, in which we hold exclusive, long-term marketing rights to ERBITUX in the U.S., has been very successful, and we believe that, by applying Bristol-Myers Squibb’s financial, R&D and marketing capabilities to support the product, we will be able to reach an even broader patient population.”

 

“For Bristol-Myers Squibb, the proposed acquisition of ImClone represents a strategically and financially sound add-on to our business, consolidating a relationship we have had for nearly seven years. The acquisition is expected to contribute to our financial performance in the 2012-2013 timeframe as well as drive growth beyond 2013,” continued Mr. Cornelius.

 

“Bristol-Myers Squibb is prepared to proceed to work with ImClone’s Board of Directors quickly and efficiently to reach a definitive merger agreement regarding our all-cash offer, which delivers full and fair value to ImClone’s shareholders. We look forward to meeting with ImClone’s Board and management to effect this transaction in an expedited manner,” concluded Mr. Cornelius.

 

ERBITUX (cetuximab) is indicated for use in the treatment of patients with metastatic colorectal cancer and for use in the treatment of squamous cell carcinoma of the head and neck. Bristol-Myers Squibb and ImClone have been engaged in the co-development and co-commercialization of ERBITUX in the U.S. and Canada under an agreement entered into in September 2001. Under the agreement, ImClone receives a distribution fee based on a flat rate of 39 percent of net sales in North America. This Agreement was amended in July 2007 to provide for additional development funding for certain indications. The Agreement expires in September 2018 with respect to ERBITUX in the U.S.

 

Bristol-Myers Squibb and ImClone have also been engaged in the co-development of ERBITUX in Japan with Merck KGaA since December 2004. In October 2007, the three companies amended this agreement to provide for co-commercialization of ERBITUX in Japan. The companies received marketing approval for ERBITUX in Japan on July 16, 2008, for use in combination with irinotecan to treat unresectable advanced or recurrent colorectal cancer.

 

Bristol-Myers Squibb’s proposal to acquire ImClone for $60.00 per share in cash was conveyed earlier this morning by Mr. Cornelius to Carl C. Icahn, chairman of the Board of Directors of ImClone, and confirmed in a letter sent to the Board of Directors. The full text of the letter follows:

 

Board of Directors

ImClone Systems Incorporated

180 Varick Street

New York, NY 10014

Care of Mr. Carl C. Icahn, Chairman of the Board 

  

July 31, 2008 

Dear Carl: 

  

This confirms that Bristol-Myers Squibb Company is offering to enter into an agreement to acquire ImClone Systems Incorporated for $60 per share in cash. Our all-cash offer represents a premium of approximately 30% over the closing price of ImClone common stock on July 30, 2008, a premium of approximately 40% over the one-month average closing price of ImClone common stock, and a premium in excess of 40% over the three-month and one-year average closing prices of ImClone common stock. A full combination of BMS and ImClone is a natural fit for both our companies, and we are convinced our proposed price represents a full and fair offer for ImClone. 

  

For nearly seven years, BMS and ImClone have worked in concert to bring ERBITUX(R) to patients and build a strong product. We value our commercial agreement with ImClone and believe our respective commercial teams have forged an excellent working relationship. We also value our interactions with your scientists and clinicians. We have high regard for the potential of ImClone's pipeline assets, while recognizing the early stage of their development and the significant investment which is required to further their development. 

  

Our Board of Directors has approved this offer. We and our advisors are prepared to meet with you and your advisors to answer any questions you may have about our offer. We are confident that, with ImClone's cooperation, we can reach a definitive agreement very quickly. We do not foresee any regulatory or other impediment to closing. Our offer is not conditioned on financing or due diligence. 

  

As you know, as a result of our current ownership of ImClone stock, we are subject to U.S. securities laws which require us to disclose any material change in our intentions with respect to ImClone as reflected in our Schedule 13D on file with the U.S. Securities and Exchange Commission. Accordingly, we are filing with the SEC an amendment to our Schedule 13D disclosing our offer and including this letter as an exhibit. 

  

In my view, and in the view of our Board of Directors, this transaction makes compelling business sense for both of our companies and is in the best interests of our respective shareholders and the cancer patients for whom our companies' life saving medicines are so important. The price we are offering represents an extremely attractive opportunity for the shareholders of ImClone to realize today the future value of the company. Our desire is to conclude a transaction which is enthusiastically supported by you and all other members of the ImClone Board. We look forward to your prompt response to our offer. 

  

Sincerely, 

  

/s/ James M. Cornelius 

  

James M. Cornelius 

Chairman and 

Chief Executive Officer 

 

 

Bristol-Myers Squibb has filed today an Amended Schedule 13D and a Form 8-K with the Securities and Exchange Commission (SEC). Those filings may be accessed at www.sec.gov or via Bristol-Myers Squibb’s website at www.bms.com/ir.

 

Morgan Stanley & Company Inc., Citigroup Global Markets Inc. and Credit Suisse Securities (USA) LLC are serving as financial advisors to Bristol-Myers Squibb in connection with the proposed acquisition. Cravath, Swaine & Moore LLP is acting as legal counsel to Bristol-Myers Squibb.

 

 

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life.

 

Source: Bristol-Myers Squibb Press Release



Genzyme and Isis Complete Licensing of Mipomersen- A Novel Antisense Lipid-Lowering Drug

 

-Isis will receive a $175 million license fee for mipomersen-

 

-Isis is also eligible to receive up to $825 million in development and regulatory milestone payments-

 

June 24, 2008-Genzyme Corp. and Isis Pharmaceuticals, Inc. today announced the finalization of the license and collaboration agreement for mipomersen. The collaboration provides Genzyme with exclusive worldwide rights to mipomersen, a novel lipid-lowering drug discovered and developed by Isis that is in phase 3 clinical development. During the second half of this year, enrollment is expected to be completed in a pivotal study of mipomersen in homozygous familial hypercholesterolemia, and a new trial in apheresis-eligible patients is expected to begin.

 

About Mipomersen

Mipomersen is a second-generation antisense drug that reduces the production of apoB-100, a protein critical to the synthesis and transport of "bad" cholesterol. Mipomersen is currently in phase 3 development for patients with homozygous familial hypercholesterolemia, a disease which creates a greatly increased risk of premature cardiovascular disease (CVD) and CVD-related death. In phase 2 studies, mipomersen, a weekly injectable therapeutic, was observed to reduce cholesterol and other atherogenic lipids beyond reductions achieved with standard lipid-lowering drugs, enabling more patients to achieve LDL-C targets.

 

As part of the agreement, Isis will receive a $175 million license fee for mipomersen. In February, Isis received a $150 million payment from Genzyme to purchase 5 million shares of Isis common stock at $30 per share.

 

The companies have updated the deal terms so that Isis will contribute up to $50 million in additional development funding for mipomersen, bringing Isis' development funding commitment up to $125 million. Thereafter Isis and Genzyme will share development costs equally. The initial Isis development funding commitment and the shared funding will end when the program is profitable. In exchange for this additional contribution, Isis has the opportunity to receive $75 million in milestone payments early.

 

"Mipomersen is an innovative treatment that has the potential to change the standard of care for severely ill patients whose needs cannot be addressed by current cholesterol-lowering therapies," said Henri A. Termeer, Genzyme's chairman and chief executive officer. "This treatment is an important addition to Genzyme's robust late-stage pipeline. We will manage the clinical development of mipomersen within our current R&D budget and financial guidance."

 

Over the next 30 days, the companies will transition the mipomersen IND and all regulatory authority to Genzyme. As the sponsor of mipomersen, Genzyme will take the lead on discussions with regulatory agencies and filings. In response to guidance received from the FDA, the companies have modified the initial development plan for mipomersen, subject to further discussions with the agency.

 

The key changes to the plan include:

-The addition of clinical studies of mipomersen in apheresis-eligible patients.

 

-Consolidation of the planned filings for heterozygous FH patients and other high-risk, high cholesterol patients into a single registration in the U.S.

 

 -Acceleration of the planned outcome study so that it can be used to support the above mentioned consolidated U.S. filing.

 

 

“Mipomersen is an important drug that demonstrates the power and precision of antisense drugs. We believe now, as we did in January, that Genzyme is the ideal partner for mipomersen,” said Stanley Crooke, Chairman and Chief Executive Officer of Isis. “We will continue to work with Genzyme on a development plan that is responsive to the FDA and other regulatory agencies, and maximizes the value of the drug. In addition, we look forward to exploring new areas of therapeutic opportunity with Genzyme in CNS and certain rare diseases as part of this alliance.”

 

Deal Terms

As a result of the changes in the development plan and consistent with the premise of the transaction in which the companies are sharing the value of mipomersen, the following changes to the original financial terms of the deal have been made:

 

 Isis will contribute up to the first $125 million in development funding, reflecting an additional contribution of up to $50 million. Thereafter Isis and Genzyme will share development costs equally. The initial Isis development funding commitment and the shared funding will end when the program is profitable. In exchange for this additional contribution, Isis has the opportunity to receive certain milestone payments early.

 

 $75 million of the $150 million milestone associated with the heterozygous FH indication (the portion related to U.S. registration) may be accelerated, to be paid $25 million at annual product revenue of $250 million and $50 million at annual product revenue of $500 million. The $75 million milestone for European approval of the heterozygous FH indication remains the same.

 

All other financial terms of the transaction remain unchanged. As part of the agreement, Isis will receive a total of $325 million in up-front payments from Genzyme, including the $175 million license fee and the $150 million February 2008 stock purchase.

 

Isis is eligible to receive up to $750 million in commercial milestone payments, in three increments of $250 million, when annual net revenues meet $3 billion, $4 billion, and $5 billion for two consecutive years.

 

Isis is also eligible to receive up to $825 million in development and regulatory milestone payments, which are broken out as follows:

 

 Total milestones related to homozygous FH -- $50 million

 

 Total milestones related to heterozygous FH -- $150 million

-$75 million for U.S. approval (may be accelerated based on earlier achievement of sales targets)

-$75 million for E.U. approval

 

 Total milestones related to approvals of a first Non-FH indication -- $375 million

 

 Total milestones related to approvals of a follow-on product -- $250 million

 

 Total -- $825 million

 

Isis and Genzyme will allocate responsibility for funding development expenses as described above. Genzyme will be responsible for funding sales and marketing expenses until revenues are sufficient to cover them.

 

Genzyme and Isis will share mipomersen profits, beginning with a 70/30 Genzyme/Isis split. This split will adjust on a sliding scale, reaching 50/50 when annual revenues reach $2 billion. As part of the strategic relationship, Genzyme will also have preferred access to future Isis drugs for CNS and certain rare diseases.

 

Mipomersen Development Plan

The initial indication sought for mipomersen will be for patients with homozygous FH, and a phase 3 trial in this patient population is ongoing. A U.S. filing for this indication is expected during the second half of 2010. The companies also plan to study mipomersen's use in other very high risk patient groups, including apheresis-eligible patients. Data from a trial in apheresis-eligible patients is expected before the filing for the initial homozygous FH indication.

 

LDL apheresis is a blood-filtering procedure that targets "bad" cholesterol, and is indicated for individuals for whom diet and maximum drug therapy has either been ineffective or not tolerated. Specific LDL levels defining apheresis eligibility vary by country. Many patients who are eligible, however, choose not to undergo apheresis due to its negative impact on quality of life. The procedure is painful and inconvenient, requiring patients to go to apheresis centers for treatment once every one to two weeks. Apheresis can cost $75,000 to $150,000 per year.

 

The trial in apheresis-eligible patients is an important addition to the mipomersen development program. Like homozygous FH patients, apheresis-eligible patients are characterized by extremely high LDL levels and are not able to be managed by existing therapies. There are an estimated 10,000 – 15,000 apheresis-eligible patients in the United States and Europe.

 

Genzyme and Isis expect to begin three additional trials of mipomersen in high-risk patients during the second half of this year. These trials will include: one for heterozygous FH patients, and two for high-risk, high cholesterol patients. These trials will continue to build the body of clinical evidence around mipomersen's value in managing very high risk patients.

 

Data from these five trials will also inform the design of the morbidity and mortality outcome study for potential expansion of mipomersen's label to include a larger group of at-risk, high cholesterol patients. In addition to the ongoing discussions with the FDA, plans are underway to engage in discussions with regulatory authorities in Europe, where the development path for mipomersen may differ from that in the U.S.

 

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.

 

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

 

 

About Isis Pharmaceuticals, Inc.

Isis is exploiting its expertise in RNA to discover and develop novel drugs for its product pipeline and for its partners. The Company has successfully commercialized the world's first antisense drug and has 18 drugs in development. Isis’ drug development programs are focused on treating cardiovascular and metabolic diseases. Isis’ partners are developing antisense drugs invented by Isis to treat a wide variety of diseases. Ibis Biosciences, Inc., Isis’ majority-owned subsidiary, is developing and commercializing the Ibis T5000™ Biosensor System, a revolutionary system to identify infectious organisms. Isis is a joint owner of Regulus Therapeutics LLC, a joint venture focused on the discovery, development and commercialization of microRNA therapeutics. As an innovator in RNA-based drug discovery and development, Isis is the owner or exclusive licensee of over 1,500 issued patents worldwide. Additional information about Isis is available at www.isispharm.com.

 

Source: Genzyme Press Release

 



Alnylam and Takeda Form Strategic Worldwide Platform Alliance in RNAi Therapeutics

 

-Alnylam Selects Takeda as its Sole Asian Strategic Partner and Obtains options for 50-50 Development and Commercialization of Takeda RNAi Therapeutic Programs in U.S. Market –

 

– Takeda Gains Access and Enablement to Alnylam’s Leading RNAi Therapeutics Technology and Intellectual Property in Fields of Oncology and Metabolic Disease –

 

-Alliance Includes $150 Million in Upfront and Near-Term Technology Transfer Payments, and Additional Future Research & Development and Commercial Milestones-

 

CAMBRIDGE, Mass., USA and OSAKA, Japan, May 27, 2008 – Alnylam Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited announced that they have formed a strategic platform alliance in RNAi therapeutics in the fields of oncology and metabolic disease with the option to expand to additional therapeutic areas. This landmark alliance is the first major RNAi therapeutics partnership between a Japanese pharmaceutical company and a U.S. biotechnology company, representing a new frontier in the advancement of RNAi therapeutics to patients on a global basis.

 

RNAi is an entirely new approach for the discovery of breakthrough medicines that utilizes a natural mechanism found within the body to inhibit expression of certain genes. Harnessing the activity of RNAi creates a direct opportunity to develop specific and potent new medicines for the treatment of a broad range of diseases, including those that are difficult to treat with today’s drug approaches. The discovery of RNAi was awarded the 2006 Nobel Prize and the advancement of RNAi is recognized as one of the most important advances in biomedical sciences in decades.

 

“We are very pleased and honored to have a strategic platform partnership with Takeda, one of the world’s leading pharmaceutical companies. As the first RNAi technology partnership with a pharmaceutical company located in Asia, this new alliance expands the advancement of RNAi therapeutics to patients on a global basis,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “Across multiple dimensions, this new partnership is a major event in Alnylam’s efforts to build a leading biopharmaceutical company. A particularly important element in this new platform alliance is Alnylam’s opportunity to co-develop and co-commercialize Takeda RNAi therapeutic products with Takeda in the U.S. market.”

 

“We are excited to work with Alnylam, as the leading worldwide company in the field of RNAi therapeutics with a strong commitment to scientific excellence and an unparalleled intellectual property position,” said Yasuchika Hasegawa, President of Takeda. “We believe this alliance will accelerate our initiatives to establish the foundation for RNAi drug discovery supported by Alnylam’s platform technologies and know-how. We expect that our product portfolio will be enhanced by the addition of RNAi therapeutics to our current small molecule and anti-body research platforms.”

 

This collaboration provides Takeda with broad, worldwide, non-exclusive access to and enablement with Alnylam’s RNAi therapeutics platform technology and intellectual property in the fields of oncology and metabolic disease, with the right to expand the number of therapeutic fields in the future. The agreement also includes the transfer of platform technology from Alnylam to Takeda, a collaboration and cross-license of delivery technologies between the two companies, and a drug discovery collaboration on certain RNAi therapeutic targets, subject to certain Alnylam third party obligations.

 

Takeda becomes Alnylam’s strategic partner for RNAi therapeutics over a five-year period and the only Asian company to obtain a right of first negotiation to develop and commercialize Alnylam RNAi therapeutic development programs for the Asian market, excluding Alnylam’s ALN-RSV01 program. In addition, Alnylam obtains opt-in options to co-develop and co-commercialize Takeda RNAi therapeutic programs in the U.S. market on a 50-50 basis.

 

The partnership includes $100 million in upfront payments and $50 million in near-term technology transfer payments for a non-exclusive license in two therapeutic fields and is valued at potentially over $1 billion in future research and development and commercial milestones, upon successful commercialization of multiple products. At Takeda’s option, the scope of the partnership can be expanded to include additional fields with a $50 million per field expansion payment. Alnylam is also eligible to receive research and development funding related to the drug discovery collaboration. In addition, Alnylam is eligible to receive up to $171 million in development and commercial milestone payments and significant royalties per product. Alnylam plans to update financial guidance when it announces its second quarter 2008 financial results.

 

 

About RNA Interference (RNAi)

RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. RNAi therapeutics target the cause of diseases by potently silencing specific messenger RNAs (mRNAs), thereby preventing disease-causing proteins from being made. RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way.

 

About Alnylam Pharmaceuticals

Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. The company is applying its therapeutic expertise in RNAi to address significant medical needs, many of which cannot effectively be addressed with small molecules or antibodies, the current major classes of drugs. Alnylam is leading the translation of RNAi as a new class of innovative medicines with peer-reviewed research efforts published in the world’s top scientific journals including Nature, Nature Medicine, and Cell. The company is leveraging these capabilities to build a broad pipeline of RNAi therapeutics; its most advanced program is in Phase II human clinical trials for the treatment of respiratory syncytial virus (RSV) infection. In addition, the company is developing RNAi therapeutics for the treatment of a wide range of disease areas, including hypercholesterolemia, liver cancers, and Huntington’s disease. The company’s leadership position in fundamental patents, technology, and know-how relating to RNAi has enabled it to form major alliances with leading companies including Medtronic, Novartis, Biogen Idec, Roche, and Takeda. To reflect its outlook for key scientific, clinical, and business initiatives, Alnylam has established “RNAi 2010” which includes the company’s plan to significantly expand the scope of delivery solutions for RNAi therapeutics, have four or more programs in clinical development, and to form four or more new major business collaborations, all by the end of 2010. Alnylam is a joint owner of Regulus Therapeutics LLC, a joint venture focused on the discovery, development, and commercialization of microRNA therapeutics. Founded in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts. For more information, visit http://www.alnylam.com/

 

About Takeda

Founded in 1781 and located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.

 

Additional information about Takeda is available through its corporate website, http://www.takeda.com/

 

Source: Takeda Press Release

 



Biocon Acquires 70% Stake In German Pharmaceutical Company, Axicorp : Biosimilars Will Be Main Focus

 

Bangalore, 2008-Indian Biotechnology major, Biocon  announced that it has reached agreement to acquire a 70% stake in German pharmaceutical company, AxiCorp GmbH for a consideration of €30 Million.  This will enable the marketing and distribution of a range of pharmaceuticals including generics, biosimilars, biologics and innovative pharmaceutical products in Germany and Europe. Allegro Capital were the financial advisors to Biocon on this transaction.

 

AxiCorp is a specialized marketing and distribution company established in 2002 by a group of industry experts to address the lucrative generics and parallel distribution market in Germany and Europe. AxiCorp is ISO 9001 certified with a differentiated distribution model that is aligned to the radically altered way the German pharmaceutical market now functions.

 

Kiran Mazumdar-Shaw, Chairman and Managing Director of Biocon said, “AxiCorp is a key strategic investment for Biocon as it heralds our European foray for biosimilars like Recombinant Human Insulin. Biocon is investing in AxiCorp’s very impressive entrepreneurial team and its highly differentiated business model, which will help us build strong marketing and distribution capabilities in Europe. Both companies share a common vision of affordable healthcare which we can deliver through a combination of Biocon’s low cost manufacturing and AxiCorp’s low cost distribution. We are delighted to welcome AxiCorp to the Biocon group of companies as an autonomous subsidiary. We look forward to the continued leadership role played by Holger Gehlhar and Dirk Ullrich in steering AxiCorp to new levels of growth. ”

 

“The entry of Biocon adds significantly to our competence.” says Holger Gehlhar, Co-founder of AxiCorp. “With EMEA opening the doors to biosimilars, we believe Biocon will add a new dimension to our current product offerings through biosimilars and innovative drugs. Biocon’s manufacturing and drug development capabilities will also enable us to effectively compete for increased market share.”

 

“The clinical development costs involved in commercializing bio-similars and biologics limit small and mid-sized pharmaceutical companies in Europe to participate in this emerging segment”, explains Dirk Ullrich, who has managed the diabetology business of Sanofi-Aventis before he became General Manager of AxiCorp in 2007. “Biocon will now make it possible for AxiCorp to assert its position in this important therapeutic segment. We are confident that we can take Biocon’s expanding drug pipeline rapidly and efficiently to the market in Germany and elsewhere in Europe.”

 

With the strategic investment in AxiCorp, Biocon establishes its first presence in Europe in order to market its injectible insulin on its own, and also to build up marketing and distribution capabilities for many other products of its portfolio.

 

About Biocon

Established in 1978, Biocon Limited is recognized as India's premier biotechnology company. Biocon and its two subsidiary companies, Syngene International Ltd and Clinigene International Ltd form a fully integrated biotechnology enterprise, specializing in biopharmaceuticals, custom research and clinical research. With successful initiatives in clinical development, bio-processing and global marketing, Biocon delivers products and solutions to partners and customers across the globe. Many of these products have USFDA and EMEA acceptance. Biocon launched the world's first Pichia derived recombinant human insulin, INSUGEN® in 2004 and India's first indigenously produced

monoclonal antibody BIOMAb-EGFR® in 2006. Visit us at www.biocon.com

 

About AxiCorp

Established in 2002, AxiCorp is headquartered in Friedrichsdorf, (near Frankfurt) Germany and markets parallel distributed EU-pharmaceuticals as well as its own generic brand “axcount”. This unique business approach contributes to significant cost savings for German health providers and patients in the patented pharmaceuticals market as well as in the off-patent market. AxiCorp is amongst the fastest growing pharmaceutical companies in Germany, with a turnover of €75 Million in 2007. Today, the company

employs about 170 employees and has launched more than 180 products.

Please visit our website www.AxiCorp.de for more information.

 

PR contact:

Biocon Limited

Paula Sengupta

Email: paula.sengupta@biocon.com

 

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Pfizer to Acquire Serenex to Extend Oncology Pipeline and Novel Technology Platform

 

-Serenex owns a Phase I clinical candidate and an extensive compound library that targets Heat Shock Protein 90 (Hsp90)-

 

March3, 2008--Pfizer Inc today announced that it has entered into an agreement to acquire Serenex, Inc., a privately-held biotechnology company with a Phase I clinical candidate and an extensive compound library that targets Heat Shock Protein 90 (Hsp90), an exciting target in the fight against cancer.

 

As per the agreement, Pfizer will acquire the rights to SNX-5422, an oral Hsp90 inhibitor currently in Phase I trials for the potential treatment of solid tumors and hematological malignancies. Pfizer will also acquire Serenex’s proprietary drug discovery technology and extensive small molecule Hsp90 inhibitor compound library. Compounds from this library have potential uses in treating deadly and debilitating diseases, such as cancer, inflammatory and neurodegenerative diseases. SNX-1012, another compound in clinical development for the treatment of oral mucositis in cancer patients, is not included in the agreement.

 

The transaction is expected to close in the second quarter of 2008, subject to customary closing conditions, including approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Financial terms of the deal were not disclosed.

 

“The agreement to acquire Serenex is the latest step in the execution of Pfizer’s strategy to expand our commitment to oncology, an area where Pfizer plans to establish a leadership position,” said Jeffrey Kindler, chairman and chief executive officer of Pfizer.

 

“Pfizer is committed to pursuing compelling science taking place outside our laboratories, and the agreement to acquire Serenex is a splendid example of those efforts,” added Martin Mackay, Ph.D., president of Pfizer Global Research and Development. “The Serenex oncology candidate extends Pfizer’s substantial internal research efforts to develop novel treatments for cancer, a leading cause of death in the United States and much of the world. The library of early phase compounds also has wide potential for utility in a range of neurodegenerative and anti-inflammatory disorders, such as Alzheimer’s disease, Parkinson’s disease and arthritis.”

 

Serenex discovered its small molecule Hsp90 inhibitors using a proprietary high–content screening platform that enabled the company to rapidly and simultaneously optimize libraries of compounds against a multitude of important therapeutic and toxicity targets. This novel technology improved the overall efficiency across the entire spectrum of drug discovery by dramatically improving library screening, mechanism of action determination and toxicity testing, lead optimization and candidate selection.

 

Hsp90 is an important molecular chaperone protein that regulates the folding and degradation of client proteins involved in cell growth and survival. These signaling proteins play key roles in cancer, inflammatory diseases, and neurodegenerative diseases such as Alzheimer’s. The potential of this exciting drug class in many other therapeutic indications is yet to be fully explored.

 

“We are pleased that our proprietary screening platform and product pipeline will become part of the superb scientific environment at Pfizer,” said Richard Kent, M.D., president and chief executive officer of Serenex, Inc. “We are confident that Pfizer has the vision and resources necessary to leverage these new assets in its continuing efforts to produce much-needed new medicines.”

 

Covington & Burling LLP advised Pfizer on this transaction. Lehman Brothers and Cooley Godward Kronish LLP advised Serenex.

 

More information on both companies, Hsp90 inhibitors and the proprietary technology platform, is available at www.pfizer.com and www.serenex.com.

 

Source: Pfizer Press Release

 



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AstraZeneca Updates on Restructuring of AstraZeneca and Merck’s Joint Venture in the United States

 

February 28, 2008. AstraZeneca announced that, under the provisions of the agreements relating to the restructuring of the AstraZeneca and Merck & Co. joint venture in the United States, AstraZeneca has been informed that Merck has elected not to exercise the First Option related to the relinquishment of Merck’s rights over the products not covered by the Partial Retirement (see paragraph below), other than Nexium™ and Prilosec™. As a result of this decision, contingent payments will continue on the products Atacand™, Lexxel™, Plendil™ and Entocort™ until at least 2010, at which time AstraZeneca may exercise this option at the 2008 Appraised Value of approximately $650 million. The Appraised Value also includes rights to certain products that are still in clinical development (AZD6140, AZD3355, AZD0328 and AZD2327). AstraZeneca made contingent payments in respect of the products included in the First Option of $69 million in 2007.

 

Other aspects of the scheduled termination arrangements will proceed as previously disclosed:

 

The Partial Retirement of Merck’s limited partnership interest, under which Merck’s rights in respect of certain products will end. The products covered by the Partial Retirement include Toprol-XL™, Pulmicort™, Rhinocort™ and Symbicort™. AstraZeneca made contingent payments in respect of these products amounting to $182 million in 2007. AstraZeneca will pay Merck approximately $4.27 billion in respect of the Partial Retirement.

 

A true-up of the Advance Payment, which was triggered at the time of the merger between Astra and Zeneca, under which Merck relinquished all rights, including contingent payment on future sales, to potential Astra products with no existing or pending US patents at the time of the merger, amounting to a payment by Merck to AstraZeneca of approximately $0.24 billion, inclusive of interest.

 

Settlement of the loan note receivable by AstraZeneca from Merck, in the amount of $1.4 billion inclusive of accrued interest

 

The combined effects of these three items will be a net cash outflow from AstraZeneca to Merck of approximately $2.63 billion upon settlement during the first quarter 2008.

 

Under the provision of the agreements a Second Option exists whereby AstraZeneca has the option to repurchase Merck’s interests in Prilosec™ and Nexium™ in the US. This option is exercisable by AstraZeneca in 2012 should AstraZeneca exercise the First Option in 2010. Exercise of the second option by AstraZeneca at a later date is also provided for in 2017 or if combined sales of the two products fall below a minimum amount provided, in each case, that the First Option has been exercised. The exercise price for the Second Option is the net present value of the future annual contingent payments on Prilosec™ and Nexium™ as determined by the average valuation of two appraisers (one selected by each party) at the time of exercise, which is subject to a potential true-up mechanism under certain conditions. AstraZeneca made contingent payments in respect of US sales for Prilosec™ and Nexium™ amounting to $931 million in 2007.

 

Further details on the accounting treatment of these events from an AstraZeneca perspective will be provided in conjunction with the Q1 2008 earnings announcement on 24 April, 2008.

 

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

 

For further information:

 

Media Enquiries:

Neil McCrae, +44 207 304 5045 (24 hours)

Steve Brown, +44 207 304 5033 (24 hours)

Chris Sampson, +44 207 304 5130 (24 hours)

 

Investor Enquiries:

Jonathan Hunt, +44 207 304 5087

Ed Seage, +1 302 886 4065

Karl Hard, +44 207 304 5322

Jorgen Winroth, +1 212 579 0506

Mina Blair, +44 20 7304 5084

Peter Vozzo, (MedImmune) +1 301 398 4358

 

Source: AstraZeneca Press Release



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Roche Reports a 25% Increase in Profit for 2007 at $10.48 Billion

 

---2007 Sales at $42.22 Billion; Beating its Rival Novartis for the First Time with Sales of $39.83 Billion---

 

---Earnings per share grow twice as fast as sales – Double-digit sales growth for seventh year in succession – Sharp 35% dividend increase proposed---

 

Annual Report 2007

 

Roche Group

Group sales grow 10% to 46.1 billion Swiss francs.

Operating profit up by 22% to 14.5 billion Swiss francs.

Increase in net income of 25% in francs to 11.4 billion Swiss francs.

Increase in Core EPS1 of 20% in francs to 11.85 Swiss francs.

Increase in proposed dividend of 35% from 3.40 to 4.60 Swiss francs, representing the 21st consecutive year of dividend growth.

 

Pharma

Division posts double-digit sales growth of 11% (13% excl. Tamiflu pandemic sales) to 36.8 billion Swiss francs, again significantly outpacing global markets.

Operating profit up by 22% to 13.0 billion Swiss francs and operating profit margin up by 3.8 percentage points to 35.5%.

Additional indications and introductions strengthen leadership position in oncology.

Mircera launched in Europe for treatment of renal anemia.

Actemra filed in US and EU for rheumatoid arthritis.

Substantially higher R&D expenses of 7.6 billion Swiss francs reflect strong pipeline and large number of late-stage clinical trials.

New agreements with Transgene (therapeutic vaccines), Toyama (rheumatoid arthritis) and Alnylam (RNAi).

 

Diagnostics

Division maintains global market leadership as sales rise 6% to 9.3 billion Swiss francs.

Operating profit increases to 1.6 billion Swiss francs and operating profit margin up 1.3 percentage points to 17.6%.

Acquisitions of 454 Life Sciences, BioVeris Corporation and NimbleGen Systems, Inc. completed.

Merger agreement signed with Ventana Medical Systems, Inc. (US).

 

Outlook

High single-digit sales increase for the Group2.

Sales increase of both Divisions2 above market growth.

Core Earnings per Share3 target at least at record 2007 level despite significant increase in R&D investment and considerably lower Tamiflu pandemic sales.

Continued increase in dividend payout ratio over next three years.

 

Barring unforeseen events

Unless otherwise stated, all growth rates are in local currencies.

1) Core EPS (Earnings per Share)

2) Excluding Tamiflu pandemic sales

3) Core Earnings per Share target is based on constant exchange rates

 

 

Franz B. Humer, Roche Chairman and CEO, on the annual results: “In 2007 our operating businesses continued to post healthy growth and excellent results. Sales increased by 10% to 46 billion Swiss francs and have thus shown double-digit growth for the seventh year in succession. In the Pharmaceuticals Division, sales increased at almost twice the global market growth rate. The Diagnostics Division maintained its lead in in-vitro diagnostics with above-market growth. Additional operating improvements have enabled Roche to achieve an increase in earnings per share double that in sales. We are also strongly positioned for the future: our steady focus on innovation, our global pharmaceutical research network, our strengths in biotechnology, our leadership in diagnostics, our strong product pipeline and the integration of pharmaceuticals and diagnostics are important short- and long-term competitive advantages.”

 

 

Roche Group

Roche Group
Marked sales increase – entirely through organic growth

Key figures

In millions of
CHF

In millions of   
CHF

% change 

% change 

as % of sales

as % of sales

 

2007

2006

in CHF

in local cur.

2007

2006

Sales

46,133

42,041

+10

+10

100.0

100.0

Research and development

8,385

7,365

+14

+16

18.2

17.5

Operating profit before exceptional items

14,468

11,730

+23

+22

31.4

27.9

Net income

11,437

9,171

+25

 

24.8

21.8

 

 

2007  

2006                    

% Change                    

Equity ratio (in %)

68.2

62.9

 

Core earnings per share (in CHF)

11.85

9.86

+20

Dividend per share* (in CHF)

4.60

3.40

+35

Number of emploees (at 31. Dec.)    

78,604

74,372

+6


* Proposed by the Board of Directors

The Roche Group posted record results in 2007. Group sales were up significantly, advancing 10% in local currencies (10% in Swiss francs; 15% in US dollars) to 46.1 billion Swiss francs. This 4.1 billion Swiss franc rise in full-year sales was all organic growth. The Pharmaceuticals Division’s sales increased 11% in local currencies (10% in Swiss francs; 15% in US dollars) to 36.8 billion Swiss francs; this was approximately twice the global market growth rate. Demand remained very strong for the cancer medicines Avastin, Herceptin, MabThera/Rituxan, Tarceva and Xeloda. Combined sales of the division’s oncology products were up 20% for the year, reinforcing Roche’s market leadership in this therapeutic area. Other pharmaceuticals driving growth included Bonviva/Boniva for osteoporosis, CellCept in transplantation, Pegasys in virology and the ophthalmology medicine Lucentis. The Diagnostics Division strengthened its market leadership with sales totalling 9.3 billion Swiss francs, a 6% increase in local currencies (7% in Swiss francs; 12% in US dollars) over 2006. Professional Diagnostics and Applied Science were the business areas posting the strongest growth.

Operating profit margin over 30% for first time
The higher Group sales had a very positive impact on earnings performance. The Group’s operating profit increased 22% in local currencies to 14.5 billion Swiss francs. The operating profit margin grew 3.5 percentage points to 31.4%. In the Pharmaceuticals Division, operating profit rose 22% in local currencies to 13.0 billion Swiss francs, with the corresponding margin showing a 3.8 percentage point increase to 35.5%. This margin growth was achieved while the Group continued to significantly increase investments in its strong development pipeline. This is reflected in the Pharmaceuticals Division’s higher research and development expenses, which grew 18% in local currencies to 7.6 billion Swiss francs. The Diagnostics Division’s operating profit rose 14% in local currencies to 1.6 billion Swiss francs, and its operating profit margin improved 1.3 percentage points to 17.6%.

Strong earnings growth – high equity ratio
Net financial income totalled 834 million Swiss francs, compared with 855 million Swiss francs in 2006. The Group’s effective tax rate declined to 25.3% from 27.3%.
Net income increased 25% to 11.4 billion Swiss francs. Core Earnings per Share (Core EPS), which excludes amortisation and impairment of intangible assets, increased by 20% to 11.85 Swiss francs.
The Group’s business operations continued to show strong cash generation of 18.5 billion Swiss francs, driven by continued growth in EBITDA. Net cash increased by more than one billion to 17.3 billion Swiss francs.
There was a further significant improvement in the Group’s financial position. The ratio of equity to total assets reached 68% (up from 63% in 2006), and over 80% of total assets are now financed long-term.

Outlook
For 2008 the Group expects sales in local currencies to increase at a high single-digit rate, with above-market sales growth in both divisions. This excludes government and corporate stockpiling orders of Tamiflu for pandemic use. As most of the existing pandemic stockpiling orders have now been filled, Roche anticipates a significant decrease in Tamiflu sales in 2008.
The progress in Roche’s rich clinical development pipeline is especially important to our future growth outlook. Accordingly, the Group plans to increase research and development spending again significantly in 2008 in order to realise the full potential of Roche’s strong development portfolio. The activities this will support include late-stage clinical testing of promising compounds such as pertuzumab (breast cancer), ocrelizumab (autoimmune disorders), GLP-1 analogue (type 2 diabetes) and the CETP inhibitor (dyslipidemia), and several programmes aimed at expanding the use of Roche’s leading anticancer medicines into additional indications.
The Group anticipates continued strong growth in 2009 and 2010, driven by the launch of Actemra, Mircera and additional new indications for MabThera in rheumatoid arthritis, Avastin and other cancer medicines. Very importantly, Roche also anticipates pivotal clinical trial data on the use of Avastin in early-stage cancer (adjuvant therapy) by 2010.
Despite anticipated considerably lower Tamiflu sales and significantly higher R&D spending Roche is aiming for 2008 Core EPS at constant exchange rates to remain at least in line with the record level achieved in 2007. Roche expects and intends to continue raising its dividend payout ratio over the next three years.

21st dividend increase in a row
In view of Roche’s excellent full-year results, the Board of Directors will propose that the dividend for 2007 be increased by 35% to 4.60 Swiss francs per share and non-voting equity security (up from 3.40 Swiss francs for 2006). Subject to approval at the next Annual General Meeting of Shareholders, this will be Roche’s 21st consecutive annual dividend increase.


Pharmaceuticals Division
Sales increase again significantly outpacing global market growth rate

Key figures

in millions of CHF

% change in CHF

% change in local currencies

as % of sales

 

 

 

 

 

Sales

36,783

+10

+11

100

- Roche Pharmaceuticals

22,970

+11

+9

63

- Genentech

10,414

+14

+19

28

- Chugai

3,399

-3

+3

9

EBITDA

14,706

+21

+20

40.0

Operating profit before exceptional items

13,042

+24

+22

35.5

Research and development    

7,598

+15

+18

20.6

 

The Pharmaceuticals Division continued its strong, above-market performance in 2007. Sales for the full year rose 11% in local currencies and 10% in Swiss francs (15% in US dollars) to 36.8 billion Swiss francs, around twice the global market growth rate (6%)1. Excluding pandemic stockpiling sales of Tamiflu to governments and corporations, pharmaceutical sales grew 13%2 for the year. Regional sales growth significantly outpaced the market average in North America (15% vs 5%) and Europe (10% vs 7%). In Japan, at 3%, sales development was slightly below market growth. The major growth drivers were key products in the oncology, transplantation, metabolism/bone and virology franchises, as well as Genentech’s ophthalmology medicine Lucentis. The division’s operating profit advanced 22% in local currencies to 13.0 billion Swiss francs, and the operating margin 3.8 percentage points to 35.5%. Sales growth and higher royalty and other operating income more than compensated for – in particular – substantially higher research and development expenses, with significant investments in our strong pipeline reflecting the expanded portfolio and large number of late-stage clinical trials. EBITDA3 totalled 14.7 billion francs or 40.0% of sales, compared with 36.5% in 2006.

Oncology – five life-prolonging drugs
Sales of the division’s oncology portfolio4 grew 20% in 2007 and now account for 50% of pharmaceutical sales. Excluding supportive care products, combined sales of cancer therapeutics rose 23%, increasing the Roche Group’s share of the global market for cancer medicines to just under 30%.

MabThera/Rituxan (rituximab), for the treatment of patients with non-Hodgkin’s lymphoma (NHL), maintained strong sales growth throughout 2007. Increases were driven by the use of MabThera for maintenance treatment in follicular lymphoma, the most common form of indolent lymphoma, as well as first-line treatment for indolent forms of the disease in all markets, particularly in Europe/Rest of World (RoW)5. This growth was supported by strong uptake of first-line treatment of patients with aggressive NHL in emerging markets. In January 2008 the European Commission approved an application filed by Roche last July to extend the product’s existing first-line indolent lymphoma indication to include the use of MabThera with any chemotherapy combination. The expanded indication makes treatment with MabThera available to a wider group of patients across Europe.

Sales of Herceptin (trastuzumab), which is designed to treat a particularly aggressive form of tumour (HER2-positive) that accounts for 20-30% of all breast cancers, continued to deliver strong growth throughout the year. This performance was primarily driven by growth in the adjuvant (early-stage) breast cancer segment in Germany, France, Italy, Spain and the United Kingdom, the top five European markets. Due to earlier, rapid adoption of Herceptin for adjuvant treatment, the product’s market penetration in the United States stabilised at a high level during 2007. In the metastatic setting, adoption rates and treatment duration remained stable both in the US and in the top five European markets. New data from the NeOAdjuvant Herceptin (NOAH) study released in June show that treatment with Herceptin to reduce tumour size before surgery helps eradicate HER2-positive tumours and may reduce the need for breast removal. These results add to the substantial evidence supporting Herceptin as the foundation of care for women with HER2-positive breast cancer at all stages of the disease. In May Roche gained EU approval for the use of Herceptin in combination with hormonal therapy (aromatase inhibitor) for the treatment of patients with metastatic breast cancer that is both HER2-positive and hormone receptor-positive.

Avastin (bevacizumab), the first antiangiogenic therapy to demonstrate overall and/or progression-free survival benefits in patients with colorectal, lung, breast and kidney cancer, continued to record strong sales growth in all regions. Sales growth in the United States was driven primarily by increased use in advanced non-small cell lung cancer (NSCLC). In Europe sales growth was boosted by further uptake of the product in the metastatic colorectal cancer setting. In March the European authorities approved Avastin for the treatment of metastatic breast cancer in combination with chemotherapy (paclitaxel). The approval is based on clinical trial data showing that patients have the chance to live twice as long without their cancer progressing if treated with Avastin plus paclitaxel, compared with paclitaxel alone. Avastin was approved in April in Japan for advanced or recurrent colorectal cancer and in August in Europe, in combination with platinum-based chemotherapy, for the treatment of advanced NSCLC. Avastin is the first medicine to prolong the life of NSCLC patients beyond one year. In December the EU authorities approved Avastin in combination with interferon for the treatment of advanced renal cell carcinoma, the most common form of kidney cancer. In January the European Commission approved expanding the product’s existing marketing authorisation in advanced colorectal cancer to allow Avastin to be combined with any chemotherapy in any line of therapy. The broader marketing approval means that virtually all patients with metastatic colorectal cancer now have access to Avastin’s proven survival benefits. In August Genentech resubmitted its supplemental marketing application to the US Food and Drug Administration (FDA) for use of Avastin in combination with paclitaxel as first-line treatment of patients with locally recurrent or metastatic breast cancer. In December the agency’s Oncologic Drugs Advisory Committee voted five to four that the data are not sufficient to establish a favourable risk/benefit analysis for Avastin in this setting. Genentech will continue to work with the FDA to make Avastin available for US breast cancer patients. The FDA is expected to make a decision on the application by 23 February 2008.

Xeloda (capecitabine), an oral anticancer medicine that greatly simplifies treatment, recorded double-digit sales growth in 2007, with the main contributions coming from the US (+19%) and Europe/RoW (+19%). Sales were boosted by EU approval of Xeloda for the treatment of advanced gastric (stomach) cancer and by positive data on its use in colorectal cancer. In December the CHMP recommended approval of an application filed by Roche in April to broaden the product’s EU marketing authorisation to allow Xeloda to be used in any therapeutic combination in any line of metastatic (advanced) colorectal cancer treatment, including combinations with Avastin. The FDA is currently reviewing Roche’s application for US approval of Xeloda in combination with oxaliplatin, with or without Avastin, for first-line treatment and in combination with oxaliplatin for second-line treatment of metastatic colorectal cancer. In December Chugai received approval in Japan for Xeloda as therapy for adjuvant (post-surgery) colon cancer. Five-year follow-up data from the X-ACT trial presented at the European Cancer Conference (ECCO) in September show that patients with advanced colon cancer whose disease has progressed live longer when taking Xeloda compared with intravenous 5-fluorouracil plus folinic acid, the current standard treatment. In addition, data from a major trial in breast cancer published in December show that Xeloda in combination with Herceptin and docetaxel extended survival in HER2-positive patients by a further five months.

Tarceva (erlotinib), a targeted drug with proven survival benefit in advanced non-small cell lung cancer (NSCLC) and advanced pancreatic cancer, grew strongly over the previous year, mainly thanks to increased uptake in NSCLC and launches in additional countries. Tarceva was launched in China early in 2007, and in December Chugai launched the product in Japan for the second- and third-line treatment of NSCLC. Tarceva is now approved in 87 countries worldwide for the second- and third-line treatment of patients with advanced NSCLC. The EU launch in pancreatic cancer also contributed to Tarceva’s strong performance. Tarceva is currently approved in more than 60 countries for patients with this difficult to treat disease, with further approvals anticipated in 2008.

Anemia – promising Mircera launch
Combined sales of the erythropoietin-stimulating agents (ESAs) NeoRecormon and Epogin (epoetin beta) from Roche and Chugai, respectively, declined in a market that remains highly competitive due to pricing pressure from branded competitors and the entry of biosimilar versions of epoetin alfa in Europe. While the decline in NeoRecormon sales was slight, sales of Epogin in Japan were affected by competitive pricing pressures and, in the first quarter, the residual impact of government-mandated price cuts and reimbursement changes.

Following EU marketing approval in July, Mircera (methoxy polyethylene glycol-epoetin beta), Roche’s innovative continuous erythropoietin receptor activator for the treatment of anemia associated with chronic kidney disease (CKD), has now been launched in Germany, the United Kingdom, Ireland, Sweden, Austria, Slovenia and Hungary, as well as Norway and Switzerland. Initial sales have been in line with expectations. In November, the FDA approved Mircera for the same indication, and further applications for marketing approval are pending worldwide. Mircera allows stable hemoglobin levels with once-monthly dosing during maintenance treatment. It enables correction of anemia with twice-monthly dosing and direct conversion from dosing schedules of up to three times a week with other ESAs to once-monthly dosing in all CKD patients.

In October a US District Court in Massachusetts found in favour of Amgen in a patent infringement lawsuit brought by Amgen relating to Mircera. Roche is currently evaluating its legal options, including the possibility of an appeal.

Transplantation – leading position maintained
CellCept (mycophenolate mofetil) is the world’s most widely used immunosuppressant medication. Revenue growth in 2007 was driven by solid sales in both the US and Europe, based on physicians’ recognition of the long-term protective benefits of CellCept compared with other, more toxic therapies.

Virology – Tamiflu pandemic stockpiling orders completed
Sales of the anti-influenza medicine Tamiflu (oseltamivir) declined sharply in the second half of 2007 due to the completion of most of the existing pandemic stockpiling orders from governments and corporations. Guidelines issued by the WHO in 2007 have reinforced the position of Tamiflu as the treatment of choice for avian influenza. Seasonal sales of Tamiflu in Japan were negatively affected by restrictions imposed by the authorities on the use of the medicine in adolescents. This was compensated, however, by a substantial increase in pandemic sales to the Japanese government. The global manufacturing network put in place by Roche can produce 400 million treatment courses of Tamiflu annually, if required. Production levels have been tailored to current demand but can be increased should the need arise. In July and September respectively, Roche received marketing approvals in US and Europe for a smaller, lower-strength capsule formulation of Tamiflu intended primarily for use in children.

Throughout 2007, sales of Pegasys (peginterferon alfa-2a), for the treatment of hepatitis B and C remained strong despite an overall decline in market volume in the US and Western Europe. Growth was particularly strong in emerging markets such as China and Turkey. Copegus (ribavirin) sales were up 6% compared with 2006, as the launch in Japan more than outweighed declines due to generic competition in the United States and Europe/RoW. There has been a positive market response in Japan to the rollout of combined Pegasys plus Copegus for hepatitis C. Final results from a landmark study in previous non-responders, presented at the annual meeting of the American Association for the Study of Liver Diseases in November, show that Pegasys plus Copegus is a promising treatment option for patients who have failed to respond to treatment with another anti-HCV medicine.

Roche’s HIV medicines Fuzeon (enfuvirtide) and Invirase/Fortovase (saquinavir) recorded steady growth throughout 2007. In October the European Commission reinstated the suspended marketing authorisation for the HIV medication Viracept (nelfinavir) in the European Union. This followed the recall of Viracept earlier in the year in all markets where Roche supplies the product, following the discovery of higher than usual levels of a chemical impurity in some production batches.

Combined sales of Valcyte (valganciclovir) and Cymevene (ganciclovir), the standard of care for the treatment of cytomegalovirus infection in transplant patients and people with HIV/AIDS, again grew strongly in 2007.

Inflammatory and autoimmune diseases – marketing applications for Actemra filed in US and EU
Adoption by physicians of MabThera/Rituxan, the first and only selective B cell therapy for the treatment of rheumatoid arthritis (RA) in patients who have an inadequate response to or cannot tolerate TNF inhibitors, continued to increase throughout 2007. The product has now been launched in the major European markets, North and Latin America, and other markets worldwide. Data published in May show that, in patients whose RA had not responded adequately to TNF inhibitor therapy, treatment with MabThera controlled disease activity more effectively than switching to an alternative TNF inhibitor. In February new data were added to the European prescribing information on the ability of MabThera to significantly slow progression of joint damage in patients with inadequate response or intolerance to TNF inhibitor therapy. In August MabThera was recommended by the National Institute for Clinical Excellence (NICE) in England and Wales, making it the first and only therapy recommended by the Institute for patients with an inadequate response to at least one TNF inhibitor.

Actemra (tocilizumab) is a first-in-class humanised monoclonal antibody designed to block the effects of interleukin-6 (IL-6), a key protein involved in the inflammation that drives RA. In 2007 four phase III trials reported significant clinical benefits for a wide range of RA patients who received Actemra. Based on these results, Roche filed marketing applications for Actemra in RA in the US and the EU in November. The Japanese authorities are reviewing an application filed by Chugai in 2006 for approval of Actemra in adult RA and systemic onset juvenile idiopathic arthritis.

Metabolic disorders – strong growth of Bonviva/Boniva
Bonviva/Boniva (ibandronic acid) is the first and only once-monthly oral bisphosphonate approved for the treatment of postmenopausal osteoporosis. In a highly competitive market, sales of Bonviva/Boniva continued to show strong growth. The majority of sales were in the US, where the product’s market share (total prescriptions) increased to over 15%. Sustained growth was also helped by successful launches of Bonviva once-monthly tablets in France and Spain, additional launches of Bonviva Injection, and new efficacy data showing that the product can reduce the risk of non-vertebral fractures (fractures at sites other than the spine).
Sales of the prescription weight-loss medication Xenical (orlistat 120 mg) declined worldwide, especially in the United States, where Roche’s partner GlaxoSmithKline successfully launched non-prescription orlistat 60 mg under the brand name alli in June. As licensor, Roche receives royalties on sales of alli in the US. GSK has exclusive rights to market non-prescription formulations of orlistat globally, except in Japan.

Research and development – R&D pipeline strengthened further
In 2007 the Pharmaceuticals Division filed 14 major new marketing applications and gained 18 major regulatory approvals. At the beginning of 2008 the Division’s R&D pipeline comprised 115 clinical projects, including 57 new molecular entities (NMEs) and 58 additional indications. Thirty-four NMEs are currently in phase I, 19 in phase II and four in phase III or filed for regulatory review. In 2007 the total number of late-stage projects (NMEs and additional indications) increased from 47 to 50.
Roche Pharmaceuticals currently has 92 projects in preclinical research across five therapeutic areas and 85 development projects in six therapeutic areas, including nine in phase 0 (transition from preclinical to clinical development).
In 2007 ten Roche-managed projects were either terminated or reverted to our R&D partners. Of these, six were in phase I and four in phase II. No phase III projects were discontinued during the year.

Phase III testing of the HER dimerisation inhibitor pertuzumab in patients with HER2-positive metastatic breast cancer is expected to start patient recruitment early in 2008. This follows positive results of a phase II study in patients with pretreated metastatic HER2-positive breast cancer in which pertuzumab showed substantial antitumour activity when used in combination with Herceptin. In the phase III study women who have not previously been treated for metastatic HER2-positive breast cancer will receive Herceptin plus docetaxel or combined Herceptin, docetaxel and pertuzumab. The potential role of pertuzumab in other cancer types is also being investigated.

Ocrelizumab is a humanised anti-CD20 monoclonal antibody being developed by Roche and Genentech for the treatment of autoimmune diseases. Like MabThera/Rituxan, ocrelizumab also targets B cells. As a humanised antibody, it has the potential to be less immunogenic, better tolerated and more convenient to administer. An extensive global phase III clinical development programme was started in 2007, including three phase III trials in rheumatoid arthritis and phase III trials in systemic lupus erythematosus and lupus nephritis. A phase II programme in relapsing-remitting multiple sclerosis will be initiated in the first half of 2008.

Low levels of high-density lipoprotein cholesterol (HDLC), or ‘good’ cholesterol, are associated with an increased risk of cardiovascular disease. R1658 (JTT-705), licensed from Japan Tobacco, is designed to raise levels of HDLC by inhibiting cholesteryl ester transfer protein (CETP) activity. Based on promising phase II data, Roche has decided to move R1658 into phase III clinical trials.

R1583 (BIM 51077, licensed from Ipsen) is a long-acting glucagon-like peptide-1 (GLP-1) analogue being developed for the treatment of type 2 diabetes. The structure of the molecule is similar to that of the natural human hormone GLP-1, with potential for weekly or longer administration intervals. Phase II testing of R1583 was completed in 2007, and the initial data are very encouraging. Roche expects to make a decision on entry into phase III clinical trials in the first half of 2008.

 

Diagnostics Division
Global market leadership maintained

Key figures

in millions of CHF

% change in CHF

% change in
local currencies

as % of sales

Sales

9,350

+7

+6

100

- Professional Diagnostics

4,294

+9

+8

46

- Diabetes Care

3,216

+6

+5

34

- Molecular Diagnostics

1,148

-2

-2

12

- Applied Science

692

+11

+11

8

EBITDA

2,580

+3

+2

27.6

Operating profit before exceptional items

1,648

+16

+14

17.6

Research and development 

787

+2

+1

8.4

 

 

Roche Diagnostics remained the global market leader in 2007 with a market share of approximately 19%. Divisional sales for the year totalled 9.3 billion Swiss francs, an increase of 6% in local currencies (7% in Swiss francs; 12% in US dollars) over 2006.6 The Professional Diagnostics and Diabetes Care businesses posted solid single-digit sales increases. Roche Applied Science’s sales grew at a double-digit rate. As expected, pressure on industrial reagent prices continued to affect Roche Molecular Diagnostics’ sales, which were down 2% for the year. Excluding industrial reagents, this business area posted 3% top-line growth.

All regions contributed to growth, with sales advancing at double-digit rates in Latin America and Asia–Pacific and at single-digit rates in Europe, North America and Japan. Sales in Asia-Pacific grew almost twice as fast as the market.
The acquisitions of 454 Life Sciences, BioVeris Corporation and NimbleGen Systems, Inc., were completed in May, June and August, respectively. In January 2008 Roche signed a definitive merger agreement with Ventana Medical Systems, Inc., of Tucson (Arizona). The acquisition of Ventana will mark Roche’s entry into tissue-based diagnostics and be an important step in the Group’s strategy of delivering personalised healthcare solutions to patients.

Divisional operating profit rose 14% to 1.6 billion Swiss francs, while the operating profit margin increased 1.3 percentage points to 17.6%. The margin improvement was driven by sales growth and was positively impacted by the reversal of royalty accruals relating to BioVeris and the absence in 2007 of the significant impairment charges recorded on intangible assets in 2006. These factors compensated for continued heavy investments in launch activities and significantly reduced industrial reagent sales in 2007. EBITDA7 totalled 2.6 billion Swiss francs, or 27.6% of sales, compared with 28.6% in 2006. This is well above the industry average.

Professional Diagnostics – increased market share
Roche Professional Diagnostics gained market share in 2007 on overall sales growth of 8%. Immunochemistry remained the biggest growth driver, with sales revenues rising 13% for the year; this was the seventh consecutive year of above-market growth in immunochemistry sales. Sales of clinical chemistry products grew 3% in a highly competitive, cost-sensitive market. Roche remains the leading supplier of clinical chemistry and immunochemistry analysers in all markets except the United States.
The increase in immunochemistry sales was fuelled by continued strong demand for assays for the cardiac markers NT-proBNP and troponin T and for a TSH (thyroid-stimulating hormone) assay used to assess thyroid function. A vitamin D assay to diagnose osteoporosis and an assay for monitoring mycophenolic acid (MPA) therapy in heart and kidney transplant recipients were launched in the second half of the year and are expected to contribute to future growth. Monitoring MPA, the active form of Roche’s leading immunosuppreseant CellCept, enables physicians to maintain adequate immunosuppression at critical time points such as when initiating therapy or when reducing other, more toxic anti-rejection drugs.

Demand for the cobas 6000 analyser series for medium-workload laboratories (up to about 500 tests per day) remains very strong and helped drive immunochemistry and clinical chemistry sales. Introduced in 2006, the cobas 6000 was the first of several new modular platforms designed to integrate and improve the efficiency of immunochemistry and clinical chemistry testing in different-sized laboratories. Two new configurations were launched in 2007, increasing the platform’s competitiveness; all seven cobas 6000 configurations will be available by the end of 2008.

The rollout of the cobas 4000 series of benchtop instruments for small- to medium-size laboratories began in early 2007 with the launch of the cobas e 411 immunochemistry analyser. The entire cobas 4000 package, including the cobas c 311 clinical chemistry instrument, will be available in 2008.
In June Roche and Sysmex Corporation of Japan strengthened their long-standing partnership by extending an agreement that gives Roche exclusive distribution rights for Sysmex hematology instruments in some markets in Europe, Latin America, Southern Africa and Oceania. Hematology sales showed strong double-digit growth in all regions covered by the new 10-year agreement. A separate agreement with Sysmex covering urinalysis products was also extended; these products achieved above-market growth in 2007.

Sales of point-of-care diagnostic products rose 7%, helped by the continued trend towards testing outside the laboratory. Coagulation monitoring sales grew 14%, driven by the CoaguChek XS monitor for patient use and the CoaguChek XS Plus monitor for healthcare professionals, both launched in their first markets in 2006. These systems were released in the United States and Japan in the first half of 2007, and uptake in these major additional markets has been strong. Cardiac marker sales accelerated steadily following the launch of the cobas h 232 system in early 2007. This portable cardiac testing device provides highly reliable results in just 15 minutes. Sales of Accu-Chek Inform hospital blood glucose meters and test strips grew significantly, particularly as a result of the increasing adoption of tight glycemic control protocols in US hospitals.

The ambulatory care portfolio was strengthened in November by the launch of Accutrend Plus (cobas h 152), a hand-held instrument capable of measuring cholesterol, triglyceride and glucose levels (important indicators of cardiac risk) and lactate in blood. Roche expects this easy-to-use device to be an additional growth driver in 2008.

Integration of BioVeris Corporation, acquired in June, is proceeding as planned. The transaction, which gives Roche ownership of all patents relating to the electrochemiluminescence (ECL) detection technology used in its Elecsys product line, will enable Roche to expand its fast-growing immunochemistry business into new areas such as life science research, clinical trials and drug development.
In November Roche signed a licensing agreement with Ortho-Clinical Diagnostics, Inc., and Novartis Vaccines & Diagnostics giving Roche access to their broad portfolio of hepatitis C virus (HCV) patents for use in immunodiagnostics. The agreement also includes cross-licensing of patents owned by Roche Diagnostics. Roche is already a leader in nucleic acid testing for HCV, and the agreement will strengthen its position as a supplier of immunoassays for this major cause of liver disease, including chronic hepatitis, cirrhosis and liver cancer.

Diabetes Care – global market leadership maintained
Roche Diabetes Care remained the global market leader in 2007. Its full-year sales increased 5%, slightly below average growth in an increasingly competitive market. Healthcare system changes affecting pricing and reimbursement had a negative impact on sales growth in several major markets.
The Accu-Chek Aviva and Accu-Chek Compact blood glucose monitoring systems both posted sales increases, compensating for declining sales of the older Accu-Chek Advantage. Accu-Chek Aviva sales were up sharply from 2006 as a result of additional launches and continued market penetration. Accu-Chek Active, a compact, robust meter enabling discreet testing anywhere, also sold well, particularly in some EMEA (European, Middle Eastern and African) and South American markets.

Roche’s insulin delivery business posted double-digit growth, led by sales increases in Europe and North America. Consumer uptake of the Accu-Chek Spirit insulin pump in the United States was positive during its first full year on the US market.

Three new products were added to the diabetes care portfolio in 2007. Accu-Chek Performa, a blood glucose meter launched in the first quarter, automatically minimises the effects of temperature and other factors on test integrity. In the fourth quarter a new model of the Accu-Chek Compact meter was introduced in Germany, the United Kingdom and Norway. Among its features and benefits, this all-in-one system has a built-in test strip drum and is self-coding, for greater safety and only half the usual number of test steps. Accu-Chek 360°, last year’s third new product, is a software package that enables people with diabetes and their health professionals to store, track and analyse blood glucose readings, insulin dosages and other health information quickly and conveniently. The rollout of all three products will continue in 2008.

Molecular Diagnostics – further increase in virology product sales
Roche Molecular Diagnostics remained the industry leader in 2007 with a 36% share of a growing but increasingly competitive market. Overall sales decreased 2% as revenues from the industrial reagents business continued to decline. Excluding industrial reagents, sales advanced 3% compared with 2006.
Sales of virology products rose 4% in 2007, with placements of the automated Cobas AmpliPrep/Cobas TaqMan (CAP/CTM) platform continuing to show good growth in Europe and Asia–Pacific. This platform was successfully launched in the US and Japanese markets in the second half of the year. Virology is Roche Molecular Diagnostics’ largest segment by sales.

Automated tests for HIV-1 and hepatitis B and hepatitis C virus (HBV, HCV) were launched for the CAP/CTM platform in Japan, and the HIV-1 test was also introduced during the year in the United States. Uptake of all three tests remains strong in Europe, where they have been available since 2005. By the end of the year 122 supply contracts for the HIV-1 test had been signed with US laboratories, including a three-year contract with LabCorp of America. In 2008 Roche anticipates US approval and commercial launches of the HCV test for the CAP/CTM platform and an HBV test for the Cobas TaqMan 48 system; this will make Roche the first company to market a full suite of automated real-time PCR tests for major viral markers in the United States.

In the second largest segment, blood screening, full-year sales were down 1% in a very competitive market. In October Roche signed a five-year contract, effective from 2008, to supply its fully automated and integrated cobas s 401 instrument and cobas TaqScreen MPX (multiplex) Test to screen the entire Japanese Red Cross blood supply (roughly 5 million blood donations annually). Capable of simultaneously detecting HIV-1 (Groups M & O), HIV-2, HBV and HCV in donated blood and plasma, the cobas TaqScreen MPX Test has already been adopted by more than 50 sites across Europe, which run it on the fully automated modular cobas s 201 blood screening system. In 2008 Roche expects this test to be approved and launched in the United States, where it will also run on the cobas s 201. The cobas s 201 system was introduced in the United States with a test for West Nile virus in the second half of 2007.
The Amplicor and Linear Array tests for detecting and identifying low- and high-risk strains of human papillomavirus (HPV) also contributed to growth. Persistent infection with some strains of HPV is a major cause of cervical cancer.

Applied Science – well ahead of life sciences market growth
Roche Applied Science’s sales increased 11% in 2007, well ahead of the average growth of the life sciences market. Once again the main growth drivers were the LightCycler 480 instrument, the Genome Sequencer systems and research reagents. All of the business area’s main products sold well. Roche Applied Science maintained its share of the genomics systems market while more than doubling its share of the rapidly expanding market for DNA sequencing products. This significant increase was due primarily to the versatile, ultra-fast Genome Sequencer FLX system, launched in the first half of 2007. Gene scanning software and reagents, also launched in 2007, have enhanced the versatility of the LightCycler 480 system, which can now be used to screen DNA samples for previously unknown variations in genes as well as to detect known genetic variants.

The integration of 454 Life Sciences and NimbleGen Systems, Inc., both acquired by Roche in 2007, is proceeding as planned. As a result of these acquisitions, Roche now offers the industry’s most comprehensive, high-throughput workflow solutions for unlocking the secrets of the genome. In November the business area also strengthened its capabilities in cell analysis by signing an exclusive agreement with ACEA Biosciences Inc. to develop, supply and distribute systems based on ACEA’s real-time cell assay technology.

Industrial reagents and substrates, which account for a major part of Roche Applied Science’s sales revenues, remained important contributors to growth in 2007.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at
www.roche.com.


Disclaimer: Cautionary statement regarding forward-looking statements
This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, among others: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for 2006 or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.

1) Market growth figures here and elsewhere according to IMS (to end of October 2007).
2) Unless otherwise stated, all growth rates are in local currencies.
3) Earnings before financial income, financing costs, tax, depreciation and amortisation, including impairment.
4) Oncology portfolio (main products): MabThera/Rituxan, Herceptin, Avastin, Xeloda, Tarceva, NeoRecormon, Kytril, Neutrogin, Neupogen, Bondronat, Roferon-A, Furtulon, Vesanoid.
5) Roche defines Europe/Rest of World as covering Europe and all other countries except Japan and the United Sates.
6) Unless otherwise stated, all growth rates are in local currencies.
7) Earnings before financial income, financing costs, tax, depreciation and amortisation, including impairment.

 

Source: Roche Press Release



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Affymetrix to Acquire USB Corporation for $75 million in Cash

 

 

--USB's Extensive Reagent Platform Will Complement Affymetrix' Current GeneChip(R) Platform and Accelerate the Development of Next-Generation Products --

 

SANTA CLARA, Calif--Affymetrix Inc. announced  that it has entered into a definitive agreement to acquire USB Corporation, a privately held Cleveland, Ohio-based company that develops, manufactures and markets an extensive line of molecular biology and biochemical reagent products. The acquisition will enable Affymetrix to accelerate the development and commercialization of new genetic analysis solutions and increase the value of its current product portfolio.

 

Under the terms of the agreement, Affymetrix will pay approximately $75 million in cash to acquire USB. The transaction is expected to close in the first quarter of 2008, subject to customary closing conditions and regulatory approvals.

 

"The integration of USB's biochemical reagents with Affymetrix' current and future products will greatly accelerate our ability to develop and commercialize more complete customer solutions," said Kevin King, president of Affymetrix. "USB is a recognized leader in the life sciences industry with strong brand equity and established manufacturing capabilities. This acquisition is a strategic fit for Affymetrix' growth strategy and we expect it to be modestly accretive to our 2008 earnings per share, before anticipated charges relating to the transaction."

 

USB is a leading developer, manufacturer and supplier of enzymes, reagents and kits for life sciences research and industrial applications. The company's offerings are grouped into three major product lines consisting of molecular biology enzymes and kits, biochemical reagents and products used in membrane protein research applications. The company history extends back to the 1970s, known then as United States Biochemical. In 1993, United States Biochemical was purchased by Amersham Life Science, a company that later merged with Swedish-owned Pharmacia Biotech in 1997. The current USB Corporation was founded in 1998 after members of the senior management team acquired the three original product lines back from Amersham Pharmacia Biotech.

 

"Affymetrix is a pioneer in the life science research market that continues to set the standard in genetic analysis by successfully commercializing its innovations," said Mike Lachman, CEO and president of USB. "The USB and Affymetrix combination drives higher customer value today and opens the door to new and emerging market opportunities for tomorrow."

 

Affymetrix will discuss the impact of this acquisition during the fourth quarter and fiscal 2007 year-end earnings call, which is scheduled for January 31, 2008 at 2:00 p.m. PT. Affymetrix will provide dial-in information for this call by January 17, 2008.

 

About USB

 USB Corporation has a long-standing reputation as a leader in the life sciences, fueling innovation in basic research, drug discovery and molecular diagnostics. The company's history reaches back to the 1970s, known then as United States Biochemical, a company that specialized in supplying biochemicals to the research market. In the 1980s, a collaboration with scientists (Tabor & Richardson) at Harvard University led to the commercialization of Sequenase(TM) DNA Polymerase and the first easy-to-use DNA sequencing kits. This technology pioneered development of themostable enzymes and automation for high-throughput sequencing.

 

In 1993, United States Biochemical was purchased by Amersham Life Science, a British company that later merged with Swedish-owned Pharmacia Biotech in 1997. At that time, members of the senior management team at USB acquired three of the original main product lines: molecular biology enzymes, biochemicals and manual DNA sequencing reagents. These products formed the basis of the current USB Corporation, founded in 1998. For more information on USB, please visit the company's website at http://www.usbweb.com/.

 

About Affymetrix

Affymetrix GeneChip(R) microarray technology is the industry-standard tool for analyzing complex genetic information. After inventing microarray technology in the late 1980s, Affymetrix scientists have been dedicated to developing innovative products that provide researchers with a more complete view of the genome. These products continue to accelerate genetic research and enable scientists to develop diagnostics and tailor treatments for individual patients by identifying and measuring the genetic information associated with complex diseases.

 

Today, Affymetrix technology is used by the world's top pharmaceutical, diagnostic and biotechnology companies, as well as leading academic, government and not-for-profit research institutes. More than 1,600 systems have been shipped around the world and more than 10,600 peer-reviewed papers have been published using the technology.

 

Affymetrix is headquartered in Santa Clara, Calif., and has manufacturing facilities in Sacramento, Calif., and Singapore. The company has about 1,100 employees worldwide and maintains sales and distribution operations across Europe and Asia. For more information about Affymetrix, please visit the company's website at www.affymetrix.com.

Source: Affymetrix Inc.



Details of Merck Agreement to Resolve U.S. VIOXX® Product Liability Lawsuits

 

Merck’s Settlement Agreement http://www.merck.com/newsroom/vioxx/pdf/Settlement_Agreement.pdf 

 

Timeline of Key Dates for the Settlement Agreement

 

Merck & Co., Inc. announced that it has entered into an agreement with the law firms that comprise the executive committee of the Plaintiffs' Steering Committee of the federal multidistrict VIOXX litigation as well as representatives of plaintiffs' counsel in state coordinated proceedings to resolve state and federal myocardial infarction (MI) and ischemic stroke claims already filed against the Company in the United States.  The agreement, which also applies to tolled claims, was signed by the parties this morning after they met with three of the four judges overseeing the coordination of more than 95 percent of the current claims in the VIOXX litigation.

 

If certain conditions under the agreement are met, the Company will pay a fixed amount of $4.85 billion into a settlement fund for qualifying claims that enter into the resolution process.  This is not a class-action settlement.  Claims will be evaluated on an individual basis.

 

"This is a good and responsible agreement that will allow the Company to concentrate even more fully on its mission of discovering, developing and delivering novel medicines and vaccines," said Richard T. Clark, chairman, president and chief executive officer of Merck.  "The agreement is structured to provide a significant degree of certainty toward resolving the majority of the outstanding VIOXX product liability claims in the United States for a fixed amount."

 

The conditions in the agreement, which is open only to those cases filed or tolled on or before Nov. 8, 2007, include:

 

To qualify, claimants will have to pass three gates: an injury gate requiring objective, medical proof of MI or ischemic stroke (as defined in the agreement), a duration gate based on documented receipt of at least 30 VIOXX pills, and a proximity gate requiring receipt of pills in sufficient number and proximity to the event to support a presumption of ingestion of VIOXX within 14 days before the claimed injury;

 

Individual cases will be examined by administrators of the resolution process to determine qualification based on objective, documented facts provided by claimants, including records sufficient for a scientific evaluation of independent risk factors;

The agreement provides that Merck does not admit causation or fault;

Neither stroke claims that are hemorrhagic in nature nor transient ischemic attacks will qualify;

 

Law firms on the federal and state Plaintiffs' Steering Committees and firms that have tried cases in the coordinated proceedings must recommend enrollment in the program to 100 percent of their clients who allege either MI or ischemic stroke;

 

The parties agree to seek court orders from the four coordination judges requiring plaintiffs' attorneys to promptly register all of their VIOXX claims, whether filed or tolled, and to identify the alleged injury - in order to establish the universe of all existing claims in the United States;

 

Participation conditions: payment obligations under the agreement will be triggered only if, by March 1, 2008 (subject to extension by Merck), plaintiffs enroll in the settlement process: (a) 85 percent or more of all currently pending and tolled MI claims, (b) 85 percent or more of all currently pending and tolled ischemic stroke claims; (c) 85 percent or more of all eligible claims involving a death; and (d) 85 percent or more of all eligible claims alleging more than 12 months of use; and

This agreement applies only to U.S. legal residents and those who allege that their MI or ischemic stroke occurred in the United States.

 

 

Under the agreement, separate funds will be created by the Company in the amount of $4 billion for MI claims and $850 million for ischemic stroke claims.  Once triggered, Merck's total payment for both funds of $4.85 billion is a fixed amount to be allocated among qualifying claimants based on their individual evaluation.  While at this time the exact number of claimants covered by this agreement is unknown, the total dollar amount is fixed.  Payments to individual qualifying claimants could begin as early as August 2008 and then will be paid over a period of time.  Merck retains its right to terminate this process without any payment to any claimant, and to defend each claim individually at trial if any of the participation conditions in the agreement are not met.

 

The Company expects to record a fourth-quarter 2007 pre-tax charge in the amount of $4.85 billion to cover the cost of the agreement.

 

"This agreement is the product of our defense strategy in the United States during the past three years and is consistent with our commitment to defend each claim individually through rigorous scientific scrutiny.  Under the agreement, there will be an orderly, documented and objective process to examine individual claims to determine if they qualify for payment," said Bruce N. Kuhlik, senior vice president and general counsel of Merck. "This agreement also makes sense for the Company because since 2004, we have reserved approximately $1.9 billion for defending VIOXX litigation and, absent this agreement, could anticipate that the litigation might stretch on for years."

 

"Creating a process to look at individual claims is the fairest way to efficiently and quickly provide payment to qualified claimants," said Russ Herman, Liaison Counsel in the federal multidistrict VIOXX litigation and Chair of the Plaintiffs' Negotiating Committee.  "Specific causation has been a very difficult issue.  This is an opportunity to end a long and difficult litigation that has stretched on for more than three years.  A fair resolution is in everybody's best interest.  This agreement would only apply to claims already filed or tolled."

 

"This is the right time for an agreement," said Mr. Kuhlik.  "Recent court rulings confirmed that the window has closed for filing suits in a number of states, consistent with our view that statutes of limitations have expired in almost every state.  Additionally, three of the coordination judges have issued orders that require non-eligible and non-participating plaintiffs to provide documentation of the factual basis for their claims early in the litigation process.  Merck reserves the right under this agreement to terminate our involvement unless the vast majority of eligible claimants elect to participate."

 

Forty-two states, Puerto Rico and the District of Columbia have statutes of limitations of three years or less.  Already, New Jersey Superior Court Judge Carol Higbee and Federal District Court Judge Eldon Fallon have issued orders in cases from New Jersey and eight other jurisdictions ruling that the statutory period for making VIOXX personal injury claims has passed.  Merck voluntarily withdrew VIOXX from the marketplace on Sept. 30, 2004.

 

The discussions between Merck and the plaintiffs were originally requested by Judge Fallon, Judge Higbee, California Superior Court Judge Victoria Chaney, and Texas County Court Judge Randy Wilson.  Judges Fallon, Higbee and Chaney, who met with the parties prior to the agreement being signed, issued case management orders that will require plaintiffs seeking to pursue VIOXX claims outside this resolution process to provide in a timely fashion certified copies of their medical and pharmacy records, as well as expert causation opinions.

 

Merck has submitted a similar order to Judge Wilson.

 

The Company will continue to defend all claims that are not included in the resolution process.

 

Plaintiffs requesting additional information should contact the Chair of the Plaintiffs' Negotiating Committee for further information:

Russ Herman of Herman, Herman, Katz & Cotlar, LLP at (504) 581-4892.

 

Status of Litigation

Juries have now decided in favor of the Company 12 times and in plaintiffs' favor five times.  One Merck verdict was set aside by the court and has not been retried.  Another Merck verdict was set aside and retried, leading to one of the five plaintiff verdicts.  There have been two unresolved mistrials.

 

As of Oct. 9, 2007, in the United States, the Company had been served or was aware that it had been named as a defendant in approximately 26,600 lawsuits, filed on or before Sept. 30, 2007, which include approximately 47,000 plaintiff groups, alleging personal injuries resulting from the use of VIOXX, and in approximately 264 putative class actions alleging personal injuries and/or economic loss.

 

Merck has entered into a tolling agreement with the multidistrict litigation Plaintiffs' Steering Committee that establishes a procedure to halt the running of the statute of limitations for certain categories of claims allegedly arising from the use of VIOXX by non-New Jersey citizens.  The Tolling Agreement requires any tolled claims to be filed in federal court.  As of Sept. 30, 2007, approximately 14,100 claimants had entered into Tolling Agreements.  The parties agreed that April 9, 2007, was the deadline for filing Tolling Agreements and no additional Tolling Agreements are being accepted.

 

The claims of over 5,550 plaintiff groups had been dismissed as of Sept. 30, 2007.  In addition, about 20 cases scheduled for trial were either dismissed or withdrawn from the trial calendar by plaintiffs before a jury could be selected.

 

Source: Merck Press Release 



Affymetrix Files Second Wave of Patent Infringement Lawsuits Against Illumina in United States and Europe

 

--New Filings Target Recently Acquired Solexa(R) Technology and Illumina’s BeadArray(TM) Products--

 

Oct. 24, 2007--Affymetrix Inc. announced that it has filed additional patent infringement lawsuits against Illumina Inc. in the United States District Court for the District of Delaware, in the U.K. High Court of Justice, Chancery Division, Patents Court and in the German Dusseldorf Regional Court, Patent Division. Affymetrix is seeking all available remedies, including injunctive relief.

 

The new suits target technology offered by Solexa(R), the company acquired by Illumina in January 2007, as well as all of Illumina's BeadArray(TM) products. Affymetrix also filed new lawsuits in Germany and the U.K. because the infringing acts extend beyond the U.S. market.

 

The filings include the following patents:

 

 Patent          Patent Title             ILMN Products Covered
 Number
----------------------------------------------------------------------
 
5,902,723    Analysis of Surface       Assays, products, and associated
             Immobilized Polymers      instrumentation under the name
                  Utilizing            BeadArray(TM) technology,
              Microfluorescence        including, but not limited to,
                   Detection           the Infinium(R) II assay.
----------------------------------------------------------------------
6,403,320   Support Bound Probes and Products and associated
             Methods of Analysis     instrumentation under the name
                Using the Same       BeadArray technology, including,
                                     but not limited to, all of
                                     Illumina's Sentrix(R) Array
                                     Matrix and BeadChip arrays, the
                                     BeadArray Reader, and the
                                     detection instrument used to
                                     decode all of Illumina's
                                     BeadArray arrays.
----------------------------------------------------------------------
6,420,169   Apparatus for Forming   Products and associated software
              Polynucleotides or     and instrumentation under the
                 Polypeptides        name Solexa Sequencing
                                     technology, including, but not
                                     limited to, the Genome Analyzer,
                                     Clonal Single Molecule Array
                                     technology, and the 1G Genome
                                     Analysis System.
----------------------------------------------------------------------
6,576,424  Arrays and Methods for   Products and associated
           Detecting Nucleic Acids  instrumentation under the name
                                     BeadArray technology, including,
                                     but not limited to, BeadArray
                                     arrays used with the Infinium(R)
                                     I and II and Direct Hybridization
                                     assays.
----------------------------------------------------------------------
7,056,666    Analysis of Surface    Products and associated software
             Immobilized Polymers    and instrumentation under the
                  Utilizing          name Solexa Sequencing
              Microfluorescence      technology, including, but not
                   Detection         limited to, the Genome Analyzer,
                                     Clonal Single Molecule Array
                                     technology, and the 1G Genome
                                     Analysis System
----------------------------------------------------------------------
 0834575      Identification of     Assays, products, software, and
               Nucleic Acids in      associated instrumentation under
                    Samples          the name BeadArray technology,
                                     including, but not limited to,
                                     all Illumina genotyping and gene
                                     expression assays.
----------------------------------------------------------------------
 0853679   Expression Monitoring by  Assays, products, software, and
            Hybridization to High    associated instrumentation under
            Density Oligonucleotide  the name BeadArray technology,
                    Arrays           including, but not limited to,
                                     all Illumina gene expression
                                     assays.
----------------------------------------------------------------------
 0799897   Kits and Methods for the   Assays, products, software, and
             Detection of Target      associated instrumentation under
            Nucleic Acids with the    the name BeadArray technology,
             Help of Tag Nucleic      including, but not limited to,
                     Acids            all Illumina GoldenGate(R) and
                                        DASL(R) assays and arrays.
----------------------------------------------------------------------

 Affymetrix previously sued Illumina for patent infringement in 2004 in the United States District Court for the District of Delaware. In March 2007, the jury returned a verdict in favor of Affymetrix. The jury found that Illumina's arrays, assays, scanners, software and related products infringed on one or more claims of all five of Affymetrix' (5,535,531, 5,795,716, 6,355,432, 6,399,365, and 6,646,243) patents-in-suit. The jury imposed a royalty of 15 percent, and awarded total damages of more than $16.7 million for the period of 2002-2005. After the final judgment, the Court will calculate the additional damages through the date of the final judgment.

 

The next phase of the trial, which will focus on the validity of Affymetrix' patents, is scheduled to begin on February 11, 2008. The following phase, expected to occur in May or June 2008, will determine whether Illumina's infringement was willful. Affymetrix has also requested injunctive relief in this case, and will ask that the Court take up this request once the patents are found to be valid.

 

Affymetrix has developed one of the industry's strongest patent portfolios, featuring more than 400 patents granted in the U.S. and more than 40 patents granted in Europe. The company continues to license its technology under appropriate circumstances to stimulate the broad commercialization of genome analysis technologies.

 

To view today's filings, please visit: http://investor.affymetrix.com/phoenix.zhtml?c=116408&p=irol-irhome  

 

Affymetrix management will be discussing this litigation during the third quarter operating results conference call at 2:00 p.m. PT on October 24, 2007. The dial-in number for domestic callers will be (866) 500-AFFX and international callers will be (706) 643-2771. To listen to a live webcast of the conference call, please go to the Investor Relations section of the company's website at www.affymetrix.com.

 

A replay of this call will be available from 5:00 p.m. PT on October 24, 2007 until 8:00 p.m. PT on October 31, 2007 at the following numbers: domestic: (800) 642-1687, international: (706) 645-9291. The passcode for both is 19331218. An archived webcast of the conference call will be available under the Investor Relations section of the Company's website at www.affymetrix.com.

 

About Affymetrix

Affymetrix GeneChip(R) microarray technology is the industry-standard tool for analyzing complex genetic information. After inventing microarray technology in the late 1980s, Affymetrix scientists have been dedicated to developing innovative products that provide researchers with a more complete view of the genome. These products continue to accelerate genetic research and enable scientists to develop diagnostics and tailor treatments for individual patients by identifying and measuring the genetic information associated with complex diseases.

 

Today, Affymetrix technology is used by the world's top pharmaceutical, diagnostic and biotechnology companies, as well as leading academic, government and not-for-profit research institutes. More than 1,600 systems have been shipped around the world and more than 10,500 peer-reviewed papers have been published using the technology.

 

Affymetrix is headquartered in Santa Clara, Calif., and has manufacturing facilities in Sacramento, Calif., and Singapore. The company has about 1,100 employees worldwide and maintains sales and distribution operations across Europe and Asia. For more information about Affymetrix, please visit the company's website at www.affymetrix.com.

 

NOTE: Affymetrix, the Affymetrix logo and GeneChip(R) are registered trademarks owned or used by Affymetrix Inc.

 

Source: Affymetrix Press Release

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Bristol-Myers Squibb to Acquire Adnexus Therapeutics

 

--Bristol-Myers Squibb to Advance Biologics Strategy Through Targeted Biologics Acquisition--

 

PRINCETON, N.J. and WALTHAM, Mass., Sept. 24 -- Bristol-Myers Squibb Company and Adnexus™ Therapeutics announced that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire privately held Adnexus Therapeutics, developer of a new therapeutic class of biologics called Adnectins™. The acquisition of Adnexus will help advance Bristol-Myers Squibb's biologics strategy across multiple therapeutic areas and includes a Phase I oncology biologic, Angiocept™. Adnexus Therapeutics will become a subsidiary of Bristol-Myers Squibb and remain based in Waltham, Massachusetts.

 

Under the terms of the agreement Bristol-Myers Squibb will acquire all of Adnexus' issued and outstanding shares of capital stock and stock equivalents in an all-cash transaction for a gross purchase price of $430 million, with the net purchase price being $415 million after deducting Adnexus' net cash balance at closing. In addition, there is an earn-out structure which could result in Bristol-Myers Squibb paying an additional amount of approximately $75 million, in three increments of approximately $25 million each, in the event certain development and regulatory milestones are achieved. The closing of the transaction is subject to customary regulatory approvals.

 

Adnectins are a proprietary class of targeted biologics developed by Adnexus. PROfusion™ is Adnexus' proprietary protein design engine, with which trillions of protein variations can be engineered at one time. Angiocept is an Adnectin designed to be an anti-angiogenic drug and is currently in Phase I development.

 

"Bringing Adnexus into the Bristol-Myers Squibb family builds upon a successful and productive collaboration between the two companies in oncology and is an important step in accelerating the strategic transformation of our pharmaceutical business to a biopharma business model," said Jim Cornelius, chief executive officer, Bristol-Myers Squibb. "Biologics are one cornerstone of our growth strategy. This investment in biologics discovery complements our continued investment in a growing biologics pipeline and portfolio, and will benefit from our expanding biologics manufacturing capabilities, both at our existing site in Syracuse, New York, and our future large-scale bulk biologics facility in Devens, Massachusetts."

 

"Adnectins and the PROfusion technology are among the most exciting next generation biologics platforms currently in development," said Elliott Sigal, M.D., Ph.D., executive vice president and chief scientific officer, Bristol- Myers Squibb. "By uniting Adnexus' innovation and discovery expertise with our internal capabilities in oncology and other therapeutic areas, we intend to fuel the company's biologic growth strategy and importantly, deliver innovative new treatment options for patients."

 

"This is an exciting milestone for our scientists, investors, and company and is a unique opportunity to further accelerate advancement of Adnectin- based medicines and our lead product, Angiocept," said John Mendlein, Ph.D., J.D., CEO of Adnexus. "We are proud to bring the strength of our science, team, and intellectual property to Bristol-Myers Squibb. We have enjoyed a highly productive and collaborative relationship to date, and look forward to helping Bristol-Myers Squibb advance its innovative pipeline."

 

For Adnexus, Lehman Brothers served as the financial advisor, Wilmer Hale provided legal counsel to the company, and Cooley Godward Kronish LLP advised Adnexus investors Atlas Venture, Flagship Ventures, HBM BioVentures, Polaris Venture Partners, and Venrock in connection with this transaction. For Bristol-Myers Squibb, Morgan Stanley acted as financial advisor with Cravath, Swain & Moore LLP serving as legal advisor.

 

About the New Adnectin Product Class and the PROfusion System

Adnectins are an emerging, proprietary protein therapeutic class that can be designed to address a broad range of diseases. They are based on human fibronectin, an extracellular protein that is naturally abundant in human serum. The intrinsic properties of an Adnectin align with the properties needed to make a successful drug, including high potency, specificity, stability, favorable half life, and high yield E. coli production.

Adnectins are designed using PROfusion, Adnexus' patented protein design engine, to achieve high potency and specificity for a therapeutic target while simultaneously selecting for ideal pharmaceutical product characteristics. PROfusion enables Adnexus to screen trillions of unique Adnectins for each drug discovery program to "redirect" naturally occurring human fibronectin to act as a protein therapeutic. This greatly accelerates Adnectin drug discovery and development.

 

Adnexus is the exclusive developer of Adnectins. Adnexus solely owns an Adnectin patent estate containing issued and pending patent properties to fundamental Adnectin forms. Because Adnectins have a different origin than antibodies, they are not bound by traditional antibody patents. In addition, Adnexus exclusively controls its patented PROfusion protein design engine. Adnexus has more than 100 issued and pending patent properties relating to Adnectins and PROfusion.

 

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. For more information, please visit http://www.bms.com/.

 

About Adnexus Therapeutics

Adnexus Therapeutics is focused on generating vital medicines through the discovery, development, and commercialization of its broadly applicable new therapeutic class, Adnectins. Adnexus' lead product candidate, Angiocept (CT-322), is in Phase 1 clinical development in oncology in the United States. The company also has a pipeline of other Adnectin products in preclinical research across multiple therapeutic areas. Adnectins are designed and optimized using PROfusion, the company's patented protein design engine that uniquely enables rapid optimization of protein therapeutics. The company is funded by five leading venture capital firms: Atlas Venture, Flagship Ventures, HBM BioVentures, Polaris Venture Partners, and Venrock. For more information, please visit http://www.adnexustx.com/.

 

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, relating to the acquisition of Adnexus Therapeutics by Bristol-Myers Squibb Company, the discovery, development and commercialization of biologics products, and Bristol-Myers Squibb Company's strategies. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the acquisition described in this release will receive all necessary regulatory approvals, that the acquisition will be completed, or if it is completed, that it will close by the timelines described in this release. If the acquisition is completed, there can be no guarantee that the development and regulatory milestones mentioned in this release will be achieved. Additionally, there can be no assurances that the Adnectin and PROfusion technologies described in this release will ultimately contribute to the growth of Bristol-Myers Squibb Company and its biologics business. There can be no guarantee that the Adnectin and PROfusion technologies will contribute to the discovery, development and commercialization of new biologic products, or if such products are commercialized, that they will be commercially successful. In addition, the Phase 1 oncology biologic described in this release, Angiocept, is subject to all the risks inherent in the drug development process, and there can be no assurance that the development of Angiocept will be successful, that it will ultimately receive regulatory approval, or that if it receives such approvals, that Angiocept will be commercially successful. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2006, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

 

SOURCE: Bristol-Myers Squibb Company

Web site: http://www.bms.com/

http://www.adnexustx.com/

 



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Court Rules That Roche Infringes One of Amgen's Erythropoietin Patents

 

 

---Court Also Rules in Amgen's Favor on Certain Defenses Raised by Roche---

 

----Case Proceeds to Trial on Remaining Issues September 4, 2007---

 

THOUSAND OAKS, Calif., Aug 28, 2007 -- Amgen (NASDAQ:AMGN) announced that the U.S. Federal District Court in Boston granted Amgen's motion for summary judgment and ruled that Roche's pegylated-erythropoietin ("peg-EPO") product will infringe Amgen's EPO pharmaceutical composition patent number 5,955,422. In a separate decision yesterday, the Court also granted summary judgment in favor of Amgen on certain Roche defenses against the patents-in-suit.

 

The case will proceed to trial Sept. 4, 2007 where the court will hear Amgen's claim of infringement for additional patents and also hear other Roche arguments on the validity and enforceability of Amgen's patents. Amgen continues to believe that its patents are valid and enforceable, and that Roche's peg-EPO product will infringe other Amgen patents relating to recombinant erythropoietin and its production.

 

In addition to infringing its EPO patents, Amgen firmly believes Roche's peg-EPO product provides no clinical or patient benefit over Amgen's innovative therapies, EPOGEN(R) (Epoetin alfa) and Aranesp(R) (darbepoetin alfa).

 

 

About Amgen

 

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.



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Merck & Co., Inc. to Acquire NovaCardia, Inc., to Boost Clinical Pipeline of Cardiovascular Drug Candidates

 

---Acquisition Gives Merck Access to KW-3902, an Investigational Phase 3 Compound for Acute Congestive Heart Failure---

 

WHITEHOUSE STATION, N.J. and SAN DIEGO, July 25, 2007 - Merck & Co., Inc., one of the world's leading research-based pharmaceutical companies, and NovaCardia, Inc., a privately held clinical-stage pharmaceutical company focused on cardiovascular diseases, today announced that they have entered into a definitive agreement under which Merck will acquire NovaCardia.

 

Under the agreement, Merck will acquire all of the outstanding equity of NovaCardia for $350 million plus the amount of cash on hand at the time of closing, all of which will be paid in Merck stock based on the average closing stock price on the five days prior to closing of the acquisition.

 

"This acquisition continues to deliver on our strategy of targeted acquisitions in areas of unmet medical need in the therapeutic areas of strategic importance for Merck such as cardiovascular diseases," said Richard Kender, vice president of business development and corporate licensing at Merck.

 

NovaCardia's lead product candidate KW-3902, an adenosine A1 receptor antagonist, is being studied in Phase 3 clinical trials in patients with acute congestive heart failure (CHF).  KW-3902 is believed to block adenosine-mediated constriction of blood flow to the kidneys and inhibit reabsorption of salt and water by the kidney, thereby increasing urine volume and maintaining renal function in patients with CHF.  To date, no other vasodilator has demonstrated the selective renal vasodilation attribute of KW-3902 that helps preserve renal function. As renal function deteriorates in patients with CHF, higher doses of diuretics are required in order to reduce fluid overload.  Multiple studies have demonstrated that renal dysfunction is a strong independent predictor of worse short- and long-term outcomes in patients with CHF.

 

"We are excited to see our lead product become part of the superb scientific environment of Merck," said Randall E. Woods, president and chief executive officer at NovaCardia.  "NovaCardia demonstrated the potential of KW-3902 in clinical trials, and we believe that Merck can expedite the development of this novel agent."

 

"Merck is very excited to have the opportunity to bring forward potential new treatments for patients with heart failure," said Richard C. Pasternak, M.D., vice president of clinical research at Merck Research Laboratories.  "Our acquisition of NovaCardia enhances Merck's considerable internal research efforts committed to the development of new medicines to treat major cardiovascular diseases that are underserved by existing therapies."

 

NovaCardia recently presented preliminary results from a pilot Phase 3 trial of KW-3902 at a late-breaking session of the European Society of Cardiology's Heart Failure Congress 2007 that indicated a strong trend toward efficacy for the 30 milligram dose.  Patients treated with KW-3902 experienced a higher rate of improvement in dyspnea, or shortness of breath, which is a common symptom of CHF, compared to the placebo group, and KW-3902 also enhanced diuresis and mitigated deterioration of renal function that is often experienced by patients undergoing standard treatment.  Two pivotal Phase 3 trials, PROTECT 1 and PROTECT 2, are currently enrolling participants in the United States, Canada, Europe, Israel and Russia.  NovaCardia in-licensed KW-3902 from Kyowa Hakko Kogyo Co., Ltd., in 2003.

 

"NovaCardia's management team has done an exceptional job advancing KW-3902 into Phase 3 clinical trials, demonstrating the compound's potential and building NovaCardia into a successful company," said Eckard Weber, M.D., founder and chairman of NovaCardia and partner at Domain Associates.

 

In addition to Domain Associates, NovaCardia's investors include Forward Ventures, Montreux Equity Partners, Versant Ventures, Skyline Ventures and InterWest Partners.  NovaCardia will spin-out a new corporate entity to support clinical development of the company's second compound, K201 (JTV-519) for atrial fibrillation.

 

"This acquisition gives Merck the possibility to expand its cardiovascular product pipeline into congestive heart failure, an area of important unmet medical need and significant burden to the healthcare system," said Guy Eiferman, general manager of the atherosclerosis and cardiovascular franchise at Merck.

 

The acquisition is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.  The two companies expect to close the acquisition within 45 days.

 

Merck's 2007 full-year financial guidance, provided on July 23, 2007, did not include the anticipated overall financial impact of any charges associated with the NovaCardia acquisition.  Merck will provide an update to the full-year 2007 financial guidance following the closing of the acquisition.

 

About Congestive Heart Failure

CHF is a widespread and debilitating disease most often caused by a weakening or stiffening of the heart muscle, which leads to a progressive loss in the heart's ability to pump blood effectively throughout the body.  There are nearly 5 million people in the United States with CHF, according to the American Heart Association (AHA).  With the aging population and more patients surviving the early stages of cardiovascular diseases, the prevalence of CHF is increasing.  Approximately 550,000 new cases of CHF are reported in the United States each year, according to the AHA.

 

About NovaCardia

NovaCardia, Inc. is a clinical-stage pharmaceutical company focused on developing drugs to treat major cardiovascular diseases that are underserved by existing therapies.

 

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first.  Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs.  The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them.  Merck also publishes unbiased health information as a not-for-profit service.  For more information, visit http://www.merck.com.

 

Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.  Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

 

 

 Source: Merck Press Release



Abbott and Genentech Announce Global, Integrated Research, Development and Commercialization Collaboration in Oncology

 

Abbott Park, Ill. and South San Francisco, Calif. --  June 26, 2007 --  Abbott  and Genentech, Inc. have formed a collaboration for the global research, development and commercialization of two of Abbott's investigational anti-cancer compounds. The companies will work together on all aspects of further development and any commercialization of ABT-263 and ABT-869, which were discovered by Abbott scientists.

 

The companies will co-promote any resulting products in the United States. Abbott will promote any resulting products outside the United States. Financial terms of the collaboration will not be disclosed.

 

These compounds are targeted therapies that represent promising, unique scientific approaches to treating cancer. ABT-263, a Bcl-2 family protein antagonist, restores apoptosis - a natural process by which damaged or unwanted cells die and are cleared from the body - in a variety of cancer cells. ABT-869, a VEGFR-based multi-targeted kinase inhibitor, suppresses tumor growth by preventing the growth of new blood vessels that supply the tumor with oxygen and nutrients and by inhibiting key angiogenic signaling pathways. Both compounds are currently in Phase I clinical trials in a number of tumor types. Phase II clinical trials for ABT-869 in several tumor types will begin this year.

 

Beyond those two compounds, scientists at the two companies will use their expertise to conduct additional follow-on research in the area of Bcl-2 family protein antagonists and VEGFR-targeted (vascular endothelial growth factor receptor) kinase inhibitors.

 

"We hope that the combination of Abbott's scientific discoveries and Genentech's proven experience in the oncology arena can help bring these promising anti-cancer compounds to patients," said John Leonard, M.D., vice president, global research and development, Abbott. "It takes significant resources to discover and develop new medicines. We believe that our collaboration with Genentech, in addition to our pipeline of other cutting-edge scientific approaches to fighting cancer, will allow Abbott to build a world-class oncology franchise."

 

"We are very pleased to be entering into this collaboration with Abbott for the development of therapies that may offer new options to treat patients with cancer," said Hal Barron, M.D., senior vice president, Development and chief medical officer for Genentech. "We believe that these molecules are strong complements to our existing anti-angiogenesis and apoptosis research and development programs and have the potential to broaden our pipeline with important, innovative compounds."

 

Bcl-2 Family Protein Antagonists (ABT-263)

Apoptosis, also known as programmed cell death, is a natural process by which damaged or unwanted cells, including those that are or could become cancerous, die and are cleared from the body. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, in tumor formation, tumor growth and resistance to treatment. Researchers have been interested in the pro-survival members of the Bcl-2 family since their role in preventing apoptosis was established more than a decade ago. Pioneering structural biology work at Abbott showed how Bcl-2-like proteins interact with one another, thereby setting the stage for Abbott researchers to develop novel compounds that cause cancer cells to self-destruct.

 

ABT-263 restores programmed cell death by blocking the function of prosurvival Bcl-2 family proteins. Pre-clinical data have shown that Abbott's Bcl-2 family protein antagonists effectively kill certain cancer cell types. Additionally, Abbott Bcl-2 family antagonists were found to enhance the effects of chemotherapy and radiation in other types of cancer, such as non-small cell lung cancer. ABT-263 recently entered Phase I clinical trials for lymphomas, chronic lymphocytic leukemia (CLL) and solid tumors, including small cell lung cancer.

 

VEGFR-Based Kinase Inhibitors (ABT-869)

Oncology researchers are currently developing agents that target kinases, a class of enzymes that are often overly activated in cancer patients. ABT-869 inhibits a distinct set of kinases that are involved in angiogenesis, a process by which tumors gain access to new blood vessels. Inhibition of these kinases suppresses tumor growth by cutting off tumor blood supply. ABT-869 is currently being tested against several tumor types in Phase I clinical trials. Phase II clinical trials will begin this year.

 

Abbott's Oncology Pipeline

Abbott is committed to the discovery and development of innovative cancer treatments that enable patients to live longer and healthier lives. Abbott's oncology research is focused on developing more targeted, less toxic therapies than are currently available to improve the quality of life for patients living with cancer.

 

Abbott scientists are dedicated to exploring a variety of cutting-edge treatments in the fight against cancer. In addition to Bcl-2 family protein inhibitors and kinase inhibitors, other compounds moving through Abbott's development pipeline include:

 

ABT-751, an oral antimitotic in Phase II studies for non-small cell lung cancer and neuroblastoma ABT-888, a PARP inhibitor that can prevent DNA damage repair in cancer cells, and thereby enhance the effectiveness of current cancer therapies

ABT-828, a biologic anti-tumor agent with a novel mechanism of action. These compounds are not part of the collaboration with Genentech.

 

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.

 

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.

 

Source: Genentech Press Release

 



Novartis Pursues Legal Actions To Defend Intellectual Property Rights For High Blood Pressure Medicine Lotrel Following US Court Ruling

 

May 21, 2007. Novartis has a valid US patent for Lotrel - a single-tablet combination therapy for high blood pressure - until December 2017, will continue to enforce patent rights. US judge extends temporary restraining order until May 29 but allows Teva to sell any Lotrel generics already shipped to distributors and customers

 

Novartis evaluating potential impact of Teva actions on full-year 2007 results.

 

Novartis is pursuing its legal defense after a US federal court judge on Monday extended a temporary restraining order related to a patent infringement lawsuit involving Lotrel® until May 29 and stopped Teva Pharmaceuticals from shipping any further generic copies of this Novartis medicine to distributors and customers until further notice.

 

However, the judge has allowed Teva to sell any generic copies of Lotrel, a single-tablet combination therapy for patients with high blood pressure, that reached distributors and customers before a court order on Saturday to halt sales before Monday's hearing.

 

US District Court Judge Dennis M. Cavanaugh issued the ruling on Monday after the issuance of the temporary restraining order on May 19, a day after Teva received final US Food and Drug Administration (FDA) approval for its generic version and began shipments to customers.

 

Novartis sought the restraining order since it still has a valid US patent for Lotrel that does not expire until December 2017. The US approval does not mitigate Teva's patent infringement in launching a generic version. Novartis will continue to vigorously defend its intellectual property rights, including the validity of the Lotrel patent, against any generic challengers.

 

Also on Monday, the judge prevented Novartis from launching a so-called "authorized generic" version of Lotrel, which is sold only in the US, until the next hearing in this lawsuit on May 29. A hearing on a preliminary injunction sought by Novartis to prevent the launch of Teva's generic version of Lotrel currently remains scheduled for July 11.

 

Novartis filed a patent infringement lawsuit in a US district court in New Jersey against Teva in September 2004 after Teva sought approval from the US Food and Drug Administration to market a generic version of Lotrel. The patent for Lotrel (No. 6162802) covers, among other aspects, a pharmaceutical composition of amlodipine besylate and benazepril hydrochloride. Both of these active ingredients no longer have patent protection in the US.

 

Lotrel is a leading high blood pressure medicine sold only in the US that combines in a single tablet the angiotensin converting enzyme (ACE) inhibitor benazepril hydrochloride and the calcium channel blocker (CCB) amlodipine besylate.

 

Financial update

Novartis is evaluating the potential impact of Teva's actions on the full-year 2007 net sales, operating and net income results. Lotrel, which is sold only in the US, had 2006 annual sales of USD 1.35 billion.

 

Disclaimer

The foregoing release contains forward-looking statements which can be identified by the use of terminology such as "pursuing", "will continue", "evaluating", "potential", "scheduled" or similar expressions, or by express or implied discussions regarding the patent life of Lotrel, the potential for the continued maintenance of the injunction imposed against Teva, the potential for Novartis to succeed in the underlying litigation against Teva, potential future revenue to be earned from Lotrel and the potential impact of Teva's actions on the net sales, operating income and net income results for Novartis. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Novartis will be successful in its efforts to defend its Lotrel patent, or that the court will continue to impose an injunction against the marketing of a generic version of Lotrel by Teva, or that Novartis will ultimately succeed in its litigation against Teva. Neither can there be any guarantees that Lotrel will achieve or maintain any particular sales levels in the future or that the Novartis Group will achieve any particular levels of net sales, operating income or net income results. In particular, management's expectations regarding Lotrel could be affected by, among other things, uncertainties involved in US patent law and the US litigation process; the company's ability to maintain patent or other proprietary intellectual property protection; increased government, industry, and general public pricing pressures; competition in general; unexpected regulatory actions or delays or government regulation generally; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

 

About Novartis

Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

 

# # #

 



Overview of the Pharmaceutical & Biotechnology Industry

 

e-Published March 1st, 2007

by Krishan Maggon Ph.D. and Sunita Maggon Ph. D., Pharmaceutical Biotechnology R&D Advisor, ICC- Route de Pré Bois 20, PO Box 1887,1215 GENEVA 15, Switzerland

 Email: maggonk@yahoo.com

Abstract

A review of the 2006 sales, market, earning and R&D showed several new changes, trends and surprises in the top ten company listing as well as best selling medicinal brands. Pfizer which has been the most valuable company since the past five years was overtaken by Johnson & Johnson in sales and market cap last year. Pfizer retained the top spot in R&D budgets and profits. Glaxo Smith Kline followed by Roche and Novartis were able to register highest sales increase in 2006 over 2005. The blockbuster drug model showed continued growth by increased numbers and accounting for major share of the sales and profits. Lipitor remains the top selling medicinal brand with $12.9 billion in sales followed by Advair and Plavix. Consolidation of the industry continued in 2006 involving generic/OTC, German, Japanese companies and buyout of biotechnology companies by big pharma.

 Several pharmaceutical companies highlighted their R&D in biologic and sales of biologic brands. Roche and Sanofi Aventis ranked 2nd and 3rd by sales of biologics as in 2005. Rituxan with sales of $4.7 billion was the best selling biologic brand followed by Enbrel, Remicade and Darbepoetin. Medicinal brands with highest sales increase in 2006 were mostly biologic and all the brands with highest sales decline due to patent expiry and introduction of generics were synthetic chemicals. Overall increased R&D spending by the pharmaceutical and biotechnology industry failed to increase the number of new drug approved. Roche emerged as the most efficient R&D company based on a new model.  The market and sales data in 2006 provides once again strong support for the R&D paradigm shift to biologic and within biologic towards human monoclonal antibodies.

 

Introduction

Most of the top pharmaceutical and biotechnology companies have reported their 2006 earnings and results within the first two months this year. The listing of their top selling drugs, sales and R&D portfolio and new drug filings and approval is available at company web sites. Some German companies like Bayer-Schering and Boehringer Ingelheim report their annual results in mid March but as these companies are neither listed nor have any brand in the top ten categories, it is possible to pool and reviews reported sales data and generate comparative analysis of results.

Table 1 lists companies’ performance by total sales, net sales increase, sales of biologics, profits and market cap. Pfizer has been the top selling company since 2001 and was overtaken by Johnson & Johnson in 2006 in total sales and market cap, although Pfizer remained the most profitable pharmaceutical company. Glaxo Smith Kline (GSK) retained the 3rd position by total sales, market cap and profitability and topped the list with highest sales increase in 2006. Companies’ reliance on the blockbuster drugs for sales and profit continued despite the end of the blockbuster model announced by big consultancy groups. Roche consolidated its return to the top ten groups by overtaking Novartis in market cap and closing the gap with Amgen in sales of biologics. Roche was in second position after GSK in net sales increase which contributes to increased market cap. Companies with high biologic sales and biotechnology companies were the main contributors to increased net sales in 2006 in comparison to 2005. Roche is likely to overtake Amgen in biologic sales this year to emerge as the top biotechnology company. One of Roche unit, Genentech is the most valued biotechnology company. The big pharmaceutical companies made significant strides in biologic sales and Roche, Sanofi Aventis, Merck-Serono, J&J and Wyeth made the top ten biotechnology company list leaving only 5 pure biotech companies in the top ten.  Teva the world’s top generic company took the 4th position in increased net sales.

Table 1.  Pharmaceutical Biotechnology Industry Performance Rankings 2006 

Sales       $ Billion

 

Net Sales  Increase $ Billion

Biologics Sales

$ Billion

Blockbuster Drug sales %

Profits before taxes $ Billion

Market Cap

$ billion

21 Feb 2007

J&J                 53.3

GSK                    9

Amgen          14.3

Amgen           98

Pfizer             19.3

J&J                190

Pfizer              48

Roche               5.6

Roche            13.5

Lilly                82

J&J                 14.5

Pfizer             189

GSK                43

Novartis            5

Sanofi Aventis

                         8.7

Roche            76

GSK               14.43

GSK               162

Sanofi Aventis

                       37

Sanofi Aventis 

                          4.8

Novo

Nordisk          7.25

Astra  Zeneca

                       71

Sanofi            12.6

Aventis

Roche            161

(Genentech 92)

Novartis       36.8  

Teva                 3.7

J&J                  6.2

GSK               71

Astra            8.54     Zeneca

Novartis        139

Roche          33.6

J&J                   3.3

Baxter              4.4

Novartis        71

Roche            7.34

Sanofi Aventis

                       118

Astra Zeneca

                     26.5

Wyeth             2.4

Allergan         3.5

Merck            61

Novartis        7.20

Merck             96

Merck         22.6 

Novo Nordisk  

                         2.2

Wyeth           3.46

BMS             60.5

Merck            6.22

Astra Zeneca  88

Abbott        22.5

Amgen            1.9 

Genzyme        3.2

Sanofi            59

Aventis

Takeda           5.4

Abbott             81

Wyeth        22.4

Lilly                 1.6

Schering Plough

Merck-Serono   

                       3.2

Schering Plough

                       52

Lilly                3.42

Amgen             78

Annual Sales of Bayer-Schering were not available with estimated biological sales in the $2.5 billion range for 2006. Boehringer Ingelheim annual results were not available

Data compiled from companies annual report, web site, financial and R&D presentations,  financial web sites like yahoo, msn etc.

Table 2 lists the best selling medicinal brands and several new trends emerged. Lipitor the top selling drug for the past 5 years retained its top position with sales of $12.9 billion but failed to make its annual billion dollar sales increase of the past five years. Zocor the second best selling statin drug and in 5th position in 2005 lost its place in the top ten listing in 2006 due to patent expiry and generic competition. The third statin drug Pravastatin/Pravachol in spite of the patent expiry still retained its place at 12th position. Introduction of the generic Clopidrogel in the US market resulted in probably over $1 billion in lost sales of Plavix to Bristol Myers Squibb. As a result Plavix which was the second best selling brand in 2005 traded its position in 2006 with Advair which was in 3rd position in 2005. As in previous years, black box warnings dampened the sales increase for top medicinal brands for schizophrenia and depression. Nexium and Diovan consolidated their leadership position in the proton pump inhibitor ulcer and angiotensin II receptor blocker hypertension markets. At this time comparative global sale and marketing data from IMS and other commercial data bases was not available in the public domain. However as in past years, billion dollar differences in top medicinal brands are expected to persist.

Table 2.  Top Selling Medicinal Brands 2006 NCE/NME

 

Generic Name

Brands

Companies

Indications

Sales $ billion

2005   2006

Atorvastatin

Lipitor

Pfizer

Cholesterol

12.2    12.9

Fluticasone Salmetrol

Advair

Glaxo Smith Kline

Asthma

 5.5     6.13

Clopidrogel

Plavix

Bristol Myers Squibb, Sanofi Aventis

Atherosclerosis

6.2      5.55

Esomaprazole

Nexium

AstraZeneca

Ulcers

4.63     5.2

Amlodipine

Norvasc

Pfizer

Hypertension

4.76     4.8

Rituximab

Rituxan

Roche, Biogen Idec

Leukemia, Lymphoma Rheumatoid Arthritis

3.2       4.7 

Etanercept

Enbrel

Amgen, Wyeth

RA, JRA,  Ps, PsA, AS

3.7        4.4

Glanzapine

Zyprexa

Lilly

Schizophrenia

4.2        4.36

Valsartan

Diovan

Novartis

Hypertension

3.67      4.22

Infliximab

Remicade

J&J, Schering Plough

RA, UC, CD, Ps, PsA, AS

3.5        4.2

 

Darbepoetin

Aranesp

Amgen

Anemia

3.3       4.12

Lansoprazole

Prevacid

Takeda, Abbott

Ulcers

3.8        3.8

Venlafaxine

Effexor

Wyeth

Depression

 3.5       3.7

Montelukast

Singulair

Merck

Asthma

3.0        3.6

Glatiramer

Copaxone

Teva, Sanofi Aventis

Multiple Sclerosis

2.4        3.6

NCE   New Chemical Entity (Pharmaceuticals)

NME New Molecular Entity (Biologics)

Zocor which was 5th in 2005 failed to make the list in 2006.

RA Rheumatoid Arthritis, JRA Juvenile Rheumatoid Arthritis, Ps Psoriasis, PsA Psoriatic arthritis, CD Crohn’s Disease; UC Ulcerative Colitis, AS  Ankylosing Spondylitis.

 

Table 2 includes the top four best selling biologic brands of last year. Anticancer, tumor necrosis factor inhibitors, monoclonal antibodies and vaccines had significant sales growth. The substitution of older erythropoietins by newer ones with improved properties slowed down the growth of the overall market for anemia. The monoclonal antibody Rituxan for cancer and arthritis emerged as the top selling biologic brand followed by TNF inhibitors Enbrel, Remicade and Darbepoetin each with sales above $4 billion. These four top biologics made the combined NCE/NME top 15 list provided in Table 2.

If one considers the top medicinal brands with highest annual sales increase last year, only two NCE Tamiflu and Lipitor made the top ten lists in 5th and 9th position (Table 3). Copaxone although synthetic is a glycopeptide thus mainly a biologic product and emerged as the market leader in the treatment of multiple scelrosis. All other products were biologic and included four monoclonal antibodies as well as improved insulin and erythropoietin.

Table 3. Medicinal Brands with Significant Sales Increase in 2006

 

Generic Name

Brands

Companies

Indications

Sales $ billion

2005   2006     Diff

Trastuzumab

Herceptin

Roche

Breast Cancer

1.65     3.14     1.59

Rituximab

Rituxan

Roche, Biogen Idec

Leukemia, Lymphoma Rheumatoid Arthritis

3.2       4.7       1.5

Glatiramer

Copaxone

Teva, Sanofi Aventis

Multiple Sclerosis

2.4        3.6       1.2

Bevacizumab

Avastin

Genentech, Roche

Colon cancer

1.3        2.4       1.1

Oseltamivir

Tamiflu

Roche

Influenza

 1.2       2.1      0.90

Darbepoetin

Aranesp

Amgen

Anemia

3.3       4.12     0.82

Insulin

Lantus

Sanofi Aventis

Diabetes

1.4        2.2      0.80

Etanercept

Enbrel

Amgen, Wyeth

RA, JRA,  Ps, PsA, AS

3.7        4.4      0.70