 |
 |
 |
 |
 |
 |
 |
|||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
BUSINESS
|
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 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-- 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 Pfizer will have responsibility for development, regulatory and commercialization outside the 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 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 “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 Bristol-Myers Squibb and ImClone have also been engaged in the co-development of ERBITUX in 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 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 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
- 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 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, The companies have updated the deal terms so that Isis will contribute up to $50 million in additional development funding for mipomersen, bringing "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 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 -Acceleration of the planned outcome study so that it can be used to support the above mentioned consolidated “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: $75 million of the $150 million milestone associated with the heterozygous FH indication (the portion related to All other financial terms of the transaction remain unchanged. As part of the agreement, Total milestones related to homozygous FH -- $50 million Total milestones related to heterozygous FH -- $150 million -$75 million for -$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 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 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 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 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 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. 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 – - 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 “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 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 About Takeda Founded in 1781 and located in 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
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 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 “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 With the strategic investment in AxiCorp, Biocon establishes its first presence in About Biocon Established in 1978, Biocon Limited is recognized as monoclonal antibody BIOMAb-EGFR® in 2006. Visit us at www.biocon.com About AxiCorp Established in 2002, AxiCorp is headquartered in Friedrichsdorf, (near Frankfurt) 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 Share your Favorite Biotech/Pharma/Medicine/Clinical Trials articles on Your Helix!-Professional Networking Site Designed for Biotech/Pharma Community: |
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 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 |
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 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 |
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 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), 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 Key figures In millions of In millions of % 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 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 Diagnostics Division Key figures in millions of CHF % change in CHF % change in 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. Source: Roche Press Release |
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 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 |
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 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 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 "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 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 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. |
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, 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 The filings include the following patents: 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 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 NOTE: Affymetrix, the Affymetrix logo and GeneChip(R) are registered trademarks owned or used by Affymetrix Inc. Source: Affymetrix Press Release |
Bristol-Myers Squibb to Acquire Adnexus Therapeutics
--Bristol-Myers Squibb to Advance Biologics Strategy Through Targeted Biologics Acquisition-- 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 "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 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/ |
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. |
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 "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 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. |
Abbott and Genentech Announce Global, Integrated Research, Development and Commercialization Collaboration in Oncology
The companies will co-promote any resulting products in the 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 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. 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 Also on Monday, the judge prevented Novartis from launching a so-called "authorized generic" version of Lotrel, which is sold only in the Novartis filed a patent infringement lawsuit in a Lotrel is a leading high blood pressure medicine sold only in the 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 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 # # # |
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. 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 Table 2. Top Selling Medicinal Brands 2006 NCE/NME
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
|