Share your Favorite Biotech/Pharma/Medicine/Clinical Trials articles on Your Helix!-Professional Networking Site Designed for Biotech/Pharma Community:

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

-Isis will receive a $175 million license fee for mipomersen-   -Isis is also eligible to receive up to $825 million in development and regulatory milestone payments-   June 24, 2008-Genzyme Corp. and Isis Pharmaceuticals, Inc. today announced the finalization of the license and collaboration agreement for mipomersen. The collaboration provides Genzyme with exclusive worldwide rights to mipomersen, a novel lipid-lowering drug discovered and developed by Isis that is in phase 3 clinical development. During the second half of this year, enrollment is expected to be completed in a pivotal study of mipomersen in homozygous familial hypercholesterolemia, and a new trial in apheresis-eligible patients is expected to begin.   About Mipomersen Mipomersen is a second-generation antisense drug that reduces the production of apoB-100, a protein critical to the synthesis and transport of "bad" cholesterol. Mipomersen is currently in phase 3 development for patients with homozygous familial hypercholesterolemia, a disease which creates a greatly increased risk of premature cardiovascular disease (CVD) and CVD-related death. In phase 2 studies, mipomersen, a weekly injectable therapeutic, was observed to reduce cholesterol and other atherogenic lipids beyond reductions achieved with standard lipid-lowering drugs, enabling more patients to achieve LDL-C targets.   As part of the agreement, Isis will receive a $175 million license fee for mipomersen. In February, Isis received a $150 million payment from Genzyme to purchase 5 million shares of Isis common stock at $30 per share.   The companies have updated the deal terms so that Isis will contribute up to $50 million in additional development funding for mipomersen, bringing Isis' development funding commitment up to $125 million. Thereafter Isis and Genzyme will share development costs equally. The initial Isis development funding commitment and the shared funding will end when the program is profitable. In exchange for this additional contribution, Isis has the opportunity to receive $75 million in milestone payments early.   "Mipomersen is an innovative treatment that has the potential to change the standard of care for severely ill patients whose needs cannot be addressed by current cholesterol-lowering therapies," said Henri A. Termeer, Genzyme's chairman and chief executive officer. "This treatment is an important addition to Genzyme's robust late-stage pipeline. We will manage the clinical development of mipomersen within our current R&D budget and financial guidance."   Over the next 30 days, the companies will transition the mipomersen IND and all regulatory authority to Genzyme. As the sponsor of mipomersen, Genzyme will take the lead on discussions with regulatory agencies and filings. In response to guidance received from the FDA, the companies have modified the initial development plan for mipomersen, subject to further discussions with the agency.   The key changes to the plan include: -The addition of clinical studies of mipomersen in apheresis-eligible patients.   -Consolidation of the planned filings for heterozygous FH patients and other high-risk, high cholesterol patients into a single registration in the U.S.    -Acceleration of the planned outcome study so that it can be used to support the above mentioned consolidated U.S. filing.     “Mipomersen is an important drug that demonstrates the power and precision of antisense drugs. We believe now, as we did in January, that Genzyme is the ideal partner for mipomersen,” said Stanley Crooke, Chairman and Chief Executive Officer of Isis. “We will continue to work with Genzyme on a development plan that is responsive to the FDA and other regulatory agencies, and maximizes the value of the drug. In addition, we look forward to exploring new areas of therapeutic opportunity with Genzyme in CNS and certain rare diseases as part of this alliance.”   Deal Terms As a result of the changes in the development plan and consistent with the premise of the transaction in which the companies are sharing the value of mipomersen, the following changes to the original financial terms of the deal have been made:    Isis will contribute up to the first $125 million in development funding, reflecting an additional contribution of up to $50 million. Thereafter Isis and Genzyme will share development costs equally. The initial Isis development funding commitment and the shared funding will end when the program is profitable. In exchange for this additional contribution, Isis has the opportunity to receive certain milestone payments early.    $75 million of the $150 million milestone associated with the heterozygous FH indication (the portion related to U.S. registration) may be accelerated, to be paid $25 million at annual product revenue of $250 million and $50 million at annual product revenue of $500 million. The $75 million milestone for European approval of the heterozygous FH indication remains the same.   All other financial terms of the transaction remain unchanged. As part of the agreement, Isis will receive a total of $325 million in up-front payments from Genzyme, including the $175 million license fee and the $150 million February 2008 stock purchase.   Isis is eligible to receive up to $750 million in commercial milestone payments, in three increments of $250 million, when annual net revenues meet $3 billion, $4 billion, and $5 billion for two consecutive years.   Isis is also eligible to receive up to $825 million in development and regulatory milestone payments, which are broken out as follows:    Total milestones related to homozygous FH -- $50 million    Total milestones related to heterozygous FH -- $150 million -$75 million for U.S. approval (may be accelerated based on earlier achievement of sales targets) -$75 million for E.U. approval    Total milestones related to approvals of a first Non-FH indication -- $375 million    Total milestones related to approvals of a follow-on product -- $250 million    Total -- $825 million   Isis and Genzyme will allocate responsibility for funding development expenses as described above. Genzyme will be responsible for funding sales and marketing expenses until revenues are sufficient to cover them.   Genzyme and Isis will share mipomersen profits, beginning with a 70/30 Genzyme/Isis split. This split will adjust on a sliding scale, reaching 50/50 when annual revenues reach $2 billion. As part of the strategic relationship, Genzyme will also have preferred access to future Isis drugs for CNS and certain rare diseases.   Mipomersen Development Plan The initial indication sought for mipomersen will be for patients with homozygous FH, and a phase 3 trial in this patient population is ongoing. A U.S. filing for this indication is expected during the second half of 2010. The companies also plan to study mipomersen's use in other very high risk patient groups, including apheresis-eligible patients. Data from a trial in apheresis-eligible patients is expected before the filing for the initial homozygous FH indication.   LDL apheresis is a blood-filtering procedure that targets "bad" cholesterol, and is indicated for individuals for whom diet and maximum drug therapy has either been ineffective or not tolerated. Specific LDL levels defining apheresis eligibility vary by country. Many patients who are eligible, however, choose not to undergo apheresis due to its negative impact on quality of life. The procedure is painful and inconvenient, requiring patients to go to apheresis centers for treatment once every one to two weeks. Apheresis can cost $75,000 to $150,000 per year.   The trial in apheresis-eligible patients is an important addition to the mipomersen development program. Like homozygous FH patients, apheresis-eligible patients are characterized by extremely high LDL levels and are not able to be managed by existing therapies. There are an estimated 10,000 – 15,000 apheresis-eligible patients in the United States and Europe.   Genzyme and Isis expect to begin three additional trials of mipomersen in high-risk patients during the second half of this year. These trials will include: one for heterozygous FH patients, and two for high-risk, high cholesterol patients. These trials will continue to build the body of clinical evidence around mipomersen's value in managing very high risk patients.   Data from these five trials will also inform the design of the morbidity and mortality outcome study for potential expansion of mipomersen's label to include a larger group of at-risk, high cholesterol patients. In addition to the ongoing discussions with the FDA, plans are underway to engage in discussions with regulatory authorities in Europe, where the development path for mipomersen may differ from that in the U.S.   About Genzyme One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation.   With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.     About Isis Pharmaceuticals, Inc. Isis is exploiting its expertise in RNA to discover and develop novel drugs for its product pipeline and for its partners. The Company has successfully commercialized the world's first antisense drug and has 18 drugs in development. Isis’ drug development programs are focused on treating cardiovascular and metabolic diseases. Isis’ partners are developing antisense drugs invented by Isis to treat a wide variety of diseases. Ibis Biosciences, Inc., Isis’ majority-owned subsidiary, is developing and commercializing the Ibis T5000™ Biosensor System, a revolutionary system to identify infectious organisms. Isis is a joint owner of Regulus Therapeutics LLC, a joint venture focused on the discovery, development and commercialization of microRNA therapeutics. As an innovator in RNA-based drug discovery and development, Isis is the owner or exclusive licensee of over 1,500 issued patents worldwide. Additional information about Isis is available at www.isispharm.com.   Source: Genzyme Press Release

Alnylam and Takeda Form Strategic Worldwide Platform Alliance in RNAi Therapeutics

-Alnylam Selects Takeda as its Sole Asian Strategic Partner and Obtains options for 50-50 Development and Commercialization of Takeda RNAi Therapeutic Programs in U.S. Market –   – Takeda Gains Access and Enablement to Alnylam’s Leading RNAi Therapeutics Technology and Intellectual Property in Fields of Oncology and Metabolic Disease –   -Alliance Includes $150 Million in Upfront and Near-Term Technology Transfer Payments, and Additional Future Research & Development and Commercial Milestones-   CAMBRIDGE, Mass., USA and OSAKA, Japan, May 27, 2008 – Alnylam Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited announced that they have formed a strategic platform alliance in RNAi therapeutics in the fields of oncology and metabolic disease with the option to expand to additional therapeutic areas. This landmark alliance is the first major RNAi therapeutics partnership between a Japanese pharmaceutical company and a U.S. biotechnology company, representing a new frontier in the advancement of RNAi therapeutics to patients on a global basis.   RNAi is an entirely new approach for the discovery of breakthrough medicines that utilizes a natural mechanism found within the body to inhibit expression of certain genes. Harnessing the activity of RNAi creates a direct opportunity to develop specific and potent new medicines for the treatment of a broad range of diseases, including those that are difficult to treat with today’s drug approaches. The discovery of RNAi was awarded the 2006 Nobel Prize and the advancement of RNAi is recognized as one of the most important advances in biomedical sciences in decades.   “We are very pleased and honored to have a strategic platform partnership with Takeda, one of the world’s leading pharmaceutical companies. As the first RNAi technology partnership with a pharmaceutical company located in Asia, this new alliance expands the advancement of RNAi therapeutics to patients on a global basis,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “Across multiple dimensions, this new partnership is a major event in Alnylam’s efforts to build a leading biopharmaceutical company. A particularly important element in this new platform alliance is Alnylam’s opportunity to co-develop and co-commercialize Takeda RNAi therapeutic products with Takeda in the U.S. market.”   “We are excited to work with Alnylam, as the leading worldwide company in the field of RNAi therapeutics with a strong commitment to scientific excellence and an unparalleled intellectual property position,” said Yasuchika Hasegawa, President of Takeda. “We believe this alliance will accelerate our initiatives to establish the foundation for RNAi drug discovery supported by Alnylam’s platform technologies and know-how. We expect that our product portfolio will be enhanced by the addition of RNAi therapeutics to our current small molecule and anti-body research platforms.”   This collaboration provides Takeda with broad, worldwide, non-exclusive access to and enablement with Alnylam’s RNAi therapeutics platform technology and intellectual property in the fields of oncology and metabolic disease, with the right to expand the number of therapeutic fields in the future. The agreement also includes the transfer of platform technology from Alnylam to Takeda, a collaboration and cross-license of delivery technologies between the two companies, and a drug discovery collaboration on certain RNAi therapeutic targets, subject to certain Alnylam third party obligations.   Takeda becomes Alnylam’s strategic partner for RNAi therapeutics over a five-year period and the only Asian company to obtain a right of first negotiation to develop and commercialize Alnylam RNAi therapeutic development programs for the Asian market, excluding Alnylam’s ALN-RSV01 program. In addition, Alnylam obtains opt-in options to co-develop and co-commercialize Takeda RNAi therapeutic programs in the U.S. market on a 50-50 basis.   The partnership includes $100 million in upfront payments and $50 million in near-term technology transfer payments for a non-exclusive license in two therapeutic fields and is valued at potentially over $1 billion in future research and development and commercial milestones, upon successful commercialization of multiple products. At Takeda’s option, the scope of the partnership can be expanded to include additional fields with a $50 million per field expansion payment. Alnylam is also eligible to receive research and development funding related to the drug discovery collaboration. In addition, Alnylam is eligible to receive up to $171 million in development and commercial milestone payments and significant royalties per product. Alnylam plans to update financial guidance when it announces its second quarter 2008 financial results.     About RNA Interference (RNAi) RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. RNAi therapeutics target the cause of diseases by potently silencing specific messenger RNAs (mRNAs), thereby preventing disease-causing proteins from being made. RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way.   About Alnylam Pharmaceuticals Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. The company is applying its therapeutic expertise in RNAi to address significant medical needs, many of which cannot effectively be addressed with small molecules or antibodies, the current major classes of drugs. Alnylam is leading the translation of RNAi as a new class of innovative medicines with peer-reviewed research efforts published in the world’s top scientific journals including Nature, Nature Medicine, and Cell. The company is leveraging these capabilities to build a broad pipeline of RNAi therapeutics; its most advanced program is in Phase II human clinical trials for the treatment of respiratory syncytial virus (RSV) infection. In addition, the company is developing RNAi therapeutics for the treatment of a wide range of disease areas, including hypercholesterolemia, liver cancers, and Huntington’s disease. The company’s leadership position in fundamental patents, technology, and know-how relating to RNAi has enabled it to form major alliances with leading companies including Medtronic, Novartis, Biogen Idec, Roche, and Takeda. To reflect its outlook for key scientific, clinical, and business initiatives, Alnylam has established “RNAi 2010” which includes the company’s plan to significantly expand the scope of delivery solutions for RNAi therapeutics, have four or more programs in clinical development, and to form four or more new major business collaborations, all by the end of 2010. Alnylam is a joint owner of Regulus Therapeutics LLC, a joint venture focused on the discovery, development, and commercialization of microRNA therapeutics. Founded in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts. For more information, visit http://www.alnylam.com/   About Takeda Founded in 1781 and located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.   Additional information about Takeda is available through its corporate website, http://www.takeda.com/   Source: Takeda Press Release

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

Bangalore, 2008-Indian Biotechnology major, Biocon  announced that it has reached agreement to acquire a 70% stake in German pharmaceutical company, AxiCorp GmbH for a consideration of €30 Million.  This will enable the marketing and distribution of a range of pharmaceuticals including generics, biosimilars, biologics and innovative pharmaceutical products in Germany and Europe. Allegro Capital were the financial advisors to Biocon on this transaction.   AxiCorp is a specialized marketing and distribution company established in 2002 by a group of industry experts to address the lucrative generics and parallel distribution market in Germany and Europe. AxiCorp is ISO 9001 certified with a differentiated distribution model that is aligned to the radically altered way the German pharmaceutical market now functions.   Kiran Mazumdar-Shaw, Chairman and Managing Director of Biocon said, “AxiCorp is a key strategic investment for Biocon as it heralds our European foray for biosimilars like Recombinant Human Insulin. Biocon is investing in AxiCorp’s very impressive entrepreneurial team and its highly differentiated business model, which will help us build strong marketing and distribution capabilities in Europe. Both companies share a common vision of affordable healthcare which we can deliver through a combination of Biocon’s low cost manufacturing and AxiCorp’s low cost distribution. We are delighted to welcome AxiCorp to the Biocon group of companies as an autonomous subsidiary. We look forward to the continued leadership role played by Holger Gehlhar and Dirk Ullrich in steering AxiCorp to new levels of growth. ”   “The entry of Biocon adds significantly to our competence.” says Holger Gehlhar, Co-founder of AxiCorp. “With EMEA opening the doors to biosimilars, we believe Biocon will add a new dimension to our current product offerings through biosimilars and innovative drugs. Biocon’s manufacturing and drug development capabilities will also enable us to effectively compete for increased market share.”   “The clinical development costs involved in commercializing bio-similars and biologics limit small and mid-sized pharmaceutical companies in Europe to participate in this emerging segment”, explains Dirk Ullrich, who has managed the diabetology business of Sanofi-Aventis before he became General Manager of AxiCorp in 2007. “Biocon will now make it possible for AxiCorp to assert its position in this important therapeutic segment. We are confident that we can take Biocon’s expanding drug pipeline rapidly and efficiently to the market in Germany and elsewhere in Europe.”   With the strategic investment in AxiCorp, Biocon establishes its first presence in Europe in order to market its injectible insulin on its own, and also to build up marketing and distribution capabilities for many other products of its portfolio.   About Biocon Established in 1978, Biocon Limited is recognized as India's premier biotechnology company. Biocon and its two subsidiary companies, Syngene International Ltd and Clinigene International Ltd form a fully integrated biotechnology enterprise, specializing in biopharmaceuticals, custom research and clinical research. With successful initiatives in clinical development, bio-processing and global marketing, Biocon delivers products and solutions to partners and customers across the globe. Many of these products have USFDA and EMEA acceptance. Biocon launched the world's first Pichia derived recombinant human insulin, INSUGEN® in 2004 and India's first indigenously produced monoclonal antibody BIOMAb-EGFR® in 2006. Visit us at www.biocon.com   About AxiCorp Established in 2002, AxiCorp is headquartered in Friedrichsdorf, (near Frankfurt) Germany and markets parallel distributed EU-pharmaceuticals as well as its own generic brand “axcount”. This unique business approach contributes to significant cost savings for German health providers and patients in the patented pharmaceuticals market as well as in the off-patent market. AxiCorp is amongst the fastest growing pharmaceutical companies in Germany, with a turnover of €75 Million in 2007. Today, the company employs about 170 employees and has launched more than 180 products. Please visit our website www.AxiCorp.de for more information.   PR contact: Biocon Limited Paula Sengupta Email: paula.sengupta@biocon.com   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 United States and much of the world. The library of early phase compounds also has wide potential for utility in a range of neurodegenerative and anti-inflammatory disorders, such as Alzheimer’s disease, Parkinson’s disease and arthritis.”   Serenex discovered its small molecule Hsp90 inhibitors using a proprietary high–content screening platform that enabled the company to rapidly and simultaneously optimize libraries of compounds against a multitude of important therapeutic and toxicity targets. This novel technology improved the overall efficiency across the entire spectrum of drug discovery by dramatically improving library screening, mechanism of action determination and toxicity testing, lead optimization and candidate selection.   Hsp90 is an important molecular chaperone protein that regulates the folding and degradation of client proteins involved in cell growth and survival. These signaling proteins play key roles in cancer, inflammatory diseases, and neurodegenerative diseases such as Alzheimer’s. The potential of this exciting drug class in many other therapeutic indications is yet to be fully explored.   “We are pleased that our proprietary screening platform and product pipeline will become part of the superb scientific environment at Pfizer,” said Richard Kent, M.D., president and chief executive officer of Serenex, Inc. “We are confident that Pfizer has the vision and resources necessary to leverage these new assets in its continuing efforts to produce much-needed new medicines.”   Covington & Burling LLP advised Pfizer on this transaction. Lehman Brothers and Cooley Godward Kronish LLP advised Serenex.   More information on both companies, Hsp90 inhibitors and the proprietary technology platform, is available at www.pfizer.com and www.serenex.com.   Source: Pfizer Press Release   Share your Favorite articles on the following Social Networks: Share on Facebook

AstraZeneca Updates on Restructuring of AstraZeneca and Merck’s Joint Venture in the United States   February 28, 2008. AstraZeneca announced that, under the provisions of the agreements relating to the restructuring of the AstraZeneca and Merck & Co. joint venture in the United States, AstraZeneca has been informed that Merck has elected not to exercise the First Option related to the relinquishment of Merck’s rights over the products not covered by the Partial Retirement (see paragraph below), other than Nexium™ and Prilosec™. As a result of this decision, contingent payments will continue on the products Atacand™, Lexxel™, Plendil™ and Entocort™ until at least 2010, at which time AstraZeneca may exercise this option at the 2008 Appraised Value of approximately $650 million. The Appraised Value also includes rights to certain products that are still in clinical development (AZD6140, AZD3355, AZD0328 and AZD2327). AstraZeneca made contingent payments in respect of the products included in the First Option of $69 million in 2007.   Other aspects of the scheduled termination arrangements will proceed as previously disclosed:   The Partial Retirement of Merck’s limited partnership interest, under which Merck’s rights in respect of certain products will end. The products covered by the Partial Retirement include Toprol-XL™, Pulmicort™, Rhinocort™ and Symbicort™. AstraZeneca made contingent payments in respect of these products amounting to $182 million in 2007. AstraZeneca will pay Merck approximately $4.27 billion in respect of the Partial Retirement.   A true-up of the Advance Payment, which was triggered at the time of the merger between Astra and Zeneca, under which Merck relinquished all rights, including contingent payment on future sales, to potential Astra products with no existing or pending US patents at the time of the merger, amounting to a payment by Merck to AstraZeneca of approximately $0.24 billion, inclusive of interest.   Settlement of the loan note receivable by AstraZeneca from Merck, in the amount of $1.4 billion inclusive of accrued interest   The combined effects of these three items will be a net cash outflow from AstraZeneca to Merck of approximately $2.63 billion upon settlement during the first quarter 2008.   Under the provision of the agreements a Second Option exists whereby AstraZeneca has the option to repurchase Merck’s interests in Prilosec™ and Nexium™ in the US. This option is exercisable by AstraZeneca in 2012 should AstraZeneca exercise the First Option in 2010. Exercise of the second option by AstraZeneca at a later date is also provided for in 2017 or if combined sales of the two products fall below a minimum amount provided, in each case, that the First Option has been exercised. The exercise price for the Second Option is the net present value of the future annual contingent payments on Prilosec™ and Nexium™ as determined by the average valuation of two appraisers (one selected by each party) at the time of exercise, which is subject to a potential true-up mechanism under certain conditions. AstraZeneca made contingent payments in respect of US sales for Prilosec™ and Nexium™ amounting to $931 million in 2007.   Further details on the accounting treatment of these events from an AstraZeneca perspective will be provided in conjunction with the Q1 2008 earnings announcement on 24 April, 2008.   About AstraZeneca AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.   For further information:   Media Enquiries: Neil McCrae, +44 207 304 5045 (24 hours) Steve Brown, +44 207 304 5033 (24 hours) Chris Sampson, +44 207 304 5130 (24 hours)   Investor Enquiries: Jonathan Hunt, +44 207 304 5087 Ed Seage, +1 302 886 4065 Karl Hard, +44 207 304 5322 Jorgen Winroth, +1 212 579 0506 Mina Blair, +44 20 7304 5084 Peter Vozzo, (MedImmune) +1 301 398 4358   Source: AstraZeneca Press Release Share your Favorite articles on the following Social Networks: Share on Facebook

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

---2007 Sales at $42.22 Billion; Beating its Rival Novartis for the First Time with Sales of $39.83 Billion---   ---Earnings per share grow twice as fast as sales – Double-digit sales growth for seventh year in succession – Sharp 35% dividend increase proposed---   Annual Report 2007   Roche Group Group sales grow 10% to 46.1 billion Swiss francs. Operating profit up by 22% to 14.5 billion Swiss francs. Increase in net income of 25% in francs to 11.4 billion Swiss francs. Increase in Core EPS1 of 20% in francs to 11.85 Swiss francs. Increase in proposed dividend of 35% from 3.40 to 4.60 Swiss francs, representing the 21st consecutive year of dividend growth.   Pharma Division posts double-digit sales growth of 11% (13% excl. Tamiflu pandemic sales) to 36.8 billion Swiss francs, again significantly outpacing global markets. Operating profit up by 22% to 13.0 billion Swiss francs and operating profit margin up by 3.8 percentage points to 35.5%. Additional indications and introductions strengthen leadership position in oncology. Mircera launched in Europe for treatment of renal anemia. Actemra filed in US and EU for rheumatoid arthritis. Substantially higher R&D expenses of 7.6 billion Swiss francs reflect strong pipeline and large number of late-stage clinical trials. New agreements with Transgene (therapeutic vaccines), Toyama (rheumatoid arthritis) and Alnylam (RNAi).   Diagnostics Division maintains global market leadership as sales rise 6% to 9.3 billion Swiss francs. Operating profit increases to 1.6 billion Swiss francs and operating profit margin up 1.3 percentage points to 17.6%. Acquisitions of 454 Life Sciences, BioVeris Corporation and NimbleGen Systems, Inc. completed. Merger agreement signed with Ventana Medical Systems, Inc. (US).   Outlook High single-digit sales increase for the Group2. Sales increase of both Divisions2 above market growth. Core Earnings per Share3 target at least at record 2007 level despite significant increase in R&D investment and considerably lower Tamiflu pandemic sales. Continued increase in dividend payout ratio over next three years.   Barring unforeseen events Unless otherwise stated, all growth rates are in local currencies. 1) Core EPS (Earnings per Share) 2) Excluding Tamiflu pandemic sales 3) Core Earnings per Share target is based on constant exchange rates     Franz B. Humer, Roche Chairman and CEO, on the annual results: “In 2007 our operating businesses continued to post healthy growth and excellent results. Sales increased by 10% to 46 billion Swiss francs and have thus shown double-digit growth for the seventh year in succession. In the Pharmaceuticals Division, sales increased at almost twice the global market growth rate. The Diagnostics Division maintained its lead in in-vitro diagnostics with above-market growth. Additional operating improvements have enabled Roche to achieve an increase in earnings per share double that in sales. We are also strongly positioned for the future: our steady focus on innovation, our global pharmaceutical research network, our strengths in biotechnology, our leadership in diagnostics, our strong product pipeline and the integration of pharmaceuticals and diagnostics are important short- and long-term competitive advantages.”     Roche Group Roche Group Marked sales increase – entirely through organic growth Key figures In millions of CHF In millions of    CHF % change  % change  as % of sales as % of sales   2007 2006 in CHF in local cur. 2007 2006 Sales 46,133 42,041 +10 +10 100.0 100.0 Research and development 8,385 7,365 +14 +16 18.2 17.5 Operating profit before exceptional items 14,468 11,730 +23 +22 31.4 27.9 Net income 11,437 9,171 +25   24.8 21.8     2007   2006                     % Change                     Equity ratio (in %) 68.2 62.9   Core earnings per share (in CHF) 11.85 9.86 +20 Dividend per share* (in CHF) 4.60 3.40 +35 Number of emploees (at 31. Dec.)     78,604 74,372 +6 * Proposed by the Board of Directors The Roche Group posted record results in 2007. Group sales were up significantly, advancing 10% in local currencies (10% in Swiss francs; 15% in US dollars) to 46.1 billion Swiss francs. This 4.1 billion Swiss franc rise in full-year sales was all organic growth. The Pharmaceuticals Division’s sales increased 11% in local currencies (10% in Swiss francs; 15% in US dollars) to 36.8 billion Swiss francs; this was approximately twice the global market growth rate. Demand remained very strong for the cancer medicines Avastin, Herceptin, MabThera/Rituxan, Tarceva and Xeloda. Combined sales of the division’s oncology products were up 20% for the year, reinforcing Roche’s market leadership in this therapeutic area. Other pharmaceuticals driving growth included Bonviva/Boniva for osteoporosis, CellCept in transplantation, Pegasys in virology and the ophthalmology medicine Lucentis. The Diagnostics Division strengthened its market leadership with sales totalling 9.3 billion Swiss francs, a 6% increase in local currencies (7% in Swiss francs; 12% in US dollars) over 2006. Professional Diagnostics and Applied Science were the business areas posting the strongest growth. Operating profit margin over 30% for first time The higher Group sales had a very positive impact on earnings performance. The Group’s operating profit increased 22% in local currencies to 14.5 billion Swiss francs. The operating profit margin grew 3.5 percentage points to 31.4%. In the Pharmaceuticals Division, operating profit rose 22% in local currencies to 13.0 billion Swiss francs, with the corresponding margin showing a 3.8 percentage point increase to 35.5%. This margin growth was achieved while the Group continued to significantly increase investments in its strong development pipeline. This is reflected in the Pharmaceuticals Division’s higher research and development expenses, which grew 18% in local currencies to 7.6 billion Swiss francs. The Diagnostics Division’s operating profit rose 14% in local currencies to 1.6 billion Swiss francs, and its operating profit margin improved 1.3 percentage points to 17.6%. Strong earnings growth – high equity ratio Net financial income totalled 834 million Swiss francs, compared with 855 million Swiss francs in 2006. The Group’s effective tax rate declined to 25.3% from 27.3%. Net income increased 25% to 11.4 billion Swiss francs. Core Earnings per Share (Core EPS), which excludes amortisation and impairment of intangible assets, increased by 20% to 11.85 Swiss francs. The Group’s business operations continued to show strong cash generation of 18.5 billion Swiss francs, driven by continued growth in EBITDA. Net cash increased by more than one billion to 17.3 billion Swiss francs. There was a further significant improvement in the Group’s financial position. The ratio of equity to total assets reached 68% (up from 63% in 2006), and over 80% of total assets are now financed long-term. Outlook For 2008 the Group expects sales in local currencies to increase at a high single-digit rate, with above-market sales growth in both divisions. This excludes government and corporate stockpiling orders of Tamiflu for pandemic use. As most of the existing pandemic stockpiling orders have now been filled, Roche anticipates a significant decrease in Tamiflu sales in 2008. The progress in Roche’s rich clinical development pipeline is especially important to our future growth outlook. Accordingly, the Group plans to increase research and development spending again significantly in 2008 in order to realise the full potential of Roche’s strong development portfolio. The activities this will support include late-stage clinical testing of promising compounds such as pertuzumab (breast cancer), ocrelizumab (autoimmune disorders), GLP-1 analogue (type 2 diabetes) and the CETP inhibitor (dyslipidemia), and several programmes aimed at expanding the use of Roche’s leading anticancer medicines into additional indications. The Group anticipates continued strong growth in 2009 and 2010, driven by the launch of Actemra, Mircera and additional new indications for MabThera in rheumatoid arthritis, Avastin and other cancer medicines. Very importantly, Roche also anticipates pivotal clinical trial data on the use of Avastin in early-stage cancer (adjuvant therapy) by 2010. Despite anticipated considerably lower Tamiflu sales and significantly higher R&D spending Roche is aiming for 2008 Core EPS at constant exchange rates to remain at least in line with the record level achieved in 2007. Roche expects and intends to continue raising its dividend payout ratio over the next three years. 21st dividend increase in a row In view of Roche’s excellent full-year results, the Board of Directors will propose that the dividend for 2007 be increased by 35% to 4.60 Swiss francs per share and non-voting equity security (up from 3.40 Swiss francs for 2006). Subject to approval at the next Annual General Meeting of Shareholders, this will be Roche’s 21st consecutive annual dividend increase. Pharmaceuticals Division Sales increase again significantly outpacing global market growth rate Key figures in millions of CHF % change in CHF % change in local currencies as % of sales           Sales 36,783 +10 +11 100 - Roche Pharmaceuticals 22,970 +11 +9 63 - Genentech 10,414 +14 +19 28 - Chugai 3,399 -3 +3 9 EBITDA 14,706 +21 +20 40.0 Operating profit before exceptional items 13,042 +24 +22 35.5 Research and development     7,598 +15 +18 20.6   The Pharmaceuticals Division continued its strong, above-market performance in 2007. Sales for the full year rose 11% in local currencies and 10% in Swiss francs (15% in US dollars) to 36.8 billion Swiss francs, around twice the global market growth rate (6%)1. Excluding pandemic stockpiling sales of Tamiflu to governments and corporations, pharmaceutical sales grew 13%2 for the year. Regional sales growth significantly outpaced the market average in North America (15% vs 5%) and Europe (10% vs 7%). In Japan, at 3%, sales development was slightly below market growth. The major growth drivers were key products in the oncology, transplantation, metabolism/bone and virology franchises, as well as Genentech’s ophthalmology medicine Lucentis. The division’s operating profit advanced 22% in local currencies to 13.0 billion Swiss francs, and the operating margin 3.8 percentage points to 35.5%. Sales growth and higher royalty and other operating income more than compensated for – in particular – substantially higher research and development expenses, with significant investments in our strong pipeline reflecting the expanded portfolio and large number of late-stage clinical trials. EBITDA3 totalled 14.7 billion francs or 40.0% of sales, compared with 36.5% in 2006. Oncology – five life-prolonging drugs Sales of the division’s oncology portfolio4 grew 20% in 2007 and now account for 50% of pharmaceutical sales. Excluding supportive care products, combined sales of cancer therapeutics rose 23%, increasing the Roche Group’s share of the global market for cancer medicines to just under 30%. MabThera/Rituxan (rituximab), for the treatment of patients with non-Hodgkin’s lymphoma (NHL), maintained strong sales growth throughout 2007. Increases were driven by the use of MabThera for maintenance treatment in follicular lymphoma, the most common form of indolent lymphoma, as well as first-line treatment for indolent forms of the disease in all markets, particularly in Europe/Rest of World (RoW)5. This growth was supported by strong uptake of first-line treatment of patients with aggressive NHL in emerging markets. In January 2008 the European Commission approved an application filed by Roche last July to extend the product’s existing first-line indolent lymphoma indication to include the use of MabThera with any chemotherapy combination. The expanded indication makes treatment with MabThera available to a wider group of patients across Europe. Sales of Herceptin (trastuzumab), which is designed to treat a particularly aggressive form of tumour (HER2-positive) that accounts for 20-30% of all breast cancers, continued to deliver strong growth throughout the year. This performance was primarily driven by growth in the adjuvant (early-stage) breast cancer segment in Germany, France, Italy, Spain and the United Kingdom, the top five European markets. Due to earlier, rapid adoption of Herceptin for adjuvant treatment, the product’s market penetration in the United States stabilised at a high level during 2007. In the metastatic setting, adoption rates and treatment duration remained stable both in the US and in the top five European markets. New data from the NeOAdjuvant Herceptin (NOAH) study released in June show that treatment with Herceptin to reduce tumour size before surgery helps eradicate HER2-positive tumours and may reduce the need for breast removal. These results add to the substantial evidence supporting Herceptin as the foundation of care for women with HER2-positive breast cancer at all stages of the disease. In May Roche gained EU approval for the use of Herceptin in combination with hormonal therapy (aromatase inhibitor) for the treatment of patients with metastatic breast cancer that is both HER2-positive and hormone recepto