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Press release from PR Newswire

Amgen And Servier Announce Product Collaboration

Tuesday, July 09, 2013

Amgen And Servier Announce Product Collaboration

09:00 EDT Tuesday, July 09, 2013

Amgen Obtains US Rights to Novel EU-Approved Cardiovascular Therapy; Servier Receives Option for Omecamtiv Mecarbil in Europe

THOUSAND OAKS, Calif., and SURESNES, France, July 9, 2013 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Servier today announced a new collaboration agreement leveraging each company's commitment to cardiovascular disease.

Under the terms of the agreement, Amgen has obtained commercial rights in the U.S. to Servier's novel oral drug, approved in the EU as Procoralan® (ivabradine), for chronic heart failure and stable angina in patients with elevated heart rates. Amgen has also received an exclusive option to develop and commercialize Servier's investigational molecule, S38844, for cardiovascular diseases in the U.S. Currently, S38844 is in Phase 2 studies for the treatment of heart failure. Through the collaboration, Servier has obtained rights to commercialize omecamtiv mecarbil in Europe. Omecamtiv mecarbil is an activator of cardiac myosin, which is currently being tested for potential applications in the treatment of heart failure in patients with systolic dysfunction.

Both companies can exercise their respective options for the investigational therapies up to completion of certain Phase 2 studies. Under the terms of the agreement, Amgen will make a one-time $50 million upfront payment and future milestone and royalty payments for ivabradine. Financial terms associated with Amgen's option for S38844 and Servier's option for omecamtiv mecarbil were not disclosed.

"Amgen is pleased to enter into this collaboration with Servier to bring potential new cardiovascular treatment options to patients in both the U.S. and Europe," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "A critical unmet medical need remains for patients who don't respond adequately to current available therapies for heart failure and angina. Ivabradine, an If inhibitor, offers a novel alternative approach for patients with elevated heart rates. We value Servier's extensive experience in cardiovascular disease and look forward to working with them as Amgen continues to build our presence in this area."

"Servier is very pleased to establish a collaboration with Amgen, a leading biotechnology company with a unique track record of bringing innovative medicines to patients. This is a clear recognition of the medical value of ivabradine, one of our major cardiovascular innovations, which could also benefit U.S. patients," said Jean-Philippe Seta, M.D., chief executive officer at Servier.

"Ivabradine is a first-in-class innovative drug for the treatment of heart failure and angina. The clinical benefit and safety profile are supported by the results of clinical studies performed or being performed in more than 40,000 patients. I strongly believe that Servier's expertise in heart failure will complement Amgen's efforts in making omecamtiv mecarbil, a very innovative and complementary approach to treating heart failure, available to patients in Europe," said Emmanuel Canet, M.D., Ph.D., head of Research and Development at Servier.

Ivabradine is an If inhibitor approved by the European Medicines Agency in 2005 for the symptomatic treatment of stable angina and in 2012 for chronic heart failure, as well as approved in more than 100 other countries, excluding the U.S. Omecamtiv mecarbil activates cardiac muscle contractility and operates to strengthen heart function in patients with systolic dysfunction. Omecamtiv mecarbil is in Phase 2 studies and is being developed under a collaboration between Cytokinetics and Amgen.

About Amgen Amgen discovers, develops, manufactures 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, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping people around the world in the fight against serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

About Servier Servier is a privately-run French research-based pharmaceutical company. Current therapeutic domains for Servier medicines are cardiovascular, metabolic, neurological, psychiatric and bone and joint diseases, as well as oncology. Servier is established in 140 countries worldwide with over 20,000 employees and a 2012 turnover of ?3.9 billion. Servier invests 25% of its turnover in R&D. More information is available at: http://www.servier.com  

Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on Amgen's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen's business. Unless otherwise noted, Amgen is providing this information as of July 9, 2013, and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen's products after they are on the market. Amgen's business may be impacted by government investigations, litigation and product liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development.

In addition, sales of Amgen's products are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of Amgen's products. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen's products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen's ability to obtain or maintain patent protection for its products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen's stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen's business and results of operations.

The scientific information discussed in this news release related to product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA) or other regulatory authorities, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA or other regulatory authorities can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for products is preliminary and investigative and is not part of the labeling approved by the FDA or other regulatory authorities for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA or other regulatory authority can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the approved labeling for the products, and not the information discussed in this news release.

CONTACT:

Amgen, Thousand Oaks Ashleigh Koss, 805-313-6151 (media) Arvind Sood, 805-447-1060 (investors)

Servier Communication Department + 33 (0)1 55 72 60 37 presse@servier.fr

(Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)

(Logo: http://photos.prnewswire.com/prnh/20130708/LA44084LOGO)

SOURCE Amgen; Servier

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