Amgen And Servier Extend Omecamtiv Mecarbil Collaboration In Chronic Heart Failure

THOUSAND OAKS, Calif. and SURESNES, France, Sept. 1, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Servier today announced an advancement in their cardiovascular collaboration, with Servier's decision to exercise its option to commercialize omecamtiv mecarbil in chronic heart failure in Europe, as well in as the Commonwealth of Independent States, including Russia, which were added to the collaboration. The companies also announced the omecamtiv mecarbil Phase 3 development program will move forward in collaboration with Cytokinetics.

Under the terms of the agreement, Servier will make a $10 million option exercise payment, as well as future milestone and royalty payments, to Amgen. Servier will assume a share of the development costs.

"We are very pleased to strengthen our collaboration with Servier and for the continued advancement of the novel cardiac myosin activator omecamtiv mecarbil," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are working closely with our research collaborators and regulators on the Phase 3 outcomes study for omecamtiv mecarbil and look forward to assessing the potential of this unique therapy to benefit patients with chronic heart failure worldwide."

The decision to advance omecamtiv mecarbil into Phase 3 was based on positive results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating the treatment in patients with chronic heart failure, which were presented as a Late-Breaking Clinical Trial at the American Heart Association (AHA) Scientific Sessions in November 2015.¹ This first chronic dosing trial of omecamtiv mecarbil met its primary pharmacokinetic objective and demonstrated significant improvement in all pre-specified secondary measures of cardiac function in the treatment group employing pharmacokinetic-based dose titration.

"Omecamtiv mecarbil is a very innovative approach to treating chronic heart failure, bringing new hope to patients suffering from this severe condition," said Emmanuel Canet, M.D., Ph.D., executive vice-president of Research and Development at Servier. "We are pleased to collaborate with Amgen in the late stage of its clinical development for omecamtiv mecarbil."

Heart failure is a grevious condition that affects more than 23 million people worldwide,^2,3 about half of whom have reduced left ventricular function.^4,5 It is the leading cause of hospitalization and readmission in people age 65 and older.^6,7 Despite broad use of standard treatments and advances in care, the prognosis for patients with heart failure is poor.⁸ An estimated one in five people over the age of 40 are at risk of developing heart failure, and approximately 50 percent of people diagnosed with heart failure will die within five years of initial hospitalization.^9,10

About Omecamtiv Mecarbil 
Omecamtiv mecarbil is a novel cardiac myosin activator. Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction. Cardiac myosin activators are thought to accelerate the rate-limiting step of the myosin enzymatic cycle and shift the enzymatic cycle in favor of the force-producing state. Preclinical research has shown that cardiac myosin activators increase contractility in the absence of changes in intracellular calcium in cardiac myocytes.^11-13 

Omecamtiv mecarbil is being developed by Amgen in collaboration with Cytokinetics and Servier. Amgen holds an exclusive, worldwide license to omecamtiv mecarbil and related compounds, subject to Cytokinetics' specified development and commercialization rights. Additionally, Servier has exercised an exclusive option for the co-development and exclusive commercialization of omecamtiv mecarbil in Europe, as well as the Commonwealth of Independent States, including Russia.

About Amgen Cardiovascular
Building on more than three decades of experience in developing biotechnology medicines for patients with serious illnesses, Amgen is dedicated to addressing important scientific questions to advance care and improve the lives of patients with cardiovascular disease, the leading cause of morbidity and mortality worldwide.¹⁴ Amgen's research into cardiovascular disease, and potential treatment options, is part of a growing competency at Amgen that utilizes human genetics to identify and validate certain drug targets. Through its own research and development efforts, as well as partnerships, Amgen is building a robust cardiovascular portfolio consisting of several approved and investigational molecules in an effort to address a number of today's important unmet patient needs, such as high cholesterol and heart failure.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit and follow us on www.twitter.com/amgen.

About Servier 
Servier is an international pharmaceutical company governed by a non-profit Foundation and headquartered in France. With a strong international presence in 148 countries and a turnover of 3.9 billion euro in 2015, Servier employs over 21,200 people worldwide. Corporate growth is driven by Servier's constant search for innovation in five areas of excellence: cardiology, oncology, metabolism, neuropsychiatry and rheumatology, as well as by its activities in high quality generic drugs. Being completely independent, the Group reinvests 25% of Servier's products turnover in Research and Development and all its profits in its growth.

Servier has played a critical role in shaping the medical practice in cardiology and hypertension over the past two decades through its engagement in landmark clinical trials. Servier's marketed portfolio in cardiovascular consists of 12 major products, generating a turnover of more than 1.5 billion euro in 2015. Currently, there are 12 new fixed-dose combinations and 10 new molecular entities in research or development phase, mainly targeting heart failure. This portfolio of innovative treatments is being developed with partners worldwide.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. 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 reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

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. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. 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 its products after they are on the market.

Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen's products are affected by pricing pressure, political and public scrutiny and 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. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen or others could identify safety, side effects or manufacturing problems with its products after they are on the market. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between it and the U.S. government, Amgen could become subject to significant sanctions. Further, 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, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key manufacturing facilities and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. 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 its business and results of operations. Amgen's efforts to acquire other companies or products and to integrate the operations of companies Amgen has acquired may not be successful. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. Amgen is increasingly dependent on information technology systems, infrastructure and data security. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock.

The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration or European Commission, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

CONTACT: Amgen, Thousand Oaks 
Kristen Davis, 805-447-3008 (media)  
Kristen Neese, 805-313-8267 (media) 
Arvind Sood, 805-447-1060 (investors)

CONTACT: Servier External Communication
+33 1 5572 6037
presse@servier.fr

REFERENCES

1. Teerlink J, Felker GM et al. Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (COSMIC-HF): Results from a Double-blind, Randomized, Placebo-controlled, Multicenter Study. Circulation Vol 132, No 23, December 8, 2015.
2. Bui AL, Horwich TB, Fonarow GC. Epidemiology and risk profile of heart failure. Nat Rev Cardiol. 2011;8:30-41.
3. McMurray JJ, Petrie MC, Murdoch DR, Davie AP. Clinical epidemiology of heart failure: public and private health burden. Eur Heart J. 1998;19 (Suppl P):P9P16. 
4. Yancy  CW, Jessup  M, Bozkurt  B et al. ACC/AHA/HFSA focused update on new pharmacological therapy for heart failure: an update of the 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol2016:doi:10.1016/j.jacc.22016.05.012.
5. Ponikowski  P, Voors  AA, Anker  SD et al . ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J2016;37:21292200.
6. Centers for Disease Control and Prevention. National Health Statistics Report: 2006 National Hospital Discharge Survey. http://www.cdc.gov/nchs/data/nhsr/nhsr005.pdf. Accessed August 2016.
7. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among Patients in the Medicare Fee-for-Service Program. NEJM. 2009;360:1418-1428.
8. Jhund PS, MacIntyre K, Simpson CR, et al. Long-Term Trends in First Hospitalization for Heart Failure and Subsequent Survival Between 1986 and 2003. Circulation. 2009;119:515-523.
9. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke Statistics2015 Update: A Report From the American Heart Association. Circulation. 2015;131:e1-e294.
10. Rogers VL, Weston SA, Redfield MM, et al. Trends in Heart Failure Incidence and Survival in a Community-Based Population. JAMA. 2004;292:344-350.
11. Malik FI, Hartman JJ, Elias KA, et al. Cardiac myosin activation: a potential therapeutic approach for systolic heart failure. Science. 2011;331(6023):1439-1443.
12. Shen YT, Malik FI, Zhao X, et al. Improvement of Cardiac Function by a Cardiac Myosin Activator in Conscious Dogs With Systolic Heart Failure. Circ Heart Fail. 2010;3(4):522-527.
13. Malik FI, Morgan BP. Cardiac myosin activation part 1: From concept to clinic. J Mol Cell Cardiol. 2011;51:454-461.
14. World Health Organization. Cardiovascular diseases (CVDs) fact sheet. http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed August 2016.

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