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Amgen and Servier extend Omecamtiv Mecarbil collaboration in Chronic Heart Failure01/09/2016
Servier Provides Notice to Exercise its Commercialization Option in Europe and Commonwealth of Independent States, Including Russia
THOUSAND OAKS, Calif. and SURESNES, France (Sept. 1, 2016) – 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 clinicaldevelopment for omecamtiv mecarbil.”
Heart failure is a greviouscondition 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.6,7Despite 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.
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.
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.
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CONTACT: Amgen, Thousand Oaks
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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):P9–P16.
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;37:2129–2200.
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 Statistics—2015 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.