Amgen (AMGN) Announces Servier Exercises Option to Commercialize Omecamtiv Mecarbil in Europe

September 1, 2016 8:38 AM EDT

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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



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