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Amgen and Servier announce product collaboration

Posted: 9 July 2013 | | No comments yet

Amgen obtains US rights to novel EU-approved cardiovascular therapy; Servier receives option for omecamtiv mecarbil in Europe…

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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.

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