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A blockbuster of a trade
THOUSAND OAKS, Calif.—U.S. biotechnology giant Amgen and French research- based pharmaceutical company Servier Laboratories have announced a product collaboration agreement that exchanges development and commercialization rights to certain cardiology products in their respective international markets.
The agreement grants Amgen the commercial rights in the United States to Servier's novel oral drug for chronic heart failure and stable angina in patients with elevated heart rates—which has been approved in the European Union as Procoralan (ivabradine). The agreement also gives Amgen the exclusive option to develop and commercialize in the United States Servier's investigational molecule S38844 for cardiovascular diseases, including heart failure. In exchange, Servier obtains the rights to commercialize Amgen's product omecamtiv mecarbil, an activator of cardiac myosin, in Europe.
Servier will receive a one-time, upfront payment from Amgen of $50 million, plus unspecified future milestone and royalty payments for ivabradine.
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. It has been approved in more than 100 countries, but has yet to be approved for use in the United States.
Ivabradine has a unique mechanism of action that is complementary to highly used and effective standard of care therapies, including beta-blockers. In a randomized, placebo-controlled study known as the SHIFT study (Systolic Heart failure treatment with If inhibitor ivabradine Trial) in more than 6,500 patients, ivabradine demonstrated a clinically and statistically significant reduction in the risk of cardiovascular death or hospitalization due to worsening heart failure over the three months following treatment.
"A critical, unmet medical need remains for patients who don't respond adequately to current available therapies for heart failure and angina," says Dr. Sean E. Harper, executive vice president of research and development at Amgen. "Ivabradine … offers a novel alternative approach for patients with elevated heart rates."
"If approved in the U.S., ivabradine will provide an additional therapeutic option for heart failure and chronic angina patients with remaining medical needs," says Ashleigh Koss, a spokesperson for Amgen. "For the 5 to 15 percent of Americans with refractory angina who are not eligible for revascularization, ivabradine offers an additional therapeutic option for medical management."
The company is evaluating the next steps required to bring the product onto the U.S. market as soon possible.
Financial terms surrounding Amgen's option for S38844 and Servier's option for omecamtiv mecarbil were not disclosed. Under the terms of the agreement, both companies can exercise their options for these therapies up to completion of certain Phase II studies.
S38844 is currently in Phase II studies for the treatment of heart failure. S38844 shares a similar mechanism of action to ivabradine, but with once-daily dosing. Other differences between the molecules are being explored in ongoing clinical studies.
Omecamtiv mecarbil, also called AMG 423, is being tested for applications in treating heart failure in patients with systolic dysfunction; the compound activates cardiac muscle contractility and operates to strengthen heart function in these patients. It is being developed in a collaboration between Cytokinetics and Amgen, and is currently in Phase II studies.
"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," says Harper.
"Ivabradine will enable Amgen to expand its new cardiology franchise in the United States, alongside AMG 145 [a monoclonal antibody to reduce LDL cholesterol], and will also complement AMG 423," says Koss.
"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," Servier CEO Dr. Jean-Philippe Seta said in a media statement announcing the collaboration. "This is a clear recognition of the medical value of ivabradine, one of our major cardiovascular innovations, which could also benefit U.S. patients."
Amgen is currently the largest independent biotech company in the world, employing approximately 17,000 people and posting revenues approaching $16 billion in 2011. Its products include Aranesp, Enbrel, Epogen, Kineret and Neulasta. Amgen possesses a robust and diverse pipeline of potential new medicines.
Servier Laboratories is the largest independent French pharmaceutical company, with a 2012 turnover of $4.75 billion and more than 20,000 employees in 140 countries. Current therapeutic areas for Servier include cardiovascular, metabolic, neurological, psychiatric and bone and joint diseases. Servier invests 25 percent of its turnover into research and development.