THOUSAND OAKS, Calif.—U.S. biotechnology giant Amgen andFrench research-based pharmaceutical company Servier Laboratories haveannounced a product collaboration agreement that exchanges development andcommercialization rights to certain cardiology products in their respectiveinternational markets.
The agreement grants Amgen the commercial rights in theUnited States to Servier's novel oral drug for chronic heart failure and stableangina in patients with elevated heart rates—which has been approved in theEuropean Union as Procoralan (ivabradine). The agreement also gives Amgen theexclusive option to develop and commercialize in the United States Servier'sinvestigational molecule S38844 for cardiovascular diseases, including heartfailure. In exchange, Servier obtains the rights to commercialize Amgen'sproduct omecamtiv mecarbil, an activator of cardiac myosin, in Europe.
Servier will receive a one-time, upfront payment from Amgenof $50 million, plus unspecified future milestone and royalty payments forivabradine.
Ivabradine is an If inhibitor approved by the EuropeanMedicines Agency in 2005 for the symptomatic treatment of stable angina and in2012 for chronic heart failure. It has been approved in more than 100countries, but has yet to be approved for use in the United States.
Ivabradine has a unique mechanism of action that iscomplementary to highly used and effective standard of care therapies,including beta-blockers. In a randomized, placebo-controlled study known as theSHIFT study (Systolic Heart failure treatment with If inhibitor ivabradineTrial) in more than 6,500 patients, ivabradine demonstrated a clinically andstatistically significant reduction in the risk of cardiovascular death orhospitalization due to worsening heart failure over the three months followingtreatment.
"A critical, unmet medical need remains for patients whodon't respond adequately to current available therapies for heart failure andangina," says Dr. Sean E. Harper, executive vice president of research anddevelopment at Amgen. "Ivabradine … offers a novel alternative approach forpatients with elevated heart rates."
"If approved in the U.S., ivabradine will provide anadditional therapeutic option for heart failure and chronic angina patientswith remaining medical needs," says Ashleigh Koss, a spokesperson for Amgen."For the 5 to 15 percent of Americans with refractory angina who are noteligible for revascularization, ivabradine offers an additional therapeuticoption for medical management."
The company is evaluating the next steps required to bringthe product onto the U.S. market as soon possible.
Financial terms surrounding Amgen's option for S38844 andServier's option for omecamtiv mecarbil were not disclosed. Under the terms ofthe agreement, both companies can exercise their options for these therapies upto completion of certain Phase II studies.
S38844 is currently in Phase II studies for the treatment ofheart failure. S38844 shares a similar mechanism of action to ivabradine, butwith once-daily dosing. Other differences between the molecules are beingexplored in ongoing clinical studies.
Omecamtiv mecarbil, also called AMG 423, is being tested forapplications in treating heart failure in patients with systolic dysfunction;the compound activates cardiac muscle contractility and operates to strengthenheart function in these patients. It is being developed in a collaborationbetween Cytokinetics and Amgen, and is currently in Phase II studies.
"Amgen is pleased to enter into this collaboration withServier to bring potential new cardiovascular treatment options to patients inboth the U.S. and Europe," says Harper.
"Ivabradine will enable Amgen to expand its new cardiologyfranchise in the United States, alongside AMG 145 [a monoclonal antibody toreduce LDL cholesterol], and will also complement AMG 423," says Koss.
"Servier is very pleased to establish a collaboration withAmgen, a leading biotechnology company with a unique track record of bringinginnovative medicines to patients," Servier CEO Dr. Jean-Philippe Seta said in amedia statement announcing the collaboration. "This is a clear recognition ofthe medical value of ivabradine, one of our major cardiovascular innovations,which could also benefit U.S. patients."
Amgen is currently the largest independent biotech companyin the world, employing approximately 17,000 people and posting revenues approaching$16 billion in 2011. Its products include Aranesp, Enbrel, Epogen, Kineret andNeulasta. Amgen possesses a robust and diverse pipeline of potential newmedicines.
Servier Laboratories is the largest independent Frenchpharmaceutical company, with a 2012 turnover of $4.75 billion and more than20,000 employees in 140 countries. Current therapeutic areas for Servierinclude cardiovascular, metabolic, neurological, psychiatric and bone and jointdiseases. Servier invests 25 percent of its turnover into research anddevelopment.