Date: 2016-09-01
Type of information: Licensing agreement
Compound: Procoralan® (ivabradine), S38844, omecamtiv mecarbil
Company: Amgen (USA) Servier (France)
Therapeutic area: Cardiovascular diseases
Type agreement: licensing
commercialisation
Action mechanism: bradycardic agent/myosin activator. 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 .
Disease: chronic heart failure, stable angina, heart failure in patients with systolic dysfunction
Details: * On August 12, 2013, Amgen and Servier have announced the early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in connection with the cardiovascular product collaboration agreement announced on July 8, 2013 , completing the transaction. 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 an exclusive option to commercialize omecamtiv mecarbil in Europe.* On July 8, 2013, Amgen and Servier have 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.
Financial terms: 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.
Latest news: * On September 1, 2016, Amgen and Servier 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.
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 . 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.
