SOUTH SAN FRANCISCO, Calif.—MyoKardia Inc., a clinical stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, announced recently that Sanofi has notified the company that it has elected to continue the global cardiomyopathy research collaboration formed in August 2014.
The terms of the research agreement provided Sanofi the option of either concluding the collaboration at year-end 2016 or extending the agreement. Per Sanofi’s decision to advance the collaboration, MyoKardia is now eligible for a $45 million milestone payment payable by Jan. 31, 2017.
“MyoKardia and Sanofi share a passion for science and a commitment to patients,” said Tassos Gianakakos, CEO of MyoKardia. “The continuation of this research collaboration provides valuable support for further innovation and development of critically important therapies for patients with serious cardiovascular diseases.”
The research and development agreement is one of the most significant commitments to heritable cardiomyopathies, and encompasses three MyoKardia programs, he added. Two of these programs are focused on hypertrophic cardiomyopathy (HCM) and one targets dilated cardiomyopathy (DCM).
In September, MyoKardia outlined its expected path to registration for its lead product candidate MYK-461 in the initial indication of symptomatic, obstructive HCM, for which the company was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA). MyoKardia is studying MYK-461 in the Phase 2 PIONEER-HCM trial.
MyoKardia received a separate, $25-million milestone payment from Sanofi in November 2016 for the filing of an Investigational New Drug application with the FDA for its MYK-491 program in DCM. MyoKardia intends to initiate a Phase 1 study of MYK-491 in healthy volunteers in the first half of 2017.
In the United States, MyoKardia maintains commercial rights to MYK-461 and HCM-2 as well as co-promotion rights for MYK-491.
SOURCE: MyoKardia news release