MyoKardia, Inc. (Nasdaq: MYOK) today announced updates related to its hypertrophic cardiomyopathy (HCM) treatment portfolio, including lead therapeutic candidate, mavacamten.
Patient screening has closed for the Phase 3 EXPLORER-HCM registrational clinical study to assess the effect of mavacamten in treating patients with obstructive hypertrophic cardiomyopathy (oHCM). Clinical site engagement remains high, and enrollment into the pivotal trial is expected to be completed by mid-August. MyoKardia now anticipates reporting topline data from the EXPLORER-HCM trial in the second quarter of 2020, ahead of previous guidance of the second half of 2020.
“The enthusiasm for mavacamten, along with the hard work and partnership of the EXPLORER-HCM clinical sites and our MyoKardia team, enabled this first-of-its-kind study to enroll ahead of expectations,” said Tassos Gianakakos, MyoKardia’s Chief Executive Officer. “We are greatly appreciative of the investigators, support staff and the oHCM patients and their families who have participated in this pioneering study. The data generated from our mavacamten program to date indicate that this first-in-class medicine has the potential to provide substantial benefit to individuals with symptomatic, obstructive HCM.”
MyoKardia also announced the re-acquisition of U.S. royalty rights to mavacamten and MYK-224 from Sanofi S.A. (Sanofi). As consideration for the buyback of the U.S. royalty rights to these programs, MyoKardia is paying Sanofi $50 million upfront, with an additional $30 million payable by June 30, 2020. Under the terms of the former license and collaboration agreement with Sanofi, Sanofi was eligible for tiered royalties, ranging from 5 percent to 10 percent, on U.S. sales of mavacamten and MYK-224 in HCM or any additional indications.
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“Regaining U.S. royalty rights for mavacamten and MYK-224 allows us to capture the economic value of our HCM therapies on a global basis and increases our strategic flexibility and control over their development and commercialization,” Mr. Gianakakos said. “This was an important strategic step for us as we look ahead to mavacamten’s potential registration and commercial launch in the U.S. and the imminent advancement of MYK-224 into clinical studies.”
MyoKardia’s cash guidance remains unchanged. The company anticipates that current cash, cash equivalents and investments will be sufficient to fund planned operations into the second half of 2021. The company will announce second quarter financial results on August 7, 2019.
Date: July 22, 2019
Source: GlobeNewswire
