Bayer and Cytokinetics, Inc. (Nasdaq: CYTK) have announced a collaboration and license agreement for the exclusive development and commercialization of aficamten in Japan. Aficamten is a cardiac myosin inhibitor being developed for the potential treatment of obstructive and non-obstructive hypertrophic cardiomyopathy (HCM).
This partnership combines Cytokinetics’ extensive development program for aficamten with Bayer’s regional expertise in specialty cardiology diseases, aiming to address unmet patient needs in Japan.
As part of the collaboration, Bayer will conduct a Phase III clinical trial in Japanese patients with obstructive HCM, while Cytokinetics will expand its ongoing global Phase III ACACIA-HCM trial for non-obstructive HCM into Japan. Additionally, Cytokinetics will include Japan in its CEDAR-HCM study, focused on pediatric patients with obstructive HCM, to support aficamten’s potential marketing approval in Japan.
Earlier this year, aficamten received Breakthrough Therapy designations from both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) for the treatment of symptomatic obstructive HCM.
“We are excited about aficamten’s potential and are committed to bringing this treatment to Japanese patients as soon as possible,” said Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer’s Pharmaceuticals Division. “This collaboration reflects our dedication to addressing high unmet cardiovascular needs and advancing transformative treatments from discovery to commercialization.”
“We are thrilled to partner with Bayer as we expand aficamten’s commercialization efforts in the U.S. and Europe,” said Robert I. Blum, President and CEO of Cytokinetics. “This partnership will help bring our innovative treatment to more patients suffering from HCM in Japan.”
Under the terms of the agreement, Cytokinetics will receive an upfront payment of €50 million and is eligible for up to €90 million in milestone payments leading to commercial launch, including €20 million in near-term milestones. Cytokinetics could also receive up to €490 million in additional commercial milestone payments based on Bayer’s sales performance, as well as tiered royalties on net sales of aficamten in Japan.
