Cytokinetics and Bayer Partner to Develop Aficamten for HCM in Japan
Key Insights
Cytokinetics (search) and Bayer have entered an exclusive licensing agreement to develop and commercialize aficamten in Japan for hypertrophic cardiomyopathy (search) (HCM).
The agreement includes an upfront payment of €50 million to Cytokinetics (search), with potential milestones totaling up to €580 million plus tiered royalties.
Bayer will conduct a Phase 3 trial for obstructive HCM in Japan, while Cytokinetics (search) will expand its ACACIA-HCM and CEDAR-HCM trials into the region.
Cytokinetics (search) and Bayer have announced an exclusive licensing collaboration for aficamten in Japan, focusing on the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (search) (HCM). The agreement aims to leverage Cytokinetics' development program and Bayer's regional expertise to address unmet needs in cardiovascular care for Japanese patients.
Financial Terms of the Agreement
Under the terms of the agreement, Cytokinetics (search) will receive an upfront payment of €50 million. Furthermore, Cytokinetics is eligible to receive up to an additional €90 million upon achieving milestones through commercial launch, including €20 million in the near term. The agreement also includes up to €490 million in commercial milestone payments based on Bayer's achievement of certain sales targets, as well as tiered royalties on net sales of aficamten in Japan.
Clinical Development Plans
The collaboration outlines a joint development plan where Bayer will conduct a Phase 3 clinical trial in Japanese patients with obstructive HCM. Cytokinetics (search) will expand its ongoing Phase 3 clinical trial, ACACIA-HCM, evaluating aficamten in patients with non-obstructive HCM, into Japan. Additionally, the CEDAR-HCM study, which focuses on a pediatric population with obstructive HCM, will also be expanded into Japan. These trials aim to support the potential marketing authorization of aficamten in Japan.
Executive Perspectives
Robert I. Blum, President and Chief Executive Officer of Cytokinetics (search), stated, "As we pursue commercialization of aficamten in the U.S. and Europe, we are pleased to enter into this partnership with Bayer to leverage their cardiovascular commitment and expertise to potentially bring aficamten to an even greater number of patients suffering from HCM."
Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer’s Pharmaceuticals Division, added, "We are very excited by the potential of aficamten as seen in previous studies and look forward to bringing this treatment option to Japanese patients as soon as possible. This collaboration underscores our mission to bring transformative treatments to patients with high unmet cardiovascular needs by leveraging our extensive drug development expertise from early discovery through regulatory approval, life cycle management and commercialization."
About Aficamten
Aficamten is an investigational selective, small molecule cardiac myosin (search) inhibitor. It was designed to reduce the number of active actin-myosin cross bridges during each cardiac cycle, thereby suppressing myocardial hypercontractility associated with HCM. In preclinical models, aficamten reduced myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, preventing myosin from entering a force-producing state.
Hypertrophic Cardiomyopathy (HCM)
HCM is a disease characterized by abnormal thickening of the heart muscle, leading to reduced ability of the left ventricle to relax and fill with blood. This results in reduced exercise capacity and symptoms such as chest pain, dizziness, and shortness of breath. HCM affects approximately 280,000 diagnosed patients in the U.S., with an estimated 400,000 to 800,000 additional undiagnosed cases. Patients with HCM are at increased risk of cardiovascular complications, including atrial fibrillation, stroke, and sudden cardiac death.