Cytokinetics and Bayer Announce Aficamten Licensing Deal in Japan

Cytokinetics and Bayer have entered into a collaboration and license agreement for the exclusive development and commercialization of aficamten in Japan. The agreement aims to treat patients with both obstructive and non-obstructive hypertrophic cardiomyopathy (HCM). As part of this deal, Cytokinetics will receive an upfront payment of €50 million, with potential additional payments totaling up to €90 million upon reaching certain milestones. In addition, Cytokinetics could earn up to €490 million in commercial milestone payments based on Bayer's sales achievements, along with tiered royalties from net sales of aficamten in Japan.

The collaboration combines Cytokinetics' comprehensive development program for aficamten with Bayer's regional expertise in developing and commercializing cardiovascular therapies. The joint development plan includes Bayer conducting a Phase 3 clinical trial in Japanese patients with obstructive HCM. Concurrently, Cytokinetics will expand its ongoing Phase 3 clinical trial, ACACIA-HCM, into Japan to support its potential marketing authorization. Additionally, Cytokinetics will continue its CEDAR-HCM study, focusing on a pediatric population with obstructive HCM.

Robert I. Blum, President and CEO of Cytokinetics, expressed enthusiasm about the partnership, highlighting Bayer's cardiovascular commitment and expertise, which could potentially benefit more patients suffering from HCM. Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer’s Pharmaceuticals Division, also expressed excitement about aficamten's potential and the opportunity to provide this treatment to Japanese patients.

Aficamten is an investigational small molecule cardiac myosin inhibitor, designed to address hypertrophic cardiomyopathy by reducing the number of active actin-myosin cross bridges during each cardiac cycle. This reduction aims to suppress myocardial hypercontractility associated with HCM. Preclinical models have shown that aficamten binds directly to cardiac myosin at a selective allosteric binding site, thereby preventing myosin from entering a force-producing state.

The development program for aficamten evaluates its potential to improve exercise capacity and alleviate symptoms in HCM patients. It also examines its long-term impact on cardiac structure and function. Aficamten has received Breakthrough Therapy Designation for symptomatic obstructive HCM from both the U.S. Food & Drug Administration (FDA) and China's National Medical Products Administration (NMPA). Cytokinetics submitted a New Drug Application (NDA) to the FDA in Q3 2024 and plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in Q4 2024.

Currently, aficamten is being assessed in multiple clinical trials, including MAPLE-HCM, a Phase 3 trial comparing aficamten monotherapy to metoprolol for obstructive HCM, ACACIA-HCM, a Phase 3 trial in patients with non-obstructive HCM, CEDAR-HCM, a trial for pediatric patients with obstructive HCM, and FOREST-HCM, an open-label extension study in HCM patients.

Hypertrophic cardiomyopathy (HCM) is a condition characterized by abnormal thickening of the heart muscle, leading to reduced heart function, chest pain, dizziness, shortness of breath, and fainting during physical activity. It is the most common monogenic inherited cardiovascular disorder, affecting approximately 280,000 diagnosed patients, with an estimated 400,000-800,000 additional undiagnosed cases in the U.S. HCM patients are at high risk for cardiovascular complications, including atrial fibrillation, stroke, and mitral valve disease, and it is one of the leading causes of sudden cardiac death in younger individuals and athletes.

Cytokinetics is a biopharmaceutical company focused on developing muscle biology-directed drug candidates for treating debilitating diseases affecting cardiac muscle performance. Following positive results from the SEQUOIA-HCM trial, Cytokinetics is progressing regulatory submissions for aficamten in the U.S. and Europe.

Bayer is a global enterprise specializing in health care and nutrition. The company aims to address the challenges of a growing and aging global population through sustainable development and innovation, striving to generate a positive impact on people and the planet. In 2023, Bayer employed around 100,000 people, with sales reaching 47.6 billion euros, and R&D expenses before special items amounting to 5.8 billion euros.