Bayer introduces aficamten in Japan to strengthen cardiovascular product line

· Bayer and Cytokinetics have signed an exclusive license agreement to develop and commercialize aficamten in Japan;

· Aficamten is used to reduce excessive contraction associated with hypertrophic cardiomyopathy, which is the most common monogenic inherited cardiovascular disease;

· Aficamten has been qualified for breakthrough therapy in symptomatic obstructive hypertrophic cardiomyopathy in the United States and China;

· Cytokinetics will receive an initial payment and near-term payments of approximately 70 million euros and is eligible to receive commercial milestone payments of up to 490 million euros, as well as future sales shares;

· This collaboration is highly consistent with Bayer's strategy and expands Bayer's commercial footprint in the field of cardiology.

On November 19, 2024, Bayer and Cytokinetics, a professional cardiovascular biopharmaceutical company, announced that the two parties have reached a cooperation and licensing agreement for the exclusive development and commercialization of Aficamten in Japan, and Cytokinetics retains some development rights. Aficamten is a cardiac myosin inhibitor for the treatment of obstructive and non-obstructive hypertrophic cardiomyopathy (HCM).

The collaboration leverages Cytokinetics' extensive research and development of aficamten and Bayer's capabilities and expertise in regional market cardiac specialty areas to benefit patients in Japan.

Based on the joint development plan, Bayer will conduct a Phase III clinical study in Japanese patients with obstructive HCM, Cytokinetics will expand the ongoing global Phase III ACACIA-HCM clinical study of aficamten in patients with non-obstructive HCM to Japan to support Bayer's marketing application for aficamten in Japan, and Cytokinetics will also support the ongoing CEDAR-HCM study in pediatric patients with obstructive HCM.

Earlier this year, aficamten received breakthrough therapy designation for symptomatic obstructive HCM from the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA).

"Aficamten has shown exciting potential in previous studies and we look forward to bringing this treatment option to patients in Japan as soon as possible," said Dr. Juergen Eckhardt, head of global business development and licensing at Bayer's Pharmaceuticals division. "This collaboration underscores Bayer's mission to bring transformative therapies to patients with high unmet cardiovascular needs by leveraging our full range of drug development expertise, from early discovery to regulatory approval, lifecycle management and commercialization."

" We are excited to partner with Bayer to bring aficamten to more HCM patients, leveraging Bayer's commitment and expertise in cardiovascular medicine, as we pursue commercialization in the U.S. and Europe. This important regional collaboration builds on our long history of collaboration and will expand the potential applications of our innovations," said Robert I. Blum, president and CEO of Cytokinetics.

" Under the terms of the agreement, Cytokinetics will receive an initial payment of €50 million and up to €90 million in additional payments upon achievement of commercial launch milestones, including €20 million in additional payments. Cytokinetics is eligible for commercial milestone payments of up to €490 million upon the achievement of certain sales milestones by Bayer, as well as royalties on net sales of aficamten in Japan.

About Aficamten

Aficamten is an investigational, selective, small molecule cardiac myosin inhibitor that was discovered following extensive chemical optimization with detailed investigations of therapeutic index and pharmacokinetic properties. Aficamten is designed to reduce the number of active actin-myosin cross-bridges per cardiac cycle, inhibiting excessive myocardial contraction associated with hypertrophic cardiomyopathy (HCM). In preclinical models, aficamten binds directly to a unique, selective, ectopic binding site on cardiac myosin, preventing myosin from entering a force-producing state, thereby reducing myocardial contractility.

Aficamten is being developed to evaluate its potential to improve exercise capacity and relieve symptoms in patients with HCM, as well as its potential long-term effects on cardiac structure and function. The SEQUOIA-HCM study (A Study of the Safety, Efficacy and Quantification of the Effect of Aficamten on Obstruction in Patients with HCM) is a positive pivotal Phase III study in patients with symptomatic obstructive hypertrophic cardiomyopathy. Aficamten has received Breakthrough Therapy designation for symptomatic obstructive HCM from the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA). Cytokinetics has submitted a New Drug Application (NDA) for aficamten to the FDA in the third quarter of 2024 and plans to submit a Marketing Authorization Application (MAA) for the product to the European Medicines Agency (EMA) in the fourth quarter of 2024.

About Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle becomes abnormally thickened. The thickening of the heart muscle causes the inner wall of the left ventricle to become smaller and stiffer, which reduces the heart's ability to relax and fill with blood, ultimately limiting the heart's ability to pump blood, resulting in reduced exercise capacity and symptoms such as chest pain, dizziness, shortness of breath or syncope during exercise. HCM patients are divided into obstructive HCM (oHCM) and non-obstructive HCM (nHCM). The former refers to myocardial thickening leading to obstruction of the left ventricular outflow tract (LVOT), while the latter refers to blood flow not being affected but the myocardium is still thickened. 1. HCM patients are at risk of developing potentially fatal ventricular arrhythmias, which is also one of the main causes of sudden cardiac death in young people or athletes. 2. Some HCM patients have a higher risk of developing progressive disease, leading to dilated cardiomyopathy and heart failure, and must undergo heart transplantation surgery.