• 21 Nov 2024
• Admin
• News Article

Cytokinetics, Bayer Enter Collaboration and Licensing Pact for Aficamten in Japan

Overview

Cytokinetics, Incorporated, a late-stage, specialty cardiovascular biopharmaceutical company, and Bayer announced they have entered into a collaboration and license agreement for the exclusive development and commercialization of aficamten in Japan for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM), subject to certain reserved development rights of Cytokinetics. Aficamten is a next-in-class cardiac myosin inhibitor for the potential treatment of patients with HCM.

Cytokinetics Post Collab

• Cytokinetics will receive an upfront payment of €50 million and is eligible to receive up to an additional €90 million upon the achievement of milestones through commercial launch, including €20 million which are near-term. 
• Cytokinetics is also eligible to receive up to €490 million in commercial milestone payments upon the achievement by Bayer of certain sales milestones, and tiered royalties on net sales of aficamten in Japan.
• This collaboration leverages Cytokinetics’ broad development program of aficamten and Bayer’s regional capabilities and expertise in the development and commercialization of therapies to treat cardiovascular diseases of unmet need for the benefit of patients in Japan.

According to the Plan

Under the joint development plan, Bayer will conduct a phase 3 clinical trial in Japanese patients with obstructive HCM and Cytokinetics will expand ACACIA-HCM, the ongoing phase 3 clinical trial of aficamten in patients with non-obstructive HCM, into Japan to support the potential marketing authorization of aficamten in Japan and CEDAR-HCM, its ongoing study for a paediatric population of patients with obstructive HCM.

Words from the CEO: Cytokinetics

• “As we pursue commercialization of aficamten in the US 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,” said Robert I. Blum, Cytokinetics’ president and chief executive officer. “
• This important regional deal follows on our rich history of collaborations to expand potential access to our innovative science.”

From Bayer’s Pharmaceuticals Division

• “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,” said Juergen Eckhardt, M.D., head of business development and licensing at Bayer’s Pharmaceuticals Division. 
• “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 inhibitor discovered following an extensive chemical optimization programme that was conducted with careful attention to therapeutic index and pharmacokinetic properties and as may translate into next-in-class potential in clinical development. 
• Aficamten was designed to reduce the number of active actin-myosin cross bridges during each cardiac cycle and consequently suppress the myocardial hypercontractility that is associated with hypertrophic cardiomyopathy (HCM). 
• In preclinical models, aficamten reduced myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state.

Studies for Aficamten

• The development program for aficamten is assessing its potential as a treatment that improves exercise capacity and relieves symptoms in patients with HCM as well as its potential long-term effects on cardiac structure and function. 
• Aficamten was evaluated in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), a positive pivotal phase 3 clinical trial in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). 
• Aficamten received Breakthrough Therapy Designation for the treatment of symptomatic obstructive HCM from the US Food & Drug Administration (FDA) as well as the National Medical Products Administration (NMPA) in China. 
• Cytokinetics submitted a New Drug Application (NDA) to the FDA in Q3 2024 and expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in Q4 2024.

Further Studies on Aficamten

Aficamten is also currently being evaluated in MAPLE-HCM, a phase 3 clinical trial of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, ACACIA-HCM, a phase 3 clinical trial of aficamten in patients with non-obstructive HCM, CEDAR-HCM, a clinical trial of aficamten in a paediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM.

Hypertrophic Cardiomyopathy

• Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle (myocardium) becomes abnormally thick (hypertrophied). 
• The thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller and stiffer, and thus the ventricle becomes less able to relax and fill with blood. 
• This ultimately limits the heart’s pumping function, resulting in reduced exercise capacity and symptoms including chest pain, dizziness, shortness of breath, or fainting during physical activity. 
• HCM is the most common monogenic inherited cardiovascular disorder, with approximately 280,000 patients diagnosed, however, there are an estimated 400,000-800,000 additional patients who remain undiagnosed in the US. 
• Two-thirds of patients with HCM have obstructive HCM (oHCM), where the thickening of the cardiac muscle leads to left ventricular outflow tract (LVOT) obstruction, while one-third have non-obstructive HCM (nHCM), where blood flow isn’t impacted, but the heart muscle is still thickened. 
• People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease. 
• People with HCM are at risk for potentially fatal ventricular arrhythmias and it is one of the leading causes of sudden cardiac death in younger people or athletes. 
• A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation.

About the Company: Cytokinetics

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which cardiac muscle performance is compromised.

About the company: Bayer

• Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. 
• In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.