Cytokinetics Partners with Bayer to Advance Aficamten in Japan

Cytokinetics Partners with Bayer to Advance Aficamten in Japan

Approximately €70 Million in Upfront and Near-term Payments to Cytokinetics

Up to €490 Million in Commercial Milestone Payments, with Tiered Royalties on Future Sales

SOUTH SAN FRANCISCO, Calif. and BERLIN — Cytokinetics, Incorporated (NASDAQ: CYTK) has forged an exclusive collaboration and license agreement with Bayer to develop and commercialize Aficamten in Japan. This partnership aims to target both obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) patients, with Cytokinetics retaining certain development rights.

Aficamten, recognized as a next-in-class cardiac myosin inhibitor, has the potential to provide significant benefits to patients affected by HCM. Through this collaboration, Cytokinetics will initially receive €50 million, along with eligibility for an additional €90 million contingent upon achieving specific commercial milestones, including €20 million that are classified as near-term payments. Moreover, there lies an opportunity for Cytokinetics to gain up to €490 million in commercial milestone payments predicated on Bayer’s progress with sales milestones and tiered royalties from Aficamten's net sales within Japan.

This strategic alignment leverages Cytokinetics’ pioneering development of Aficamten alongside Bayer’s extensive regional expertise in developing therapies for unmet cardiovascular needs, creating an effective partnership aimed at serving patients across Japan.

Joint Development and Clinical Trials

As part of the joint development strategy, Bayer is set to conduct a Phase 3 clinical trial focused on Japanese patients diagnosed with obstructive HCM. Concurrently, Cytokinetics will broaden the scope of its ongoing Phase 3 study, ACACIA-HCM, targeting non-obstructive HCM, to include Japanese participants, thereby strengthening the case for Aficamten’s marketing authorization in the Japanese market.

Further, this collaboration encompasses the CEDAR-HCM study aimed at pediatric patients presenting with obstructive HCM, emphasizing the commitment to addressing HCM across diverse demographics.

“This partnership with Bayer comes at a momentous time as we progress towards commercializing Aficamten in key markets like the U.S. and Europe. Bayer’s focus on cardiovascular health makes them a perfect ally in extending Aficamten’s reach, potentially aiding a broader patient population suffering from HCM,” stated Robert I. Blum, Cytokinetics’ President CEO. He acknowledged how this collaboration symbolizes a continuation of Cytokinetics’ legacy in expanding access to innovative healthcare solutions.

Potential Impact of Aficamten

Dr. Juergen Eckhardt, Bayer’s Head of Business Development and Licensing within its Pharmaceuticals Division, expressed enthusiasm regarding Aficamten’s potential recognized through prior studies. He noted, “Our mission is to introduce transformative treatments for patients enduring significant cardiovascular challenges, and partnering with Cytokinetics reinforces this commitment.”

Aficamten: A Breakthrough Therapy

Aficamten is emerging as a groundbreaking investigational therapy, specifically designed to target and inhibit cardiac myosin, a key player in heart muscle contraction. This innovative drug has shown promise in reducing excessive heart muscle contraction linked to HCM, thus alleviating related symptoms such as chest pain and breathlessness.

In preclinical tests, Aficamten demonstrated its ability to diminish myocardial contractility through direct interaction with cardiac myosin, blocking it from entering a force-providing state. The ongoing development initiatives focus on enhancing exercise capacity and improving patient quality of life by relieving HCM symptoms. Notably, Aficamten has already secured Breakthrough Therapy Designation from the FDA for treating symptomatic obstructive HCM.

Clinical Trials and Future Prospects

The drug is undergoing extensive assessment through several pivotal clinical trials. SEQUOIA-HCM has already shown positive results for patients with obstructive HCM, leading Cytokinetics to submit a New Drug Application (NDA) to the FDA, with another application for European authorization expected soon. Aficamten is also undergoing evaluation in multiple additional studies, including MAPLE-HCM and ACACIA-HCM, reinforcing its diverse therapeutic potential.

Understanding Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy poses significant health challenges, characterized by abnormal thickening of the heart muscle which can inhibit proper blood flow and cause symptoms like dizziness and shortness of breath during exertion. Given that HCM is recognized as the most prevalent genetic cardiovascular disorder, it is imperative that innovative treatments like Aficamten be developed to address the needs of the 280,000 diagnosed patients in the U.S. and an estimated 400,000-800,000 undiagnosed individuals.

About Cytokinetics

Cytokinetics stands at the forefront of cardiovascular biopharmaceutical development, focusing on innovative therapies to enhance muscle performance, particularly in cardiac health. With advancements in research and substantial ongoing trials, Cytokinetics is dedicated to addressing serious medical conditions like heart failure and HCM. Future projects may include other cardiac muscle activators and inhibitors aimed at improving heart health and delivering new treatment options for patients in need.

Frequently Asked Questions

What is the significance of the collaboration between Cytokinetics and Bayer?

This collaboration aims to enhance the development and commercialization of Aficamten in Japan, addressing critical needs in hypertrophic cardiomyopathy treatments.

How much is Cytokinetics expected to receive from Bayer?

Cytokinetics will receive an upfront payment of €50 million and could earn up to an additional €490 million through milestone payments and tiered royalties from sales.

What is Aficamten?

Aficamten is an investigational cardiac myosin inhibitor designed to improve heart function in patients suffering from hypertrophic cardiomyopathy.

What does hypertrophic cardiomyopathy entail?

Hypertrophic cardiomyopathy is a condition marked by the thickening of the heart muscle, which affects the heart's ability to pump blood effectively, leading to various symptoms.

What future studies are planned for Aficamten?

Aficamten is being evaluated in multiple trials, including MAPLE-HCM, ACACIA-HCM, and CEDAR-HCM, focusing on its efficacy and safety in diverse patient populations.

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