German biotechnology company Bayer has signed an exclusive collaboration and license agreement with Cytokinetics to develop and commercialise Cytokinetics’ aficamten in Japan.
Cytokinetics is a US-based speciality biopharmaceutical company focused on discovering, developing, and commercialising muscle biology-driven therapies.
Under the terms of the agreement, Cytokinetics will receive an upfront payment of €50m and up to €90m in potential milestone payments, including €20m near-term payments.
The US drugmaker will also receive up to €490m in commercial milestone payments, contingent on Bayer achieving certain sales milestones, along with tiered royalties.
Bayer’s pharmaceuticals division business development and licensing head Juergen Eckhardt said: “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 commercialisation.”
Under the collaboration, Cytokinetics will leverage its aficamten development program and Bayer its regional capabilities and expertise in the development and commercialisation.
Bayer will conduct a Phase 3 clinical trial in Japanese patients with obstructive hypertrophic cardiomyopathy (HCM), as part of a joint development plan.
Cytokinetics will expand its ongoing Phase 3 ACACIA-HCM trial in patients with non-obstructive HCM, and CEDAR-HCM study in paediatric patients with obstructive HCM.
The Phase 3 study will support the potential marketing authorisation of aficamten in Japan.
Aficamten is an investigational selective, small-molecule cardiac myosin inhibitor used as the potential treatment of patients with obstructive and non-obstructive HCM.
The drug was designed to reduce active actin-myosin cross bridges and suppress myocardial hypercontractility, which is associated with HCM.
In the preclinical studies, aficamten reduced myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site.
Earlier this year, the drug received Breakthrough Therapy designations from the US Food & Drug Administration (FDA), and China’s National Medical Products Administration (NMPA).
Cytokinetics president and CEO Robert Blum said: “As we pursue commercialisation 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.
“This important regional deal follows on our rich history of collaborations to expand potential access to our innovative science.”
Earlier this year, Bayer extended its existing collaboration with life science company Evotec, to focus on precision treatments for cardiovascular diseases (CVDs).
