Astellas Pharma and Cytokinetics are working together on research, development, and commercialization of skeletal muscle activators in a deal worth up to $490 million.

The firms will for two years jointly conduct research in the area of skeletal muscle activation in an effort to develop therapies for diseases and conditions associated with muscle weakness. They will first focus on expanding emerging opportunities in skeletal muscle contractility, and together identify, characterize, and optimize fast skeletal troponin activators and other potential skeletal muscle activators.

“Cytokinetics will combine its foremost position in the discovery and mechanistic biology of small molecule activators of skeletal muscle contractility with Astellas’ advanced pharmaceutical discovery, development, and commercialization capabilities,” the firms said in a statement.

Under the terms of the agreement, Cytokinetics is eligible to receive an upfront payment and reimbursement of sponsored R&D activities of at least $40 million during the initial two years of the collaboration, plus up to an additional $450 million in pre-commercialization and commercialization milestones plus royalties. Astellas will be responsible for the activities and costs associated with the development of collaboration products, and will have the exclusive right to commercialize collaboration products worldwide, subject to Cytokinetics’ option to co-promote collaboration products in the U.S. and Canada.

Additionally, Cytokinetics has granted Astellas an exclusive license to co-develop and commercialize its skeletal troponin activator drug candidate CK-2127107—currently in Phase I development—for potential application in non-neuromuscular indications. Under the terms of this licensing and co-development pact, “Cytokinetics will be primarily responsible for the conduct of Phase I clinical trials and certain Phase II readiness activities for CK-2127107 and Astellas will be primarily responsible for the conduct of subsequent development and commercialization activities for CK-2127107,” the companies said. From there, “Astellas will have exclusive rights to develop and commercialize other fast skeletal troponin activators in non-neuromuscular indications and to develop and commercialize other novel mechanism skeletal muscle activators in all indications, subject to certain Cytokinetics’ development and commercialization rights,” the firms added.

“We are pleased to enter into this collaboration with Astellas, which will enable us to expand our research and development in the area of skeletal muscle activators,” Cytokinetics President and CEO, Robert I. Blum, said in a statement. “Through this collaboration, we intend to jointly investigate the potential role that CK-2127107 and follow-on skeletal muscle activators can play in providing functional improvements in patients with diseases characterized by muscle weakness and fatigue.”

Added Astellas’ Yoshihiko Hatanaka, president and CEO: “We are excited to work with Cytokinetics to expand the new frontier of muscle biology related to the very innovative mechanism of action of skeletal muscle activation.”

Cytokinetics noted that, outside of this collaboration, it will continue to independently develop tirasemtiv—its skeletal troponin activator currently in Phase II clinical trials for the potential treatment of amyotrophic lateral sclerosis and other neuromuscular disorders.

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