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Flexing their muscles
SAN FRANCISCO—California-based biopharmaceutical company Cytokinetics and Tokyo-based Astellas Pharma Inc. have announced a collaboration agreement focused on combating diseases associated with muscle weakness, which will include a joint investigation of a promising small-molecule activator of skeletal muscle contractility.
Cytokinetics is eligible to receive an upfront payment and reimbursement of sponsored research and development activities during the first two years of the partnership totaling more than $40 million, as well as more than $450 million in precommercialization and commercialization milestones, plus royalties. Astellas will have the exclusive right to commercialize collaboration products worldwide. Cytokinetics will retain the option to co-promote collaboration products in the United States and Canada, in which case Astellas will reimburse Cytokinetics for certain expenses associated with the co-promotion efforts.
The collaboration is based around Cytokinetics' drug candidate CK-2127107, a selective small-molecule activator of the fast skeletal muscle troponin complex, which controls skeletal muscle contractibility. The two companies will jointly investigate the compound, as well as follow-on novel-mechanism skeletal muscle activators identified during the collaborative research. CK-2127107 is currently in Phase I clinical development.
The collaboration terms grant Astellas an exclusive license to co-develop and commercialize CK-2127107 for potential application in non-neuromuscular indications. Cytokinetics will have the primary responsibility for conducting Phase I clinical trials and Phase II readiness activities, after which Astellas will be primarily responsible for subsequent development and commercialization.
The two organizations will undertake joint research to identify novel skeletal muscle activators to be nominated as drug candidates. 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 development and commercialization rights retained by Cytokinetics.
Astellas will be responsible for the costs associated with the development of collaboration products. Cytokinetics retains an option to conduct early-stage development for certain agreed-upon indications at its own expense, subject to reimbursement by Astellas if development continues under the collaboration.
The collaboration research term is two years.
The partnership leverages both companies' complementary capabilities and like-minded interest in expanding their opportunities for discovering and developing novel-mechanism small molecules in skeletal muscle activation.
"We are excited to work with Cytokinetics to expand the new frontier of muscle biology related to the innovative mechanism of action of skeletal muscle activation," Astellas President and CEO Yoshihiko Hatanaka said in a media statement announcing the partnership. "This new collaboration illustrates Astellas' important commitment to enhance its abilities to generate innovative drugs by deploying cutting-edge science, accessing distinguished internal and external talent and utilizing the optimal research environment."
"We are impressed with Astellas' strategic vision and capabilities in the areas of novel mechanism biopharmaceutical research and development," said Cytokinetics President and CEO Robert I. Blum in the same media statement.
The troponin complex is a heteromeric protein playing an important role in the regulation of skeletal and cardiac muscle contraction. CK-2127107 targets the troponin complex within the sarcomere, which is controlled by levels of calcium. Activating the troponin complex increases the sensitivity of skeletal muscle to calcium levels.
"We've invested a great deal in research and development in this area, not just with CK-2127107, but also with other small-molecule skeletal muscle activators," says Dr. Elisabeth Schnieders, vice president of business development at Cytokinetics.
Independently of the collaboration with Astellas, Cytokinetics will continue to develop another fast skeletal troponin activator, tirasemtiv, which is currently in Phase II clinical trials for the potential treatment of amyotrophic lateral sclerosis and other neuromuscular disorders.
Cytokinetics is a clinical-stage biopharmaceutical company focused on the discovery and development of novel small-molecule therapeutics that modulate muscle function. Cytokinetics currently has three compounds in clinical development: omecamtiv mecarbil in Phase II for acute and chronic heart failure, tirasemtiv in Phase II for amyotrophic lateral sclerosis and CK-212107 in a Phase I study in healthy volunteers. All of the company's drug candidates have arisen from Cytokinetics' muscle biology-focused research activities, and are directed towards the cytoskeleton.
Astellas Pharma is a pharmaceutical company based in Tokyo that aims to improve the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 17,000 employees globally. The company's areas of expertise include urology, immunology, oncology, neuroscience and kidney disease.