Flexing their muscles

Cytokinetics, Astellas explore novel-mechanism skeletal muscle activators

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SAN FRANCISCO—California-based biopharmaceutical companyCytokinetics and Tokyo-based Astellas Pharma Inc. have announced acollaboration agreement focused on combating diseases associated with muscleweakness, which will include a joint investigation of a promisingsmall-molecule activator of skeletal muscle contractility.
Cytokinetics is eligible to receive an upfront payment andreimbursement of sponsored research and development activities during the firsttwo years of the partnership totaling more than $40 million, as well as morethan $450 million in precommercialization and commercialization milestones,plus royalties. Astellas will have the exclusive right to commercializecollaboration products worldwide. Cytokinetics will retain the option toco-promote collaboration products in the United States and Canada, in whichcase Astellas will reimburse Cytokinetics for certain expenses associated withthe co-promotion efforts.
The collaboration is based around Cytokinetics' drugcandidate CK-2127107, a selective small-molecule activator of the fast skeletalmuscle troponin complex, which controls skeletal muscle contractibility. Thetwo companies will jointly investigate the compound, as well as follow-onnovel-mechanism skeletal muscle activators identified during the collaborativeresearch. CK-2127107 is currently in Phase I clinical development.
The collaboration terms grant Astellas an exclusive licenseto co-develop and commercialize CK-2127107 for potential application innon-neuromuscular indications. Cytokinetics will have the primary responsibilityfor conducting Phase I clinical trials and Phase II readiness activities, afterwhich Astellas will be primarily responsible for subsequent development andcommercialization.
The two organizations will undertake joint research toidentify novel skeletal muscle activators to be nominated as drug candidates.Astellas will have exclusive rights to develop and commercialize other fastskeletal troponin activators in non-neuromuscular indications, and to developand commercialize other novel-mechanism skeletal muscle activators in allindications, subject to certain development and commercialization rightsretained by Cytokinetics.
Astellas will be responsible for the costs associated withthe development of collaboration products. Cytokinetics retains an option toconduct early-stage development for certain agreed-upon indications at its ownexpense, subject to reimbursement by Astellas if development continues underthe collaboration.
The collaboration research term is two years.
The partnership leverages both companies' complementarycapabilities and like-minded interest in expanding their opportunities fordiscovering and developing novel-mechanism small molecules in skeletal muscleactivation.
"We are excited to work with Cytokinetics to expand the newfrontier of muscle biology related to the innovative mechanism of action ofskeletal muscle activation," Astellas President and CEO Yoshihiko Hatanaka saidin a media statement announcing the partnership. "This new collaborationillustrates Astellas' important commitment to enhance its abilities to generateinnovative drugs by deploying cutting-edge science, accessing distinguishedinternal and external talent and utilizing the optimal research environment."
"We are impressed with Astellas' strategic vision andcapabilities in the areas of novel mechanism biopharmaceutical research anddevelopment," said Cytokinetics President and CEO Robert I. Blum in the samemedia statement.
The troponin complex is a heteromeric protein playing animportant role in the regulation of skeletal and cardiac muscle contraction.CK-2127107 targets the troponin complex within the sarcomere, which iscontrolled by levels of calcium. Activating the troponin complex increases thesensitivity of skeletal muscle to calcium levels.
"We've invested a great deal in research and development inthis area, not just with CK-2127107, but also with other small-moleculeskeletal muscle activators," says Dr. Elisabeth Schnieders, vice president ofbusiness 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 potentialtreatment of amyotrophic lateral sclerosis and other neuromusculardisorders. 
Cytokinetics is a clinical-stage biopharmaceutical companyfocused on the discovery and development of novel small-molecule therapeuticsthat modulate muscle function. Cytokinetics currently has three compounds inclinical development: omecamtiv mecarbil in Phase II for acute and chronicheart failure, tirasemtiv in Phase II for amyotrophic lateral sclerosis andCK-212107 in a Phase I study in healthy volunteers. All of the company's drugcandidates have arisen from Cytokinetics' muscle biology-focused researchactivities, and are directed towards the cytoskeleton.
Astellas Pharma is a pharmaceutical company based in Tokyothat aims to improve the health of people around the world through theprovision of innovative and reliable pharmaceuticals. Astellas hasapproximately 17,000 employees globally. The company's areas of expertiseinclude urology, immunology, oncology, neuroscience and kidney disease.

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