Cytokinetics and Astellas Announce Option Right for Tirasemtiv and Expansion of Global Collaboration for CK-2127107 in ALS
SOUTH SAN FRANCISCO, Calif. and TOKYO,
"We are pleased to further expand our productive and successful collaboration with Astellas in the area of skeletal muscle activators and to align our interests with regard to tirasemtiv and ALS," said Robert I. Blum, Cytokinetics' President and Chief Executive Officer. "Advancing tirasemtiv and CK-2127107 for the potential treatment of ALS reinforces our shared commitment to deliver on the promise of fast skeletal troponin activation for people living with ALS who are fighting this dreadful disease."
"The expansion of our collaboration illustrates Astellas' commitment to muscle disease as an important and focused therapeutic area for research as announced in our strategic plan," said Yoshihiko Hatanaka, Astellas' President and Chief Executive Officer. "ALS is a disease with significant unmet needs worldwide, and we are excited to expand our collaboration with Cytokinetics to include promising drug candidates in ALS which reflect our shared interests in muscle biology."
Option on Tirasemtiv and Expanded Collaboration Agreement
Upon execution of the amended agreement, Cytokinetics will receive
Astellas' decision regarding its option for tirasemtiv will depend on its review of results from VITALITY-ALS and potentially other considerations by Astellas including the registration and marketing authorization of tirasemtiv in the United States and Europe. If Astellas exercises its option, the parties will enter into a global partnership in which Cytokinetics will continue to develop and commercialize tirasemtiv in North America, Europe, and other select countries, and Astellas will develop and commercialize tirasemtiv in other countries. Cytokinetics may receive over
Under this amendment of the collaboration agreement, Cytokinetics and Astellas have also agreed on a development plan for CK-2127107 in ALS. Cytokinetics will receive approximately
The effectiveness of the amended agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
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About Cytokinetics and Astellas Collaboration
In 2013, Astellas and Cytokinetics formed a partnership focused on the research, development, and commercialization of skeletal muscle activators. The primary objective of the collaboration is to advance novel therapies for diseases and medical conditions associated with muscle impairment and weakness. Under the collaboration, Cytokinetics exclusively licensed to Astellas rights to co-develop and potentially co-commercialize CK-2127107, a fast skeletal troponin activator, in non-neuromuscular indications.
In 2014, Astellas and Cytokinetics agreed to expand the collaboration to include certain neuromuscular indications, including spinal muscular atrophy (SMA), and to advance CK-2127107 into Phase 2 clinical development, initially in SMA. In connection with the expanded collaboration, the companies also agreed to extend their joint research program through 2016.
Under the recently amended collaboration, Astellas has exclusive rights to co-develop and commercialize CK-2127107 and other fast skeletal troponin activators in non-neuromuscular indications and certain neuromuscular indications (including SMA and ALS) and other novel mechanism skeletal muscle activators in all indications, subject to certain Cytokinetics' development and commercialization rights; Cytokinetics may co-promote and conduct certain commercial activities in North America and Europe under agreed scenarios.
About Tirasemtiv and CK-2127107
Tirasemtiv and CK-2127107 have demonstrated pharmacological activity that may lead to new therapeutic options for diseases associated with muscle weakness and fatigue. Tirasemtiv is a novel skeletal muscle activator that selectively activates the fast skeletal muscle troponin complex by increasing its sensitivity to calcium and, in preclinical studies and early clinical trials, demonstrated increases in skeletal muscle force in response to neuronal input and delays in the onset and reductions in the degree of muscle fatigue. Tirasemtiv has been studied in clinical trials that have enrolled over 1000 people internationally. Tirasemtiv is the subject of VITALITY-ALS, an ongoing Phase 3 clinical trial designed to confirm and extend findings on measures of respiratory function and muscle strength from prior studies. CK-2127107, a next-generation skeletal muscle activator has been the subject of five Phase 1 clinical trials in healthy volunteers, which evaluated safety, tolerability, bioavailability, pharmacokinetics and pharmacodynamics. CK-2127107 is being studied in Phase 2 studies in patients with SMA and chronic obstructive pulmonary disease (COPD).
Amyotrophic lateral sclerosis (ALS) is a progressive degenerative neuromuscular disease that afflicts approximately 30,000 people in the United States and a comparable number of patients in Europe. Approximately 6,000 new cases of ALS are diagnosed each year in the United States. In people living with ALS, motor neurons progressively die and the brain can no longer communicate with the muscles through the spinal cord. As muscles are used less and less frequently, they can atrophy, causing people with ALS to lose the ability to perform everyday activities, such as walking, speaking, and eating. The average life expectancy of an ALS patient is approximately three to five years after diagnosis and only 10% of patients survive for more than 10 years. Death is usually due to respiratory failure because of diminished strength in the skeletal muscles responsible for breathing. Few treatment options exist for these patients, resulting in a high unmet need for new therapies to address functional deficits and disease progression.
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to increase muscle function and contractility. Cytokinetics' lead drug candidate is tirasemtiv, a fast skeletal muscle troponin activator, for the potential treatment of ALS. Tirasemtiv has been granted orphan drug designation and fast track status by the
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