OREANDA-NEWS. Cytokinetics, Incorporated (NASDAQ:CYTK) and Astellas Pharma Inc. (Tokyo Stock Exchange: 4503, "Astellas") announced today an amendment to their collaboration agreement focused on the research, development and commercialization of skeletal muscle activators.  The companies have been jointly conducting research and development activities with the objective to advance novel skeletal sarcomere targeted therapies for diseases and medical conditions associated with muscle weakness in non-neuromuscular indications.  The collaboration has been expanded to enable development of CK-2127107, a fast skeletal troponin activator, in Spinal Muscular Atrophy (SMA) and potentially other neuromuscular indications.  As the companies have agreed, Cytokinetics will conduct a Phase II clinical trial of CK-2127107 in patients with SMA, which is planned to begin in 2015.  Cytokinetics and Astellas will jointly develop and may jointly commercialize CK-2127107 and other fast skeletal troponin activators in neuromuscular indications.  The companies have extended their joint research program focused on the discovery of additional skeletal sarcomere activators through 2016.

Upon execution of the amended agreement, Cytokinetics will receive \\$55 million from Astellas comprising \\$30 million as an upfront license fee, \\$10 million paid for Astellas’ purchase of Cytokinetics’ common stock and \\$15 million in a milestone payment in connection with the decision made by Astellas to advance CK-2127107 into Phase II clinical development. In addition, Cytokinetics expects to receive potentially over \\$20 million payable by Astellas to reimburse Cytokinetics for planned research and development expenses over the next 2 years.  Under the amended agreement, Cytokinetics is eligible to receive over \\$600 million in pre-commercialization and commercialization milestone payments, of which over \\$100 million is payable for CK-2127107 in each of SMA and other neuromuscular indications.  The agreed terms also provide for escalating royalties to Cytokinetics with increased sales.  Cytokinetics retains the option to co-fund the development of CK-2127107 in SMA and other neuromuscular indications in exchange for increased milestone payments and royalties and, if Cytokinetics exercises its co-promotion option, Astellas will reimburse Cytokinetics for certain expenses associated with its promotion activities. 

“We are pleased to expand our collaboration with Astellas to enable the joint pursuit of CK-2127107 in SMA and other potential neuromuscular indications as well as the indications which were the initial focus of our collaboration,” stated Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We are impressed with Astellas’ strategic vision for skeletal muscle activators and look forward to increasing the scope of our activities to prioritize the treatment of neuromuscular diseases that may benefit from our novel mechanism approach to increased muscle function and time to muscle fatigue.”

“We are excited to expand our collaboration with Cytokinetics and to advance this drug candidate into Phase II,” stated Yoshihiko Hatanaka, Astellas’ President and Chief Executive Officer.  “We are encouraged by the result of the completed Phase I studies for CK-2127107 and are hopeful for the future of this new frontier of muscle biology.  The expansion of our alliance is a testament to our productive collaboration together and illustrates the broad potential that we envision for this program.”

Expanded Scope of Collaboration

Cytokinetics and Astellas entered into collaboration in 2013.  Cytokinetics exclusively licensed to Astellas the rights to co-develop and commercialize CK-2127107, a fast skeletal troponin activator drug candidate, for potential application in non-neuromuscular indications under the collaboration agreement.  In accordance with the initial scope of the collaboration, Cytokinetics completed Phase I clinical development activities and other Phase II readiness activities.  In connection with the expanded collaboration, the companies have agreed to advance CK-2127107 into Phase II clinical development initially in SMA.  The development program may include other neuromuscular indications as the companies may agree in the future.  In connection with the expanded collaboration, Cytokinetics and Astellas have also agreed to extend their joint research program through 2016.  Under the 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 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.  Outside the collaboration, Cytokinetics may continue to independently develop tirasemtiv, a fast skeletal troponin activator that recently completed a Phase II clinical trials program for the potential treatment of amyotrophic lateral sclerosis (ALS), in ALS and other neuromuscular indications subject to certain agreed limitations.