SOUTH SAN FRANCISCO, Calif. and TOKYO, July 27, 2016 (GLOBE NEWSWIRE) — Cytokinetics, Inc.(Nasdaq:CYTK) (“Cytokinetics”) and Astellas Pharma Inc. (TSE:4503) (“Astellas”) today announced that Cytokinetics and Astellas have expanded their collaboration in skeletal muscle activators to include amyotrophic lateral sclerosis (ALS). Through this expansion, Cytokinetics has granted Astellas an option right for the development and commercialization of tirasemtiv, an investigational skeletal muscle activator. The companies have also agreed to amend their collaboration agreement to enable the development of CK-2127107 for the potential treatment of ALS and to extend their joint research focused on the discovery of additional next-generation skeletal muscle activators through 2017.
“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.”“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.”
Option on Tirasemtiv and Expanded Collaboration Agreement
Upon execution of the amended agreement, Cytokinetics will receive $65 million in committed capital from Astellas which includes upfront payments for Astellas’ option right exercisable fortirasemtiv and amended terms of the companies’ collaboration agreement to include ALS for CK-2127107.
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 $100 million in payments associated with the exercise of the option plus additional milestone payments and escalating double-digit royalties on Astellas’ sales of tirasemtiv in its territory. Astellas may be eligible to receive royalties that can reach double-digits on Cytokinetics’ sales of tirasemtiv in its territory.
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 $30 millionin additional sponsored research and development funding through 2017 which includes Astellas’ sponsorship of Cytokinetics’ conduct of the Phase 2 clinical development of CK-2127107 in ALS as well as the continuing research collaboration. Afterwards, Astellas and Cytokinetics will collaborate in the design and conduct of a potential registration program for CK-2127107 in ALS and the companies will share associated development costs. Cytokinetics would be eligible for additional milestone payments and royalties on sales based on the further development and commercialization of CK-2127107 for ALS.
The effectiveness of the amended agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
Cytokinetics Conference Call / Webcast
Cytokinetics will host a conference call on July 27, 2016 at 8:30 a.m. Eastern Time. The conference call will be simultaneously webcast and will be accessible in the Investors & Media section of Cytokinetics’ Web site; for further information please go to www.cytokinetics.com. The live audio of the conference call is also accessible via telephone to investors, members of the news media and the general public by dialing either (866) 999-2985 (CYTK) (United States and Canada) or (706) 679-3078 (International) and typing in the passcode 55539648. An archived replay of the webcast will be available via Cytokinetics’ website until August 3, 2016. The replay will also be available via telephone from July 27, 2016 at 11:30 a.m. Eastern Time until August 3, 2016 by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (International) and typing in the passcode 55539648.
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 U.S. Food and Drug Administration and orphan medicinal product designation by the European Medicines Agencyfor the potential treatment of ALS. Cytokinetics retains the right to develop and commercializetirasemtiv, subject to Astellas’ option. Cytokinetics is collaborating with Amgen Inc. to developomecamtiv mecarbil, a novel cardiac muscle activator, for the potential treatment of heart failure. Cytokinetics is collaborating with Astellas Pharma Inc. to develop CK-2127107, a fast skeletal muscle activator, for the potential treatment of spinal muscular atrophy, chronic obstructive pulmonary disease and ALS. Amgen holds an exclusive license worldwide to develop and commercialize omecamtiv mecarbil and Astellas holds an exclusive license worldwide to develop and commercialize CK-2127107. Both licenses are subject to Cytokinetics’ specified development and commercialization participation rights. For additional information about Cytokinetics, visit http://www.cytokinetics.com/.
About Astellas Pharma Inc.
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at www.astellas.com.