Cytokinetics to Receive $65 Million in Upfront Payments and $30 Million in Additional Sponsored R&D;
Potential for More than $100 Million in Payments Associated with the Exercise of the Option
SOUTH SAN FRANCISCO, Calif. and TOKYO, Japan, July 27, 2016 – 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.
“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 $65 million in committed capital from Astellas which includes upfront payments for Astellas’ option right exercisable for tirasemtiv 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 million in 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.