Vical and Astellas Announce Worldwide License Agreements for TransVax(TM) Cytomegalovirus Vaccine

Vical Incorporated VICL and Astellas Pharma Inc. today announced that they have signed exclusive license agreements for the United States and for all territories in the rest of world outside the United States to develop and commercialize TransVax™, Vical's therapeutic vaccine designed to control cytomegalovirus (CMV) reactivation in transplant recipients. The companies expect to begin a multinational Phase 3 registration trial of TransVax™ in hematopoietic stem cell transplant recipients as well as a Phase 2 trial in solid organ transplant (SOT) recipients in the first half of 2012. The agreements will become effective subject to the expiration or termination of the applicable 30-day waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the agreements, Astellas will be responsible for further development and commercialization, including all costs. Vical has an option to co-promote TransVax™ in the United States. Vical will provide assistance to Astellas with TransVax™-related manufacturing, regulatory and certain development activities, for which Astellas will reimburse all of Vical's future costs, including personnel and external expenses. Vical will receive near-term payments of $35 million, including $25 million upon the effective date and $10 million upon finalization of the Phase 3 trial design. Vical potentially will receive up to $130 million in total upfront and milestone payments through commercial launch and double-digit royalties on net sales. "We are very pleased to work with Vical on the development and commercialization of TransVax™ as Astellas is committed to reinforcing its vaccine business," said Yoshihiko Hatanaka, President and Chief Executive Officer of Astellas. "The impressive results from the TransVax™ Phase 2 trial provided evidence of safety, immunogenicity and efficacy in a highly challenging HSCT recipient patient population, and reinforce our confidence for future success. We are excited to advance this program toward commercialization to offer transplant recipients a vaccine option for potentially safe and effective control of CMV."