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news.Vical and Astellas Pharma have entered into licensing deals for the development and commercialization of Vical's TransVax vaccine as a treatment to control cytomegalovirus (CMV) reactivation in transplant recipients.
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Under the contracts, Astellas will develop and commercialize TransVax, however Vical will take care of the co-promotion in US.
Additionally, Vical will support Astellas in manufacturing, development and regulatory activities of TransVax, for which Astellas is responsible to reimburse all of Vical’s future costs, including personnel and external expenses.
Further, both the parties expect to start TransVax Phase 3 registration trial in patients with hematopoietic stem cell transplant (HSCT)and a Phase 2 trial in solid organ transplant (SOT) recipients in the first half of 2012.
As per the terms of the agreements, Astellas is responsible to pay as sum of $35m, including $25m upon the effective date and $10m upon finalization of the Phase 3 trial design to Vical.
Additionally, it will also pay $130m as total upfront and milestone payments through the commercial roll out and double-digit royalties on net sales to Vical.
Astellas president and CEO Yoshihiko Hatanaka said the positive results from the TransVax Phase 2 trial provided evidence of safety, immunogenicity and efficacy in a challenging HSCT recipient patient population, and reinforce our confidence for future success.