As previously disclosed, 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. The companies expect to begin a multinational Phase 3 registration trial of TransVax™ in hematopoietic stem cell transplant (HSCT) recipients as well as a Phase 2 trial in solid organ transplant (SOT) recipients in the first half of 2012. Vical will receive an additional $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.
About Vical
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.
The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about Vical's technologies, the TransVax™ CMV vaccine, as well as the company's focus, licensees, and independent and partnered product candidates. Risks and uncertainties include whether Vical, Astellas or others will continue development of TransVax™ or any other product candidates; whether the companies will begin a multinational Phase 3 registration trial of TransVax™ in HSCT recipients or a Phase 2 trial in SOT recipients in the first half of 2012, if at all; whether Astellas will successfully develop and commercialize TransVax™; whether Vical will co-promote TransVax™ in the United States; whether Vical will provide assistance to Astellas with manufacturing, regulatory and certain development activities; whether Astellas will reimburse all, if any, of Vical's future TransVax™-related costs; whether Vical will receive all, if any, upfront payments, development milestones and royalties under the agreements; whether Vical or its licensees will seek or gain approval to market TransVax™ or any other DNA-based human vaccine or therapeutic product candidates; whether Vical or its licensees will succeed in marketing any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the companies' judgment as of the date of this release. The companies disclaim, however, any intent or obligation to update these forward-looking statements.
CONTACT: Alan R. Engbring
(858) 646-1127
Website: www.vical.com
