Astellas and Vical Announce Initiation of Phase 2 Trial of ASP0113, a Cytomegalovirus Vaccine, in Solid Organ Transplant Recipients

NORTHBROOK, Ill. and SAN DIEGO, Dec. 10, 2013 /PRNewswire/ -- Astellas Pharma Global Development, Inc., a subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), and Vical Incorporated (Nasdaq: VICL) today announced the initiation of a Phase 2 trial of ASP0113 in approximately 140 solid organ transplant (SOT) recipients.

The global, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy of ASP0113 compared to placebo as measured by the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. The study will also evaluate the safety of ASP0113 in this patient population. Follow-up for each subject will continue for one year following enrollment.

"Following the initiation of our Phase 3 trial of ASP0113 in hematopoietic cell transplant (HCT) recipients in June, we are pleased to expand the ASP0113 program with this Phase 2 trial in SOT recipients," said Bernie Zeiher, Senior Vice President and Global Therapeutic Area Head of Immunology and Infectious Diseases at Astellas Pharma Global Development, Inc. "The unmet medical need to control CMV in transplant recipients remains high."

"We are very pleased with the collaborative nature of our relationship with Astellas and with the progress being made," said Vijay Samant, President and Chief Executive Officer of Vical.

Astellas is conducting the trial under an exclusive worldwide license agreement with Vical to develop and commercialize ASP0113. Vical is providing development, regulatory and manufacturing support.

About ASP0113
ASP0113 (formerly TransVax™) is an investigational bivalent DNA vaccine containing plasmids (closed loops of DNA) encoding human CMV pp65 and gB antigens for induction of both cellular and humoral immune responses. ASP0113 is formulated with a proprietary poloxamer-based delivery system. ASP0113 has received orphan drug designation in the United States and Europe for the prevention of CMV disease in HCT and SOT patients.

About Cytomegalovirus (CMV) Infection
CMV is a herpes virus that infects more than half of all adults in the United States by age 40, and is even more widespread in developing countries. A healthy immune system typically protects an infected person against CMV disease, but does not prevent or clear latent infection, and those whose immune systems are not fully functional are at high risk of CMV reactivation, potentially leading to severe illness or death. Those at greatest risk include transplant patients and infants born to mothers who first become infected during pregnancy.

About Astellas
Astellas Pharma Global Development, Inc., located in Northbrook, Illinois, is a member of the Astellas group of companies. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. For more information about Astellas Pharma Inc., please visit our website at www.astellas.com/en.

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 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.

Vical Forward-Looking Statement
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 the future development of ASP0113, including the anticipated Phase 2 clinical trial. Risks and uncertainties include whether Vical, Astellas or others will continue development of ASP0113 or any other product candidates; whether the Phase 2 trial of ASP0113 will be completed, and if so, whether results will support advancement to commercialization for SOT recipients; whether Astellas will successfully develop and commercialize ASP0113; whether Vical will provide assistance to Astellas with manufacturing, regulatory and development activities; whether Astellas will reimburse all, if any, of Vical's ASP0113-related costs; whether Vical or its licensees will seek or gain approval to market ASP0113 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.

SOURCE Astellas Pharma US, Inc.