Vical and Teva Establish Sales and Marketing Agreement for Allovectin-7(r) in Israel

SAN DIEGO, Aug. 3, 2009 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today announced an exclusive agreement with Abic Marketing Limited, a subsidiary of Teva Pharmaceutical Industries Ltd., for sales and marketing of the company's Allovectin-7(r) immunotherapeutic product candidate in Israel. Teva has agreed to pay Vical upfront and milestone payments in exchange for the rights to an exclusive license for Israel.

Vijay B. Samant, Vical's President and Chief Executive Officer, said, "We are pleased to collaborate with Teva in serving this key melanoma market, where we are currently enrolling patients at three of Israel's leading clinical centers. As we advance toward completion of enrollment in our pivotal Phase 3 trial of Allovectin-7(r) in patients with metastatic melanoma, we continue to explore licensing and distribution agreements in additional international markets."

About Allovectin-7(r)

Allovectin-7(r) is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and beta-2 microglobulin, which together form a Class I Major Histocompatibility Complex, or MHC-I antigen. Injection of Allovectin-7(r) directly into tumors is designed to stimulate an immune response against both local and distant metastatic tumors. Vical conducted a large Phase 2 trial evaluating Allovectin-7(r) immunotherapeutic as a single agent for patients with Stage III or IV metastatic melanoma. Based on advice from clinical experts and detailed guidance received from the U.S. Food and Drug Administration (FDA) in an End-of-Phase 2 meeting, Vical successfully completed a Special Protocol Assessment (SPA) with the FDA for a Phase 3 trial (the Allovectin-7(r) Immunotherapeutic for Metastatic Melanoma, or AIMM trial) for certain patients with Stage III or Stage IV metastatic melanoma. The SPA agreement specifies that the trial design and planned analyses address the study's objectives and the resulting study data could provide the primary basis to support a product license application.

Allovectin-7(r) has been granted orphan drug designation for the treatment of invasive and metastatic melanoma by the FDA's Office of Orphan Products Development. Orphan drug designation provides U.S. marketing exclusivity for seven years if marketing approval is received from the FDA, in addition to certain tax benefits for qualifying expenses.

About the AIMM Trial

Vical is conducting a Phase 3 pivotal trial of the company's Allovectin-7(r) cancer immunotherapeutic as first-line therapy in chemotherapy-naive patients with Stage III or IV metastatic melanoma. The AIMM trial is being conducted in accordance with the SPA agreement at more than 60 clinical sites, and is currently enrolling patients in the United States, Canada and Europe. AnGes MG, Inc., is funding the clinical trial under a collaborative agreement with Vical.

The AIMM trial calls for enrollment of approximately 375 patients with Stage III or IV metastatic melanoma. Patients may have been previously treated with surgery, adjuvant therapy, and/or biotherapy, but cannot have been previously treated with cytotoxic chemotherapy. The patients will be randomized on a 2:1 basis: approximately 250 patients will be treated with Allovectin-7(r) and approximately 125 will be treated with their physician's choice of either of two chemotherapy agents, dacarbazine or temozolomide. The primary endpoint is a variation of progression-free survival, specifically comparison of objective response rates at six months or more after randomization. The study will also evaluate safety and tolerability as well as overall survival. A patient self-screening tool for trial eligibility is available online at www.melanomaclinicaltrial.com.

About Metastatic Melanoma

The American Cancer Society has estimated that about 68,720 new diagnoses of, and approximately 8,650 deaths from, melanoma will occur in 2009 in the United States. Currently, there are no consistently effective therapies for advanced cases of metastatic melanoma where the cancer has spread to other parts of the body. The toxicity associated with FDA-approved treatments such as dacarbazine or interleukin-2 is often significant, resulting in serious or life-threatening side effects in many of the patients treated. Patients with metastatic melanoma often are treated off-label with drugs such as temozolomide, which has been approved by the FDA for the treatment of certain types of brain cancer but not for the treatment of metastatic melanoma. Temozolomide is an orally-delivered pro-drug that converts in the body into the same active compound as dacarbazine.

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 Vical's DNA delivery technology include DNA immunotherapeutics for cancer, in which the expressed protein is an immune system stimulant; DNA vaccines for infectious diseases, in which the expressed protein is an immunogen; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. Vical is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, Vical collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide Vical with mutually beneficial opportunities to expand its product pipeline and serve significant unmet medical needs. Additional information on Vical is available at www.vical.com.

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 Teva agreement, Allovectin-7(r), and the AIMM trial. Risks and uncertainties include: whether Teva will successfully sell and market Allovectin-7(r) in Israel; whether Vical will achieve any milestones and whether Teva will pay Vical any upfront or milestone payments under the agreement; whether Vical or others will continue development of Allovectin-7(r); whether Vical will be able to recruit patients into the AIMM trial as planned, if at all; whether Vical will receive all of the clinical trial funding from AnGes under the collaborative agreement; whether Allovectin-7(r) or any other product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners 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 company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

CONTACT:  Vical Incorporated
          Alan R. Engbring
          (858) 646-1127
          www.vical.com