Vical Signs Binding Letter of Intent for Sales and Marketing of Allovectin-7(R)... (peutic as a single agent for patientswit...)

Vical Signs Binding Letter of Intent for Sales and Marketing of Allovectin-7(R) in Turkey

Date:12/3/2008

peutic 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
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SOURCE Vical Incorporated
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