Vical Announces Licensee's Conditional Approval of Therapeutic Cancer Vaccine for Dogs

Vical Incorporated (Nasdaq: VICL) today announced that its licensee Merial Limited, a joint venture of Merck & Co., Inc. and sanofi-aventis, received notification of conditional approval from the U.S. Department of Agriculture (USDA) to market a therapeutic DNA vaccine designed to treat melanoma, a serious form of cancer in dogs. The approval triggers a $0.2 million milestone payment to Vical. "Conditional approval" means the product has been shown to be safe and have a reasonable expectation of efficacy in treating melanoma. The designation allows Merial to market the therapeutic vaccine while collecting additional efficacy data to support full marketing approval.

"This canine melanoma therapeutic DNA vaccine is the first companion animal product to receive conditional approval for our licensee Merial," said Vijay B. Samant, Vical's President and Chief Executive Officer, "which represents a significant advancement for our DNA delivery platform technology, building on the previous approval of a vaccine for farm-raised salmon for another of our licensees. Through our independent and partnered programs, we continue advancing toward initial approvals of DNA-based human health products for infectious diseases, cancer, and angiogenesis. We believe the progress of this DNA-based therapeutic vaccine for canine melanoma bodes well for DNA- based approaches for human melanoma. We are particularly encouraged by the prospects for our Allovectin-7(R) DNA-based immunotherapeutic for patients with metastatic melanoma."

Melanoma is an aggressive form of cancer that commonly occurs in the dog's mouth, toes or footpads, and is virtually always malignant at these sites. Normal treatment for canine melanoma includes surgery, radiation, and combination chemotherapy, but even after successful treatment, the melanoma often recurs. Merial's melanoma therapeutic DNA vaccine is designed as an adjunct to treat melanoma in dogs.