Title: Vical Announces Licensee's Conditional Approval of
Therapeutic Cancer Vaccine for Dogs SAN DIEGO, March 26 /PRNewswire-FirstCall/ -- 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."
About Canine 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.
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.
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 Merial's melanoma therapeutic DNA
vaccine, Vical's technology and its current and potential applications, as well as the
company's focus, collaborative partners, and product candidates. Risks and uncertainties
include whether Merial will successfully market and distribute its melanoma therapeutic
DNA vaccine, and if so, to what extent; whether Merial's melanoma therapeutic DNA vaccine
will be a successful adjunct treatment for melanoma in dogs; whether Merial will collect
sufficient additional efficacy data on its melanoma therapeutic DNA vaccine to support
full marketing approval; whether Vical's Allovectin-7(R) or any other product candidates
under development by Vical or its collaborative partners will be shown to be safe and
effective in clinical trials; 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.
Contacts: Investors: Media:
Alan R. Engbring Susan Neath
Vical Incorporated Porter Novelli Life Sciences
(858) 646-1127 (619) 849-6007
Website: www.vical.com
SOURCE Vical Incorporated
-0- 03/26/2007
/CONTACT: Investors, Alan R. Engbring of Vical Incorporated,
+1-858-646-1127; or Susan Neath of Porter Novelli Life Sciences,
+1-619-849-6007, for Vical Incorporated/
/Web site: http://www.vical.com /
(VICL)
CO: Vical Incorporated; Merial Limited; U.S. Department of Agriculture; USDA
ST: California
IN: HEA MTC BIO
SU: LIC PET
LP
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