SAN DIEGO, Dec. 3 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL) today announced an exclusive, binding letter of intent with EIP Eczacibasi Ilac Pazarlama A.S. (EIP) for sales and marketing of the company's Allovectin-7(R) immunotherapeutic product candidate in Turkey and the Turkish Republic of Northern Cyprus. EIP has agreed to obtain the necessary regulatory approvals for the territory and to pay Vical upfront and milestone payments plus a specified transfer price in exchange for the rights to an exclusive license for the territory. EIP is a leading Turkish pharmaceutical company and has multiple licensing agreements with major biotech and pharmaceutical companies including Amgen, Pfizer, Procter & Gamble, and sanofi-aventis.
Vijay B. Samant, Vical's President and Chief Executive Officer, said, "As we advance toward completion of enrollment in our Phase 3 trial of Allovectin-7(R) in patients with advanced metastatic melanoma, we are also looking ahead to commercialization opportunities in key global markets. As an established pharmaceutical company in Turkey with a significant cancer franchise, EIP has the expertise to guide Allovectin-7(R) through the Turkish approval process and the strength to launch and sell Allovectin-7(R) successfully in the Turkish market. We continue to explore licensing and distribution agreements in additional international markets."
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 more than 62,000 new diagnoses of, and approximately 8,400 deaths from, melanoma will occur in 2008 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.
EIP is part of the Eczacibasi Group, a prominent Turkish industrial group of companies primarily involved in healthcare, consumer products, and building products. EIP focuses on sales and marketing of imported pharmaceuticals in specific therapeutic areas and has multiple licensing agreements with leading biotech and pharmaceutical companies.
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 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. 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 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 EIP agreement, Allovectin-7(R), and the AIMM trial. Risks and uncertainties include: whether EIP will obtain the necessary regulatory approvals for the Turkish territory; whether EIP will successfully sell and market Allovectin-7(R) in Turkey and the Turkish Republic of Northern Cyprus; whether Vical will achieve any milestones and whether EIP 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; whether defined sales levels will be achieved in any markets; 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: Alan R. Engbring
(858) 646-1127 Website: http://www.vical.com
|SOURCE Vical Incorporated|
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