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Vical Signs Binding Letter of Intent for Sales and Marketing of Allovectin-7(R) in Turkey
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."
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 http://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.
About EIP
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.
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 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 http://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
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