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

December 3, 2008

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
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 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 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

Source: newswire

comments powered by Disqus