Coley Pharmaceutical
Group, Inc. (Nasdaq: COLY) today announced that the company has amended its
strategic alliance license agreement with GlaxoSmithKline (GSK) for the use
of Coley's VaxImmune(TM) vaccine adjuvant product in the development of
certain infectious disease vaccines. As a result of this amendment, Coley
will be able to enter into additional non-exclusive licenses with other
vaccine developers for the use of VaxImmune in infectious disease vaccines.
Coley and GSK have an additional agreement for the use of VaxImmune in
certain cancer vaccines. The amendment announced today does not modify the
agreement relating to GSK's cancer program with VaxImmune.
Coley and GSK originally entered into a worldwide co-exclusive license
for the use of Coley's proprietary VaxImmune vaccine adjuvant compound in
certain therapeutic and prophylactic vaccines for infectious diseases in
December 1998. As a result of the amendment to the agreement being
announced today, certain co-exclusive licenses in the original agreement
for the use of VaxImmune with select infectious disease antigens will be
converted to non-exclusive licenses. As part of the conversion, there was
an adjustment to the financial terms (milestones and royalties) including a
$17.4 million reduction in the potential regulatory and development
milestones to be earned by Coley under the original $79.3 million
infectious disease agreement.
Coley believes that this amendment provides an important business
advantage by creating new partnership opportunities for VaxImmune with
biotech, pharmaceutical and government organizations who may be interested
in leveraging the vaccine adjuvant in the development of prophylactic and
therapeutic vaccines for infectious diseases. The amendment enables Coley
to license VaxImmune for use in virtually all infectious disease vaccines.
VaxImmune is a proprietary Toll-like receptor 9 (TLR9) agonist designed
to induce both an enhanced antibody response and a potent killer T cell
immune response to infection or tumors in order to achieve and sustain a
clinical response without compromising safety. In clinical trials conducted
by GSK to date, the product has shown effective immunostimulatory
properties and a positive safety profile. Coley has made VaxImmune
available to several partners for evaluation in a wide array of vaccines
for infectious diseases and various cancer indications.
In the field of cancer, GSK's most advanced VaxImmune program is in
Phase II clinical testing for breast cancer. GSK has also initiated
clinical testing with VaxImmune paired with prostate and lung cancer
antigens.
"In our eight years of corporate history, Coley has demonstrated its
ability to be a prolific partner," said Steve Bernitz, Senior Vice
President, Business and Commercial Development of Coley. "As vaccine
developers increasingly embrace adjuvant technology as a critical component
of good vaccine design and development, the demand increases for promising
adjuvant technologies, like VaxImmune, that have the potential to enhance
and direct immune responses without compromising safety. We believe that
amending our agreement with GSK allows us the flexibility to further
capitalize on the value of VaxImmune."
About Coley Pharmaceutical Group
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical
company, headquartered in Wellesley, Massachusetts, USA, that discovers and
develops TLR Therapeutics(TM), a new class of investigational drug
candidates that direct the human immune system to fight cancers, infectious
diseases, asthma and allergy. Coley has established a pipeline of four TLR
Therapeutic product candidates currently advancing through clinical
development either independently or with partners, and additional product
candidates in preclinical development. Coley has product development,
research and license agreements with Pfizer, sanofi-aventis, Novartis
Vaccines & Diagnostics (formerly Chiron), GlaxoSmithKline and the United
States government. For further information on Coley Pharmaceutical Group
please visit coleypharma/.
Safe Harbor Statement
Certain statements in this news release concerning Coley's business are
considered "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements include, but are
not limited to, those relating to Coley's ability to form future VaxImmune
partnerships. Any or all of the forward-looking statements in this press
release may turn out to be wrong. They can be affected by inaccurate
assumptions Coley might make or by known or unknown risks and
uncertainties, including, but not limited to: the early stage of product
development; uncertainties as to the future success of ongoing and planned
clinical trials; the risk that results from early stage clinical trials may
not be indicative of results in later stage trials; the unproven safety and
efficacy of products under development; intellectual property rights and
litigation; competitive products; and other risks identified in Coley's
filings with the Securities and Exchange Commission including, but not
limited to, Coley's Annual Report on Form 10-K for the fiscal year ended
December 31, 2005. Consequently, no forward-looking statement can be
guaranteed, and actual results may vary materially. Coley undertakes no
obligation to publicly update forward-looking statements, whether because
of new information, future events or otherwise, except as required by
applicable law.
Coley Pharmaceutical Group, Inc.
coleypharma/