Coley Pharmaceutical Group Grants Dynavax License for Commercialization of HEPLISAV(TM)
28 Giugno 2007 - 11:02PM
PR Newswire (US)
WELLESLEY, Mass. and BERKELEY, Calif., June 28
/PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc.
(NASDAQ:COLY) and Dynavax Technologies Corporation (NASDAQ:DVAX)
today announced they have entered into a license agreement relating
to certain TLR Therapeutics(TM) patents from Coley. Under the terms
of the agreement, Dynavax receives a non-exclusive license under
Coley's immunostimulatory oligonucleotide patent estate for the
commercialization of HEPLISAV(TM), a hepatitis B prophylactic
vaccine, currently in Phase 3 clinical trials. Coley will receive a
$5.0 million up- front payment. Coley is also eligible to receive
up to an additional $5.0 million upon regulatory approvals of
HEPLISAV, as well as royalty payments for any future sales of
HEPLISAV. About HEPLISAV and Hepatitis B HEPLISAV is currently
being evaluated in a Phase 3 clinical trial in Canada and in
Europe. The multi-center trial, known as PHAST (Phase 3 HeplisAv
Short-regimen Trial), is comparing a two-dose regimen of HEPLISAV
administered at 0 and 1 month to the conventional three-dose
regimen of Engerix-B(R). The enrollment target of the study is
approximately 2,000 subjects, ages 11 to 55 years. Dynavax expects
to submit a BLA in 2008 for approval of the product with a database
of approximately 4,000 patients In several previous clinical
studies, HEPLISAV has been shown to provide seroprotection against
hepatitis B faster and with fewer doses than conventional hepatitis
B vaccines. Additionally, HEPLISAV has provided 100% seroprotection
in all subjects who have received the full regimen, including those
who are difficult-to-immunize. About Coley's TLR Therapeutics(TM)
Coley's TLR Therapeutics are a new class of investigational drug
candidates that target certain immune cells through Toll-like
receptors. The patents licensed today to Dynavax relate to Coley's
Toll-like receptor 9(TLR9) agonist technology that induce enhanced
antigen-specific antibody and T-cell immune responses when used in
combination with vaccines. Coley's TLR9 agonist drug candidate has
been included in approximately 35 clinical trials of vaccines in
development for use in various cancer indications, infectious
diseases and biowarfare defense. The most advanced clinical program
with Coley's TLR9 agonist vaccine adjuvant candidate is a planned
Phase III clinical trial under the direction of GlaxoSmithKline
(GSK) as part of a treatment for resectable, early stage lung
cancer. 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,
asthma and allergic diseases and to enhance the effectiveness of
vaccines. Coley has established a pipeline of TLR Therapeutic
product candidates currently advancing through clinical development
with partners and has additional product candidates in preclinical
development. Coley has product development, research and license
agreements with Pfizer, sanofi-aventis, GSK, Novartis Vaccines,
Merck and the United States government. For further information on
Coley Pharmaceutical Group please visit http://www.coleypharma.com/
. About Dynavax Dynavax Technologies Corporation discovers,
develops, and intends to commercialize innovative TLR9
agonist-based products to treat and prevent infectious diseases,
allergies, cancer, and chronic inflammatory diseases using
versatile, proprietary approaches that alter immune system
responses in highly specific ways. The company's TLR9 agonists are
based on immunostimulatory sequences, or ISS, which are short DNA
sequences that enhance the ability of the immune system to fight
disease and control chronic inflammation. Dynavax's pipeline
includes: HEPLISAV, a hepatitis B vaccine in Phase 3; TOLAMBA(TM),
a ragweed allergy immunotherapeutic; a therapy for non- Hodgkin's
lymphoma (NHL) in Phase 2 and for metastatic colorectal cancer in
Phase 1; and a therapy for hepatitis B also in Phase 1. A
preclinical asthma and COPD program is partnered with AstraZeneca.
The National Institutes of Health (NIH) partially funds preclinical
work on a vaccine for influenza; Symphony Dynamo, Inc., funds the
company's colorectal cancer trials and a preclinical hepatitis C
therapeutic program. While the NIH and Symphony provide program
support, Dynavax has retained rights to seek strategic partners for
future development and commercialization. For more information,
please visit http://www.dynavax.com/ . Safe Harbor Statements
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
royalty payments for any future product sales involving HEPLISAV.
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, 2006. 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. This press release
contains forward-looking statements concerning Dynavax that are
subject to a number of risks and uncertainties, including
statements about Dynavax's Heplisav hepatitis B vaccine and
financial terms of its agreement with Coley. Actual results may
differ materially from those set forth in this press release due to
the risks and uncertainties inherent in Dynavax's business,
including difficulties or delays in development; achieving the
objectives of collaborative and licensing efforts; and obtaining
regulatory approval for Heplisav; the scope and validity of patent
protection; possible claims based on the patent rights of others;
the ability to obtain additional financing to support operations;
and other risks detailed in the "Risk Factors" section of Dynavax's
Quarterly Report on Form 10-Q. Dynavax undertakes no obligation to
revise or update information herein to reflect events or
circumstances in the future, even if new information becomes
available. TLR Therapeutics is a trademark of Coley Pharmaceutical
Group. HEPLISAV is a trademark of Dynavax Technologies Corporation.
All other trademarks are the property of their respective holders.
DATASOURCE: Coley Pharmaceutical Group, Inc. CONTACT: Susan Hager
of Coley Pharmaceutical Group, Inc., Senior Director, Investor
Relations and Corporate Communications, +1-781-431-9079, ; or Karen
L. Bergman, +1-650-575-1509, kbergman@bccpartner, or Michelle
Corral, +1-415-794-8662, , both of BCC Partners for Coley; or Shari
Annes of Dynavax, +1-650-888-0902, for Coley Web site:
http://www.coleypharma.com/
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