Gilead & GlobeImmune Announce License & Collaboration Agreement to Develop Therapeutic Vaccine Products for Treatment of Chro...
October 24 2011 - 4:25PM
Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD) and GlobeImmune, Inc. today
announced that the companies have entered into an exclusive
worldwide license and collaboration agreement for the development
and commercialization of therapeutic vaccine products for use in
conjunction with Viread® (tenofovir disoproxil fumarate) and other
oral therapies for the treatment of chronic hepatitis B virus (HBV)
infection.
Under the terms of the agreement, Gilead will pay GlobeImmune an
upfront payment and provide support for GlobeImmune’s continued
development of its HBV therapeutic vaccine program through Phase 1a
clinical trials. Gilead can assume full responsibility for clinical
development following Phase 1a. GlobeImmune also could receive
additional payments based upon achievement of certain development
milestones, as well as royalties on future potential net sales.
The goal of the research collaboration is to create and develop
therapeutic vaccine products that have specific HBV DNA antigens
cloned into S. cerevisiae (a species of yeast). The companies
anticipate that the combination of a therapeutic vaccine with oral
suppressive antiviral therapy could help increase surface antigen
(HBsAg) loss with seroconversion – a marker of the resolution of
chronic HBV infection.
“This collaboration is a significant milestone in GlobeImmune’s
efforts to advance therapies for major unmet medical needs,” said
David Apelian, MD, PhD, Senior Vice President Research &
Development and Chief Medical Officer at GlobeImmune. “Based on the
proof-of-concept studies in hepatitis C infection, we believe that
the combination of GlobeImmune’s Tarmogen immunotherapy products
with oral suppressive antiviral therapy will help eliminate the
cells harboring the hepatitis B virus, thus increasing
seroconversion within a finite period.”
“Finite therapy remains a significant unmet
need for patients with chronic hepatitis B,” said Norbert W.
Bischofberger, PhD, Gilead’s Executive Vice President, Research and
Development and Chief Scientific Officer. “We are hopeful that this
approach will allow us to explore whether adaptive immunomodulatory
approaches to HBV will help us improve HBsAg seroconversion,
thereby eliminating the need for life-long daily therapy.”
About GlobeImmune
GlobeImmune, Inc. is a private company developing therapeutic
vaccines called Tarmogen® products for the treatment of cancer and
infectious diseases. Tarmogens stimulate the natural production of
T cells that are capable of locating and eliminating cancer cells
and virally-infected cells. GlobeImmune has raised over $160
million to date in support of its programs. For additional
information, please visit the company’s website at
www.globeimmune.com.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of
unmet medical need. The company’s mission is to advance the care of
patients suffering from life-threatening diseases worldwide.
Headquartered in Foster City, California, Gilead has operations in
North America, Europe and Asia Pacific. For more information on
Gilead, please visit www.gilead.com.
Gilead Forward-Looking
Statement
This press release includes forward-looking statements, within
the meaning of the Private Securities Litigation Reform Act of
1995, that are subject to risks, uncertainties and other factors,
including risks related to the development and commercialization of
therapeutic vaccines for the treatment of chronic HBV infection.
Further, there are risks related to clinical trials of therapeutic
vaccines under the collaboration, including the ability to enroll
sufficient patients, the possibility of unfavorable results, the
need to modify or delay the studies or to perform additional trials
and the risk of failing to obtain approvals from the regulatory
authorities. As a result, therapeutic vaccines under the
collaboration may never be successfully commercialized. In
addition, Gilead and GlobeImmune may make a strategic decision to
terminate the collaboration or discontinue development of certain
therapeutic vaccines under the collaboration. These risks,
uncertainties and other factors could cause actual results to
differ materially from those referred to in the forward-looking
statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead's Quarterly Report on Form 10-Q for the quarter
ended June 30, 2011, as filed with the U.S. Securities and Exchange
Commission. All forward-looking statements are based on information
currently available to Gilead, and Gilead assumes no obligation to
update any such forward-looking statements.
Viread is a registered trademark of Gilead
Sciences, Inc.
Tarmogen is a registered trademark of
GlobeImmune, Inc.
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