Gilead Grants Intellectual Property Rights for Tenofovir Topical Gel to the International Partnership for Microbicides and CONRA
December 11 2006 - 4:00PM
Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD), the International Partnership
for Microbicides (IPM) and CONRAD today announced an agreement
under which Gilead has granted rights to IPM and CONRAD to develop,
manufacture and, if proven efficacious, arrange for distribution in
resource-limited countries of tenofovir as a microbicide to prevent
infection with HIV, the virus that causes AIDS. There are currently
several microbicide candidates in clinical development designed to
prevent HIV transmission and possibly other�sexually
transmitted�infections. Tenofovir gel has previously been evaluated
in a Phase I study, and Phase II studies are being conducted
through the National Institutes of Health�s HIV Prevention Trials
Network. �We are grateful to Gilead for their leadership in the
development of microbicides for women,� said Dr. Zeda Rosenberg,
Chief Executive Officer of the International Partnership for
Microbicides. �Tenofovir has a successful track record as a
therapeutic, and an excellent safety profile. We are pleased to be
working with CONRAD, the NIH and the US Agency for International
Development to further study tenofovir as a microbicide candidate.
IPM and CONRAD will also investigate tenofovir in combination with
other antiretroviral agents.� Under the terms of the agreement,
Gilead will provide to both IPM and CONRAD a royalty-free license
to develop and, if proven efficacious, distribute tenofovir as a
microbicide in approximately 100 resource-limited countries hardest
hit by the HIV epidemic. Gilead will also facilitate the
manufacturing of tenofovir by third-party contract manufacturers to
supply ongoing clinical studies for two years, after which time
other suppliers, including generic manufacturers, may be utilized.
As a female-initiated technology, microbicides could fill an
important prevention gap for women who are unable to successfully
negotiate mutual monogamy, condom use, or other safer sex
practices. According to the latest UN report on the global AIDS
epidemic, in every region of the world more women than ever before
are living with HIV/AIDS. The 17.7 million women living with
HIV/AIDS in 2006 represent an increase of over one million compared
with 2004, making the need for female-initiated prevention tools
especially urgent. �Collaboration within the microbicide field is
crucial to our eventual success,� said Dr. Henry Gabelnick,
Executive Director of CONRAD. �It is through public-private
partnerships and the combined expertise of organizations like
CONRAD and IPM that we will get an effective microbicide quickly to
the women who urgently need this technology.� �The International
Partnership for Microbicides and CONRAD have broad expertise in the
development of microbicides for the potential prevention of HIV,�
said John C. Martin, PhD, President and CEO, Gilead Sciences.
�Their knowledge and leadership will help ensure the appropriate
clinical studies to evaluate the potential of tenofovir as a
microbicide advance as quickly as possible.� Tenofovir was
discovered through a collaborative research effort between Dr.
Antonin Holy, Institute of Organic Chemistry and Biochemistry,
Academy of Sciences of the Czech Republic (IOCB) in Prague and Dr.
Erik DeClercq, Rega Institute for Medical Research, Katholic
University in Leuven, Belgium. The inventors have agreed to waive
their right to a royalty on sales of products containing tenofovir
in the 97 developing countries served by the Gilead Access Program
to ensure the product can be offered at a no-profit price in parts
of the world where the AIDS epidemic has hit the hardest. About IPM
IPM was established in 2002 to accelerate the development and
accessibility of microbicides to prevent the transmission of HIV in
women. By screening compounds, designing optimal formulations,
establishing manufacturing capacity, developing trial sites and
conducting efficacy trials, the organization works to improve the
efficiency of all efforts to develop and deliver safe and effective
microbicides as soon as possible. More information on IPM is
available at www.ipm-microbicides.org. About CONRAD CONRAD is a
cooperating agency of USAID committed to improving reproductive
health by expanding the contraceptive choices of women and men and
by helping to prevent the transmission of HIV/AIDS and other
sexually transmitted diseases. CONRAD is administered through the
Department of Obstetrics and Gynecology at Eastern Virginia Medical
School (EVMS) in Norfolk, VA, with the main office located in
Arlington, VA. More information on CONRAD is available at
www.conrad.org. 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 Australia. For more information on Gilead, please visit
us at www.gilead.com. 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 that 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 the Gilead Annual Report
on Form 10-K for the year ended December 31, 2005, 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.
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