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.
