January 30, 2008
Silver Spring, Md. -- Expanding the pipeline of HIV prevention tools in development, the International Partnership for Microbicides (IPM) today announced that Pfizer Inc. (Pfizer) has agreed to give IPM a royalty-free license to maraviroc, its newly-approved HIV treatment, as a microbicide for the prevention of HIV infection. Maraviroc, sold under the trade name SelzentryTM/Celsentri®, is one of a new class of antiretroviral drugs known as CCR5 blockers, which works to prevent HIV infection by preventing the virus from gaining entry into target cells.
This agreement marks only the second time a pharmaceutical company has licensed an already approved HIV therapy to be developed as a microbicide. Researchers hope that maraviroc's safety and efficacy data as a therapeutic will speed its development as a microbicide.
"This agreement adds a promising new compound to IPM's pipeline, allowing us to explore new ways to prevent HIV infection," said Dr. Zeda Rosenberg, CEO of the International Partnership for Microbicides. "Pfizer and IPM's other industry partners deserve recognition for their significant leadership in the global effort to protect women from HIV."
Microbicides are products, such as gels and films, that could be applied vaginally to prevent transmission of HIV during vaginal intercourse. IPM is also developing other delivery methods such as long-lasting vaginal rings that release drug gradually over time.
"Pfizer is proud to contribute to the effort to develop a safe and effective microbicide with the potential to give women around the world new ways to protect themselves from HIV," said Pfizer Vice President Dr. Jack Watters. "Given maraviroc's mechanism of action blocking entry of HIV into the CD4 cells, the possibility for use in a microbicide is exciting. In addition to developing new drugs to treat AIDS, we are committed to searching for ways our drugs can be used to slow down or stop this epidemic."
Under this agreement, IPM would work to develop maraviroc as a vaginal microbicide with the right to develop, manufacture and distribute the microbicide in developing countries. Pfizer has granted these rights to IPM without a royalty.
"Women in the developing world are especially vulnerable to HIV, and urgently need new ways to protect themselves," said Dr. Tachi Yamada, president of the Bill & Melinda Gates Foundation's Global Health Program. "For Pfizer to offer one of its most important new drugs to benefit the poorest of the poor shows a special act of commitment. I hope their example will point the way for other companies to consider how they can address major global health challenges as well."
To date, five leading pharmaceutical companies have entered partnerships with IPM. In March 2004, IPM signed an agreement with Johnson & Johnson subsidiary Tibotec Pharmaceuticals Ltd. to develop the company's non-nucleoside reverse transcriptase inhibitor dapivirine as a microbicide. In October 2005, IPM entered agreements with Merck & Co. and Bristol-Myers Squibb to develop CCR5 blocker and entry inhibitor compounds early in development, and in December 2006 IPM reached an agreement with Gilead Sciences to develop tenofovir (PMPA), a nucleoside reverse transcriptase inhibitor.
HIV/AIDS ranks among the world's most devastating diseases because it has spread rapidly and mainly afflicts young people in their most productive years. Women, particularly those in developing countries, bear an increasing burden of the epidemic as both caregivers for the ill and because of their heightened risk of infection due to greater physiological, economic and social vulnerabilities. According to the UN, in sub-Saharan Africa, almost 61 percent of adults living with HIV are women. In many African countries, women and girls aged 15 to 24 are three times more likely to be HIV-infected than their male counterparts.