SILVER SPRING, Md. (October 21, 2013) The International Partnership for Microbicides (IPM) announced today that it has received two competitive five-year awards with a combined US$40 million ceiling from the US Agency for International Development (USAID). Both awards aim to advance new HIV prevention tools for women and to help ensure their availability in developing countries where the epidemic has hit hardest.
HIV infection is the leading cause of death among women of reproductive age worldwide. USAID's funding will support IPM's dapivirine vaginal ring designed to prevent HIV, now in late-stage clinical trials, and spur development of other promising products that will expand women's options with tools they can use to protect themselves against the virus.
"We commend USAID's continued leadership in improving the lives of the world's most vulnerable women," said Dr. Zeda Rosenberg, Chief Executive Officer of IPM. "USAID has been at the helm of efforts to protect women from HIV. This new funding will reduce the time it takes for novel, lifesaving products to go from development to the hands of women in developing countries."
IPM's dapivirine vaginal ring the first product of its kind could provide women with a discreet and easy-to-use tool to protect themselves against HIV infection. The ring slowly releases the antiretroviral (ARV) drug dapivirine over the course of one month. Because women would only need to replace the ring monthly, it may encourage consistent use, which would increase its effectiveness.
The ring is currently being studied in two Phase III clinical trials: IPM's Ring Study and the ASPIRE study being conducted by our partner, the Microbicide Trials Network. The Ring Study and ASPIRE are being conducted in Africa where the epidemic's toll is greatest. These sister studies, along with smaller safety studies, are designed to together provide the strength of evidence needed to secure regulatory approvals and licensure.
With this new award, USAID has committed up to US$25 million over five years toward the successful completion of IPM's Ring Study, and to obtain regulatory approval for the dapivirine ring in Africa and other regions of the world with a high HIV burden. This critical support will help ensure that, pending trial results in 2016, the ring will be distributed quickly at low cost to women who need it most.
This new award will also support a follow-on Phase IIIb study in 2016 that will give women who volunteered for The Ring Study access to the product prior to regulatory approval. The USAID funding will also support initial work to keep the cost of the ring for women as low as possible.
Bringing the global HIV epidemic to an end will require a diverse toolkit of products that women can fit into their varying lifestyles. To that end, USAID is also providing up to an additional US$15 million to support IPM's pipeline to spur the development of other microbicides currently in earlier stage research.
"When it comes to HIV prevention, there is no 'one-size-fits-all' product. Women urgently need a range of new tools that are tailored to their needs, and to the complex social, cultural and behavioral realities they face," said Dr. Lee Claypool, USAID Biologist. "To beat the epidemic, we must continuously invest in innovative HIV prevention tools for women."
USAID's award will advance IPM's diverse portfolio of promising products including single and combination rings and other formulations containing potent ARVs that target HIV at different stages of its lifecycle which is critical to broadening protection and staying one step ahead of the virus.
Top among them is a compound called DS003, a gp 120 inhibitor that blocks the virus from entering healthy cells and has few potential side effects. Because gp 120 inhibitors are not used for HIV treatment or prevention, this new compound would be unlikely to interfere with therapeutic regimens or result in resistance to other ARVs. With USAID's support, IPM will also continue development of a ring that includes maraviroc, an ARV that acts early in HIV's life cycle.
With the new funding, IPM will continue to forge public-private collaborations to further expand its pipeline and expedite development of potentially lifesaving tools. IPM already holds six licensing agreements with major pharmaceutical partners, including one for dapivirine with Janssen R&D Ireland, one for DS003 with Bristol Myers-Squibb, and one for maraviroc with Pfizer (now ViiV Healthcare).
IPM's leading-edge pipeline responds to women's urgent need for tools that can address their broad sexual and reproductive health concerns. Under an existing award, USAID is supporting IPM to develop a 60-day multipurpose prevention technology (MPT) ring, which combines dapivirine along with the contraceptive hormone levonorgestrel to simultaneously protect against HIV and unintended pregnancy.
Today's announcement follows two previous awards from USAID, bringing the institution's total investment in IPM to up to US$63 million. Additional IPM supporters include Denmark, Ireland, the Netherlands, Norway, the United Kingdom, the Bill and Melinda Gates Foundation, the MAC AIDS Fund and the OPEC Fund for International Development.
|Contact: Holly Seltzer|
International Partnership for Microbicides (IPM)