IPM Receives License from Janssen to Develop FDA-Approved HIV-1 Drug as Microbicide for HIV Prevention
Expands pipeline of next-generation sexual and reproductive health products for women
SILVER SPRING, Md. (December 1, 2015) – The International Partnership for Microbicides (IPM), a nonprofit product developer, today expanded its relationship with Janssen Sciences Ireland UC (Janssen), one of the pharmaceutical companies of Johnson & Johnson, through a new agreement to help protect women against sexual transmission of HIV. This new agreement grants IPM an exclusive, royalty-free license to develop darunavir, an antiretroviral (ARV) medicine used for HIV-1 treatment, as a vaginal or rectal microbicide for HIV prevention in selected developing countries at an affordable cost. Today, on World AIDS Day, this agreement marks an important advancement in the pipeline of HIV and multipurpose prevention products for women’s sexual and reproductive health.
Today’s announcement marks the first time a pharmaceutical company has licensed a protease inhibitor to be developed as a microbicide. Currently marketed by Janssen’s affiliates as PREZISTA®, darunavir is a second-generation protease inhibitor co-administered with ritonavir (PREZISTA®/r) and other ARVs for HIV treatment in adults, targeting HIV inside infected cells to prevent the formation of new virus capable of infecting healthy cells. Under the agreement, IPM may develop and commercialize vaginal or rectal microbicides containing darunavir in selected developing countries at a no-profit price.
This agreement builds on IPM’s groundbreaking public-private partnership with Janssen that began in 2004. In that agreement, Janssen granted IPM a license to develop the ARV dapivirine, which IPM developed as a vaginal ring that women could use to prevent sexual transmission of HIV. Dapivirine is a non-nucleoside reverse transcriptase inhibitor that prevents HIV from replicating after entering a healthy cell. The monthly ring is now in two Phase III trials with initial efficacy results expected early next year. That agreement expanded in scope in 2014, when IPM received exclusive worldwide rights to develop dapivirine as a microbicide, either by itself or in combination with other ARVs or with contraceptives. Today’s agreement also enables IPM to advance microbicides that combine darunavir with dapivirine. As with HIV treatment, combining two or more ARVs using different mechanisms of action may offer greater protection than a single drug alone when used for prevention.
“We are proud to continue partnering with Janssen to find new prevention solutions for the millions of women and girls at risk for HIV infection,” said Dr. Zeda F. Rosenberg, chief executive officer of IPM. “This arrangement is an important step in expanding our pipeline of innovative HIV prevention products that can meet women’s sexual and reproductive health needs and help end the epidemic.”
Microbicides are being developed in the form of long-acting vaginal rings, on-demand films and tablets, and rectal gels that would prevent sexual transmission of HIV using one or more ARVs. This agreement enables IPM to develop certain darunavir-based products, including combinations with other ARVs such as DS003, a novel gp120 binding inhibitor that blocks HIV’s ability to enter a healthy cell. IPM has a non-exclusive, royalty-free license from Bristol Myers-Squibb to develop DS003 as a microbicide. IPM can also combine darunavir with one or more of the contraceptive hormones ethinyl estradiol, etonogestrel and levonorgestrel to offer women multipurpose protection against overlapping risks to their health: HIV and unintended pregnancy, a leading contributor to maternal mortality.
“Janssen aspires to make a lasting difference in human health by addressing comprehensive health needs and delivering meaningful and enduring impact amongst vulnerable populations, and especially for women and girls,” said Wim Parys, M.D., vice president for global public health research and development of Janssen. “We are proud to collaborate with IPM and contribute our medical innovations to help IPM achieve ambitious goals. By combining our expertise, tools, and passion, we are working to develop medical solutions that might eventually help protect generations of women and girls against HIV.”
HIV/AIDS remains among the greatest obstacles to women’s health and development. Although remarkable advances have been made in reducing new infections, this progress has largely left women behind. In some parts of sub-Saharan Africa, young women and adolescent girls ages 15 to 24 are as much as eight times as likely to be infected as their male counterparts. New women-initiated tools, including microbicides and multipurpose prevention technologies, are being developed because stopping HIV’s spread among women requires a range of options that meet women’s individual needs.
“As a new mechanism of action in IPM’s pipeline with well-established safety and efficacy data as a therapeutic, darunavir has tremendous potential for HIV prevention,” said Dr. Brid Devlin, IPM’s executive vice president for product development. “The addition of this potent compound to our portfolio will help accelerate the development of next-generation microbicides and multipurpose prevention technologies.”
Since 2004, five major pharmaceutical companies — Bristol-Myers Squibb, Gilead, Janssen, Merck & Co., and ViiV Healthcare — have entered into royalty-free licenses with IPM to develop, manufacture and distribute eight ARVs as microbicides in developing countries. These licenses ensure that any new product will be provided at low cost in the settings where it is most urgently needed.
IPM’s work is made possible through generous support from the Ministry of Foreign Affairs of Denmark, Flanders Department of Foreign Affairs, Irish Aid, the Ministry of Foreign Affairs of the Netherlands, the Norwegian Agency for Development Cooperation (Norad), the United Kingdom Department for International Development (DFID), the American people through the United States Agency for International Development (USAID) through the President’s Emergency Plan for AIDS Relief (PEPFAR), and the Bill and Melinda Gates Foundation.
IPM is a nonprofit organization dedicated to developing new HIV prevention tools and other sexual and reproductive health technologies for women, and making them available in developing countries. IPM has offices in the United States and South Africa. Please visit www.IPMglobal.org.
IPM US and Europe: Holly Seltzer, hseltzer@IPMglobal.org, +1.301.608.4277
IPM Africa: Leonard Solai, lsolai@IPMglobal.org, +27.21.860.2314