Gilead has granted royalty-free rights to the International Partnership for Microbicides to use its antiretroviral drug tenofovir in microbicides to prevent HIV transmission, the company announced this week. A royalty-free license has also been granted to CONRAD, an agency funded by the US National Institutes of Health and USAID to carry out research in reproductive health and microbicides.
The International Partnership for Microbicides (IPM) is a non-profit product development partnership (PDP) established in 2002 to prevent HIV transmission by accelerating the development and availability of a safe and effective microbicide for use by women in developing countries.
Tenofovir is already being tested as an ingredient in a microbicide gel in a phase II trial run by the US government-funded HIV Prevention Trials Network.
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 utilised.
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.”
IPM has already been granted rights to develop another antiretroviral product in a microbicide. Dapirivine (TMC-120) was licensed by Tibotec, a division of Johnson & Johnson, in 2004.
For an overview of the HIV microbicide pipeline, click here.