Royalty-free license granted for development of tenofovir and topical microbicide

On 11 December, Gilead announced that it has granted royalty-free licenses to develop, and if effective, to manufacture and distribute, tenofovir, used in a topical gel as a microbicide, to the International Partnership for Microbicides, and Conrad.

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 Healths HIV Prevention Trials Network.

The 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 used.

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.

Source: Gilead press release. Gilead grants intellectual property rights for tenofovir topical get to the International Partnership for Microbicides and Conrad. 12 Dec 2006