Gilead grants royalty-free licenses for tenofovir use in microbicides

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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.

Glossary

microbicide

A product (such as a gel or cream) that is being tested in HIV prevention research. It could be applied topically to genital surfaces to prevent or reduce the transmission of HIV during sexual intercourse. Microbicides might also take other forms, including films, suppositories, and slow-releasing sponges or vaginal rings.

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

efficacy

How well something works (in a research study). See also ‘effectiveness’.

phase II

The second stage in the clinical evaluation of a new drug or intervention, in which preliminary data on effectiveness and additional information about safety is collected among a few hundred people with the disease or condition.

safer sex

Sex in which the risk of HIV and STI transmission is reduced or is minimal. Describing this as ‘safer’ rather than ‘safe’ sex reflects the fact that some safer sex practices do not completely eliminate transmission risks. In the past, ‘safer sex’ primarily referred to the use of condoms during penetrative sex, as well as being sexual in non-penetrative ways. Modern definitions should also include the use of PrEP and the HIV-positive partner having an undetectable viral load. However, some people do continue to use the term as a synonym for condom use.

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.