International Partnership for Microbicides (IPM) said that it has reached an agreement with Tibotec Pharmaceuticals Limited, a subsidiary of Johnson & Johnson to develop the TMC120 as a safe and effective microbicide to help protect women from infection with HIV. This agreement marks the first collaboration in the microbicide field between a major health care company and a public-private partnership such as IPM.
Microbicides in the form of gels, films, sponges and other products, would be applied topically (such as intravaginally) to help prevent sexual transmission of HIV. TMC120 belongs to the class of drugs known as NNRTIs (non-nucleoside reverse transcriptase inhibitors). NNRTIs are already widely used therapeutically to treat people living with HIV/AIDS; their promise as topical microbicides to prevent the transmission of HIV has been recognized for some time.
About half of all HIV infections globally occur among women. They are biologically more vulnerable to infections and are often powerless to abstain from sex or to insist on condom use. According to a recent Rockefeller Foundation Report1, a microbicide that is even partially effective against HIV could avert 2.5 million HIV infections over three years. Experts believe it will take five-10 years to develop such a microbicide.
Under the arrangement, Tibotec provides a royalty-free license to IPM to develop, manufacture and distribute TMC120 as a microbicide in resource poor countries. Tibotec Pharmaceuticals Limited has already developed a TMC120-containing gel which is currently in Phase I clinical testing. IPM will assume responsibility for development of this compound. Additionally, IPM will look to develop other formulations with TMC120, both alone and in combination with other active ingredients. Under the agreement, Tibotec Pharmaceuticals Limited will bear the cost of the compound through Phase II testing and will remain active as a scientific advisor.
"We applaud Tibotec Pharmaceuticals Limited and Johnson & Johnson for this act of corporate citizenship," said Zeda Rosenberg, CEO of IPM. "This agreement demonstrates that the public and private sectors can come together to confront the global AIDS pandemic and work to save women's lives."
"IPM is uniquely positioned to undertake the development of TMC120," said Paul Stoffels, M.D., president of Tibotec Pharmaceuticals Limited. "With their commitment to accelerate the discovery, development and accessibility of safe and effective microbicides for HIV and their breadth of expertise, we are confident that IPM will maximize the potential benefit of this compound for women in resource-poor countries."
"This agreement is a major milestone in global efforts to develop a microbicide for all women around the world, and is a model of the innovative collaboration that is crucial to reversing the AIDS epidemic," said Dr Peter Piot, executive director of UNAIDS in Geneva. "Microbicides must be at the centre of a comprehensive prevention agenda for women and girls, who account for about half of all HIV infections worldwide."
"Microbicides are one of the most exciting scientific prospects we have in the fight against HIV/AIDS. An accelerated research breakthrough could give the women of Africa a significant measure of sexual autonomy, without which the pandemic cannot be defeated," said Stephen Lewis, UN Special Envoy on HIV/AIDS in Africa.
Public-private partnerships such as IPM are not-for-profit organizations that work with the public and private sectors to accelerate the development of international public goods.
IPM's major financial supporters include five European countries - Denmark, Ireland, the Netherlands, Norway and the United Kingdom - as well as the Bill & Melinda Gates Foundation, the Rockefeller Foundation, UNFPA and the World Bank.