What are microbicides?
Why do women need microbicides?
What is the state of microbicide development?
When will women have safe and effective microbicides?
What resources are needed to develop a microbicide in that time frame?
What is the International Partnership for Microbicides (IPM)?
How does IPM work?
Who is funding IPM?
How does IPM work with the private sector on microbicide development?
How will IPM ensure that women in low-income countries get timely and affordable access to microbicides?
How are women’s preferences considered in microbicide development?
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| What are microbicides? |
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Microbicides are vaginal products being developed to reduce the transmission of HIV during sexual intercourse. Microbicides could take the form of a gel, cream, film, suppository or sponge, or be contained in a vaginal ring that releases the active ingredient gradually. A microbicide could also be in a new formulation and use a delivery method yet to be invented. Microbicides would be a useful complement to other HIV-prevention measures, including safer sex education, condom distribution, voluntary testing and counseling, testing and treatment of sexually transmitted infections, anti-stigma campaigns, safe blood supplies and (hopefully, one day) a vaccine. |
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| Why do women need microbicides? |
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Increasingly, women and girls bear the brunt of the HIV/AIDS epidemic. More than 17.3 million women are now living with HIV and AIDS globally, and the number continues to rise. In sub-Saharan Africa, 59% of all adults living with HIV are women (UNAIDS, “2006 Report on the Global AIDS Epidemic”). Women are becoming infected with HIV at a faster rate than men due largely to their increased biological susceptibility and pervasive gender inequality. Many women have little or no control over the conditions under which they have sex and often cannot negotiate the use of condoms. A microbicide has the potential to put the power of protection from HIV infection into the hands of women and save millions of lives. |
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| What is the state of microbicide development? |
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Three first-generation microbicide candidates are in large-scale efficacy trials, in which thousands of women in Africa are enrolling. The three products are BufferGel, Carraguard, and PRO 2000. In addition, dozens of next-generation microbicide candidates are in safety studies and pre-clinical development. |
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| When will women have safe and effective microbicides? |
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With proper funding and political commitment, it may be possible to put microbicides into the hands of women in the next five to seven years. |
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| What resources are needed to develop a microbicide in that time frame? |
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In 2005, US$163 million (€128 million) was committed to microbicide research, development and advocacy worldwide. Projections developed by IPM, the Alliance for Microbicide Development and the Global Campaign for Microbicides estimate that the global annual investment to ensure timely development of a safe and effective microbicide must increase to US$280 million (€220 million) per year over the next five years – and remain at approximately US$260 million (€205 million) per year until satisfactory microbicides are licensed. |
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| What is the International Partnership for Microbicides (IPM)? |
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IPM is a non-profit product development partnership (PDP) established in 2002 to prevent HIV transmission by accelerating the development and availability of safe and effective microbicides for use by women in developing countries. |
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| How does IPM work? |
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IPM promotes the rapid development and delivery of microbicides by pioneering a “best-practices” approach to:
- screen compounds and design optimal formulations;
- develop clinical trial sites and conduct clinical trials;
- identify appropriate regulatory pathways for microbicide products;
- establish manufacturing and distribution capacity to ensure rapid access to microbicides as soon as they become available.
IPM also funds, co-funds or leverages resources to support the drug development projects of other entities. In some cases, however, the most efficient approach is for IPM, itself, to take the lead in developing, testing and conducting clinical trials of promising microbicide compounds. |
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| Who is funding IPM? |
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IPM receives funding from the governments of Belgium, Canada, Denmark, France, Germany, Ireland, the Netherlands, Norway, Sweden, the United Kingdom and the United States, as well as the Bill and Melinda Gates and Rockefeller Foundations, the European Commission, UNFPA and the World Bank. |
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| How does IPM work with the private sector on microbicide development? |
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As a product development partnership, IPM seeks to marshal expertise and resources in the private sector to advance microbicide research. IPM establishes agreements with private companies that allow it to develop industry products for use as microbicides in less-developed countries. To date, IPM has acquired royalty-free licenses to develop, manufacture and distribute antiviral compounds as microbicides in developing countries from four major drug companies: Tibotec Pharmaceuticals, Ltd. (a subsidiary of Johnson & Johnson) licensed dapivirine (TMC120) to IPM in March 2004; Merck and Co., Inc. and Bristol-Myers Squibb in October 2005 each licensed antiretrovirals known as “entry inhibitors” that bind directly to HIV or the CCR5 receptor designed to prevent HIV from efficiently entering host cells; and Gilead Sciences, Inc. granted rights for tenofovir to IPM and CONRAD in December 2006. |
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| How will IPM ensure that women in low-income countries get timely and affordable access to microbicides? |
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IPM works on numerous fronts to foster a social and policy environment supportive of and conducive to rapid microbicide introduction and use by:
- conducting a series of consumer studies to determine women’s preferences, raise their awareness of this new technology and elicit their input in the development of a microbicide gel;
- learning lessons from the introduction of other health commodities in developing countries and anticipating opportunities to support future microbicide use in current commitments to scaling up global responses to HIV and AIDS and to improve health in developing countries;
- identifying regulatory pathways to optimize product approval and licensure;
- developing comprehensive country profiles to help anticipate possible barriers to microbicide accessibility and resolve potential problem areas; and
- supporting studies to model the use of microbicides as part of comprehensive HIV prevention strategies in different country and epidemiological settings.
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| How are women’s preferences considered in microbicide development? |
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Effectiveness is influenced by acceptability. Even the most efficacious microbicide in the world will not work if it is not used correctly. Feedback from safety studies in many developing countries points to the need for microbicides that do not interfere with sexual intercourse and may be used discreetly. It is crucial that cultural differences surrounding sexual practices are considered in the development of novel delivery methods for microbicides. IPM has already completed one of several consumer studies aimed at determining the preferences and opinions of African women and their male partners regarding different types of gels, and is also planning for an acceptability study for the vaginal ring. Results from these studies and others will enable IPM and other microbicide developers to appropriately address women’s preferences for different types of microbicide delivery methods. |
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Last updated: March 2007 |
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