Table of Contents

Section I. Executive Summary (See Below)

Section II. Microbicides/Spermicides: Opportunities for Industrial Collaboration

Section III. The Need for Vaginal Microbicides

• Market Research
• Microbicides under Study
• Research Challenges
• The Regulatory Process
• Other Private Sector Concerns

Section IV. Conclusion

About FHI, About CICCR, Acknowledgments

Section I. Executive Summary

Worldwide, many women urgently need the option of a vaginal microbicide to reduce their risk of acquiring sexually transmitted diseases (STDs), particularly HIV/AIDS, during heterosexual intercourse. Thus, a potentially large market exists for such a product. A vaginal microbicide, with or without spermicidal activity, could serve as an alternative or adjunct to existing methods of protection.

Male latex condoms currently provide the best protection against both bacterial and viral STDs, but require consistent and correct use. In addition, many women at high risk for STDs cannot negotiate condom use with their sexual partners. While female condoms also show promise of providing protection against STDs and have the advantage of being controlled by women, they are expensive, not widely available in many parts of the world, and may require partner consent. Furthermore, some women may choose not to use either type of condom because they wish to conceive, although they are still interested in STD protection.

There are multiple challenges involved in the development of a safe, effective and acceptable vaginal microbicide, making collaboration between the private and public sectors essential.

First, because microbicide development and testing is highly complex, bringing a product to market will be costly. Pharmaceutical company representatives say they want to "do good" for the world, but they also must "do well" financially. They need and want to know how they can better assess the financial risks or benefits of investing in microbicide research and development. That means that they need better estimates of the size of the potential market, more scientific information, and encouragement that they will receive guidance on regulatory requirements. They need to consider how to reduce risks of liability, and they need help to gain access to foreign markets and retain intellectual property rights.

In an effort to encourage discussion of microbicide development challenges and public/private sector collaborative solutions by representatives of nonprofit organizations and pharmaceutical companies, Family Health International (FHI), the Consortium for Industrial Collaboration in Contraceptive Research (CICCR) of the Contraceptive Research and Development (CONRAD) Program, and the International Working Group on Microbicides (IWGM) held an international conference to explore opportunities for collaboration between the public and private sectors. Participants reviewed current scientific knowledge about vaginal microbicides, identified research priorities and acceptability issues, described regulatory processes affecting and often facilitating the conduct of both preclinical and clinical investigations, evaluated potential consumer demand, and considered the product in the context of women's issues. In addition, industry representatives shared their views and perspectives on collaboration, and liability issues were explored.

Emerging from the conference were several themes that suggest avenues for further work:

• Research should focus on the development of an agent for vaginal and perhaps rectal use that is effective against HIV. Evidence strongly suggests that the presence of other STDs promotes HIV infection, justifying efforts to develop a microbicide active against these other STDs as well. However, a product that does not directly reduce the risk of HIV infection will be difficult to market.
• More scientific data are needed. The pharmaceutical industry wants to be able to quantify the financial risk of developing a topical microbicide, but that risk is difficult to evaluate without more safety and efficacy data on the effectiveness of a microbicide in humans.
• Involving regulatory agencies early in the research process should be encouraged. The U.S. Food and Drug Administration (FDA) is committed to a priority review of marketing applications for products that would prevent serious and life-threatening diseases, and is prepared to review the development of topical microbicides for HIV prevention in an expedited manner. The regulatory requirements of the European Union (EU) for testing topical microbicides are likely to be similar to those of the FDA.
• Additional information about the possible market for such a product is needed. If the market is large enough, pharmaceutical companies will feel encouraged to invest substantially in product development.
• Educating potential users about the product's value should be considered. Providing clear and accurate information will likely serve both to increase the market for the product and later decrease liability risks.
• Partnerships should be established to speed up the development of vaginal microbicides. The need for these products is urgent.

Willard Cates, Jr., MD, MPH
President, Family Health Institute
Family Health International

Henry L. Gabelnick, PhD
Director
The Contraceptive Research and Development (CONRAD) Program