Medicines360 and the Population Council Pursue Agreement to Develop Product to Prevent HIV and Unintended Pregnancy for Worldwide Distribution

SAN FRANCISCO and NEW YORK, Dec. 1, 2021 /PRNewswire/ -- Medicines360, a mission-driven nonprofit women's health pharmaceutical organization, and the Population Council, a global nonprofit research organization, have entered into a Memorandum of Understanding to develop a dual prevention pill (DPP) product to prevent both pregnancy and HIV in a single tablet – for global distribution. The organizations intend to expedite the development, regulatory, and manufacturing pathways of one of the newest multi-purpose prevention technologies (MPTs) specifically for women.  The organizations are seeking philanthropic support for product development, and clinical and regulatory work to bring the product to market.

Oral pre-exposure prophylaxis (PrEP) is an effective method of HIV prevention proven to reduce the risk of infection by about 99% when taken as prescribed.ⁱ, yet uptake of and adherence to PrEP in countries with high rates of HIV remains low, especially among adolescent girls and young women, who account for two-thirds of new HIV infections in sub-Saharan Africa. Research suggests that women would prefer an HIV prevention method that also prevents pregnancy, however more investment in developing these types of options for women is needed. To date, condoms have been the only available MPT.

"This collaboration has the potential to be a ground-breaking innovation for women's health," said Tina Raine-Bennett, MD, MPH, Chief Executive Officer of Medicines360. "For too long, women have had to deal with their family planning needs and sexual health needs in silos. The opportunity to provide women access to a high-quality product that effectively combines HIV prevention and contraception could increase uptake of PrEP among women and have countless benefits for their families, communities, and public health."

The DPP is designed for women of reproductive age who want to prevent pregnancy and are at high risk of contracting HIV. The Population Council has already completed early formulation work to support the feasibility of the development program. Medicines360 is developing the DPP product and together with Population Council, plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).

Published research suggests there is a market size of between 250,000 and 1.25 million potential users of the DPP in 15 sub-Saharan African countries where oral contraceptive use is stable or growing. Data suggests that current oral contraceptive users are likely to be early adopters of the DPP given their acclimation to a daily pill regimen.ⁱⁱ 

According to the U.S. Centers for Disease Control and Prevention, 1.2 million people in the United States are eligible for PrEPⁱⁱⁱ; of those, 486,000 are women.^iv  In 2016, women accounted for only 4.7% of patients who filled prescriptions for PrEP in the United States.^v  Conversely, oral contraceptive use remains the most popular form of reversible contraception among women in the U.S.: with roughly 9.1 million women aged 15-49 citing current use of oral contraceptive pills between 2015 and 2017.^vi

"Our research shows that women would be much more likely to use an HIV prevention product if it were also combined with a contraceptive," said Julia Bunting, president of the Population Council.  "An MPT that prevents both HIV and unintended pregnancy could help overcome barriers to negotiating condom use and has the potential to address adherence issues related to HIV stigma and to gender and power dynamics that can be associated with use of sexual and reproductive products." 

In 2018, the Population Council began development of a DPP formulation. The envisioned arrangement with Medicines360, with support from philanthropy, would accelerate the development of the DPP product, enabling launch within five years.

About Medicines360
Medicines360, located in San Francisco, California, is a nonprofit global women's health pharmaceutical organization with a mission to catalyze equitable access to medicines and devices. For more information, visit www.medicines360.org

About the Population Council
The Population Council confronts critical health and development issues—from stopping the spread of HIV to improving reproductive health and ensuring that young people lead full and productive lives. Through biomedical, social science, and public health research in 50 countries, we work with our partners to deliver solutions that lead to more effective policies, programs, and technologies that improve lives around the world. Established in 1952 and headquartered in New York, the Council is a nongovernmental, nonprofit organization governed by an international board of trustees. Learn more at www.popcouncil.org.

i Begg L, Brodsky R, Friedland B, et al Estimating the market size for a dual prevention pill: adding contraception to pre-exposure prophylaxis (PrEP) to increase uptake. BMJ Sexual & Reproductive Health 2021;47:166-172.
iⁱ Smith DK, Van Handel M, Grey J. Estimates of adults with indications for HIV pre-exposure prophylaxis by jurisdiction, transmission risk group, and race/ethnicity, United States, 2015. Ann Epidemiol. 2018 Dec;28(12):850-857.e9. doi: 10.1016/j.annepidem.2018.05.003. Epub 2018 May 18. PMID: 29941379.
ⁱⁱⁱ CDC. https://www.cdc.gov/hiv/basics/prep/prep-effectiveness.html#:~:text=PrEP%20is%20highly%20effective%20for,74%25%20when%20taken%20as%20prescribed.
^iv Raifman J, Sherman S. U.S. Guidelines that empower women to prevent HIV with pre-exposure prophylaxis. Sexually Transmitted Diseases 2018 June: 45(6): e38-e39.
^v Huang YA, Zhu W, Smith DK, Harris N, Hoover KW. HIV Preexposure Prophylaxis, by Race and Ethnicity — United States, 2014–2016. MMWR Morb Mortal Wkly Rep 2018;67:1147–1150. DOI: http://dx.doi.org/10.15585/mmwr.mm6741a
^vi Daniels K, Abma JC. Current contraceptive status among women aged 15–49: United States, 2015–2017. NCHS Data Brief, no 327. Hyattsville, MD: National Center for Health Statistics. 2018.

SOURCE Medicines360