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

SAN FRANCISCO and NEW YORK, N.Y.: 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.

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 through product development, policy advocacy, and collaboration with global and US partners. Medicines360, through its subsidiary Impact RH360, launched the Avibela Project to expand access to hormonal IUDs in low- and middle-income countries. For more information, visit medicines360.org

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AVIBELA can be made available in the following 88 countries

  1. Algeria
  2. Angola
  3. Bangladesh
  4. Belize
  5. Benin
  6. Bhutan
  7. Botswana
  8. Burkina Faso
  9. Burundi
  10. Cambodia
  11. Cameroon
  12. Cape Verde
  13. Central African Republic
  14. Chad
  15. Comoros
  16. Costa Rica
  17. Cuba
  18. Democratic Republic of the Congo
  19. Djibouti
  20. Dominica
  21. Dominican Republic
  22. Egypt
  23. El Salvador
  24. Equatorial Guinea
  25. Eritrea
  26. Ethiopia
  27. Gabon
  28. Ghana
  29. Grenada
  30. Guatemala
  31. Guinea
  32. Guinea-Bissau
  33. Haiti
  34. Honduras
  35. India
  36. Indonesia
  37. Ivory Coast
  38. Jamaica
  39. Kenya
  40. Lao PDR
  41. Lesotho
  42. Liberia
  43. Libya
  44. Madagascar
  45. Malawi
  46. Malaysia
  47. Maldives
  48. Mali
  49. Mauritania
  50. Mauritius
  51. Mayotte
  52. Morocco
  53. Mozambique
  54. Myanmar
  55. Namibia
  56. Nepal
  57. Nicaragua
  58. Niger
  59. Nigeria
  60. Pakistan
  61. Panama
  62. Papua New Guinea
  63. Philippines
  64. Republic of the Congo
  65. Rwanda
  66. Sao Tome and Principe
  67. Senegal
  68. Seychelles
  69. Sierra Leone
  70. Somalia
  71. South Africa
  72. South Sudan
  73. Sri Lanka
  74. Kitts and Nevis
  75. Lucia
  76. Vincent & the Grenadines
  77. Sudan
  78. Swaziland
  79. Tanzania
  80. Thailand
  81. The Gambia
  82. Timor-Leste
  83. Togo
  84. Tunisia
  85. Uganda
  86. Vietnam
  87. Zambia
  88. Sri Lanka

Tina Raine-Bennett, MD, MPH, FACOG

Chief Executive Officer

Tina Raine-Bennett, MD, MPH, is CEO of Medicines360. Previously, she served as a senior research scientist at the Kaiser Permanente Northern California Division of Research and the research director of the Women’s Health Research Institute. She is a Board-Certified Obstetrician Gynecologist who received her medical training at the University of California, San Diego, and post-graduate residency training and MPH at the University of Washington in Seattle, where she also completed a Robert Wood Johnson Clinical Scholars Fellowship. She was also senior staff physician at Kaiser Permanente and has a special interest in family planning and adolescent reproductive health.

As the director of the Women’s Health Research Institute, Dr. Raine-Bennett focused on expanding research on women’s health within the Division and translating women’s health research into clinical practice and policy within the Ob/Gyn departments in Northern California. She also promoted the involvement of clinicians in research designed to improve the health outcomes and healthcare experiences of women at Kaiser Permanente and women in general.

Prior to Kaiser Permanente, Dr. Raine-Bennett was a professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at University of California, San Francisco (UCSF). She was based at San Francisco General Hospital where she was also the medical director of the New Generation Health Center, a UCSF affiliate site that provides community-based reproductive health services. Dr. Raine-Bennett’s research has focused on contraceptive methods and on elucidating factors that influence contraceptive choice and continuation, and she was principal investigator on NIH grants to assess hormonal contraceptive use predictors and develop interventions to improve contraceptive access.

Her past and current research on emergency contraception has focused on the safety of making emergency contraception more accessible and she conducted a pivotal clinical trial to make emergency contraception available to teens without a prescription. She served on the editorial board of Obstetrics and Gynecology and has over 100 peer-reviewed publications. She was the Treasurer of the Board of Directors for the Society of Family Planning and Society of Family Planning Research Fund. She has also served as an examiner for the American Board of Obstetrics and Gynecology, and on national committees for the American College of Obstetrics and Gynecology and the National Medical Board of Planned Parenthood Federation of America.