Collaboration to Develop State-of-the-Art Levonorgestrel Releasing Intrauterine Device (LNG IUD) As Highly Effective Long-acting Reversible Contraceptive

Medicines360, the US-based non-profit that addresses unmet medical needs of women and children by developing innovative, affordable and sustainable medical solutions, today announced a strategic partnership with European women’s health pharmaceutical company Uteron Pharma Operations (UPO), based in Liege Belgium, to develop a long-acting LNG IUD. As part of the collaborative agreement, Uteron is responsible for the design and manufacture of the product, and Medicines360 is responsible for Phase III clinical development.

SAN FRANCISCO – Medicines360, the US-based non-profit that addresses unmet medical needs of women and children by developing innovative, affordable and sustainable medical solutions, today announced a strategic partnership with European women’s health pharmaceutical company Uteron Pharma Operations (UPO), based in Liege Belgium, to develop a long-acting LNG IUD. As part of the collaborative agreement, Uteron is responsible for the design and manufacture of the product, and Medicines360 is responsible for Phase III clinical development.

Levonorgestel IUDs are one of the most frequently used and safe long-acting contraceptives in the world.

The objective of the Medicines360’s-Uteron partnership, is to gain regulatory approval through the US Food & Drug Administration (FDA) and a European regulatory health authority for an LNG IUD as a means for long-acting reversible contraception for ultimate approval around the world, including the developing world. The LNG IUD is one of the first products to be introduced by the privately-funded Medicines360, and is designed to provide highly effective, reversible contraception for at least five years.

Medicines360 launched this year as a non-profit and self-sustaining social enterprise focused on women’s health, and dedicated to developing products for use in both the public and private sectors. Commercial sales of Meds360 products to private payors are intended to subsidize and sustain Medicines360’s public sector mission.

“We are delighted to forge this innovative partnership with Uteron Pharma Operations to provide all women around the world with access to this state-of-the-art long-acting reversible contraception,” said Dr. Victoria Hale, Medicines360’s Founder and Chief Executive Officer.

“As a pharmaceutical company with a history and track record of dedication to innovation in women’s health, we’re pleased to partner with Medicines360, who bring a wealth of experience and expertise to this collaboration,” noted Stijn Van Rompay, Chief Executive Officer of Uteron Pharma Operations. “The partnership allows us to fully leverage our research and development skills, and we anticipate successful development and subsequent commercialization.”

About Medicines360

Medicines360 is a 501(c)(3) US nonprofit organization established in 2009 as a self-sustaining social enterprise to address the global health needs of women and children.

M360 Media Contact

Sedef Onder – 212.699.3761/office or 212.464.7332/mobile

Uteron Pharma Operations (UPO)

UPO, a wholly owned subsidiary of Uteron Pharma Holding, is dedicated to the development of pharmaceutical devices using different long-acting release technologies. UPO has research labs and employs a production site located in Liege (Belgium). Its levonorgestrel-releasing intrauterine device, developed together with the University of Liege, is currently in clinical development.
 www.uteron-operations.com
.

Contact: Eric Poskin – +32 (0)477 205 771

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.