NEW YORK and SAN DIEGO, Nov. 4, 2015 (GLOBE NEWSWIRE) -- In a major step forward for women's health, the Population Council and WomanCare Global (WCG) today announced an exclusive worldwide licensing agreement for WCG to make the Council's investigational NES/EE contraceptive ring available in the developed and developing worlds. This announcement marks an important contribution to achieving the goal of universal access to family planning for women and couples around the world.
Today, more than 225 million women in developing countries want to prevent pregnancy but are not using modern forms of contraception. During clinical trials, the NES/EE ring was tested for effectiveness and for its ability to act as a long-acting and reversible method of user-controlled contraception that does not require a trained provider to insert. If approved for the studied indication with the expected storage conditions, the ring may be a good option for women in developing countries where it may be more difficult to access a health care facility or a pharmacy regularly, according to the Population Council.
Two pivotal open-label safety and efficacy phase III clinical trials of the ring were completed involving approximately 2,270 healthy women at 27 sites in the United States, Latin America, Europe, and Australia. The women were between 18 and 40 years of age and were instructed on using the ring over 13 menstrual cycles, or one full year. Efforts are underway for the Population Council to prepare and submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in early 2016.
"There is significant global need for new long-acting and reversible, woman-controlled methods of contraception," said Julia Bunting, President of the Population Council. "For years, the Population Council has prioritized research and development of contraceptive products, including some of the most widely used like the Copper T IUD, Mirena®, and the implant Jadelle®. Having partners like WomanCare Global that share our commitment to women's empowerment and expanding access and choice ensures that we continue to focus on what is best for women around the world."
"We are committed to the goal of addressing the unmet reproductive health needs of women globally," said Saundra Pelletier, CEO of WomanCare Global. "Partnerships like the one between WomanCare Global and the Population Council will accelerate the achievement of the goal of FP2020, to increase contraception access to 120 million more women by 2020. The Population Council's focus on research and development makes them an incredible ally in our mission to empower women by giving them the options that will allow them to decide if, how and when they want to have children. We are motivated to develop and distribute woman-controlled reproductive products like the NES/EE ring."
WCG will leverage its distribution network and regulatory expertise to facilitate product registration, market introduction and commercialization of the NES/EE contraceptive ring globally, including to facilitate the product's access to the public sector. WCG's strategic partner, Evofem, Inc. will have certain commercial rights under this agreement.
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. The Council has developed and licensed some of the most widely used long-acting, reversible contraceptives in the world, including the Copper T intrauterine device; Mirena®, the levonorgestrel-releasing intrauterine system; and the implant Jadelle®. More than 170 million women worldwide are currently using contraceptives developed by or based on Council technology. Established in 1952 and headquartered in New York, the Population Council is a nongovernmental, nonprofit organization governed by an international board of trustees.
About Woman Care Global
WomanCare Global is a global non-profit healthcare company founded in 2009, whose mission is to provide reproductive health solutions for women and girls around the world. Leveraging our medical, social and commercial expertise, we have built a sustainable value chain that enables us to reliably deliver high-quality products and point of care services, resulting in more informed providers and more family planning options for women and girls. Our hybrid model redirects financial surplus achieved from sales in developed countries to under-served markets thereby eliminating economic and geographic barriers and increasing impact.
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Source: WomanCare Global