BOCA RATON, Fla.--(BUSINESS WIRE)--TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced that it has entered into an exclusive license agreement with the Population Council to commercialize its investigational segesterone acetate/ ethinyl estradiol one-year vaginal system for contraception in the United States (U.S.). The one-year vaginal contraceptive system is in the shape of a ring and combines a novel progestin, segesterone acetate (Nestorone®), with a widely used estrogen to prevent ovulation for an entire year (13 cycles).
The New Drug Application (NDA) for the one-year vaginal contraceptive system is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date for the completion of the FDA’s review of the NDA of August 17, 2018. If approved, the product would be the first and only procedure-free, reversible prescription contraceptive to provide a full year of protection against unintended pregnancy while fully under a woman’s control. TherapeuticsMD intends to leverage its existing infrastructure to commercialize the one-year vaginal contraceptive system together with the company’s recently-approved Imvexxy™ (estradiol vaginal inserts) and its TX-001HR product candidate, if approved.
Under the terms of the agreement, TherapeuticsMD will pay the Population Council milestone payments of $20 million upon FDA approval of the one-year vaginal contraceptive system and $20 million upon release of the first commercial batch of the product. The Population Council is also eligible to receive milestone payments and royalties from commercial sales of the one year vaginal contraceptive system. The Population Council will reinvest all proceeds from the agreement into continued research and development programs.
TherapeuticsMD will be responsible for marketing expenses related to the commercialization of the product. If the product is approved, TherapeuticsMD plans to work with payors to obtain coverage for the one-year vaginal contraceptive system at an affordable out-of-pocket cost to U.S. women. As part of the license agreement, TherapeuticsMD has agreed to provide significantly reduced pricing to federally designated Title X family planning clinics serving lower-income women.
The Population Council has previously developed long-acting, reversible contraception products including intrauterine devices like ParaGard® and Mirena®; implants like Norplant® and Jadelle®; and the contraceptive vaginal ring for breastfeeding women Progering®. The U.S. market for prescription contraceptives generated more than $5 billion in net sales in 20171. An estimated 43 million women in the U.S. are at risk of unintended pregnancy and nearly half of all pregnancies that occur each year in the U.S. are unintended2,3. According to the National Center for Health and Statistics, use of long-acting reversible contraceptives increased nearly 5-fold in the last decade among women aged 15 to 444.
The NDA for the one-year vaginal contraceptive system under review by the FDA is supported by data from two pivotal Phase 3 open-label safety and efficacy trials that were completed involving 2,308 healthy women at 27 sites in the United States, Latin America, Europe, and Australia. Women in the Phase 3 trials of the one-year vaginal contraceptive system ranked it highly in terms of convenience, ease of use, and their overall satisfaction with the vaginal contraceptive system.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning/ reproductive health and menopause management. The company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit www.therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.
About the Population Council
The Population Council (http://www.popcouncil.org) 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, the Council works with 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.
Forward-Looking Statements
This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: whether the FDA will approve the NDA for the company’s TX-001HR product candidate and whether such approval will occur by the PDUFA target action date; whether the FDA will approve the NDA for the company’s one-year vaginal contraceptive system licensed product candidate and whether such approval will occur by the PDUFA target action date; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY, its hormone therapy drug candidates and its contraceptive drug candidates and obtain additional financing necessary therefor; whether the company be able to comply with the covenants and conditions under its term loan agreement; the length, cost and uncertain results of the company’s clinical trials; the potential of adverse side effects or other safety risks that could preclude the approval of the company’s hormone therapy drug candidates or one-year vaginal contraceptive system licensed product candidate or adversely affect the commercialization of the company’s current or future approved products; the company’s reliance on third parties to conduct its clinical trials, research and development and manufacturing; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership. PDF copies of the company’s historical press releases and financial tables can be viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.
1 QuintilesIMS MIDAS, QuintilesIMS Analysis, Company filings.
2 Contraceptive Use in the United States, Guttmacher, September 2016.
3 Finer LB and Zolna MR, Declines in unintended pregnancy in the United States, 2008–2011, New England Journal of Medicine, 2016, 374(9):843–852, http://nejm.org/doi/full/10.1056/NEJMsa1506575.
4 Branum A and Jones J, Trends in Long-Acting Reversible Contraception Use Among U.S. Women Aged 15-44, NCHS Data Brief, Number 188, February 2015.
