-If approved by the U.S. FDA, it will be the first and only
patient-controlled, procedure-free, long-acting, reversible prescription
birth control product to provide a full year of protection-
-Significantly expands TherapeuticsMD’s product portfolio and includes
exclusive rights to negotiate co-development of two other
investigational vaginal contraceptive systems-
BOCA RATON, Fla.--(BUSINESS WIRE)--Jul. 31, 2018--
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180731005942/en/
Source: TherapeuticsMD, Inc.
TherapeuticsMD, Inc.
Investor Contact
Nichol Ochsner,
561-961-1900, ext. 2088
Vice President Investor Relations
Nochsner@TherapeuticsMD.com
