TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, and Theramex, a dedicated women’s health company, announced that BIJUVE® has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the United Kingdom and, from the Federal Agency for Medicines and Health Products (FAMHP) for use in Belgium under BIJUVA®.
A “decentralized procedure” (DCP) for the regulatory approval of BIJUVA® in several European countries was completed in February. Following this each country undertakes a national process which includes approvals for labeling and other country specific requirements. Theramex expects approvals from other major EU countries shortly.
“The approval of BIJUVE in the UK and BIJUVA in Belgium marks a significant accomplishment by Theramex that offers a new treatment option to post-menopausal women,” said Robert Finizio, Chief Executive Officer of TherapeuticsMD.
“We are excited to bring this first and only combination of micronized progesterone and estradiol to the UK and Belgium through our license agreement with TherapeuticsMD,” said Robert Stewart, Chief Executive Officer of Theramex.
BIJUVA is the first and only oral combined HRT with bio-identical hormones*, made available to patients across Europe through the license agreement that TherapeuticsMD and Theramex signed in June 2019 granting Theramex the exclusive license and supply agreement to commercialize BIJUVA outside the United States, Canada, and Israel. Under the terms of the license agreement related to BIJUVA, Theramex will pay TherapeuticsMD a milestone fee for the regulatory approval in certain specified European markets of BIJUVA, sales milestone fees based upon certain aggregate annual net sales of BIJUVA, and royalties based on aggregate annual net sales of BIJUVA in licensed territories.
In the U.S., BIJUVA is marketed by TherapeuticsMD and is indicated in a woman with a uterus for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.
*Bio-identical hormones are hormones that are structurally identical to the hormones your body produces naturally. It is not known if there is a difference in risks between synthetic hormones and bio-identical hormones.
BIJUVA was developed and approved in the U.S. for the treatment of moderate to severe VMS due to menopause in women with a uterus. It is a combination of 1 mg bio-identical estradiol and 100 mg bio-identical progesterone in a once-daily oral softgel capsule.
Please see U.S. Important Safety Information for BIJUVA, including BOXED WARNING for cardiovascular disorders, breast cancer, endometrial cancer and probable dementia, available at https://www.bijuva.com/pi.pdf.
Theramex is a leading, global specialty pharmaceutical company dedicated to women and their health. With a broad portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis, Theramex supports women at every stage of their lives. Theramex’s commitment is to understand its patients, serve their needs, and offer healthcare solutions to help improve their lives. Theramex’s vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing innovative, effective solutions that care for and support women as they advance through each stage of their lives. To learn more about Theramex, please visit www.theramex.com.
About TherapeuticsMD, Inc.
TherapeuticsMD, Inc. is an innovative, leading 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.
Forward-Looking Statements for TherapeuticsMD Inc.
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: the effects of the COVID-19 pandemic; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility; whether the company will be able to successfully divest its vitaCare business and the proceeds that may be generated by such divestiture; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; whether the FDA will approve the lower dose of BIJUVA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the ability of the company’s marketing contractors to market ANNOVERA; 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.
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