TherapeuticsMD (TXMD) and Theramex Announce Approval of BIJUVE Capsules Indicated for Hormone Replacement Therapy in the United Kingdom and Under the Trade Name BIJUVA in Belgium

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.

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