TherapeuticsMD, Inc. (NASDAQ:TXMD) rose in early Friday trading after the company, and Theramex, announced the approval of BIJUVE capsules indicated for hormone replacement therapy in the U.K. and under the trade name BIJUVA in Belgium.
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 European Union countries shortly.
Said CEO Robert Finizio, "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."
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
TXMD shares gained three cents, or 2.3%, to $1.35.
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