UK-based Theramex has agreed to acquire exclusive licensing and supply rights from TherapeuticsMD to commercialise BIJUVA (estradiol and progesterone capsules) and IMVEXXY (estradiol vaginal inserts) outside of the US.
As per the terms of the deal, Theramex will have exclusive commercialisation rights for BIJUVA and IMVEXXY outside the US with the exception of Canada and Israel where TherapeuticsMD has licensed the products to Knight Therapeutics.
According to TherapeuticsMD, BIJUVA, which was approved by the US Food and Drug Administration (FDA) in October 2018, reduces moderate to severe hot flashes caused by menopause in women with a uterus, while decreasing risk to the lining of the organ. The drug combines bio-identical estradiol and bio-identical progesterone in a single daily oral capsule.
The company claims that the hormones in BIJUVA were made to be identical with what the body naturally generates, thereby helping in restoring what’s lost during menopause.
TherapeuticsMD CEO Robert Finizio said:
“We are very pleased to announce our partnership with Theramex to bring BIJUVA and IMVEXXY to women outside of the United States. We believe this agreement provides our company with important non-dilutive upfront capital to help fund our product launches in the United States as well as an incremental royalty stream to support future growth.”
Theramex, which is a portfolio company of CVC Capital Partners, will be responsible for undertaking all regulatory and commercial activities related to the two products in the licensed territories.
In this connection, the global specialty pharma company will pay €14m (£12.49m) in cash as an upfront fee to the US-based TherapeuticsMD.
The US women’s healthcare company will also be entitled to an additional €29.5m (£26.33m) based on certain regulatory and sales milestones of the two products.
TherapeuticsMD will also be paid royalty payments by the UK firm on net sales of BIJUVA and IMVEXXY in the licensed territories.
Theramex CEO Anish Mehta said:
“This partnership with TherapeuticsMD marks another exciting milestone in the execution of our women’s health growth strategy. By leveraging our best in class commercial capabilities and global footprint, we intend to rapidly commercialize these novel and innovative medicines for women around the world.”