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Mayne Pharma signs license agreement for women’s health products

Posted on December 5, 2022December 5, 2022 by Kiran

SYDNEY, Australia: Mayne Pharma has signed a transaction agreement and related license agreement for a portfolio of on-market women’s health products from TherapeuticsMD, for US$140 million, a payment for acquired working capital and contingent payments based on achieving certain sales-based milestones and sales-based royalties.

Under the License Agreement the Company will exclusively license ANNOVERA®, IMVEXXY®, BIJUVA® and the BocaGreenMD® and vitaMedMD® lines of prenatal vitamins (the Products) and acquire selected assets including inventory and regulatory filings to support the operation and commercialisation of the portfolio.

ANNOVERA® (segesterone acetate/ethinyl estradiol), is a patent protected ring for birth control. It is the first and only patient-controlled, procedure free, reversible prescription birth control product to provide a full year of protection from pregnancy.

IMVEXXY® (estradiol) vaginal inserts are approved in the US for the treatment of moderate-tosevere dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.

BIJUVA® (estradiol and progesterone) capsules are the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral daily capsule for the treatment of moderate-to-severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.

The Products’ net revenue in the third calendar quarter 2022 were US$20.9m and gross profit was US$17.1m as reported by TherapeuticsMD. Mayne Pharma will leverage its existing women’s health sales team and add additional sales representatives into new territories not currently covered for Nextstellis®. Approximately, US$20m in additional annual operating expenses are expected to be provided by Mayne Pharma to support the Products.

Mayne Pharma’s CEO Mr Shawn O’Brien said, “We are pleased to add these highly complementary and patent protected women’s health products to our portfolio. The Products will be supported by our existing commercial capability across sales and marketing, customer service and medical affairs. Women’s health is a core therapeutic area for the Company and this deal enables Mayne Pharma to accelerate and extend its position in this specialty.”

“We are very attracted by the underlying fundamentals of the contraceptive and menopause market and these products provide a solid foundation to creating a market leadership position in the US women’s health market.”

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