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TherapeuticsMD and Theramex Enter into Exclusive License and Supply Agreement to Commercialize BIJUVA™ and IMVEXXY® Outside the United States | SEBIO

TherapeuticsMD and Theramex Enter into Exclusive License and Supply Agreement to Commercialize BIJUVA™ and IMVEXXY® Outside the United States

Posted by on Jun 10, 2019

BOCA RATON, FL. – TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today announced that it has entered into an exclusive license and supply agreement with Theramex, a leading, global specialty pharmaceutical company dedicated to women’s health, to commercialize BIJUVA (estradiol and progesterone capsules) and IMVEXXY (estradiol vaginal inserts) outside of the United States. Theramex is a portfolio company of CVC Capital Partners.

Theramex will have exclusive commercialization rights for BIJUVA and IMVEXXY outside the U.S., excluding Canada and Israel, for which TherapeuticsMD has licensed BIJUVA and IMVEXXY to Knight Therapeutics. Theramex will be responsible for conducting all regulatory and commercial activities in connection with BIJUVA and IMVEXXY in the licensed territories.

Under the terms of the license and supply agreement, Theramex will pay TherapeuticsMD EUR 14 million in cash as an upfront fee. TherapeuticsMD is eligible to receive up to an additional EUR 29.5 million in cash milestone payments, comprised of (i) an aggregate of EUR 2 million in regulatory milestone payments based on regulatory approvals for each of BIJUVA and IMVEXXY in certain specified markets and (ii) an aggregate of EUR 27.5 million in sales milestone payments to be paid in escalating tranches based on first attaining certain aggregate annual net sales milestones in the licensed territories ranging from EUR 25 million to EUR 100 million. TherapeuticsMD is also entitled to receive royalty payments on net sales of BIJUVA and IMVEXXY in the licensed territories.

“We are very pleased to announce our partnership with Theramex to bring BIJUVA and IMVEXXY to women outside of the United States,” said Robert G. Finizio, CEO of TherapeuticsMD. “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.”

Anish Mehta, CEO of Theramex, 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.”

“BIJUVA and IMVEXXY strengthens Theramex’s already exciting range of women’s health treatment options for doctors and their patients,” said Fred Hassan, Chairman of Theramex.

Additional information concerning the license and supply agreement is contained in the Form 8-K filed by TherapeuticsMD today with U.S. Securities and Exchange Commission.

Copies of the U.S. Full Prescribing Information, including Boxed Warnings, for BIJUVA and IMVEXXY are available at https://www.bijuva.com/pi.pdf and www.imvexxy.com/pi.pdf, respectively.

About Theramex

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.

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