Mithra And Rafa Laboratories Sign Binding Head Of Terms To Commercialize DONESTA In Israel

• Rafa Laboratories to receive the exclusive commercial rights for DONESTA in Israel on the signing of the final license and supply agreement
• Mithra is eligible to receive a total of EUR 2.05 million sales-related milestones, along with tiered double-digit royalties on annual net sales and payments at signature of the license agreement and for regulatory milestones
• DONESTA to target an addressable menopause market in Israel of ~900,000 women aged between 45 and 64¹

Mithra a company dedicated to Women’s Health, today announces the signing of a binding Head of Terms (HoT) agreement for the commercialization of DONESTA in Israel with Rafa Laboratories LTD, an Israeli pharmaceutical company. DONESTA is Mithra’s investigational, next generation hormone therapy medicine containing estetrol (E4) for the treatment of the symptoms of menopause.

Rafa Laboratories will have the exclusive commercial rights for DONESTA in Israel and the Palestinian Territories on the signing of the final license and supply agreement — planned in Q1 2024.

Mithra is eligible to receive a total of EUR 2.05 million sales-related milestones, along with tiered double-digit royalties on annual net sales.

David Horn Solomon, CEO of Mithra stated, “We are thrilled that Mithra and Rafa Laboratories will work together to offer DONESTA to women who suffer from the symptoms of menopause. We look forward to working closely with Rafa Laboratories to support its success in delivering differentiated efficacy, safety, and convenience to a market of hundreds of thousands of women.”

Amir Levin, CEO of Rafa, commented, “We are excited to cooperate with Mithra on this new product which will enable Rafa Laboratories to add to its Women’s Health portfolio. We are pleased to offer this next generation, orally administered estetrol-based hormone therapy product candidate to the Israeli market. It’s innovative nature and the prospect it offers to women suffering from the symptoms of menopause can be a game-changer.”

¹ World Health Organization data, 2021