Richter and Mithra sign a licence agreement for the commercialisation of Donesta®, the first Estetrol-based hormone therapy

The completion of the agreement follows the signing of the Binding Term Sheet by the parties on 20 December 2022. The territories covered by the agreement are geographical Europe, the CIS countries, Latin America, Australia and New Zealand.

Donesta® is Mithra’s next-generation orally-administrated estetrol (E4)-based hormone therapy product candidate offering a potential long-term solution for treating the different symptoms of menopause. Estetrol (E4), the first native estrogen from human fetal origin. E4 acts differently from classical estrogens. Its selective activation of nuclear Estrogen receptors and its unique metabolism result in a low impact on haemostasis and breast with an improved benefit/safety profile. Early 2022, Mithra announced positive top-line efficacy results of Donesta® Phase 3 Program, which demonstrated a meaningful reduction in vasomotor symptoms (VMS) from baseline and compared to placebo with all co-primary efficacy endpoints statistically met (improved quality of life and reduction of genito-urinary symptoms of menopause).

Hormone therapy (HT) is the most effective treatment for the relief of vasomotor symptoms and the genitourinary syndrome, while slowing osteoporosis and fracture risk. It contributes to maintain glucose homeostasis and epidemiological studies point to a 2/3 decreased risk of all cause dementias of menopause while slowing bone loss and demonstrating fracture prevention. Estetrol (E4) clinical results to date point towards the biggest advance in post-menopausal hormone therapy in the past decades. Upon study completion and approval it will offer clinicians and women a novel treatment option to strengthen practitioners and women confidence in the benefits of hormone therapy to address most effectively the challenges of the menopause confidence in the benefits of menopause treatment.

Under the terms of the licence agreement, Mithra is eligible to receive EUR 55 million in upfront payment – EUR 5 million was paid upon signature of the binding term sheet in December 2022 and EUR 50 million upon signature of this license agreement –, as well as EUR 15 million in additional milestone payments subject to specific regulatory achievements and tiered double-digit royalties depending on net sales’ evolution during the 20-year term contract. Richter will be in charge of the supply and the production of the product for all its territories.

"We are pleased to capitalise on our well established cooperation with Mithra and we are looking forward to further expand the therapeutic reach of our niche Women’s Healthcare business by adding a meaningful product to our existing Hormone replacement therapy portfolio” – said Erik Bogsch, Chairman of the Board. “We consider that serving women of all age groups is of paramount importance in Europe, which is characterised by aging population. We are convinced that the current transaction is a perfect fit for our specialty strategy.”

Leon Van Rompay, CEO Mithra Women’s Health, commented: “We are very pleased to announce the closing of this agreement with Gedeon Richter, our long-standing partner for the commercialisation of the contraceptive pill Drovelis® in Europe, the UK and Russia. Together we will be able to deliver an innovative product to menopausal women, a market that has been underserved for decades and where women today are actively looking for solutions. Recent media attention around the globe demonstrates a clear shift towards Hormone Therapy. Building further upon our product lifecycle development plan, we remain confident to sign a future partnership for Donesta® in the US, representing 57% of the menopause market in value (1).”

(1) IQVIA MAT Q3 2022 (hormonal menopausal treatment based on ATC class G3C, G3F and G2F)