Mithra receives EUR 1.25 million milestone payment from Fuji Pharma under Estelle® licensing agreement
Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces it has received a milestone payment of EUR 1.25 million from its partner Fuji Pharma, the Japanese leader in women’s health, under a license and supply agreement for its Estetrol (E4) native estrogen-based product Estelle® in Japan and ASEAN territories.
The payment was triggered by completion of the interim clinical study reports of Phase 3 trials investigating Estelle® for the treatment of Japanese patients with dysmenorrhea or endometriosis. Fuji announced positive top-line results from the double-blind, placebo-controlled studies in February 2023, showing the first trial met its primary endpoint by demonstrating a statistically significant difference for the change in the total dysmenorrhea score when compared to placebo. The second trial in patients with endometriosis also met its primary endpoint by demonstrating a statistically significant difference for the change in the Visual Analog Scale for the most severe pelvic pain when compared to placebo.
It is the second milestone payment received by Mithra under this agreement with Fuji, which was signed in 2016. The first milestone of EUR 1.25 million was received by Mithra upon completion of Phase 3 trials in Europe and the United States. Mithra remains eligible to receive a further EUR 12.5 million in total milestones prior to commercialization and to receive revenue from supply of the manufactured product post-commercialization.
David Horn Solomon, Chief Executive Officer of Mithra, commented: “We are pleased with the strong progress made by our partner Fuji Pharma with Estelle®. This EUR 1.25 million milestone payment marks strong Phase 3 results, which indicate that this could be an excellent treatment for patients with dysmenorrhea and endometriosis, and will further boost Mithra’s balance sheet, as we pursue our aim of becoming a global leader in women's health. We are looking forward to continuing our close cooperation with Fuji as we work to bring Estelle® to patients in Japan and ASEAN territories.”
Estelle®, Mithra’s first E4-based product composed of 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP), is commercialized as a combined oral contraceptive in the US (NEXTSTELLIS®), Canada (NEXTSTELLIS®), and Europe (DROVELIS® and LYDISILKA®).
Mithra’s core asset Estetrol (E4) is a native estrogen produced by the human fetus during pregnancy, passing into maternal blood at relatively high levels. Because of its unique mode of action and safety profile, Estetrol could represent a major breakthrough in various therapeutic fields of women’s health and beyond.