Mithra, a company dedicated to women’s health, has received €1.25 million milestone payment from Fuji Pharma 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 interim reports from Phase 3 trials investigating Estelle for the treatment of dysmenorrhea or endometriosis. Fuji announced positive top-line results from the double-blind, placebo-controlled studies, showing the first trial met its primary endpoint demonstrating a statistically significant difference for the change in total dysmenorrhea score when compared to placebo. The second trial also met its primary endpoint demonstrating a statistically significant difference for the most severe pelvic pain when compared to placebo.

This is Mithra’s second milestone payment under the agreement with Fuji, which was signed in 2016. The first milestone of €1.25 million Mithra received upon completion of Phase 3 trials in Europe and the U.S. Mithra remains eligible to receive a further €12.5 million in total milestones.

David Horn Solomon, CEO of Mithra said, “We are pleased with the strong progress made by our partner Fuji Pharma with Estelle. This 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 U.S. (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, according to the company.