- Relates to the submission of a marketing approval application in Japan
- Marks strong progress in 2016 agreement and further boosts Mithra’s cash position
- Additional EUR 10 million in milestone payments expected at approval of marketing authorization
- Mithra eligible for revenue from supply of the manufactured product post-commercialization
Liege, Belgium, 23 October 2023 – 07:00 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, announces today that its licence holder Fuji Pharma Co., Ltd. has submitted an application for marketing approval of ESTELLE® in Japan in a drive to help combat dysmenorrhea. The submission marks another key milestone in the agreement for which Mithra will receive a EUR 2.5 million milestone payment.
Fuji Pharma obtained the right to commercialize both ESTELLE® and DONESTA® in Japan and the ASEAN region in 2016, targeting a potential market of 330 million patients. The product contains Mithra’s core asset Estetrol (E4), which has been confirmed to selectively act on estrogen receptors and has a low impact on the liver and the coagulation cascade. 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, E4 could represent a breakthrough in various therapeutic fields of women’s health and beyond. Furthermore, the selectivity of E4 is expected to provide a variety of benefits for patients.
Fuji obtained development and commercialization rights from Mithra in 2016. In Thailand, a subsidiary of Fuji began selling the product under the product name NEXTSTELLIS™ in April 2023.
David Horn Solomon, CEO at Mithra: “We are very proud of our partnership with Fuji Pharma and today’s announcement marks another key milestone in Mithra’s drive for growth and achieving its mission. Mithra aims to redefine women’s health through the delivery of innovative products in the fields of contraception and menopause. Japan is a key market for Mithra to achieve this, and according to recent research by the Nikkei BP Intelligence Group Medical & Healthcare Institute, 70% of working women report menstruation related symptoms before and during their monthly cycle.”
Dysmenorrhea is a medical condition that occurs with menstruation and is commonly referred to as menstrual cramps, driven by, amongst others lower abdominal pain and back pain, as well as a tight stomach, nausea, headache, fatigue and weakness, loss of appetite, irritability, diarrhea, and depression. The global dysmenorrhea market was worth EUR 257 million in 20221.
1 Source: AL IQVIA 2023