Mithra Biotech, a company dedicated to women’s health, has announced that its licence holder Fuji Pharma 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 € 2.5 million milestone payment.

Fuji Pharma obtained the right to commercialise both ESTELLE and DONESTA in Japan and the ASEAN region in 2016, targeting a potential market of 330 million patients. Fuji obtained development and commercialisation rights from Mithra in 2016. In Thailand, a subsidiary of Fuji began selling the product under the product name NEXTSTELLIS in April 2023.

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 € 257 million in 2022.

David Horn Solomon, CEO at Mithra said, “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.”