Mithra and Fuji announce approval of NEXTSTELLIS™ in Thailand
Fuji Pharma Co., Ltd. (Tokyo Stock Exchange:4554, “Fuji”) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA, “Mithra”) today are pleased to announce that OLIC (Thailand) Limited (“OLIC”), a subsidiary of Fuji, has obtained the approval of import license for NEXTSTELLIS™, a novel combination contraceptive containing estetrol and drospirenone (“Product”), for the indication of Contraception. OLIC anticipates the commercial launch of NEXTSTELLIS™ contraceptive pill in Thailand by the end of 2023.
The Product combines the native and selective estrogen, estetrol (E4) with drospirenone (DRSP). Estetrol has been confirmed to act selectively on estrogen receptors, and this selectivity is expected to provide a variety of benefits to the patients. The Product is already commercialized globally, including major markets such as the US, Canada, Australia and several European countries. Under the terms of the agreement signed in August 2016, Fuji has obtained the development and commercialization rights of the Product in Japan and ASEAN countries. A total oral contraceptive market of ASEAN is around EUR 182 million annual sales (1). In Japan, the development name of the Product is FSN-013, and Fuji is currently conducting Phase III clinical trials for FSN-013 for the indication of "Dysmenorrhea" and "Improvement effect on pain associated with endometriosis".
OLIC is one of the largest contract manufacturing organizations (CMO) in the Southeast Asia and is in the middle of transformation from a pure CMO company to a new hybrid company with CMO and pharmaceutical business with own brand products. This approval is the first step in that direction. This approval was conducted for the purpose of importing and selling the Product by OLIC in Thailand.
Takayuki Iwai, President & Chief Executive Officer of Fuji, commented: “This is an exciting opportunity and a significant global step for Fuji pharma group. The approval will enable OLIC to make NEXTSTELLIS™ available to women across Thailand by the end of 2023. After which, we plan to market the Product in other ASEAN countries through the collaboration with partner companies. Fuji will accelerate the development of the Product to provide patients with new treatment options that contain Estetrol."
Leon Van Rompay, CEO Mithra Women’s Health, commented: “We are pleased to announce this additional marketing authorization for our contraceptive pill in Asia, following the recent approvals for Taiwan and Hong Kong obtained last month. We would like to thank our partner Fuji for this fruitful collaboration, which translates today into an important milestone for our Product in these territories which, considering the two potential indications of contraception and dysmenorrhea, represents a real market opportunity.”