Tokyo – Fuji Pharma Co., Ltd. (Tokyo Inventory Trade: 4554, ‘Fuji’) and Mithra Prescription drugs, SA (Euronext Brussels: MITRA, ‘Mithra’) at the moment are happy to announce that OLIC (Thailand) Restricted (‘OLIC’), a subsidiary of Fuji, has obtained the approval of import license for NEXTSTELLIS, a novel mixture contraceptive containing estetrol and drospirenone, for the indication of Contraception.
OLIC anticipates the industrial launch of NEXTSTELLIS contraceptive tablet in Thailand by the top of 2023.
The Product combines the native and selective estrogen, estetrol (E4) with drospirenone (DRSP). Estetrol has been confirmed to behave selectively on estrogen receptors, and this selectivity is predicted to supply quite a lot of advantages to the sufferers. The Product is already commercialized globally, together with main markets such because the US, Canada, Australia and several other European nations. Underneath the phrases of the settlement signed in August 2016, Fuji has obtained the event and commercialization rights of the Product in Japan and ASEAN nations. A complete oral contraceptive market of ASEAN is round EUR 182 million annual gross sales. In Japan, the event title of the Product is FSN-013, and Fuji is at the moment conducting Section III medical trials for FSN-013 for the indication of ‘Dysmenorrhea’ and ‘Enchancment impact on ache related to endometriosis’.
OLIC is among the largest contract manufacturing organizations (CMO) within the Southeast Asia and is in the midst of transformation from a pure CMO firm to a brand new hybrid firm with CMO and pharmaceutical enterprise with personal model merchandise. This approval is step one in that course. This approval was carried out for the aim of importing and promoting the Product by OLIC in Thailand.
Takayuki Iwai, President & Chief Government Officer of Fuji, commented: ‘That is an thrilling alternative and a major world step for Fuji pharma group. The approval will allow OLIC to make NEXTSTELLIS accessible to girls throughout Thailand by the top of 2023. After which, we plan to market the Product in different ASEAN nations via the collaboration with associate firms. Fuji will speed up the event of the Product to supply sufferers with new remedy choices that include Estetrol.’
Leon Van Rompay, CEO Mithra Ladies’s Well being, commented: ‘We’re happy to announce this extra advertising and marketing authorization for our contraceptive tablet in Asia, following the latest approvals for Taiwan and Hong Kong obtained final month. We wish to thank our associate Fuji for this fruitful collaboration, which interprets at the moment into an vital milestone for our Product in these territories which, contemplating the 2 potential indications of contraception and dysmenorrhea, represents an actual market alternative.’
Contact:
Tel: +32 (0)4 349 28 22
E mail: information@mithra.com
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