Mithra, a company specialized in Women’s Health, announces that it has signed an exclusive License and Supply Agreement (LSA) with Fuji Pharma, the leader in Women’s Health in Japan, for the commercialization of Donesta® in Japan and ASEAN (Association of Southeast Asian Nations: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam) territories. Donesta® is Mithra’s next generation Hormone Therapy (HT) candidate for which a dose-finding Phase II study is currently ongoing, with top-line results expected late Q1 2018.
Under the terms of the agreement, Mithra is entitled to EUR 1 million upon signature as well asfuture low double digit million development, regulatory and commercialization milestones. Fuji Pharma and Mithra or one of its partners will undertake and equally fund the development of Donesta® Phase III in Japanese subjectsin the HT indication. Furthermore, based on the annual minimum order quantities agreed upon, the exclusive supply agreement will provide Mithra’s Contract Development and Manufacturing Organization with a steady flow of production work, and will be a source of recurring revenue for Mithra for the duration of the contract.
The Donesta® LSA follows the binding term sheet announced in March 2017. Mithra and Fuji Pharma already have an exclusive LSA in place, agreed in August 2016, for Estelle®, Mithra’s combined oral contraceptive candidate which is also based on the E4 platform and is currently in Phase III studies.
The Japanese and ASEAN HT markets are valued at approximately EUR 42.6 million(1). Fuji Pharma is fully committed to expanding the current market with Donesta®, given the potentially improved safety profile of E4 versus currently available HTs, including a lower VTE risk profile and a reduced risk of drug-drug interactions(2,3).
François Fornieri, CEO of Mithra: “We are very pleased to sign this agreement with Fuji Pharma for Donesta® in Japan and ASEAN, and signing as early as Phase II highlights Fuji Pharma’s commitment to the program. As the leader in Women’s Health in Japan and our existing partner for Estelle® in these territories, Fuji Pharma is our partner of choice for the commercialization of Donesta®. Partnering our lead E4-based products in territories outside of Europe and the US is also a key part of our strategy and we look forward to creating additional partnerships with Women’s Health players for both Donesta® and Estelle®. These innovative product candidates could provide women with potentially safer alternatives to currently marketed hormone-based menopause and contraception products.”
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(1) IMS Health 2016; data based on Japan and 6 ASEAN countries (no data available for Cambodia, Laos, Myanmar, and Brunei)
(2) Kluft et al. 2017. Contraception 95(2) : 140-7
(3) Visser et al. 2012. Oncotarget 6(19): 17621-36