Join our 20.000 subscribers and receive the monthly newsletter for free!

RELATED ARTICLES
argenx signs billion-dollar deal with Janssen

Another Belgian biotech on the up and up: argenx just closed a billion-dollar deal with Janssen Pharmaceutica for their antibody cusatuzumab. Unde…


Galapagos and MorphoSys to receive up to EUR 850mil in deal with Novartis

Galapagos (Belgium) and MorphoSys (Germany) recently announced that they have entered into an exclusive global license agreement with Novartis. Th…


Argenx raised over $300 million in their US public offering

18 September 2018 - Read the press release here. Argenx is a Belgian clinical-stage biotechnology company, developing differentiated antibody-…

POPULAR TAGS

Mithra Signs Deal with Fuji Pharma for Donesta in Asia

Written by DS on in the category news with the tags , .


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.”

Read more about Mithra 

References

(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

Read more about: , .

RELATED ARTICLES
argenx signs billion-dollar deal with Janssen

Another Belgian biotech on the up and up: argenx just closed a billion-dollar deal with Janssen Pharmaceutica for their antibody cusatuzumab. Unde…


Galapagos and MorphoSys to receive up to EUR 850mil in deal with Novartis

Galapagos (Belgium) and MorphoSys (Germany) recently announced that they have entered into an exclusive global license agreement with Novartis. Th…


Argenx raised over $300 million in their US public offering

18 September 2018 - Read the press release here. Argenx is a Belgian clinical-stage biotechnology company, developing differentiated antibody-…

POPULAR TAGS

Sign up to our Mailing List to receive updates
of our latest News, Events & Magazines

Turnstone GSK Janssen Biowin Flanders.bio XpandInnovation KU Leuven UGent Itera Life Science V-Bio Ventures

ABOUT BIOVOX - Sharing Life Sciences Innovations

BioVox showcases interesting life sciences breakthroughs for and from Belgian innovators. Through our partnership with BioCentury we share relevant worldwide innovations and business updates while our local journalists focus on regional highlights. 

Interested to get involved? Get in touch! We are looking for content, writers and partners! Blogs are available for research institutes, companies and freelance experts.

You want to reach out to the biotechnology and life sciences community, targetting selected audiences? Discover our sponsor and publication opportunities as well as tailored packages!

Contact BioVox via news@biovox.be or by completing the contact form.