Fuji Pharma in Hormone Therapy Deal
By

Fuji Pharma, a Tokyo based company that develops, manufactures, and markets pharmaceutical products, has signed a binding term sheet with Mithra Pharmaceuticals, a Liège, Belgium- headquartered pharmaceutical company focused on women’s health, for the rights to commercialize Donesta (estetrol), an estrogen-based hormone replacement therapy currently under Phase II clinical trials for treating vasomotor menopausal symptoms.

With the binding term sheet agreement, Fuji Pharma gains the rights to commercialize Donesta in Japan and the Association of Southeast Asian Nations, which consists of Brunei Darussalam, Cambodia, Indonesia, Lao People’s Democratic Republic, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam.

This agreement is part of an earlier 20-year partnership agreement signed by Fuji Pharma and Mithra in August 2016, which includes an exclusive supply agreement with Mithra’s contract development and manufacturing organization (CDMO), for a combined oral contraceptive, Estelle (estetrol, 15 mg and drospirenone, 3mg), Mithra’s lead product candidate currently under Phase III clinical trials.

Under the agreements, Mithra will, depending on the progress of the development, receive single digit milestones. The term sheet comprises an exclusive supply obligation for the duration of the contract, which would provide Mithra’s CDMO with a steady flow of production work for its estetrol-based products. In addition, Fuji Pharma and Mithra, or one of its partners, will undertake and equally fund the development of Donesta in Phase III trials in Japan in the hormone replacement therapy indication.

Source: Fuji Pharma

Leave a Reply

Your email address will not be published. Required fields are marked *