Gedeon Richter Plc, a Hungarian pharmaceutical company, and Belgium’s Mithra (OTCMKTS: MITPF) have entered into a licensing agreement that grants Gedeon the rights to develop and commercialize two of Mithra’s products in the Chinese market. The products in question are the oral contraceptive Estelle, which contains 15 mg estetrol (E4) / 3 mg drospirenone, and the investigational next-generation menopause treatment Donesta, which features estetrol.
Under the terms of the agreement, Gedeon will pay EUR 4.5 million (USD 4.8 million) upon closing the deal, an additional EUR 1.2 million (USD 1.3 million) for regulatory milestones, and up to EUR 8.5 million (USD 9.2 million) in sales-based milestones, along with royalties on future net sales. The total deal value is estimated at EUR 14.2 million (USD 15.4 million). Gedeon will also be responsible for funding and managing the clinical trials required for the approval of both products in China.
Mithra specializes in the development of drugs that utilize plant-based estrogen or estetrol. Estelle, the first estetrol-based product, is already commercialized as a combined oral contraceptive in the US and Canada under the brand name Nextstellis, and in Europe by Gedeon Richter as Drovelis. Meanwhile, preparations are underway for an NDA filing for Donesta in the US.- Flcube.com