Richter, Mithra partner on commercialization of oral contraceptive Estelle
Hungarian drugmaker Gedeon Richter on Wednesday said it is partnering with Mithra Pharmaceuticals to commercialize the Belgium companyʼs oral contraceptive Estelle in Europe and Russia, Hungarian news agency MTI reports
Mithra CEO Francois Fornieri notes that the deal was "by far the biggest contract in Mithraʼs history".
Richter will make an upfront payment of EUR 35 million to Mithra upon signing the contract and additional milestone payments amounting to EUR 20 mln. Richter will sell the product under a different brand name.
Mithra is conducting open-label single arm trials to assess the safety and efficency of Estelle in over 1,550 participants in Europe and Russia and about 2,000 participants in the United States and Canada, over a period of 13 cycles. Mithra recently announced positive top-line results for its EU and Russia Phase III study, with the results of the US and Canada study to follow in Q1 2019.
Estelle is a combined oral contraceptive containing 15 mg estetrol (E4) and 3 mg drospirenone.
"The product is considered a novel oral contraceptive with natural, native estrogen acting selectively in tissues combined with drospirenoneʼs non contraceptive benefits," Richter and Mithra say in a joint statement.
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