Liège, Belgium 28 June 2016 – Mithra announces that it signed a non-exclusive License and Supply Agreement with the Hungarian company Gedeon Richter for its product Tibelia®. Under the terms of this contract, Mithra grants Gedeon a non-exclusive license for the commercialization of Tibelia® in Italy, Switzerland, Spain, Germany, Belgium and Luxembourg.
Liège, Belgium 10 May 2016 – Mithra announces that the production of the first technical and clinical batches of Myring, a combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA), has started within its external CMO (Macors). These clinical batches will be used in the bioequivalence study.
· After Xena® and Levosert®, Tibelia® becomes the third R&D project in which Mithra has been involved from research phase to approval from regulatory authorities, underlining the strength and expertise of its development and regulatory teams in tackling complex generic developments.
· This step allows Mithra to enter the worldwide tibolone market, a growing market of 131 Million euro, and means that Tibelia® looks set to provide Mithra with a source of near-term cash flow in terms of license payments and sales revenue
· Additionally, this approval reinforces the pipeline of products that Mithra can produce in-house at its CDMO in Flémalle.
• Mithra buys 50% of Novalon SA
• Mithra (Novalon) buys back rights relating to Zoreline® and Myring (therapeutic equivalent products of branded products having realized, in 2014, worldwide sales in excess of 1.6 billion EUR) from GSP
• Mithra (Novalon) concludes its first commercialisation partnership for Zoreline® for selected countries
Liège, Belgium, 08 December 2015 – REGULATED INFORMATION- Mithra and GSP are pleased to announce that they have entered into a number of transactions by which Mithra has acquired the complete ownership of Novalon SA, the company which develops the projects Zoreline® and Myring, which are therapeutic equivalents to branded products which, in 2014, realized aggregate worldwide sales in excess of 1.6 billion EUR, as well as the global rights to these products. In parallel, they have entered into the first distribution deal for selected countries in respect of Zoreline®.
Liège, Belgium 18 November 2015 – Regulated information: Mithra Pharmaceuticals, leader in Women’s Health and cutting-edge technological company in the field of API slow-release drugs based on polymere (subcutaneous implants, biocompatible rings, hormonal IUD’s), announced today that it has enrolled the last patient required in the pharmacodynamics & pharmacokinetics studies of its Zoreline® subcutaneous implant 10.8 mg.
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