29 May 2017
Mithra obtains marketing authoriZation for Tibelia® in France
French MA completes decentralized procedure with MAs granted in 15 European countries
Tibelia® is currently marketed in a number of countries through existing supply and license agreements
Further agreements and product launches anticipated in 2017
Liège, Belgium, 29 May 2017 – Mithra (Euronext Brussels: MITRA), a company specialized in Women’s Health, announces that it has received a Marketing Authorization (MA) for the commercialization of Tibelia® in France. The French MA completes the decentralized procedure started in 2016, with MAs now granted in 15 European countries.
Tibelia is already on the market in the UK, Spain, and the Netherlands, through existing supply and license agreements signed in 2016, with launches in Italy, Finland and Sweden expected in coming months. Mithra expects to sign further agreements, including in France, in 2017.
Tibelia® is a generic version of Livial® developed by Mithra. The product is a synthetic steroid (tibolone) for use in hormone replacement therapy. This includes the relief of postmenopausal symptoms, in addition to prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products.
These indications represent a global market of EUR 114.5 million, equating to 299 million tablets sold each year. The French market alone represents approximately EUR 2.3 million in annual sales.
Mithra intends to transfer the production of Tibelia® to its Contract Development and Manufacturing Organization (CDMO), its state of the art research, development & production facility in Liège, Belgium.
 IMS Health 2016.
“We are very pleased to receive Marketing Authorization for the commercialization of Tibelia® in France, the final country remaining under the European decentralized procedure. The MAs obtained underline once more the development and regulatory expertise of our dedicated teams here at Mithra. We expect Tibelia® to become an increasingly important source of future revenue, especially as we transfer its production to our CDMO facility in the future. We look forward to establishing further partnerships for Tibelia® and providing greater choice to women to safely address menopausal symptoms.”
François FornieriCEO of Mithra
For more information, please contact:
Chief Communication Officer
+32 4 349 28 22 / +32 475 86 41 75
François Fornieri, CEO
+32 4 349 28 22
Sofie Van Gijsel, IRO
Consilium Strategic Communications
Jonathan Birt, Sue Stuart, Hendrik Thys, Cameron Standage
+44 2 037 095 700
Tibelia® is a synthetic steroid (tibolone) intended to be used for hormone replacement therapy. Tibelia is a bioequivalent of Livial® 2.5mg which is a product that mimics the activity of the female sex hormones in the body, and is used especially for the relief of symptoms occurring after menopause. In some countries, this product is also used for the prevention of osteoporosis. It has been demonstrated that tibolone has favourable effects on various tissues in the body, such as brain, vagina and bone.
Mithra (Euronext: MITRA) is dedicated to providing innovation and choice in women’s health, with a particular focus on fertility, contraception and menopause. Mithra’s goal is to develop new and improved products that meet women’s needs for better safety and convenience. Its two lead development candidates – a fifth generation oral contraceptive Estelle® and next-generation hormone therapy Donesta® - are built on Mithra’s unique natural estrogen platform, E4 (Estetrol). Mithra also develops, manufactures and markets complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its CDMO.
Mithra was founded in 1999 as a spin-off from the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart. Mithra is headquartered in Liège, Belgium. Further information can be found at: www.mithra.com
The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company's actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.
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 Livial® Patient Information Leaflet.