MITHRA OBTAINS FIRST MARKETING AUTHORIZATION FOR MYRING IN EUROPE

  • Marketing authorization allows for launch of Myring™ in the United Kingdom

  • Additional marketing authorizations expected in the near future

  • Mithra to produce Myring™ at its CDMO2

Liège, Belgium, 20 July 2018 - Mithra (Euronext Brussels: MITRA), a company dedicated to Women's Health, today announces that the company obtained its first marketing authorization (MA) for Myring1 in the UK, following approval by the MHRA2. Myring is Mithra's contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA) and is developed to be fully bioequivalent to Merck's Nuvaring®. In April 2018, Nuvaring® went off patent in both the US and Europe. In the UK, which is a market worth approximately EUR 1.2 million3, no generic competition exists as of yet.

Under the same decentralized procedure, in coming months, additional MA's should be received for Croatia, Hungary, the Czech Republic, Poland, Latvia, Slovakia, and Slovenia, with further MA's expected in Europe as well as the US later this year and early 2019.

François Fornieri, CEO Mithra Women's Health: "We are very pleased to obtain the first marketing authorization for Myring. This is a great achievement for our team, highlighting our expertise in polymer technology and the manufacturing capabilities at our state-of-the-art CDMO facility. We are confident to receive MA's in additional territories, including for the key US market, later this year or early 2019, and look forward to producing Myring for our partners at our CDMO."

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About Myring

Myring is developed to be a generic of Nuvaring® vaginal ring. Nuvaring®'s patent expired in April 2018 both in the US and in EU. Myring (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, combination contraceptive vaginal ring, with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. It is made of ethylene vinylacetate copolymers, and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. When placed in the vagina, each ring releases, in line with the originator (Nuvaring®), on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. The ring is to remain in place continuously for three weeks. It is removed for a one-week break, during which a withdrawal bleed usually occurs. A new ring is inserted one week after the last ring was removed.

  • 1 Myring™ will be marketed under a different brand name in the UK.

  • 2 Medicines and Healthcare products Regulatory Agency

  • 3 CAGR (2013-2017): +6.6%

For more information, please contact:

Investor Relations

Sofie Van Gijsel IRO & VP of Strategy +32 485 19 14 15investorrelations@mithra.com

About Mithra

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 a 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 Mithra CDMO. Mithra was founded in 1999 as a spin-off of the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart and is headquartered in Liège, Belgium. Further information can be found at:www.mithra.com

Important information

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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Mithra Pharmaceuticals SA published this content on 20 July 2018 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 20 July 2018 05:42:08 UTC