SUCCESS FOR MYRING EUROPEAN CLINICAL TRIAL
- Myring demonstrates bioequivalence to European version of NuvaRing®
- Mithra preparing to file for regulatory approval in Europe and the U.S. in Q2 2017
Liège, Belgium, 8 December 2016 - Mithra Pharmaceuticals (Euronext Brussels: MITRA), a company focused on women's health, today announces the results of the first of two bioequivalence studies, which demonstrate that its combined hormonal contraceptive vaginal ring, Myring, is bioequivalent to the branded European version of NuvaRing®.
Mithra plans to file for marketing approval for Myring in both Europe and the United States in Q2 2017.
Valérie Gordenne, CSO of Mithra Pharmaceuticals, said: "Myring has the potential to be an important additional contraceptive option for women. The results announced today confirm its bioequivalence to the current market leader and will be an important part of the regulatory filing for Myring in Europe as well as other markets. They will also support our ongoing negotiations with potential European and international commercialization partners. We are on track to submit Myring for regulatory approval in both Europe and the U.S. in the second quarter of 2017."
Mithra has conducted two studies of bioequivalence involving 42 subjects. The studies are required to confirm the effectiveness and the safety of the product with a view to completion of the marketing authorization applications in Europe and the U.S.
About Myring
Myring is developed to be similar to Nuvaring® vaginal ring, still under patent protection up to april 2018 both is 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.
Pictures
For pictures of François Fornieri, please click here on the following link:
http://www.mithra.com/en/logo/
For more information, please contact:
Press
Julie Dessart
Chief Communication Officer
+32 4 349 28 22 / +32 475 86 41 75
press@mithra.com
Investor Relations
François Fornieri, CEO
+32 4 349 28 22
investorrelations@mithra.com
Consilium Strategic Communications
Jonathan Birt, Sue Stuart, Hendrik Thys
mithra@consilium-comms.com
+44 2 037 095 700
About Mithra
Mithra Pharmaceuticals SA, founded in 1999 as a spin-off of the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart, is a Euronext listed pharmaceutical company (MITRA) focused on Women's Health. Mithra's mission is to improve every stage of women's life with innovative and accessible pharmaceutical solutions. As such the Company aims to become a worldwide leader in women's health by developing, manufacturing and commercialising proprietary, innovative and differentiated drugs and complex therapeutical solutions in four therapeutic fields of women's health: fertility and contraception, menopause and osteoporosis, gynecological infections and female cancers.
Mithra has an approximate headcount of 141 staff members 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.
To subscribe to Mithra's newsletter, visit investors.mithra.com
Attachments:http://www.globenewswire.com/NewsRoom/AttachmentNg/f28a6d13-ef47-46b7-a71e-fff54b29d756
