Mithra Pharmaceuticals: AGREES EXCLUSIVE LONG-TERM LICENSE AND SUPPLY AGREEMENT WITH MAYNE PHARMA TO COMMERCIALIZE MYRING(TM) IN THE US
28 februari 2017 07:00
Mithra agrees ExclusiveLONG-TERMlicense and supply agreement with Mayne Pharma to commercialize Myring(TM) in the US
Mithra grants its first exclusive license for its vaginal contraception ring, Myring(TM), to Mayne Pharma (ASX: MYX), the second-largestsupplierof oral contraceptives in the USmarket, covering commercialization in the United States
As part of the agreement, Mayne Pharma will pay milestones of at least EUR 10.0m following approval by the US FDA
Mithra will produce Myring(TM) for MaynePharmaat its Research, Development and Manufacturing facility (Mithra CDMO)
Liège, Belgium, 27 February 2017- Mithra Pharmaceuticals, a company dedicated to Women's Health, is pleased to announce an exclusive long-term license and supply agreement that extends beyond 10 years with Mayne Pharma, a leading specialty pharmaceutical company, for the commercialization in the United States of Myring(TM), Mithra's combined hormonal contraceptive vaginal ring made of ethylene vinyl acetate copolymers (EVA). Mayne Pharma is the second largest supplier of oral contraceptive products in the US market.
Under the terms of the agreement, Mithra will receive EUR 2.4m upon signature, as well as significant milestone payments on ANDA approval (market approval by the FDA) and on the commercial launch of the product. As a part of Mayne Pharma's long-term exclusive sourcing commitment, Mithra is considering the expansion of its production capacity for Myring(TM).
Currently, the US market for biocompatible contraceptive rings is worth EUR 740m  , which represents approximately 30% of the total global market by volume and over 75% by value, making this a key territory for the commercialization of Myring(TM).
Mithra is anticipating important financial contributions from this product post-commercial launch, aligned with the market potential and Mayne Pharma's commitment to the oral contraceptive market.
François Fornieri, CEO Mithra Pharmaceuticals:"This agreement with Mayne Pharma further demonstrates Mithra's attractiveness for partnerships, exemplifying our strategy to seek specialist partners around the world. It also underlines our expertise in polymers and proves the confidence that key US companies have in our know-how and the research and manufacturing capabilities of Mithra's CDMO. Furthermore, the attractive deal terms validate Mithra's acquisition of the remainder of Novalon in December 2015. Through the acquisition of a portfolio of 42 pharmaceutical products from Teva last year, Mayne Pharma became a top 25 retail generic pharmaceutical company with an extensive portfolio of women's health products. Hence, we strongly believe that we have the best partner at our side to market our vaginal ring, Myring (TM) , in the key US market."
About Mayne Pharma
Mayne Pharma is a publicly traded specialty pharmaceutical company listed on the Australian Securities Exchange (ASX: MYX). The company develops and manufactures branded and generic products globally - either directly or through distribution partners - while applying its drug-delivery expertise for contract development and manufacturing services. Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems, and its technologies have been successfully commercialized in products marketed around the world. Mayne Pharma has drug development and manufacturing facilities in Greenville, North Carolina, USA, and Salisbury, Australia, and offers expertise in formulating complex oral dose forms including highly potent compounds, controlled substances, and modified release products. In the United States, Mayne Pharma's operations consist of U.S. Generic Products, U.S. Specialty Brands, and Metrics Contract Services.
Myring(TM) is developed to be a generic of Nuvaring® vaginal ring, still under patent protection up to April 2018 both in the US and in EU. Myring(TM) (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.