Mithra Agrees to Exclusive Long-Term Agreement With Mayne Pharma

Mithra Pharmaceuticals recently announced 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 US of Myring, 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.

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.

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.

“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, in the key US market,” said François Fornieri, CEO Mithra Pharmaceuticals.

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, NC, and Salisbury, Australia, and offers expertise in formulating complex oral dose forms, including highly potent compounds, controlled substances, and modified-release products. In the US, Mayne Pharma’s operations consist of US Generic Products, US Specialty Brands, and Metrics Contract Services.

Myring 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 (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 3-week period of use. The ring is to remain in place continuously for 3 weeks. It is removed for a 1-week break, during which a withdrawal bleed usually occurs. A new ring is inserted 1 week after the last ring was removed.

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 pharmaceutical company focused on Women’s Health. Mithra’s mission is to support and assist women at every stage of their life, thereby improving their overall quality of life. As such the company aims to become a worldwide leader in women’s health by developing, manufacturing, and commercializing proprietary, innovative, and differentiated drugs and complex therapeutical entities in four therapeutic fields of women’s health, fertility and contraception, menopause, and osteoporosis, vaginal infections, and cancers. Mithra has a total headcount of approximately 85 staff members and is headquartered in Liège, Belgium. For more information, visit www.mithra.com.