Mayne Pharma Inc. has entered into a long-term, exclusive license and supply agreement with Mithra Pharmaceuticals SA for Myring, an intravaginal hormonal contraceptive delivery device. Under the agreement, Mayne Pharma will have responsibility to market, sell and distribute the product following U.S. FDA approval and Mithra will be responsible for supply.
Myring is a non-biocompatible, flexible, ring-shape device combining etonogestrel and ethinyl estradiol over a three-week period. It is currently under development by Mithra, a specialty pharma company focused on the development of therapeutic solutions in women’s health. Mithra has completed bioequivalence studies and Mayne Pharma expects to file this product with the FDA in 2017.
Myring has been developed to be an AB-rated generic to Merck’s NuvaRing, which had total U.S. sales of approximately $780 million in 2016, according to IMS Health.
Mayne Pharma’s chief executive officer Scott Richards said, "We are very pleased to have licensed Myring which is another complex and difficult-to-develop and manufacture product. Myring complements our existing women’s health franchise of 22 hormonal marketed products and four pipeline products. We also are very excited to be partnering with Mithra, a leading women’s health drug delivery company."