Mayne Pharma has entered into a long-term exclusive license and supply agreement with Mithra Pharmaceuticals SA (Mithra) for Myring®, an intravaginal hormonal contraceptive delivery device.
Under the terms of the agreement, Mayne Pharma will have responsibility to market, sell and distribute the product following U.S. Food and Drug Administration (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 pharmaceutical company focused on the development, manufacturing and commercialization of innovative and differentiated drugs and 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 for the 12 months ending Dec. 31, 2016, according to IMS Health.
Mayne Pharma’s CEO 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. Following the Teva portfolio acquisition, Mayne Pharma became the second-largest supplier of oral contraceptives in the U.S. market and we have been actively seeking complementary portfolio and pipeline product opportunities. NuvaRing® is currently the largest product sold in the $5.5 billion United States contraceptive market. We also are very excited to be partnering with Mithra, a leading women’s health drug delivery company.”