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By David Holley, Xconomy Texas
San Antonio - Evestra, an early stage drug developer focused on women's health, has made a deal with the U.S. division of Mumbai-based Glenmark Pharmaceuticals to try to bring its generic version of the NuvaRing birth control product to market.
San Antonio-based Evestra's product is still in development, and the companies say they are hoping to file an abbreviated new drug application to the FDA for regulatory approval in the 2019 fiscal year. The goal is to take a slice of the $576 million in U.S. sales recorded in 2016 by Merck (NYSE: MRK), the maker of NuvaRing. Patents on the NuvaRing delivery system are set to expire in April 2018, according to a regulatory filing, though a couple of lawsuits Merck is involved in may make that date murky.
The U.S. division of Glenmark, which is based in Mahwah, NJ, is getting the marketing and distribution rights for the generic drug product in the U.S., as well as an option to commercialize two other vaginal rings in development, Glenmark says. In return, Evestra gets potential milestone and royalty payments as it continues to develop and commercialize the drug, called EVE-119, with Glenmark. Evestra CEO Ze'ev Shaked declined to reveal any further specific terms of the deal.
Two companies applied to the FDA for approval of generic versions of the NuvaRing-a vaginal ring that delivers a combination of the hormones etonogestrel and ethinyl estradiol-sometime during or before 2013, according to court documents and a news release. Merck filed lawsuits against both, claiming infringement on its patent. After a trial for the first lawsuit, which was filed against a subsidiary of then-Dublin-based drug maker Actavis, a court ruled that Merck's patent was invalid. Merck is in the process of appealing that decision. After a string of acquisitions, Indian pharmaceutical company Dr. Reddy's Laboratories now owns Actavis's generic version of NuvaRing.
Tikva, Israel-based Teva Pharmaceuticals has the other generic version, and the lawsuit against it was dismissed in December. Merck is also appealing that ruling. The FDA can, at times, grant a period of exclusivity to a generic drug for the first drug maker to apply.
Whether or how Evestra might seek approval for the generic product outside of the U.S. is under consideration, Shaked wrote in an e-mail sent by a spokesman.
In 2015, Evestra received a $5 million convertible loan from Budapest, Hungary-based healthcare company Gedeon Richter to help develop its pipeline of products.
Specifically, the deal centered around two other vaginal ring products, EVE-112 and EVE-116. Those continue to be developed for Richter, Shaked wrote in the e-mail. He has not said whether they are related to the two other rings for the Glenmark deal.
A subsidiary of Evestra is also developing an experimental drug for endometriosis, a painful condition related to overgrowth of tissue in the uterus. The company received a $4.6 million grant last month for that work.