Development of the etonogestrel/ethinyl estradiol contraceptive is under way, according to the companies, and they plan to file an Abbreviated New Drug Application in fiscal 2019.
“This is an important U.S.-based strategic partnership for Evestra,” president & CEO Ze’ev Shaked said in prepared remarks. “By aligning our efforts, we expect to make great strides in improving women’s healthcare and access to options that are significantly more accessible due to their lower costs. We are excited to work with Glenmark.”
San Antonio-based Evestra said it will develop the product exclusively for Glenmark within the U.S. market and is slated to receive milestone payments contingent upon the vaginal ring’s development. Evestra is also eligible to receive royalties on net sales.
“Bringing high-quality and affordable options to market has been a core commitment for Glenmark since the beginning,” president of U.S. and global API biz Robert Matsuk added. “The partnership with Evestra underscores that focus, and expands our portfolio into a leading non-daily contraceptive option prescribed to millions of women in the U.S.”
Merck’s NuvaRing brought in sales of $768 million in 2016 within the U.S., the companies reported. The small, flexible ring releases a continuous low dose of hormones for 3 weeks at a time.
Research has shown that when used as directed, the NuvaRing is just as effective as a daily, oral contraceptive.