Mumbai : Glenmark Pharmaceuticals Inc., USA, and Evestra, Inc. have completed a strategic development, license and commercialization agreement to develop and market a generic version of Merck’s & Co.’s NuvaRing® product etonogestrel/ethinyl estradiol vaginal ring designed to allow women access to a more affordable birth control option.
Development on the vaginal ring product is currently under way and the two companies expect to file an Abbreviated New Drug Application (ANDA) in fiscal 2019.
Evestra will develop this product exclusively for Glenmark for the U.S. market, and will receive certain milestone payments during various stages of the product’s development, including royalties on net sales.
“Bringing high-quality and affordable options to market has been a core commitment for Glenmark since the beginning,” said Robert Matsuk, President North America and Global API, Glenmark Pharmaceuticals Ltd. “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.”
Glenmark has secured exclusive marketing and distribution rights for the product, including an option to commercialize two additional Evestra vaginal ring products, for the U.S. market.
“This is an important U.S.-based strategic partnership for Evestra,” said President and CEO Ze’ev Shaked. “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.”
Merck’s IMS Health NuvaRing® registered sales of $768 million in 2016 in the U.S. market.
NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy.