Positive data from two Phase III trials have led PregLem to confirm plans to submit its oral uterine fibroids therapy, Esmya, for approval in Europe by the end of 2010. Data from the placebo-controlled Phase III study, Pearl I, confirmed the benefits of Esmya in the treatment of symptomatic uterine fibroids in women with heavy bleeding leading to anemia.
The Pearl I data follows on just a couple of weeks after PregLem reported positive data from another Phase III trial, Pearl II, which compared oral Esmya therapy with the injectable GnRH agonist Leuprorelin for the treatment of symptomatic uterine fibroids in patients eligible for surgery. The firm points out that Leuprorelin is the only treatment currently approved for the condition.
Established in 2006, Swiss company PregLem is dedicated to the development and commercialization of drugs for women’s reproductive health. Lead product, Esmya, is a selective progesterone receptor modulator, which the firm in-licensed from HRA Pharma. The original agreement covered Europe, but in May the deal was expanded to give Preglem rights to develop and commercialize the compound for benign gynecological disorders in North America.
At the time PregLem said it was evaluating several options for commercialization of the drug in Europe and North America. HRA separately developed the molecule as an emergency contraceptive, trademarked ellaOne and approved in Europe in May 2009.