Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced it has initiated its Phase 3 trial to evaluate the efficacy and safety of Esmya® (ulipristal acetate) in women with anemia associated with uterine leiomyomas, a medical condition often referred to as uterine fibroids (myomas). Leiomyomata are benign solid tumors that often lead to excessive menstrual bleeding, anemia and pain, which ultimately may require surgical intervention.
"Initiation of the U.S. pivotal trial is underway on schedule and we are hopeful that this Phase 3 study will demonstrate improvement on pre-surgical hemoglobin concentrations, an endpoint indicating that heavy bleeding and anemia have been alleviated," said Fred Wilkinson, Executive Vice President, Watson Global Brands. "Esmya®, if approved, may be an important medicine for women whose fibroid-symptom severity often leads to excessive bleeding and related pain."
In December 2010, Watson announced that it had entered into an exclusive license agreement with Gedeon Richter Plc to develop and market Esmya® in the United States and Canada. Under terms of the agreement, Watson paid a $17 million license fee, and will pay royalties based on sales in the U.S. and Canada. The Company will also make additional payments based on the achievement of certain regulatory milestones.
During an end of phase 2 meeting, the FDA required that a new phase 3 trial be conducted evaluating anemic patients with an improvement in hemoglobin as the primary endpoint. Watson expects the U.S. Phase 3 trial to be completed by 4Q 2013, at which time the company will prepare a New Drug Application for submission to the U.S. Food and Drug Administration.
Esmya® 5mg tablet was approved last month by the European Commission (EC) for pre-operative treatment of moderate-to-severe symptoms of uterine fibroids. This approval is applicable for all Member States in the European Union. The results of the European studies were recently published in the New England Journal of Medicine.(1)(2)(3) Esmya® is expected to be launched in certain European countries in a month.
Watson has met with Health Canada and it was agreed that a New Drug Submission (NDS) could be filed based on the European clinical program. Watson intends to submit the NDS in mid 2012.
SOURCE Watson Pharmaceuticals, Inc.