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.