Watson Pharmaceuticals Inc. (WPI) recently announced the initiation of a late-stage study of Esmya (ulipristal acetate) in anemic women with uterine leiomyomas (fibroids). Patients suffering from uterine leiomyomas experience excessive uterine bleeding, anemia, pain, either frequent urination or incontinence, and occasional interruption of fertility. We note that about 300,000 surgeries are performed every year to address uterine fibroids.
The phase III study is scheduled to enroll 300 patients, belonging to the age group of 18-50 years. In the study, the patients will be dosed 10 mg Esmya plus iron or matching placebo plus iron, once daily for three consecutive menstrual cycles.
The study is designed to find out the change from baseline in hemoglobin at the start of menstrual cycle 3, and overall bleeding assessments throughout the treatment.
Watson Pharma expects this study to conclude by the fourth quarter of 2014, after which the company plans to file a new drug application (NDA) with the US Food and Drug Administration (FDA).
We note that the drug is already approved in the European Union (EU) for the pre-operative treatment of moderate-to-severe symptoms of uterine fibroids. Further, Watson Pharma plans to file for Canadian approval of Esmya in mid-2012. The company will submit the marketing application to the Health Canada on the basis of the European clinical program.
Watson Pharma has an agreement with Gedeon Richter for the development and marketing of the drug in the US and Canada. As a part of the agreement, Watson Pharma made a $17 million license fee payment to Gedeon Richter. The latter is also entitled to receive royalties based on the US and Canadian sales of Esmya. Moreover, Watson Pharma is required to make payments on the achievement of certain regulatory milestones.
We currently have a Neutral recommendation on Watson Pharma. The stock carries a Zacks #3 Rank (Hold rating) in the short-run.
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