Watson Announces Initiation of Esmya(R) U.S. Phase 3 Clinical Trial

PARSIPPANY, N.J., March 12, 2012 /PRNewswire/ -- 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.

About the Esmya® (ulipristal acetate) U.S. Phase 3 Study
The U.S. Phase 3 study is a multi-center, randomized, double-blind study designed to evaluate the safety and efficacy of ulipristal acetate 10 mg in women with anemia associated uterine leiomyomas, also known as uterine fibroids.  Approximately 300 subjects, aged 18–50 years, anemic, and who are planning a hysterectomy or myomectomy to treat their leiomyoma(s), will be randomized to receive ulipristal acetate 10 mg plus iron or matching placebo plus iron, administered orally, once daily over three consecutive menstrual cycles during which safety, efficacy, and pharmacokinetic parameters will be evaluated.

Efficacy and safety assessments will include change from baseline in hemoglobin at the start, or scheduled start, of menstrual cycle 3, and overall bleeding assessments through the end of treatment using a subject-maintained Menstrual Cycle Bleeding Diary.

About Uterine Fibroids
Uterine fibroids affect almost 25 percent of women of reproductive age.  Symptoms may include excessive uterine bleeding, anemia, pain, either frequent urination or incontinence, and occasional interruption of fertility.  Approximately 300,000 surgical procedures are performed annually to address uterine fibroids, including some 230,000 hysterectomies. Currently, GnRH agonists are the only Food and Drug Administration approved treatment for uterine fibroids associated with anemia and their use is relatively limited due to side effects resulting from the suppression of estrogen to castration levels (e.g., hot flushes, depression, mood swings, loss of libido, vaginitis and loss of bone-mineral density).

About Esmya®
Ulipristal acetate is a first-in-class, orally active selective progesterone receptor modulator which reversibly blocks progesterone receptors in target tissues. 

About Watson Pharmaceuticals
Watson Pharmaceuticals, Inc. is a leading integrated global pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets. For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.

Forward-Looking Statement
Statements contained in this press release that refer to Watson's estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. For instance, any statements in this press release concerning prospects related to Watson's strategic initiatives, product introductions and anticipated financial performance are forward-looking statements. It is important to note that Watson's goals and expectations are not predictions of actual performance. Watson's performance, at times, will differ from its goals and expectations. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions; market acceptance of and continued demand for Watson's products; costs and efforts to defend or enforce intellectual property rights; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with governmental regulations applicable to Watson's facilities, products and/or businesses; changes in the laws and regulations, including Medicare, Medicaid, and similar laws in foreign countries affecting, among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on form 10-K for the year ended December 31, 2011. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.

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(1) Donnez J. et al. N Engl J Med. 2012 Feb 2; 366(5): 409-420
(2) Donnez J. et al. N Engl J Med. 2012 Feb 2; 366(5): 421-432
(3) Stewart EA. N Engl J Med. 2012 Feb 2; 366(5): 471-473

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SOURCE Watson Pharmaceuticals, Inc.