Actavis Receives Canadian Approval to Market FIBRISTAL™ - A Treatment for Symptoms of Uterine Fibroids

PARSIPPANY, N.J., June 25, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) today announced that Health Canada has approved the company's application to market FIBRISTAL™ (ulipristal acetate) for the treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age who are eligible for surgery.  The breakthrough first-in-class oral treatment offers an important new option for women in Canada with uterine fibroids, the first approved medication to reduce fibroid size as well as control symptoms.¹  FIBRISTAL™ is expected to be available in Canada in the third quarter of 2013.

Current treatments for uterine fibroids in Canada include off-label medication to reduce symptoms, or surgery to remove fibroids if they become severe.²

Efficacy and safety were demonstrated in two double-blind, controlled, multicenter, Phase 3 studies.  In both trials, FIBRISTAL™ significantly reduced heavy bleeding during menstruation, pain and discomfort and the overall volume of fibroids. ³ The shrinkage in fibroid size was maintained for at least six months after three months of treatment with FIBRISTAL™.³  The results of the trials were published in the February 2012 edition of the New England Journal of Medicine.

"The approval of FIBRISTAL™ marks our entry into this important therapeutic area, and provides an innovative new treatment option for women whose fibroid-symptom severity often leads to excessive bleeding and related pain," said Fred Wilkinson, President, Actavis Specialty Brands.  "As a global leader in women's health, Actavis is committed to developing innovative medications to fill unmet medical needs of women in Canada and around the world."

Uterine Fibroids

Up to 75 percent of women will experience uterine fibroids in their lifetime.¹  Women report excessive uterine bleeding as the most common symptom.  They also suffer from painful menstruation, pelvic pain and frequent urination.  Fibroids can also cause infertility.

Uterine fibroids also have a serious impact on quality of life.  In an international epidemiological survey, 54 percent of women said uterine fibroid symptoms negatively impacted their quality of life.⁴

About FIBRISTAL™

FIBRISTAL™ is indicated for treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age who are eligible for surgery. The duration of treatment is limited to three months.³  FIBRISTAL™ is the first in a new class of medications in Canada called selective progesterone receptor modulators (SPRM).²  It is an orally active partial progesterone antagonist that both exerts a direct effect on the endometrium to control excessive bleeding, and inhibits cell proliferation and induces apoptosis in fibroids to reduce their size.³ The most common adverse drug reactions (greater than or equal to 5%) in the clinical trials for women receiving FIBRISTAL™ 5 mg were hot flash (13.0% overall) and headache (8.3% overall).

About Actavis

Actavis, Inc. (NYSE: ACT) is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.  Actavis has global headquarters in Parsippany, New Jersey, USA. 

Actavis Specialty Brands is Actavis' global branded specialty pharmaceutical business focused in the Urology and Women's Health therapeutic categories.  Actavis Specialty Brands also has a portfolio of five biosimilar products in development in Women's Health and Oncology.  Actavis Global Operations has more than 30 manufacturing and distribution facilities around the world, and includes Anda, Inc., a U.S. pharmaceutical product distributor.

Actavis Specialty Pharmaceuticals Co. is the Company's branded specialty pharmaceutical business in Canada engaged in the marketing, sale and distribution of branded pharmaceutical products within the Canadian market.  

For press release and other company information, visit Actavis' Web site at http://www.actavis.com.

Forward Looking Statement

Statements contained in this press release that refer to Actavis' estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Actavis' 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 Actavis' strategic initiatives, product introductions and anticipated financial performance are forward-looking statements. It is important to note that Actavis' goals and expectations are not predictions of actual performance. Actavis' performance, at times, will differ from its goals and expectations. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' 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 Actavis' products; the impact of competitive products and pricing; 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 Actavis' facilities, products and/or businesses; changes in the laws and regulations affecting, among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Actavis' periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis' Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 and Actavis' Annual Report on form 10-K for the year ended December 31, 2012.  Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

References:

¹ Uterine Fibroids. Mayo Clinic. http://www.mayoclinic.com/health/uterine-fibroids/DS00078. Accessed June 17, 2013.
² Uterine Fibroids. The American College of Obstetricians and Gynecologists. http://www.acog.org/~/media/For%20Patients/faq074.pdf?dmc=1&ts=20130617T1137475270. Accessed June 17, 2013
³ FIBRISTAL Product Monograph. May 2013.
⁴ Zimmermann A et al. Prevalence, symptoms and management of uterine fibroids. BMC Women's Health 2012;12:6 www.biomedcentral.com/1472-6874/12/6.

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SOURCE Actavis, Inc.