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Allergan Announces that the FDA Accepts New Drug Application for Ulipristal Acetate for Uterine Fibroids

DUBLIN, Oct. 10, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ulipristal acetate, an investigational drug for the treatment of abnormal uterine bleeding in women with uterine fibroids.

"Women with symptomatic uterine fibroids may suffer from physical and emotional distress2,3 without realizing their symptoms are caused by a treatable medical condition," said David Nicholson, Ph.D., Chief Research and Development Officer, Allergan. "Even when diagnosed, women in the U.S. are faced with limited treatment options. We are eager to continue working with the FDA on the potential approval of the first, once-daily oral treatment for abnormal uterine bleeding in women with uterine fibroids."

"Uterine fibroids have a serious impact on public health, and I am hopeful ulipristal acetate will offer millions of women a new, non-surgical treatment option that will help them manage their uterine fibroids," said Millie A. Behera M. D., FACOG, Reproductive Endocrinology and Fertility Medical Director, Bloom Reproductive Institute. "It is welcome news for physicians to learn about the possibility of an oral treatment option, and that's exactly what U.S. physicians can look forward to if the investigational drug ulipristal acetate is approved for abnormal uterine bleeding in women with uterine fibroids."

Allergan expects the ulipristal acetate Prescription Drug User Fee Act (PDUFA) action date to occur in the first half of 2018.

About Uterine Fibroids

According to an analysis published by the Agency for Healthcare Research and Quality (AHRQ), an agency within the United States Department of Health and Human Services, in the United States an estimated 26 million women between the ages of 15 and 50 years old have uterine fibroids,1 and at least half of these women have symptoms that may impact the routine activities of their daily lives. Common symptoms include heavy menstrual bleeding, long menstrual cycles, irregular menstrual cycles, anemia, pelvic pain, pelvic pressure and urinary symptoms.2

These symptoms can be associated with iron deficiency, fatigue, pain, social embarrassment, interference with daily and social activities as well as lost productivity in the work place.2,3

Currently, surgery is a common treatment option for symptomatic uterine fibroids. In fact, uterine fibroids are responsible for over 350,000 hospitalizations and are the leading cause of hysterectomies, accounting for more than one-third of all hysterectomies annually in the U.S.4 The economic burden of uterine fibroids is also large, costing the economy up to $34 billion each year.4

About Ulipristal Acetate

Ulipristal acetate, an investigational drug in the U.S. for the medical treatment of abnormal uterine bleeding in women with uterine fibroids, is a selective progesterone receptor modulator (SPRM), which acts directly on the progesterone receptors in three target tissues: the endometrium (uterine lining), uterine fibroids, and the pituitary gland. In the U.S, the safety and efficacy of ulipristal acetate has been evaluated in two North American Phase 3 studies (Venus I and VENUS II) of more than 500 adult women of reproductive age. Ulipristal acetate is protected by a patent that expires in 2029.

In addition to the Venus I and II trials, the efficacy of ulipristal acetate has been demonstrated in a series of four, multi-center, Phase 3, European trials involving more than 1,000 women with uterine fibroids. In Europe, ulipristal acetate is marketed under the trade name Esmya® by Gedeon Richter. In Canada, ulipristal acetate is available under the trade name Fibristal™ and marketed by Allergan. Esmya® and Fibristal™ are currently approved for the pre-operative and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

To date, approximately 500,000 women have been treated with ulipristal acetate for fibroids in over 70 countries worldwide.5

About Allergan Women's Healthcare

Allergan is a leader in women's healthcare that is dedicated to developing and commercializing best-in-class pharmaceuticals to improve the health and wellness of women. Allergan takes a holistic and a best-in-class approach to women's healthcare as it prioritizes educational partnerships with OB/GYNs. The mission of Allergan Women's Healthcare extends beyond its pharmaceutical products to ensure that all women can make informed decisions about their health and have access to high-quality medications. Allergan is committed to investing in programs that support the education and well-being of all women.

About Allergan plc

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry with 65+ mid-to-late stage pipeline programs currently in development.

Allergan's success is powered by our more than 18,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan's website at www.Allergan.com.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2016 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

1 Agency for Healthcare Research and Quality (AHRQ). Evidence-based Practice Center Systematic Review Protocol: Management of Uterine Fibroids. https://effectivehealthcare.ahrq.gov Published March 1, 2016. Accessed August 16, 2017.
2 De La Cruz MS, Buchanan EM. Am Fam Physician. 2017 Jan 15;95(2):100-107.
3 Borah BJ , Nicholson WK, Bradley L, et al. Am J Obstet Gynecol. 2013;209:3119.e1-20.
4 Wechter ME, Stewart EA, Myers ER, et al. Am J Obstet Gynecol. 2011;205(5):492.e1-492.e5.
5 Data on file.

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SOURCE Allergan plc