Allergan Presented New Phase 3 Data of Ulipristal Acetate in Women with Uterine Fibroids at the American Society for Reproductive Medicine Annual Congress

DUBLIN, Oct. 31, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN) presented new analyses of VENUS II, the second of two pivotal Phase 3 clinical trials evaluating the efficacy and safety of ulipristal acetate (UPA), an investigational drug for the treatment of abnormal uterine bleeding in women with uterine fibroids.

"For a condition that affects an estimated 26 million women in the U.S.,¹ there is a clear unmet medical need for new treatments for uterine fibroids," said Millie A. Behera M.D., FACOG, Reproductive Endocrinology and Fertility Medical Director, Bloom Reproductive Institute in Arizona. "I am hopeful that, if approved, the availability of a once-daily oral medication like ulipristal acetate will encourage women to have a discussion with their doctor about their options to treat this condition."

"Uterine fibroids are an indiscriminate disease that affect women regardless of their ethnicity or weight," said David Nicholson, Ph.D., Chief Research and Development Officer, Allergan. "However, uterine fibroids are three times more common in women of African-American ancestry compared to Caucasian women,² and the risk of developing fibroids steadily increases based on weight³."

Three oral presentations were delivered at the American Society for Reproductive Medicine's 73^rd Annual Congress (ASRM 2017) in San Antonio, Texas.

Three Key Presentations from the VENUS II Study:

Presentation O-66: UPA Treatment of Symptomatic Uterine Fibroids (UF): Subgroup Analyses By Race and BMI

Analyses from this presentation evaluated the efficacy of UPA regardless of a woman's body mass index (BMI) or race.

In VENUS II, more women achieved absence of bleeding (amenorrhea, the study's co-primary endpoint) with once-daily 10 mg and 5 mg UPA, relative to placebo, regardless of whether patients were Black or had a high BMI.

Overall, 66.9% of patients were Black and 56.7% had BMI ≥30 kg/m². In Black and Non-black patients, more achieved amenorrhea with UPA 10 mg (48.6% and 68.0%) and UPA 5 mg (34.8% and 59.6%) versus placebo (0% for both), respectively. Similar results were observed regardless of BMI, with higher amenorrhea rates following UPA 10 mg and 5 mg versus placebo (≥30 kg/m²: 58.4% and 47.3% vs 0%; <30 kg/m²: 50.0% and 33.8% vs 0%), respectively.

Presentation O-64:The Second U.S. Phase 3 Study of UPA for Treatment of Symptomatic Uterine Fibroids

This presentation reported the percentage of women who achieved absence of bleeding who received two 12-week treatment courses of once-daily UPA or placebo. Absence of bleeding or amenorrhea was defined as no bleeding (spotting permitted) for the last 35 consecutive days on treatment.

In Treatment Course 1, 157, 162, and 113 patients were randomized to UPA 10 mg, UPA 5 mg, and placebo, respectively. Significantly more patients achieved amenorrhea with UPA (10 mg, 54.8%; 5 mg, 42.0%) versus placebo (0%; both p<0.0001). In Treatment Course 2, more patients maintained absence of bleeding with UPA 10 mg (Arm 5), 57.3%; and UPA 5 mg (Arm 3), 40.5% versus placebo (Arms 4 and 6), 8.0% (all p-values < 0.0001).

The most common adverse events (AEs), ≥5% in any UPA group, during Course 1 and first off-treatment were hot flush (UPA total vs placebo, 9.5% vs 1.7%), headache (7.3% vs 5.2%), fatigue (4.4% vs 4.3%), and nausea (5.4% vs 4.3%), and for Course 2 and second off-treatment was headache (4.0% vs 2.7%).

Presentation O-65 Quality of Life with UPA Treatment of Symptomatic Fibroids

The presentation examined whether UPA 10 mg and 5 mg improved quality of life and reduced limitations on social and physical activities, versus placebo. The analysis showed patient-reported improvements in social and physical activities based on the Uterine Fibroids Symptom and Health-Related Qualify of Life questionnaire (UFS-QoL). The UFS-QoL is a disease-specific, health-related quality of life instrument that measures the symptoms and impact of uterine fibroids.

In Treatment Course 1, mean change from baseline in HRQoL (Health-Related Quality of Life) Total Score was greater with UPA (10 mg, 51.0; 5 mg, 42.9) vs placebo (11.2; both p<0.0001). Improvements were also observed for Revised Activities subscale score (UPA 10 mg, 56.7; 5 mg, 48.3; placebo, 13.0; both p<0.0001) and remaining UFS-QoL subscales (p<0.0001 for UPA vs placebo).

In Treatment Course 2, there were improvements for UPA vs placebo in HRQoLTotal Score (mean change from baseline: 10 mg [Arm 5], 49.8; 5 mg [Arm 3], 44.5; placebo [Arms 4 and 6], 18.4; both p<0.0001), Revised Activities subscale score (10 mg, 54.9; 5 mg, 50.7; placebo, 20.9; both p<0.0001), and remaining subscales (p<0.01 for UPA vs placebo).

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.⁴

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.^4,5

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.⁶ The economic burden of uterine fibroids is also large, costing the economy up to $34 billion each year.⁷

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 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.⁸

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 Marshal LM, Spiegelman D, Barbieri RL, et al. Obstet Gynecol. 1997 Dec;90(6):967-73.
³ Ross RK, Pike MC, Vessey MP, et al. Br Med J (Clin Res Ed). 1986 Aug 9;293(6543):359-62.
⁴ De La Cruz MS, Buchanan EM. Am Fam Physician. 2017 Jan 15;95(2):100-107. 
⁵ Borah BJ , Nicholson WK, Bradley L, et al. Am J Obstet Gynecol. 2013;209:3119.e1-20.
⁶ Wechter ME, Stewart EA, Myers ER, et al. Am J Obstet Gynecol. 2011;205(5):492.e1-492.e5.
⁷ Cardozo ER, Clark AD, Banks NK, et al. Am J Obstet Gynecol. 2012 Mar;206(3):211.e1-9. 
⁸ Data on file.

SOURCE Allergan plc

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