Allergan's Uterine Fibroids Treatment Shows Efficacy

Allergan PLC and Gedeon Richter PLC on Monday said a late-stage study of ulipristal acetate in women with uterine fibroids met all of its endpoints.

Shares rose 6.8% to $215.25 in midday trading, though they are still down 8.7% over the past month.

The pharmaceutical companies said patients being treated with the drug showed a statistically significant absence of uterine bleeding.

Uterine fibroids, or myomas, are the most common benign tumors that affect up to 80% of women in the U.S. by the age of 50. They are the leading cause of hysterectomies nationally.

"Ulipristal acetate has the potential to offer the first and only noninvasive long-term treatment option for women suffering from uterine fibroids in the U.S.," said David Nicholson, Allergan's president of global research a development.

The study is the first clinical trial to report top-line results. A second and final clinical trial is expected to be completed this year with top-line results expected in the first half of 2017. A new drug application for the treatment is planned for 2017.

Evercore analyst Umer Raffat said the U.S. Food and Drug Administration is allowing Allergan to enroll points for patients showing signs and symptoms of uterine fibroids who aren't planning on undergoing surgery, which "greatly expands the target population."

Mr. Raffat points out peak sales are estimated to be $500 million to $1 billion, with a launch in 2018 and a patent through 2029.

Write to Anne Steele at Anne.Steele@wsj.com

(END) Dow Jones Newswires

May 09, 2016 12:25 ET (16:25 GMT)

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