Allergan's Uterine Fibroids Treatment Shows Efficacy
2016年5月10日 - 1:40AM
Dow Jones News
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)
Copyright (c) 2016 Dow Jones & Company, Inc.
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