DUBLIN and BUDAPEST, Hungary, Jan.
17, 2017 /PRNewswire/ -- Allergan Plc (NYSE: AGN) and
Gedeon Richter Plc. today announced positive results from Venus II,
the second of two pivotal phase III clinical trials evaluating the
efficacy and safety of ulipristal acetate in women with abnormal
bleeding due to uterine fibroids. A new drug application
filing for ulipristal acetate is planned for the second half of
2017.
"We are pleased with the favorable results of Venus II
supporting the efficacy and safety profile of ulipristal acetate as
shown in our Venus I trial," said David
Nicholson, Chief Research and Development Officer, Allergan.
"Allergan is committed to identifying, developing and bringing to
market therapies that address unmet need and provide significant
value to the healthcare system, including a potential new treatment
for symptomatic uterine fibroids. We are confident that the
results of our phase III trials for ulipristal acetate may
potentially offer the first and only oral treatment option for
women suffering from uterine fibroids in the U.S."
The study included 432 U.S. patients with 162 and 157 patients
randomized to ulipristal acetate 5 and 10 mg respectively, and 113
to placebo. The average age of patients enrolled was 41 years and
67 percent of enrolled patients were Black/African Americans. The
study met all the co-primary and secondary endpoints with both
ulipristal treatment arms achieving statistically significant
results over placebo (p<0.0001). The co-primary efficacy
endpoints were percentage of patients with absence of uterine
bleeding and time to absence of uterine bleeding on treatment
during Treatment Course One (12-week duration). Significantly
more patients in the 10 mg group (54.8%) and the 5 mg group (42.0%)
achieved absence of bleeding compared to placebo (0%).
The secondary efficacy endpoints were the percentage of patients
with absence of uterine bleeding from Day 11 to end of the first
treatment course; the percentage of patients with absence of
uterine bleeding after the second treatment course; time to absence
of uterine bleeding on treatment during treatment course two; and
the change from baseline in the UFS-QOL revised Activities subscale
at the end of the first treatment course.
More patients in the 10 mg group (55.4%) and the 5 mg group
(34.6%) achieved absence of bleeding within 10 days after treatment
initiation in Treatment Course One compared to placebo (0.0%).
Significantly more patients in the 10 mg group (57.3%) and the 5 mg
group (40.5%) achieved absence of bleeding compared to placebo
(8.0%) in Treatment Course Two. The improvement from baseline
in the UFS-QOL revised activities subscale was significantly
greater in the 10 mg group (56.7%) and the 5 mg group (48.3%)
compared to placebo (13.0%).
The UFS-QOL is a validated fibroid-specific symptom and
health-related quality of life instrument. This questionnaire is an
established instrument to assess disease impact on the well-being
of women with uterine fibroids.
"It is indeed very encouraging that we have another successful
phase III study conducted in patients with uterine fibroid
symptoms, which shows that ulipristal acetate could bring promising
treatment for women suffering from this condition," added Dr István
Greiner, Research Director of Gedeon Richter Plc. "We remain
committed to the development of female healthcare products aiming
towards the improvement of the quality of life of women in all age
groups."
The most common adverse events (≥5%) on ulipristal acetate
treatment were hot flush, headache, fatigue, and nausea in the
combined period of Treatment Course One and first off-treatment
interval. The most common adverse event (≥ 5%) on
ulipristal acetate treatment was headache in the combined period of
Treatment Course Two and second off-treatment interval.
About Venus II
This study was a multi-center,
randomized, double-blind, placebo-controlled clinical trial in
premenopausal women in North
America between 18 and 50 years old with cyclic (22 to 35
days) abnormal uterine bleeding in ≥4 of the last 6 menstrual
cycles, menstrual blood loss ≥80 mL as measured by the alkaline
hematin method over the first 8 days of menses, ≥1 discrete uterine
fibroid of any size and location observable by transvaginal
ultrasound, follicle-stimulating hormone ≤20 mIU/mL, and uterine
volume ≤20 weeks by exam. Eligible patients were randomized
to ulipristal acetate 5 mg, 10 mg or placebo for two separate
12-week treatment courses followed by a 12-week treatment-free
follow-up period.
About Ulipristal Acetate
Ulipristal acetate, an
investigational drug for the medical treatment of uterine fibroids,
is a selective progesterone receptor modulator (SPRM), which acts
directly on the progesterone receptors in 3 target tissues:
the endometrium (uterine lining), uterine fibroids, and the
pituitary gland. Ulipristal acetate exerts a direct effect on
the endometrium (suppressing uterine bleeding) and direct action on
fibroid size by decreasing the formation of new fibroid cells and
promoting fibroid cell death. The safety and efficacy of ulipristal
acetate has been evaluated in two phase III US studies of more than
589 adult women of reproductive age. Ulipristal acetate is
protected by a patent that expires in 2029.
The Venus I and II trials build upon data collected from prior
efficacy and safety studies of ulipristal acetate for fibroids
conducted Ex-US. 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™. 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, more than 310,000 women have been treated with
ulipristal acetate for fibroids in over 65 countries worldwide.
About Uterine Fibroids
Uterine fibroids, also known as
myomas, are the most common benign growths that affect up to 80
percent of women in the United
States by the age of 50 and are more prevalent in
African-American women. Fibroids are made of muscle cells and
other tissues that grow in and around the wall of the uterus, or
womb. Uterine fibroids are a significant cause of morbidity. It is
estimated that up to 50 percent of women with fibroids will
experience symptoms. Women report serious symptoms such as heavy
menstrual bleeding, painful menses, pelvic pain, urinary symptoms,
bowel dysfunction, pressure within the abdomen and on adjacent
pelvic organs, and impact on fertility. In fact, women reported
severe to very severe symptoms related to menstrual pain/cramps,
heavy or prolonged bleeding, and abdominal pain/cramping. Moreover,
heavy uterine bleeding can be associated with iron deficiency
anemia, pain, social embarrassment, interference with daily and
social activities as well as lost productivity in the work
place.
The current mainstay of management is mainly surgical. In fact,
uterine fibroids are responsible for over 350,000 hospitalizations
and are the leading cause of hysterectomies, accounting for
approximately one-third of all hysterectomies annually in the US.
The economic burden of uterine fibroids is also large, costing the
economy over $34 billion each
year.
About Allergan
Allergan plc (NYSE: AGN), headquartered
in Dublin, Ireland, is a bold,
global pharmaceutical company and a leader in a new industry model
– Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing branded pharmaceuticals, devices
and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class
products for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's
R&D model, which defines our approach to identifying and
developing game-changing ideas and innovation for better patient
care. This approach has led to Allergan building one of the
broadest development pipelines in the pharmaceutical industry with
70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 15,000 global
colleagues' commitment to being Bold for Life. Together, we build
bridges, power ideas, act fast and drive results for our customers
and patients around the world by always doing what it is right.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live healthier lives
every day.
For more information, visit Allergan's website at
www.Allergan.com.
About Gedeon
Richter
Gedeon Richter Plc. (www.richter.hu),
headquartered in Budapest/Hungary,
is a major pharmaceutical company in Central Eastern Europe, with
an expanding direct presence in Western
Europe. Having reached a market capitalisation of
EUR 3.3 billion (US$ 3.6 billion) by the end of 2015, Richter's
consolidated sales were approximately EUR
1.2 billion (US$ 1.3 billion)
during the same year. The product portfolio of Richter covers many
important therapeutic areas, including gynaecology, central nervous
system, and cardiovascular areas. Having the largest R&D unit
in Central Eastern Europe, Richter's original research activity
focuses on CNS disorders. With its widely acknowledged steroid
chemistry expertise, Richter is a significant player in the female
healthcare field worldwide. Richter is also active in biosimilar
product development.
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 of existing trends and information as of the
date of this release. Except as expressly required by law, Allergan
disclaims any intent or obligation to update these forward-looking
statements. 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, 2015 and Quarterly
Report on Form 10-Q for the quarter ended September 30, 2016 (certain of such periodic
public filings having been filed under the "Actavis plc" name).
Except as expressly required by law, Allergan disclaims any intent
or obligation to update these forward-looking statements.
CONTACTS:
ALLERGAN
Investors:
Lisa
DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
Lisa Kim
(714) 246-3843
GEDEON RICHTER CONTACTS:
Investors:
Katalin Ördög
+36 1 431 5680
Media:
Zsuzsa Beke
+36 1 431 4888
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SOURCE Allergan plc