|[March 31, 2014]
Forest Laboratories, Inc. and Gedeon Richter Plc. Announce Positive Phase IIb Topline Results for Cariprazine for the Treatment of Bipolar Depression
NEW YORK & BUDAPEST, Hungary --(Business Wire)--
Forest Laboratories, Inc. (NYSE:FRX) and Gedeon Richter Plc. today
announced positive topline results from a Phase IIb trial evaluating the
efficacy and safety of the investigational antipsychotic cariprazine in
patients with bipolar depression.
The trial consisted of four treatment groups: cariprazine 0.75 mg/day,
1.5 mg/day, 3.0 mg/day, and placebo. Statistically significant
improvements were observed in the cariprazine 1.5 mg/day group relative
to placebo at 6 weeks for the primary endpoint, the Montgomery-Asberg
Depression Rating Scale (MADRS) total score and the key secondary
endpoint, the Clinical Global Impressions - Severity (CGI (News - Alert)-S) score.
"We are pleased with the positive results of this study. In addition to
previously completed Phase III trials in schizophrenia and bipolar
mania, we now have positive Phase IIb studies for cariprazine in both
bipolar depression and major depressive disorder. Our goal is to
continue developing cariprazine for patients with a broad range of
psychiatric conditions," said Marco Taglietti, M.D., Executive Vice
President of Drug Development and Research at Forest Laboratories, Inc.
"Cariprazine is a critical element to Richter's discovery platform,"
explained Dr. Zsolt Szombathelyi, Research Director of Gedeon Richter
Plc. "We are pleased with the topline results of the Phase IIb trial and
are committed to developing an important new treatment option for
patients suffering from bipolar depression."
About this Phase IIb Study
This international, randomized, placebo-controlled, fixed-dose, 8-week
Phase IIb trial evaluated the efficacy and safety of cariprazine in the
treatment of patients with depressive episodes of bipolar I disorder.
Eligible patients included those with bipolar depression who met the
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition,
Text Revision (DSM (News - Alert)-IV-TR) criteria for bipolar I disorder with a current
major depressive episode. Patients also had to have a minimum score of
20 on the 17-item Hamilton Depression Rating Scale (HAM-D), a minimum
score of 2 on item 1 of the HAM-D, a minimum score of 4 on the CGI-S,
and a maximum score of 10 on the Young Mania Rating Scale (YMRS) at both
visit 1 and visit 2.
The study consisted of up to 14 days of screening followed by 8 weeks of
double-blind treatment, followed by a 1-week safety follow-up period.
During the double-blind treatment period, 584 patients 18 - 65 years of
age were randomized to one of four treatment groups: cariprazine 0.75
mg/day, 1.5 mg/day, 3.0 mg/day, or placebo. The primary endpoint was
change from baseline in the MADRS total score versus placebo at 6 weeks,
using a mixed-effects model for repeated measures (MMRM) analyss. The
group who received cariprazine 1.5 mg/day demonstrated statistically
significant improvement in the MADRS total score versus placebo at week
6 (cariprazine 0.75 mg/day: -1.9, p=0.1292; cariprazine 1.5
mg/day: -4.0, p=0.0030; cariprazine 3.0 mg/day: -2.5, p=0.1122).
The key secondary endpoint was change from baseline in CGI-S total score
versus placebo at 6 weeks, using an MMRM analysis. The group who
received cariprazine 1.5 mg/day demonstrated statistically significant
improvement in the CGI-S score versus placebo (cariprazine 0.75 mg/day:
-0.1, p=0.3025; cariprazine 1.5 mg/day: -0.4, p=0.0132;
cariprazine 3.0 mg/day: -0.3, p=0.1122).
Across all cariprazine doses, the most common adverse events (incidence
=10% and greater than placebo) were akathisia and insomnia.
Cariprazine, an investigational drug, is an orally active, potent
dopamine D3-preferring D3/D2 receptor
partial agonist atypical antipsychotic. It has a low affinity at other
receptor sites such as 5-HT2C, muscarinic, and adrenergic
receptor sites. Cariprazine is protected by a composition-of-matter
patent that expires in 2027 without patent term extension.
Cariprazine is being developed for the treatment of schizophrenia and
bipolar mania in adults. On November 21, 2013 the companies announced
that the U.S. Food and Drug Administration issued a complete response
letter regarding the new drug application for schizophrenia and bipolar
mania. In addition, cariprazine is being investigated for the treatment
of bipolar depression and as adjunctive treatment for major depressive
disorder in adults.
About Bipolar I Disorder
Bipolar disorder, which encompasses bipolar I and bipolar II disorders,
affects approximately 5.7 million people in the U.S. Bipolar I disorder,
also known as manic-depressive illness, is characterized by unusual
shifts in mood, energy, activity levels, and the ability to carry out
day-to-day tasks. Patients experience "mood episodes" that manifest as
either a manic episode (overexcited, extreme irritability, racing
thoughts, and difficulties with sleep) or a depressive episode (extreme
sadness, fatigue, or hopelessness), or a combination of both. Depression
that occurs in patients with bipolar disorder is called "bipolar
About Gedeon Richter Plc.
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. Richter's consolidated sales were approximately EUR 1.2 billion
(USD 1.6 billion) while its market capitalization amounted to
EUR 2.8 billion (USD 3.8 billion) in 2013. The product portfolio of the
Company covers almost all important therapeutic areas, including
gynecology, central nervous system, and cardiovascular. Having the
largest R&D unit in Central Eastern Europe, the Company'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 the scope
of biosimilar product development.
About Forest Laboratories
Forest Laboratories (NYSE:FRX) is a leading, fully integrated, specialty
pharmaceutical company largely focused on the United States market. The
Company markets a portfolio of branded drug products and develops new
medicines to treat patients suffering from diseases principally in the
following therapeutic areas: central nervous system, cardiovascular,
gastrointestinal, respiratory, anti-infective, and cystic fibrosis. Our
strategy of acquiring product rights for development and
commercialization through licensing, collaborative partnerships, and
targeted mergers and acquisitions allows us to take advantage of
attractive late-stage development and commercial opportunities, thereby
managing the risks inherent in drug development. The Company is
headquartered in New York, NY. To learn more, visit www.FRX.com.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a
number of risks and uncertainties, including the difficulty of
predicting FDA approvals, the acceptance and demand for new
pharmaceutical products, the impact of competitive products and pricing,
the timely development and launch of new products, and the risk factors
listed from time to time in Forest Laboratories' Annual Report on Form
10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC (News - Alert) filings.
Forest assumes no obligation to update forward-looking statements
contained in this release to reflect new information or future events or
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