|[March 21, 2014]
Forest Laboratories, Inc. and Gedeon Richter Plc. Announce Positive Phase IIb Topline Results for Cariprazine as Adjunctive Therapy in the Treatment of Major Depressive Disorder
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 as
adjunctive treatment in adult patients with Major Depressive Disorder
(MDD) who have demonstrated an inadequate response to antidepressant
The trial consisted of three treatment groups, cariprazine 1.0 - 2.0
mg/day + ADT and cariprazine 2.0 - 4.5 mg/day + ADT, and placebo + ADT.
The group who received cariprazine 2.0 - 4.5 mg/day + ADT demonstrated
statistically significant improvement in the Montgomery-Asberg
Depression Rating Scale (MADRS) total score versus placebo at 8 weeks,
the primary endpoint.
"Forest is committed to addressing the therapeutic needs of people
living with MDD as part of our growing mental health portfolio, and we
are excited at the prospect to one day offer a new treatment option for
appropriate patients seeking an alternative treatment to manage the
condition," said Marco Taglietti, M.D., Chief Medical Officer and EVP,
Drug Development and Research at Forest Laboratories, Inc.
"We are encouraged by the positive top-line results shown in this Phase
IIb study," said Dr. Zsolt Szombathelyi, Research Director of Gedeon
Richter Plc. "We are committed to continuing the development of
cariprazine in CNS disorders."
About this Phase IIb Study
This international, multicenter, randomized, double-blind,
placebo-controlled, parallel-group, flexible-dose, 8-week Phase IIb
study evaluated the efficacy, safety, and tolerability of cariprazine as
adjunctive treatment in adult patients with MDD who demonstrated an
inadequate response to ADT. Eligible patients were those who met
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition,
Text Revision (DSM (News - Alert)-IV-TR) criteria for MDD, had a minimum score of 22 on
the MADRS scale, and had an ongoing inadequate response to ADT.
Following a 7-14 day screening and washout period, a total of 819
patients between 18 and 65 years of age were randomized to one of three
treatment groups (either cariprazine 1.0 - 2.0 mg/day + ADT, cariprazine
2.0 - 4.5 mg/day + ADT, or placebo + ADT) followed by a 1-week safety
follow-up period. The primary endpoint was defined as change from
baseline to end of week 8 in the MADRS total score. Statistically
significant improvement in the MADRS total score was observed in the
cariprazine 2.0 - 4.5 mg/day + AD group relative to the placebo + ADT
treatment group (cariprazine 2.0 - 4.5 mg/day + ADT: -2.2, p=0.0114 and
cariprazine 1.0 - 2.0 mg/day + ADT: -0.9, p=0.2404) by MMRM analysis.
Across both cariprazine dose groups the most common adverse events
(incidence =10% and greater than placebo) were akathisia, nausea,
insomnia, somnolence, and fatigue.
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, there are ongoing investigational clinical trials
for the treatment of bipolar depression and as adjunctive treatment of
major depressive disorder in adults.
About Major Depressive Disorder
MDD is a serious medical condition often requiring treatment, affecting
almost 16 million adults in the United States yearly or approximately
7.3% of the adult U.S. population. MDD, also known as depression, is a
common debilitating disorder in which feelings of sadness and other
symptoms occur nearly every day for at least two weeks and interfere
with a person's ability to work, sleep, study, eat, and enjoy
once-pleasurable activities. Among all medical illnesses, MDD is a
leading cause of disability in the U.S. The World Health Organization
predicts depression will become the second leading cause of disability
by the year 2020.
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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