Forest Laboratories Submits New Drug Application for Cariprazine for the
Treatment of Both Schizophrenia and Manic or Mixed Episodes Associated with
Bipolar I Disorder
NEW YORK & BUDAPEST, Hungary -- November 28, 2012
Forest Laboratories, Inc., (NYSE: FRX) and Gedeon Richter Plc. announced that
Forest has submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for cariprazine, a potent dopamine D/D receptor
partial agonist with preferential binding to D receptors. Cariprazine was
discovered by Gedeon Richter Plc and is licensed to Forest Laboratories Inc.,
in the U.S. and Canada.
The application for the treatment of schizophrenia includes results from three
positive trials in over 1700 patients, two fixed dose studies with active
controls and one fixed-flexible placebo-controlled dose study using the change
from baseline in Positive and Negative Syndrome Scale (PANSS) total score as
primary efficacy endpoint.
The application for the acute treatment of manic or mixed episodes associated
with Bipolar I Disorder includes results from three positive
placebo-controlled trials in over 1000 patients, two flexible dose studies and
one fixed-flexible dose study using the change from baseline in the Young
Mania Rating Scale (YMRS) total score as primary efficacy endpoint.
In the schizophrenia and bipolar mania pivotal trials, cariprazine was
generally well tolerated. The most commonly reported adverse reactions (≥5%
and twice placebo), which were predominantly mild to moderate in severity,
were akathisia, extrapyramidal disorder, dyspepsia, restlessness, tremor,
fatigue and vomiting.
Schizophrenia is a chronic and disabling disorder that affects more than 2
million American adults. It imposes significant burden on patients, their
families, and society. Symptoms fall into three broad categories: positive
symptoms (hallucinations, delusions, thought disorders, and movement
disorders), negative symptoms (such as loss of motivation and social
withdrawal), and cognitive symptoms (problems with executive functioning,
focusing, and working memory).
About Bipolar I Disorder
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. It affects more than 5.7 million American adults.
Patients experience "mood episodes" which 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.
Cariprazine is an orally active and potent dopamine D-preferring D/D
receptor partial agonist. Cariprazine has a low affinity at other receptor
sites such as 5-HT[2C], muscarinic, and adrenergic which have been associated
with adverse events.
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
wereapproximately EUR 1.1 billion (USD 1.5 billion) while its market
capitalization amounted to EUR 2.1 billion (USD 2.7 billion) in 2011. 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
About Forest Laboratories
Forest Laboratories’ (NYSE: FRX) longstanding global partnerships and track
record developing and marketing pharmaceutical products in the United States
have yielded its well-established central nervous system and cardiovascular
franchises and innovations in anti-infective and respiratory,
gastrointestinal, and pain management medicine. The Company’s pipeline, the
most robust in its history, includes product candidates in all stages of
development across a wide range of therapeutic areas. 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 Reports on Form 10-K, Quarterly Reports on Form 10-Q, and
any subsequent SEC filings. Forest assumes no obligation to update forward
looking statements contained in this release to reflect new information or
future events or developments.
Forest Laboratories, Inc
Frank J. Murdolo, 212-224-6714
Vice President - Investor Relations
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