Forest Laboratories and Gedeon Richter Receive Complete Response Letter for Cariprazine
November 21 2013 - 2:00AM
Business Wire
Forest Laboratories, Inc. (NYSE:FRX) and Gedeon Richter Plc.
announced that the U.S. Food and Drug Administration (FDA) issued a
complete response letter regarding the New Drug Application (NDA)
for cariprazine, an atypical antipsychotic for the treatment of
schizophrenia and for the acute treatment of manic or mixed
episodes associated with bipolar I disorder in adults.
In the complete response letter, the FDA acknowledged that
cariprazine clearly demonstrated effectiveness in the treatment of
schizophrenia and mania associated with bipolar disorder. However,
the Agency indicated more information, including additional
clinical trial data, would be needed. “Given the complex
pharmacokinetics and metabolism of cariprazine, we believe this
request was made to better define the optimal dosing regimen to
maintain the demonstrated efficacy, while minimizing the potential
for the development of adverse events generally associated with
this class of drug”, said Dr. Marco Taglietti, President, Forest
Research Institute.
Dr. Taglietti further noted that “the unmet medical need for
schizophrenia and bipolar disorder remains high. We are committed
to pursuing novel treatment options like cariprazine to address
patient needs. Forest and Gedeon Richter plan to meet with the FDA
in the very near future to discuss the complete response letter and
define a path forward.”
About Cariprazine
Cariprazine, an investigational drug, is an atypical
antipsychotic for the treatment of patients with schizophrenia and
for patients with manic or mixed episodes associated with bipolar I
disorder. The safety and efficacy of cariprazine was studied in a
clinical trial program of more than 2,700 patients. Cariprazine is
protected by a composition-of-matter patent that expires in 2027
without patent term extension.
About Schizophrenia
Schizophrenia is a chronic and disabling disorder that affects
more than 2 million people in the U.S. 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 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.
About Gedeon Richter Plc.
Gedeon Richter Plc. 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 1.1 billion
(USD 1.5 billion) while its market capitalization
amounted to EUR 2.3 billion (USD 3.1 billion)
in 2012. 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) 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, respiratory, gastrointestinal and pain management
medicine. Forest’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 Report 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, 212-224-6714Vice
President – Investor Relationsmedia.relations@frx.com
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