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NEW YORK & BUDAPEST, Hungary(BUSINESS WIRE)
Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc today
announced positive top-line results from a Phase IIb clinical trial of
the novel, investigational antipsychotic agent cariprazine for the
treatment of acute exacerbation of schizophrenia.
For the primary endpoint, the Positive and Negative Syndrome Scale
(PANSS), the data showed that patients with schizophrenia treated with
cariprazine experienced significant symptom improvement compared to
placebo patients within the first week of treatment and at each
subsequent time point studied.
Based on this latest schizophrenia data, subject to a complete review of
the full results, and the previously announced Phase II results in
patients suffering from acute mania associated with bipolar I disorder,
the companies intend to initiate Phase 3 trials for both indications in
early 2010. Cariprazine is currently also undergoing Phase II clinical
trials in patients with Bipolar Depressive Disorder and as adjunctive
therapy in Major Depressive Disorder.
Discovered by researchers at Gedeon Richter and licensed in the United
States and Canada by Forest Laboratories in 2004, cariprazine is an
orally active D3/D2 partial agonist with preferential binding to D3
receptors. Additionally, cariprazine has a relatively low potency at
other receptor sites, such as 5-HT2C, histamine H1, muscarinic, and
adrenergic receptor sites, that have been associated with adverse events
in some other drugs in the class.
Both the latest clinical trial results for cariprazine in patients
suffering from schizophrenia and the previous proof of concept results
in bipolar mania, confirm our long held belief in this compound. I
congratulate the research teams who have persevered in their pursuit to
develop cariprazine through sophisticated and sometimes difficult
clinical trial programs,? said Howard Solomon, Chairman and Chief
Executive Officer of Forest Laboratories. Our strategy to invest in
promising product opportunities that have been discovered by highly
creative and innovative partners, around the world, continues to bear
fruit and we look forward to advancing the late-stage cariprazine
development program.?
Dr. Marco Taglietti, President of Forest Research Institute, said: With
positive potentially pivotal trials in both schizophrenia and bipolar
mania, we are excited about the opportunity to expedite our Phase III
clinical programs and bring this important therapy to the market as
quickly as possible. We have worked closely with Gedeon Richter since
the time we licensed cariprazine and we will continue to explore the
clinical potential of cariprazine for other conditions, including
bipolar depression and as adjunctive therapy in Major Depressive
Disorder.?
We are very encouraged by these results as we believe that cariprazine
has the potential to be a valuable new treatment option for people
suffering from schizophrenia. These results are considered as a further
step towards our commitment conducting original research in the field of
CNS disorders, where our team has excellent expertise,? said Erik
Bogsch, Chief Executive Officer, Gedeon Richter Plc.
About the Study
This was a placebo- and active-controlled, fixed dose study in patients
with acute exacerbation of schizophrenia. Patients who met the
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition,
Text Revision (DSM-IV-TR) criteria for schizophrenia and had a PANSS
total score between 80 and 120 were eligible for enrollment into the
study.
Following a washout period of no antipsychotic therapy for up to seven
days, a total of 732 patients between 18 and 60 years old were
randomized to one of the following treatment arms: 1.5 mg/d cariprazine,
3.0 mg/d cariprazine, 4.5 mg/d cariprazine, 4 mg/d risperidone or
placebo given daily for six weeks followed by an additional two week
safety follow-up period, where no drug was administered. Patients were
hospitalized during the washout period and for the first four weeks of
the double-blind treatment. Thereafter, patients were followed either as
inpatients or outpatients, as determined by the site investigator and
based on patient status.
The protocol specified primary endpoint was the change from baseline to
Week 6 in the PANSS total score for the individual cariprazine fixed
dose treatment groups compared to placebo treatment using a sequential
multiple-comparison test procedure and last observation carried forward
(LOCF) analyses. The PANSS is a scale used to evaluate symptom severity
in schizophrenia. The secondary endpoint was the change from baseline to
Week 6 in the Clinical Global Impression-Severity Score (CGI-S), a scale
used to assess treatment response. Statistically significant (p < 0.001)
improvement in the PANSS total score at the end of Week 6 was observed
for the comparison of each cariprazine dose group relative to the
placebo treatment group (change of -7.5, -8.9, and -10.4 points for the
1.5, 3.0, and 4.5 mg/day dose groups, respectively) by LOCF analyses.
Statistically significant improvements were also noted in each
cariprazine dose group relative to placebo treatment in the CGI-S by
LOCF analysis. Statistically significant improvements were also seen in
the comparator risperidone group relative to placebo treatment in the
total PANSS and CGI-S measures by LOCF analysis.
Overall, 64% of the patients completed the study. Cariprazine was
generally well tolerated; more patients in the placebo group
discontinued due to adverse events than in the active treatment groups
(15% for placebo, 10%, 5% and 8% for the cariprazine 1.5, 3.0, and 4.5
mg/d dose groups, respectively and 9% for the risperidone group). The
most common adverse events (AEs) observed in any cariprazine dose group
were insomnia, extrapyramidal disorder, akathisia, sedation, nausea,
dizziness, and constipation.
About Schizophrenia
A severe and disabling brain disorder, people with schizophrenia
typically are affected by hallucinations in which they may hear voices
other people dont hear, or delusions where they believe others are
plotting to harm them.1 Approximately one percent of American
adults, or 2.4 million people are affected with schizophrenia in a given
year,2 with men and women affected equally.3
Treatment for schizophrenia can include antipsychotic medications and
various psychosocial treatments.1
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company
with a long track record of building partnerships and developing and
marketing products that make a positive difference in people's lives. In
addition to its well-established franchises in therapeutic areas of the
central nervous and cardiovascular systems, Forest's current pipeline
includes product candidates in all stages of development and across a
wide range of therapeutic areas. The company is headquartered in New
York, NY. To learn more about Forest Laboratories, 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 Report on Form 10-Q, and any subsequent SEC filings.
About Gedeon Richter Plc.
Gedeon Richter, (www.richter.hu)
headquartered in Budapest/Hungary, is a major pharmaceutical company in
Hungary and one of the largest in Central Eastern Europe, with
consolidated sales of approximately 1 billion ? (1,4 billion USD) and 2
billion ? (3 billion USD) market capitalization in 2008. Gedeon Richter
plays the role of a regional multinational company in Central Eastern
Europe and in the CIS and has a growing presence via its strategic
partners in the US and through its commercial subsidiaries in key EU
countries. The product portfolio of the company covers almost all
important therapeutic areas, such as cardiovascular, central nervous
system, gynecology, etc. The company has the largest R&D unit in Central
Eastern Europe. Original research activity focuses exclusively on CNS
disorders with main clinical targets are being schizophrenia, anxiety,
chronic pain and depression. With its widely acknowledged steroid
chemistry expertise the company is a significant player in the female
healthcare field worldwide
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 the Forest Laboratories' SEC reports,
including the Company's Annual Report on Form 10-K for the fiscal year
ended March 31, 2008.
1 U.S. Department of Health & Human Services. National
Institute of Mental Health. Schizophrenia Brochure. NIH PublicationNo.
09-3517. Revised 2009.
2 Regier DA, Narrow WE, Rae DS, Manderscheid RW, Locke BZ,
Goodwin FK. The de facto mental and addictive disorders service system.
Epidemiologic Catchment Area prospective 1-year prevalence rates of
disorders and services. Archives of General Psychiatry. 1993
Feb;50(2):85-94.
3 Robins LN, Regier DA, eds. Psychiatric disorders in
America: the Epidemiologic Catchment Area Study. New York: The Free
Press, 1991.
Forest Laboratories, Inc.
Frank J. Murdolo, 212-224-6714
Vice
President - Investor Relations
Frank.Murdolo@frx.com.
Source: Forest Laboratories, Inc.
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