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 don’t 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 Road Acquisition (NYSE:FRX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From Jul 2023 to Jul 2024