NEW YORK and BUDAPEST, Hungary, Oct. 15 /PRNewswire-FirstCall/ --
Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter today announced
preliminary top-line results from a U.S. conducted randomized,
double-blind, three-arm placebo-controlled study of RGH-188, a novel
antipsychotic, in 389 schizophrenia patients. The protocol-specified
primary endpoint was change from baseline to Week 6 on the Positive and
Negative Syndrome Scale (PANSS) and RGH-188 demonstrated a nominally
statistically significant (i.e., not adjusted for multiple comparisons)
therapeutic effect compared to placebo in the treatment of schizophrenia in
the low dose arm and a numerical improvement compared to placebo in the
high dose arm that did not reach nominal statistical significance. At this
time the companies have only been able to review top-line results and
further analyses will be completed in the coming weeks to examine the
results in greater detail.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Trial Design and Preliminary Study Results
Following a no-drug washout period of up to 7 days, patients (N=389)
were randomized to one of three treatment groups: placebo, RGH-188 low dose
(1.5- 4.5 mg/day) or RGH-188 high dose (6-12 mg/day). The double-blind
treatment period lasted 6 weeks. Patients were hospitalized throughout
screening and for at least the first 21 days following the initiation of
double-blind study medication. Following completion of the 6 weeks of
double-blind treatment, patients were followed up for safety assessments
for an additional 4 weeks. The study was conducted entirely in the United
States.
This was a flexible fixed dosage range study in which patients received
1 to 3 capsules administered as a single daily dose at bedtime. All
patients started with 1 capsule (placebo or RGH-188 1.5 mg). The daily dose
could be increased to 3 capsules given once daily by Day 5 or thereafter
depending on patient response and tolerability based on investigator's
judgment. For patients randomized to RGH-188 low dose (1.5-4.5 mg/day)
group, the maximum dose of 4.5 mg per day could be reached by Day 5,
whereas for patients randomized to RGH-188 high dose (6-12 mg/day) group,
the maximum dose of 12 mg per day could be reached by Day 9. Following a
dose increase, the dose could be decreased if there were any tolerability
problems. Any increases or decreases were to be done in increments or
decrements of one capsule.
RGH-188 was generally well tolerated and overall premature
discontinuation rates (all causes including adverse event related) were 47%
for patients receiving low dose of RGH-188, 46% for patients receiving high
dose RGH-188, and 47% for patients receiving placebo.
Future Development Plans
Based on the initial positive results for one of the active dosing arms
and subject to a complete review of the full study results for the just
completed trial, the Companies intend to continue the development of
RGH-188 as a treatment for schizophrenia and will determine the appropriate
development activities over the coming months.
Additionally, the Companies expect to receive topline results for the
proof of concept study for RGH-188 in bipolar mania in by the middle of
calendar 2008.
About RGH-188
RGH-188 (INN: cariprazine) discovered by researchers at Gedeon Richter,
is a novel antipsychotic which preferentially binds to D3 receptors and
acts as a dopamine system stabilizer.
About Forest Laboratories and Its Products
Forest Laboratories (http://www.frx.com) is a US-based pharmaceutical company
dedicated to identifying, developing and delivering products that make a
positive difference in peoples' lives. Forest Laboratories' growing product
line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for
adults for the initial and maintenance treatment of major depressive
disorder and generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl D-aspartate (NMDA)-receptor antagonist indicated for the treatment
of moderate to severe Alzheimer's disease; Benicar(R)* (olmesartan
medoxomil), an angiotensin receptor blocker, and Benicar* HCT(R)
(olmesartan medoxomil-hydrochlorothiazide), an angiotensin receptor blocker
and diuretic combination product, each indicated for the treatment of
hypertension; and Campral(R)* (acamprosate calcium), indicated in
combination with psychosocial support for the maintenance of abstinence
from alcohol in patients with alcohol dependence who are abstinent at
treatment initiation.
*Benicar is a registered trademark of Daiichi Sankyo, Inc., and Campral
is a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
About Gedeon Richter Plc.
Gedeon Richter, (http://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 USD in
2006, and 4 billion USD market capitalisation. The company was founded in
1901. Gedeon Richter plays the role of a regional multinational company in
Central Eastern Europe and in the CIS, and has a growing presence through
its commercial subsidiaries in key EU countries, and the USA. The company
has a worldwide presence through its representative offices, subsidiaries
in 30 countries. It has manufacturing sites in Hungary, Russia, Romania,
Poland, India and a recently acquired German R&D biotechnology production
facility. The product portfolio of the company covers almost all important
therapeutic areas. With its widely acknowledged steroid chemistry expertise
the company is a significant player in the gynaecological field worldwide.
16 % of the company's revenue results from original drug research and
development activity. The company has the largest R&D unit in Central
Eastern Europe focusing exclusively on CNS disorders. Following
reorganization of the proprietary R&D in 2000, main clinical targets are
schizophrenia, anxiety and chronic pain. Complementing its own preclinical
excellence R&D collaboration agreements were signed with Mitsubishi Pharma
Corporation (Japan) and Forest Laboratories in 2004 and 2005. The company
has an original R&D portfolio with 16 ongoing projects including four
compounds which are in either in Phase I or Phase II clinical trials.
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, 2007.
SOURCE Forest Laboratories, Inc.
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Related links:
http://www.frx.com
http://www.richter.hu
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Charles E. Triano, Vice President - Investor
Relations, of Forest Laboratories, Inc., +1-212-224-6714,
Charles.Triano@frx.com
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