KENILWORTH, N.J., Oct. 23 /PRNewswire-FirstCall/ -- Schering-Plough
Corporation (NYSE: SGP) today announced that its novel psychopharmacologic
agent asenapine has met the primary endpoint in a long-term schizophrenia
relapse prevention trial. Asenapine, which is administered as a
fast-dissolving sublingual tablet, is a psychopharmacologic compound with a
unique human receptor signature.
The study was a randomized, placebo-controlled, double-blind,
multicenter, multinational clinical trial evaluating the efficacy and
safety of sublingually administered asenapine (5 or 10 mg BID) compared to
placebo in the prevention of relapse in subjects with schizophrenia. A
total of 700 subjects entered the open-label treatment with asenapine for
up to 26 weeks. Of these, a total of 386 subjects met criteria for
stabilization on asenapine and were randomized to treatment in the 26-week
double-blind placebo-controlled phase of the trial.
Asenapine was statistically significantly more effective than placebo
in preventing relapse, the primary endpoint of the trial. Asenapine was
generally well tolerated during the trial. Full results of the trial,
including efficacy, safety and tolerability data will be presented at a
later date. These data are planned to be used to support a regulatory
submission for the approval of asenapine in Europe.
Schering-Plough acquired asenapine in November 2007 through its
acquisition of Organon BioSciences, which developed the product. Asenapine
is currently under review by the U.S. Food and Drug Administration for the
treatment of schizophrenia and acute manic or mixed episodes associated
with bipolar I disorder.
Schering-Plough is an innovation-driven, science-centered global health
care company. Through its own biopharmaceutical research and collaborations
with partners, Schering-Plough creates therapies that help save and improve
lives around the world. The company applies its research-and-development
platform to human prescription and consumer products as well as to animal
health products. Schering-Plough's vision is to Earn Trust, Every Day with
the doctors, patients, customers and other stakeholders served by its
colleagues around the world. The company is based in Kenilworth, N.J., and
its Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press
release includes certain "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995, including statements
relating to the plans for, the potential of and the potential market for
asenapine. Forward-looking statements relate to expectations or forecasts
of future events. Schering-Plough does not assume the obligation to update
any forward-looking statement. Many factors could cause actual results to
differ materially from Schering-Plough's forward-looking statements,
including the regulatory process, among other uncertainties. For further
details about these and other factors that may impact the forward-looking
statements, see Schering-Plough's Securities and Exchange Commission
filings, including the company's 8-K filed Oct. 21, 2008.
SOURCE Schering-Plough
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http://www.schering-plough.com
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Media, Mary-Frances Faraji, +1-908-298-7109,
or mobile, +1-908-432-2404, or Investor Contacts, Janet M. Barth,
or Joe Romanelli, +1-908-298-7436
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