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Organon (AKZOY)'s Asenapine Further Demonstrates Efficacy in Reducing Mania Symptoms for the Treatment of Bipolar I Disorder New Data From a Separate Study Also Show Minimal Effect on Heart Rhythm Changes in Schizophrenia Patients



10/17/2007 8:23:26 AM

VIENNA, Austria, Oct. 17 /PRNewswire/ -- New data show that asenapine -- a psychopharmacologic agent being developed by Organon -- is effective in treating acute manic episodes associated with bipolar I disorder. These results, from two Phase III clinical studies, were presented this week at the 20th European College of Neuropsychopharmacology (ECNP) Congress.

"The results of these clinical trials add to the body of evidence supporting the clinical efficacy and safety of asenapine," said Roger S. McIntyre, M.D., Associate Professor of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada. "The complex nature of bipolar disorders suggests that we should have many treatment options available to physicians and patients. As such, a new therapy that provides efficacy while also providing improved tolerability is critical in helping fill this unmet need."

In a separate safety study, also presented at the ECNP, asenapine demonstrated minimal effect on the QT interval (QTc) -- a measure of the heart's electrical conductance -- in patients with schizophrenia.

Study overview: bipolar I disorder (presented on Tuesday, 16 October at 12:00 p.m. CEST)

In the two Phase III, randomized, double-blind trials (Ares 7501004 and Ares 7501005), 960 adult patients with moderate-to-severe mania associated with bipolar I disorder received either asenapine (5-10 mg twice daily), olanzapine (5-20 mg once daily), or placebo for three weeks.

At day 21 in both studies, both asenapine and olanzapine produced significant mean improvements in mania symptoms versus placebo as measured by changes in YMRS (Young Mania Rating Scale) score. The YMRS is an 11-item scale used to evaluate manic symptoms. A difference in YMRS score reduction between the active treatments and placebo was seen as early as day two (1).

The overall incidences of treatment-related adverse events (AEs) for the two studies were 55.1% and 60.8% in the asenapine groups, 46.8% and 52.9% in the olanzapine groups, and 27.6% and 36.2% in the placebo groups. Most adverse events were mild to moderate. The most commonly reported AEs (reported by >5% of the patients and at twice the incidence of placebo in both studies) with asenapine included sedation, dizziness and somnolence. Olanzapine was most commonly associated with sedation, dizziness, somnolence and weight increase. The incidence of extrapyramidal symptoms reported as an adverse event was 10.3% and 7.2% in the asenapine group, 6.8% and 7.9% in the olanzapine group, and 3.1% and 2.9% in the placebo group.

Asenapine-treated patients had approximately a two-fold lower incidence of clinically significant weight gain (greater than or equal to 7%) versus olanzapine-treated patients in Ares 7501004 (7% vs. 19%, respectively) and in Ares 7501005 (6% vs.13%, respectively).

The study abstract, "Treatment of mania in bipolar I disorder: a placebo and olanzapine-controlled trial of asenapine," (P.2.e.012) was presented at ECNP on Tuesday, 16 October by Professor McIntyre.

Study overview: schizophrenia (presented on Sunday, 14 October at 12:00 p.m. CEST)

This 16-day, multicenter study examined the effects of asenapine on the QT interval -- a measure of the heart's electrical conductance. A QTc >500 milliseconds (msec) and an increase from baseline of >60 msec are risk factors for a potentially life-threatening form of ventricular tachycardia called torsades de pointes.

In the study, 151 patients with schizophrenia or schizoaffective disorder were randomized to asenapine (up to 20 mg twice daily), quetiapine 375 mg twice daily, or placebo. Investigators measured QTc using electrocardiograms (ECGs), which were administered several times throughout the 16-day study after asenapine administration.

Asenapine at doses up to 20 mg twice daily had a minimal, not considered to be clinically relevant, effect on QTc. Asenapine had an effect equal to or less than quetiapine on QTc in this study.

The study abstract, "Effect of asenapine versus quetiapine and placebo on QTc interval in patients with schizophrenia," (P.3.c.050) was presented at ECNP on Sunday, 14 October by Sheldon H. Preskorn, M.D., Department of Psychiatry, University of Kansas School of Medicine in Wichita.

About bipolar disorder

Bipolar disorder, commonly referred to as manic-depressive disorder, is a chronic, episodic illness characterized by mania (episodes of elevated moods, extreme irritability, and increased energy), depression (overwhelming feelings of sadness, suicidal thoughts), or a combination of both. It affects approximately one to five percent of adults, including more than 10 million adults in the United States and more than four million people in Europe (2,3). The condition can start early in childhood or later in life, the average age of onset is between 15 and 25 years old (4). Bipolar disorder is the sixth leading cause of disability in the world (2). About half of the patients with bipolar disorder who recover in response to treatment experience recurrence two years later (5).

About schizophrenia

Schizophrenia is a chronic, disabling brain disorder characterized by hallucinations, delusions, and disordered thinking. About 24 million people worldwide (or seven in every 1,000 adults in the population) have schizophrenia (6), including more than two million people in the U.S. (7) and more than four million people in Europe (8). People with schizophrenia may hear voices other people don't hear or may believe others are trying to harm them. As a result, they may become socially withdrawn, fearful, and agitated (7).

www.nimh.nih.gov/publicat/bipolar.cfmhttp://www.dbsalliance.org/site/PageServer?pagename=about_http://www.euro.who.int/document/MNH/emnhqa.pdfhttp://www.nami.org/Template.cfm?Section=bipolar_disorder&template=/http://www.who.int/mental_health/management/schizophrenia/en/http://www.nimh.nih.gov/health/topics/schizophrenia/index.shtmlhttp://www.euro.who.int/document/MNH/emnhqa.pdf

About Organon

Organon creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of innovation and business partnerships, Organon seeks to leverage its position as a leading biopharmaceutical company in each of its core therapeutic fields: fertility, gynecology and selected areas of anesthesia. It has extensive expertise in neuroscience and a rich and focused R&D program. Research areas also include immunology and specific areas of oncology. Organon products are distributed in over 100 countries worldwide, of which more than 50 have an Organon subsidiary. Organon is the human healthcare business unit of Akzo Nobel.

Safe Harbor Statement*

This press release may contain statements which address such key issues as growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals of Organon. Such statements should be carefully considered, and it should be understood that many factors could cause forecasted and actual results to differ from these statements. These factors include, but are not limited to, price fluctuations, currency fluctuations, progress of drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, pensions, physical and environmental risks, legal issues, and legislative, fiscal, and other regulatory measures. Stated competitive positions are based on management estimates supported by information provided by specialized external agencies. For a more comprehensive discussion of the risk factors affecting our business please see our Annual Report on Form 20-F filed with the United States Securities and Exchange Commission, a copy of which can be found on the company's corporate website www.akzonobel.com.

* Pursuant to the U.S. Private Securities Litigation Reform Act 1995.

CONTACT: Monique Mols, Director media relations, N.V. Organon,
+31-412-665440, monique.mols@organon.com; For the US only: Frances DeSena,
Senior director, communications & media relations, Organon USA Inc.,
+1-973-325-5353, f.desena@organonusa.com

Web site: http://www.akzonobel.com/


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