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      Schering-Plough Wins U.S. Approval for Antipsychotic

      Posted AtBloomberg.com

      Aug. 14 (Bloomberg) -- Schering-Plough Corp., the drugmaker being acquired by Merck & Co. won U.S. approval for a new treatment for adults with schizophrenia or bipolar mania.

      The Food and Drug Administration cleared asenapine, a fast- acting tablet that dissolves under the tongue, Schering-Plough said today in a statement. The drug, to be sold under the brand name Saphris, will compete with Eli Lilly & Co.’s Zyprexa and AstraZeneca Plc’s Seroquel.

      Outside advisers to the FDA recommended approval of Saphris July 30, calling it a valuable choice for people who can’t swallow pills or have side effects such as weight gain on other treatments. Saphris and six other drugs that Schering-Plough aims to introduce by 2012 may help Merck overcome generic competition to medicines with $8 billion in annual sales.

      “Having a new FDA-approved treatment such as Saphris is important in these serious conditions because physicians need options to help manage their patients’ symptoms,” said Roger S. McIntyre, associate professor of psychiatry and pharmacology at the University of Toronto and lead author of the pivotal bipolar mania studies of Saphris, in a statement today.

      Schering-Plough rose 1 cent to $27.12 at 4 p.m. in New York Stock Exchange composite trading.

      ‘Underappreciated’ Opportunity

      Saphris is “underappreciated” by investors who don’t give enough credit to its relative lack of side effects compared with existing treatments, said Jon LeCroy, an analyst at Natixis Bleichroeder in New York, in a July 30 note to clients. He estimates the drug will generate $650 million in 2013.

      Antipsychotics topped U.S. drug sales for the first time last year, producing $14.6 billion in revenue, according to IMS Health Inc. in Norwalk, Connecticut. The market includes at least five brand-name drugs and lower-cost versions of Johnson & Johnson’s Risperdal that were introduced last year.

      Schering-Plough acquired Saphris when it bought Organon Biosciences from Dutch chemical company Akzo Nobel NV for $16 billion in November 2007, after Organon filed for U.S. approval of the medicine. Pfizer Inc. dropped out of a partnership with Akzo on asenapine in November 2006 for undisclosed reasons.

      The FDA delayed a decision on approval and Schering-Plough submitted additional information in response to an FDA request early this year. The agency said before the advisory panel meeting that it was generally satisfied with the data and was working out the details of the prescribing information.

      An estimated 1 percent of Americans have schizophrenia, according to the National Institute of Mental Health, a U.S. agency in Bethesda, Maryland. Like many newer antipsychotics, Saphris also treats manic or mixed episodes of bipolar disorder. That disease is difficult to diagnose and may affect 1 percent to 5 percent of adults, according to Schering-Plough.

      August 25, 2009


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