An article posted on July 30th by Bloomburg.com:
By Catherine Larkin
Schering-Plough Corp. won a U.S. panel’s backing to introduce a new antipsychotic drug that would compete with Eli Lilly & Co.’s Zyprexa and AstraZeneca Plc’s Seroquel.
Outside advisers to the Food and Drug Administration voted 9-1, with two abstentions, that the drug’s benefits outweighed its risks for adults with schizophrenia, and 12-0 in favor of its use in treating manic or mixed episodes of bipolar disorder. The FDA usually follows the recommendations of its advisers, though it isn’t required to do so.Asenapine [molecular structure shown], a fast-acting tablet that dissolves under the tongue, would help patients who can’t swallow pills or have side effects such as weight gain on other treatments, the advisers said. Merck & Co. offered to buy Schering-Plough on March 9 to get asenapine, to be marketed as Saphris, and six other drugs targeted for sale by 2012.
“We believe that the opportunity for Saphris is underappreciated, as we think an antipsychotic with little to no weight gain and no cardiovascular safety issues is a lay-up blockbuster,” Jon LeCroy, an analyst at Natixis Bleichroeder in New York, said today in a note to clients. “We are modeling 2013 sales of $650 million.”
Positive Expectations
Investors anticipated a positive recommendation from the advisory panel meeting in Silver Spring, Maryland, after FDA staff voiced their support for Schering-Plough’s data in briefing documents released this week. The agency delayed asenapine last year and is now scheduled to make a decision on approval by Aug. 20.
To read the complete article, please click here.
Also see:
FDA Approves Saphris to Treat Schizophrenia and Bipolar Disorder (August 14th, 2009)
