FDA has accepted the NDA for the atypical antipsychotic asenapine and given it a ten-month standard review, Schering Plough announced Nov. 26. Schering is asking approval for the treatment of schizophrenia and acute mania or mixed episodes associated with bipolar I disorder.

The NDA for asenapine, a new molecular entity, was submitted by developer Organon BioSciences before the sale of the Dutch company to Schering-Plough was completed Nov. 19, Schering told "The Pink Sheet" DAILY. Organon had said it planned to file the application by the end of 2007.

Organon has reported positive data in comparisons of asenapine to Johnson & Johnson's Risperdal (risperidone) in the treatment of schizophrenia and against Eli Lilly's Zyprexa (olanzapine) for bipolar I disorder.

Earlier in November the company reported that in a trial comparing asenapine to Risperdal, schizophrenia patients experienced less weight gain and lower levels of prolactin, a signal associated with a lower rate of sexual side effects. Asenapine also proved more effective against negative symptoms of schizophrenia such as lack of emotional expression, Organon said (¹ Also see "Organon Asenapine Study Shows Improved Effect On Negative Schizophrenia Symptoms Over Risperdal" - Pink Sheet, 14 November, 2007.

In October, Organon reported that patients taking asenapine for acute manic episodes associated with bipolar I disorder experienced two-thirds less weight gain than those taking Zyprexa, though the efficacy of the two therapies was similar (² Also see "Organon’s Asenapine Shows Less Weight Gain Than Zyprexa In Phase III Trial" - Pink Sheet, 17 October, 2007.).

Schering announced in March that it planned to acquire Organon, the pharmaceutical and animal health care business of the chemical company Akzo Nobel, for $14.4 billion. The deal closed Nov. 19, according to Schering. In addition to the pharmaceutical business and Intervet, the animal health business, Kenilworth, N.J.-based Schering gained Nobilion, Akzo's human vaccine development unit, and Diosynth, Organon's third-party manufacturing unit. No divestitures of human health products were required.

At the time the acquisition was announced, asenapine had shown mixed results in Phase III studies and Pfizer had pulled out of development deal for the drug. Organon was engaged in further studies to support the NDA. Schering CEO Fred Hassan commented, however, that the departure of Pfizer from development was not necessarily a negative sign for the drug. "Every company makes their own judgment about products," Hassan said (³ Also see "Schering-Plough Makes Its Move, Snapping Up Organon For $14.4 Billion" - Pink Sheet, 12 March, 2007.).

-Shirley Haley (s.haley@elsevier.com)

FDA Accepts NDA For Schering-Plough Antipsychotic Asenapine

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