Schering-Plough files European MAA for antipschycotic drug

Thu. June 04, 2009; Posted: 01:15 PM

Jun 04, 2009 (Datamonitor via COMTEX) -- SGP | Quote | Chart | News | PowerRating -- Schering-Plough has reported that the European Medicines Agency has validated the company's marketing authorization application for Sycrest sublingual tablets for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the centralized procedure.

The marketing authorization application (MAA) for Sycrest includes data from the asenapine clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials.

In the US, a new drug application for asenapine, under the brand name Saphris, is currently under review by the FDA for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy.

Schering-Plough has acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the product.

Thomas Koestler, executive vice president and president of Schering-Plough Research Institute, said: "We highlighted asenapine as one of the five stars in our late-stage R&D pipeline at our R&D update meeting in November 2008. At that time, we said that our aspirational filing date for asenapine in Europe was in 2009. I am pleased that we met this important milestone for asenapine within the first half of 2009."

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For full details on Schering-Plough Corp (SGP) click here. Schering-Plough Corp (SGP) has Short Term PowerRatings of 6. Details on Schering-Plough Corp (SGP) Short Term PowerRatings is available at This Link.

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