KENILWORTH, N.J., June 2 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company’s Marketing Authorization Application (MAA) for SYCREST(R) (asenapine) sublingual tablets for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the Centralized Procedure.
The MAA for SYCREST includes data from the asenapine clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials.
“We highlighted asenapine as one of the Five Stars in our late-stage research and development 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,” noted Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. “I am pleased that we met this important milestone for asenapine within the first half of 2009.”
In the United States, a New Drug Application (NDA) for asenapine, under the brand name SAPHRIS(R), is currently under review by the U.S. Food and Drug Administration (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 acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the product.
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer health care products. Schering-Plough’s vision is to “Earn Trust, Every Day” with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the clinical development of, the commercial plans for and the potential market for SAPHRIS/SYCREST. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough’s forward-looking statements, including uncertainties in the regulatory process, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including Part II, Item 1A. “Risk Factors” in the Company’s first quarter 2009 10-Q, filed May 1, 2009.
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