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Saphris

Generic name: asenapine
Treatment for: Schizophrenia, Bipolar Disorder

Update: Saphris Now FDA Approved - August 13, 2009

FDA Advisory Committee Votes in Favor of Saphris

FDA Advisory Committee Votes in Favor of Saphris (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia

KENILWORTH, N.J., July 30 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted unanimously in favor of Saphris (asenapine) sublingual tablets as effective and safe for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and in favor of youth in acute treatment of schizophrenia in adults. If approved by FDA, Saphris would be the first psychotropic drug to be approved initially for both of these indications.

"We are very pleased with the outcome of today's advisory committee meeting and appreciate the panel's careful consideration of the efficacy and safety data for Saphris," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "In clinical studies, Saphris has demonstrated efficacy combined with an attractive metabolic safety profile. Saphris has the potential to address a significant unmet need for patients with schizophrenia and bipolar I disorder, including patients starting treatment and those who need alternative treatment options when switching or re-initiating therapy. We will continue to work with FDA to bring Saphris to the U.S. market as soon as possible so that patients can benefit from this new medication."

While the FDA is not bound by the committee's recommendations, the agency carefully considers them before making a final decision on approval. After reviewing the Saphris data, the committee voted in favor of Saphris as effective (by counts of 12/0/0 and 10/2/0, yes/no/abstain) and safe (12/0/0 and 10/0/2) for the bipolar I disorder and schizophrenia indications, respectively. In addition, the committee voted on the overall balance of safety and efficacy by counts of 12/0/0 and 9/1/2 for the bipolar I disorder and schizophrenia indications, respectively.

The New Drug Application (NDA) for Saphris includes efficacy data from a clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials, and is supported by safety data in 4,500 patients, with some treated for more than two years.

In Europe, a Marketing Authorization Application (MAA) for asenapine, under the brand name SYCREST, is currently under review by the European Medicines Agency (EMEA) for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the Centralized Procedure.

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

About Schizophrenia

Schizophrenia is a chronic, disabling brain disorder that is characterized by hallucinations, delusions and disordered thinking. The condition affects about 24 million people worldwide (or seven in every 1,000 adults in the population), including more than two million people in the United States and more than four million people in Europe. Although there are a number of medications available for patients, treatment success for any antipsychotic agent can be unpredictable because patients often respond differently to various medications. Among patients with schizophrenia who are being treated with antipsychotics, nearly three in four patients discontinue therapy within 18 months due to either poor tolerability or incomplete efficacy. Metabolic safety, including weight gain, elevation of lipid levels (dyslipidemia) and glucose dysregulation, is an important consideration with any antipsychotic treatment. Patients often need to switch treatments in order for physicians to balance effective treatment with the long-term safety of their patients.

About Bipolar I Disorder

Bipolar I disorder (also known as manic depression) is a chronic, episodic illness characterized by mania (episodes of elevated moods, extreme irritability, decreased sleep and increased energy), depression (overwhelming feelings of sadness, suicidal thoughts), or a combination of both. It is the sixth leading cause of disability in the world, affecting approximately 1 to 5 percent of adults, including 10 million Americans. About half of the patients with bipolar disorder who recover in response to treatment experience recurrence two years later. Patients may experience a high rate of failure due to lack of efficacy or side effects, including metabolic side effects. Poor tolerability frequently leads to treatment discontinuation even when the treatment is providing some benefit. To help manage this challenge, patients often receive multiple medications or need to switch treatments.

About Schering-Plough

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 second quarter 2009 10-Q, filed July 24, 2009.

Posted: July 2009

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