Schering-Plough Announces Asenapine NDA Accepted for Filing by the U.S. FDA
KENILWORTH, N.J., Nov. 26 -- Schering-Plough Corporation today announced that the U.S. Food and Drug Administration (FDA) recently accepted the filing for review of the New Drug Application (NDA) for asenapine, a fast-dissolving, sublingual tablet. Schering-Plough is seeking marketing approval from the FDA for the treatment of schizophrenia and acute mania or mixed episodes associated with Bipolar I Disorder. In accepting the NDA, the FDA indicated that asenapine will receive a standard review.
The clinical trial program thus far has consisted of schizophrenia and bipolar mania trials involving nearly 3,000 patients.
Schering-Plough acquired asenapine through its combination with Organon BioSciences on November 19, 2007.
About Bipolar Disorder
Bipolar Disorder, commonly referred to as manic-depressive disorder, is a chronic, episodic illness characterized by mania (episodes of elevated moods, extreme irritability, and increased energy), depression (overwhelming feelings of sadness, suicidal thoughts), or a combination of both. It affects approximately one to five percent of adults, including more than 10 million adults in the United States and more than four million people in Europe. (1,2,3) The condition can start early in childhood or later in life, the average age of onset is between 15 and 25 years old.(4) Bipolar Disorder is the sixth leading cause of disability in the world.(2) About half of the patients with Bipolar Disorder who recover in response to treatment experience recurrence two years later(5).
About schizophrenia
Schizophrenia is a chronic, disabling brain disorder characterized by hallucinations, delusions, and disordered thinking. About 24 million people worldwide (or seven in every 1,000 adults in the population) have schizophrenia,(6) including more than two million people in the U.S.(7) and more than four million people in Europe.(8) People with schizophrenia may hear voices other people don't hear or may believe others are trying to harm them. As a result, they may become socially withdrawn, fearful, and agitated.(7)
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 and consumer products as well as to animal health products. In November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company's ongoing transformation. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its approximately 50,000 people 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 development of and market potential for asenapine. 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 market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details and a discussion of risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A, "Risk Factors" in Schering-Plough's third quarter 2007 10-Q.
References
National Institute of Mental Health. Available online at: www.nimh.nih.gov/publicat/bipolar.cfm
Depression and Bipolar Support Alliance (DBSA). Bipolar Disorder Statistics, accessed on May 10, 2007.
http://www.dbsalliance.org/site/PageServer?pagename=about_statistics_bipolar
World Health Organization. WHO European Ministry Conference on Mental Health. Available online at:
http://www.euro.who.int/document/MNH/emnhqa.pdf.
Accessed on October 2, 2007
National Alliance on Mental Health. Understanding Bipolar Disorder and Recovery. Available online at:
http://www.nami.org/Template.cfm?Section=bipolar_disorder&template=/ContentManagement/ContentDisplay.cfm&ContentID=44951
Perlis RH, Ostacher MJ, Patel JK. Predictors of Recurrence in Bipolar Disorder: Primary Outcomes from the Systemic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). Am J Psychiatry. 2006;163:210-224.
World Health Organization. Available online at:
http://www.who.int/mental_health/management/schizophrenia/en/.
Accessed on October 2, 2007.
National Institute of Mental Health. Available online at:
http://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml
World Health Organization. WHO European Ministry Conference on Mental Health. Available online at:
http://www.euro.who.int/document/MNH/emnhqa.pdf.
Accessed on October 2, 2007.
SOURCE Schering-Plough Corporation