"We are pleased with the progress on the SAPHRIS filing and look forward to working with the agency to address its request, finalize the product labeling and gain approval," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "New treatments are needed in this therapeutic area and we believe that asenapine has the potential to be an important option in addressing this need."
Schering-Plough acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the antipsychotic agent. The New Drug Application (NDA) for asenapine includes data from a clinical trial program involving more than 3,000 patients in schizophrenia and bipolar mania trials.
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.