U.S. Food and Drug Administration files new drug application for BIFEPRUNOX, submitted in October 2006
Triggering a USD 25 million milestone payment from Wyeth
Solvay announced today that the New Drug Application (NDA) for bifeprunox submitted to the U.S. Food and Drug Administration (FDA) in October 2006 has been officially filed by the FDA. This means that the formal processing and review period both begin.
This event has triggered a milestone payment of USD 25 million from Wyeth, Solvay’s co-development and co-commercialization partner for this candidate schizophrenia treatment in the U.S. The milestone has been booked into Solvay’s 4th quarter 2006 figures. The guidance given to the markets on October 27, 2006 concerning Solvay Pharmaceuticals’ full year expected results and margins remains basically unchanged, having anticipated this payment.
Bifeprunox is an investigational, new generation atypical antipsychotic for treatment and maintenance of stability of patients with schizophrenia. The NDA file is based on safety and efficacy studies that evaluated bifeprunox for the treatment of schizophrenia in approximately 2,550 patients. Patients were evaluated with acute exacerbations for six weeks, and stable patients were evaluated for six months
Solvay Pharmaceuticals is a research driven group of companies that constitute the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines, gastroenterology, specialized markets and men’s and women’s health. Its 2005 sales were EUR 2.3 billion and it employs approximately 10000 people worldwide. For more information, visit solvaypharmaceuticals.com.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs some 30000 people in 50 countries. In 2005 its consolidated sales amounted to EUR 8.6 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. SOLVAY (Euronext : SOLB.BE – Bloomberg: SOLB.BB – Reuters: SOLB.BR) is listed on the Euronext stock exchange in Brussels. Details are available at www.solvay.com