Bifeprunox: update on registration submission plan following clinical phase III results
EU submission plan for bifeprunox now 2008
Solvay Pharmaceuticals announces today that Solvay and its European partner H Lundbeck A/S will initiate additional phase III comparative clinical work in order to satisfy European Union requirements. The European registration dossier will be submitted during 2008.
Currently available clinical results in patients with schizophrenia show that bifeprunox has significant antipsychotic activity and was generally well-tolerated . Solvay and Lundbeck have established an effective and rewarding co-operation on this project, and have mutually agreed the way forward and the new European registration plan.
As previously announced, Solvay and US partner Wyeth Pharmaceuticals are continuing to assess and analyze the clinical study data with respect to a U.S. filing in 2006.
BIFEPRUNOX is a novel compound (a D2 and 5-HT1A partial agonist), for the treatment of psychosis and mood disorders, such as schizophrenia and bipolar disorder.
SCHIZOPHRENIA is a severely debilitating chronic mental disorder characterised by profound disturbances in thinking and perception. It affects around 1% of any population, and the onset of the disease typically occurs in late adolescence or early adulthood. Most patients will experience persistent symptoms including psychotic (positive) symptoms and negative symptoms like blunted affect and social withdrawal. Many patients will in addition experience episodic exacerbations with hallucinations and delusions.
SOLVAY PHARMACEUTICALS is a research driven group of pharmaceutical companies in Solvay that seeks to fulfil carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines, pancreatic enzymes, gastroenterology and men’s and women’s health. Solvay Pharmaceuticals employs about 13,000 people worldwide after the acquisition of Fournier Pharma in July 2005
SOLVAY is an international chemicals and pharmaceuticals group with headquarters in Brussels. It is present in more than 50 countries and employs some 33,000 people in its Chemicals, Plastics and Pharmaceuticals activities. Including Fournier Pharma, its 2004 sales amounted to EUR 8.5 billion. Solvay is listed on the Euronext 100 index of top European companies. Details are available at www.solvay.com.