Schizophrenia Update, October 2003


(PRESSI.COM 09/02/2003) Solvay Pharmaceuticals and H. Lundbeck A/S today announce their joint decision to move bifeprunox into clinical phase III with immediate effect. The decision to move into phase III follows the successful completion of the joint phase II program. In December 2000 the two companies announced that they would join forces in the development and marketing of this atypical antipsychotic, bifeprunox.

Bifeprunox is a product of Solvay Pharmaceuticals' drug discovery efforts. It was formerly known under its lab code DU127090. It is a putative full spectrum atypical antipsychotic compound aimed at the treatment of both positive and negative symptoms of schizophrenia. Its mechanism of action couples a highly potent partial agonism of the dopamine D2 receptors to an additional 5HT1A receptor partial agonist effect.

A recently finalised placebo controlled dose-finding study showed bifeprunox to be efficacious and well tolerated in the treatment of patients with schizophrenia. As desired, the tolerability profile was very encouraging with no indication of weight gain, cardiovascular or extra pyramidal side effects (EPS).

Schizophrenia is a severe disabling and chronic form of psychosis that develops in approximately 1% of the population. Schizophrenia is characterised by positive, negative, affective and cognitive symptoms. Positive symptoms comprise, among others, delusions and hallucinations. The negative symptoms include social withdrawal, blunted affects and diminished capacity of speech. Affective symptoms are mainly depression and anxiety. Typical cognitive deficits are impaired attention and memory and some times disorganised speech. While currently most widely used treatments may be effective in controlling acute symptoms of schizophrenia they are all associated with a variety of side effects that negatively influence their usefulness in long-term treatment. New treatments that improve symptomatology but with reduced side effects are therefore desirable.

Solvay Pharmaceuticals global head of Research and Development, Werner Cautreels, said "new and better medicines for treating schizophrenia are really needed by psychiatrists and bifeprunox is looking very promising. We hope to be able to bring it to markets in just a few years time"

Lundbeck's Executive Vice President, Research & Development, Claus Bræstrup says "we are pleased with the smooth way this joint project is progressing between the partners, and naturally delighted that the clinical results of phase II studies encourage an immediate start of a joint phase III program".

Under the terms of the agreement between the two companies Solvay retains the marketing rights in the US, Canada, Mexico and Japan, while Lundbeck gains the marketing rights for Europe and the rest of the World. Lundbeck and Solvay will jointly market the product in Brazil and Argentina.

For further information please contact :
SOLVAY S.A. Headquarters
Martial Tardy
Corporate Press Officer
E-mail : martial.tardy(at)
Internet :



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