Clinical study results on bifeprunox for schizophrenia

Solvay Pharmaceuticals, Inc., Wyeth Pharmaceuticals and Lundbeck A/S presented clinical study results on bifeprunox, an investigational treatment for adult patients diagnosed with schizophrenia, at the 2007 annual meeting of the American Psychiatric Association.

New analyses of six-month data in stabilized adult patients with schizophrenia from a double-blind, placebo-controlled study demonstrated that bifeprunox maintained stability vs. placebo and displayed a favorable weight and lipid profile comparable with placebo.

"Schizophrenia is a chronic, lifelong illness, and long-term management of the illness presents many challenges," comments Daniel Casey, M.D., Professor, Psychiatry and Neurology, Oregon Health and Science University. "Clinicians need new treatment options to help patients manage schizophrenia over the long term."

A synopsis of abstracts containing bifeprunox data presented at the meeting follows:

In analyses of data from one Phase 3, six-month, randomized, double-blind, placebo-controlled study:

  • Compared with placebo, bifeprunox significantly prolonged time to deterioration over six months.
  • Bifeprunox patients experienced decreases in body weight and body mass index vs. placebo over six months.
  • Bifeprunox patients showed favorable effects on total cholesterol, triglycerides, very low-density lipoprotein and low-density lipoprotein, comparable with placebo over a six-month period.
  • In these analyses, the most common side effects reported with bifeprunox (incidence of greater than or equal to 5 percent and twice the placebo rate) included nausea, vomiting, dizziness, anorexia, akathisia, dyskinesia and asthenia.

"We are encouraged by these additional analyses of clinical data, which underscore bifeprunox's favorable weight and lipid profile," says Earl Sands, M.D., Vice President, Research and Development at Solvay Pharmaceuticals, Inc. "Bifeprunox, if approved, may be an important treatment option in the long-term management of adult patients with schizophrenia."

Philip Ninan, M.D., Vice President, Neuroscience at Wyeth Pharmaceuticals, says, "Patients suffering from schizophrenia require treatments that may address their specific needs. Bifeprunox, if approved, will help health care professionals provide their patients with additional treatment options."

In October 2006, Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals announced that a New Drug Application was submitted to the U.S. Food and Drug Administration for bifeprunox, an investigational antipsychotic for the treatment of schizophrenia and for maintenance of stability. Under the terms of a collaboration agreement entered into in March 2004, Solvay Pharmaceuticals and Wyeth Pharmaceuticals agreed to co-develop and co-commercialize bifeprunox and other compounds, which are in earlier stages of development, as potential treatments for schizophrenia and other psychiatric conditions. The original compound was discovered by Solvay Pharmaceuticals and is being developed by Solvay Pharmaceuticals, Lundbeck and Wyeth.

Under a new agreement that was announced in January 2007, Solvay Pharmaceuticals and Wyeth Pharmaceuticals will collaborate in a joint discovery effort targeting the identification of small molecules as potential antipsychotic medications. Any compounds discovered as part of the research collaboration will be jointly co-owned and patented by Wyeth and Solvay Pharmaceuticals as well as co-developed and co-commercialized by the two companies.

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