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Safety analyses of clinical data for bifeprunox in patients with schizophrenia


Solvay Pharmaceuticals, Inc., Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), and Lundbeck A/S presented clinical study results on bifeprunox at an international medical congress this week. Safety analyses suggest bifeprunox, an investigational treatment for adult patients diagnosed with schizophrenia, was associated with a favorable weight and lipid profile, comparable with placebo. In addition, increases in weight occurred in patients receiving active references versus placebo.

The analyses presented this week are based on further evaluation of clinical studies presented last year, which illustrated that, in a six-month trial, bifeprunox maintained stability in patients with stable schizophrenia versus placebo. In six-week trials, bifeprunox improved symptoms in patients with acute exacerbations of schizophrenia but showed a smaller mean effect than did active references versus placebo.

“Data from Phase 2 and Phase 3 trials suggest that, if approved, bifeprunox may be an important treatment option for stable patients with schizophrenia — particularly because of our concerns about the high prevalence of metabolic syndrome in this patient population,” says Herbert Y. Meltzer, M.D., Professor of Psychiatry and Director of the Division of Psychopharmacology, Vanderbilt University Medical Center. “If approved, bifeprunox may be an important alternative for treating adult patients with schizophrenia over the long term.”

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

Metabolic and Safety Parameters of Bifeprunox

-In analyses of data from Phase 3, six-week, randomized, double-blind, placebo-controlled active-referenced studies:
-Bifeprunox had favorable effects on total cholesterol, triglycerides (TG), very low-density lipoprotein (VLDL) and low density lipoprotein (LDL), comparable with placebo.
Bifeprunox patients experienced decreases in body -weight, body mass index (BMI) and prolactin and had an extrapyramidal side effects (EPS) profile similar to placebo.
-Weight, BMI and lipids were assessed in patients with acute exacerbations of schizophrenia in an analysis of another Phase 3, six-week, randomized, double-blind, placebo-controlled active-referenced study:
-Weight decreases and minor reductions in BMI were observed in patients who received bifeprunox.
Cholesterol and TG levels improved in patients who received bifeprunox.

Efficacy and Metabolic Effects

-A pooled analysis examined efficacy and metabolic effects of bifeprunox from one six-month, randomized, double-blind placebo-controlled study in stable adult patients and four six-week, randomized, double-blind, placebo-controlled active-referenced studies in patients with acute exacerbations of schizophrenia:
-Evaluations included time to deterioration in a six-month study, change in Positive and Negative Syndrome Scale (PANSS) total score in six-week studies, and body weight and lipids in all studies.
-In patients who received bifeprunox, weight decreases and improvements in lipid parameters were observed along with significant differences in primary efficacy measurements versus placebo.

Pharmacokinetic Analysis

-This abstract reported a pooled analysis of 21 clinical pharmacology studies that included pharmacokinetic profiles after single and multiple doses:
-Bifeprunox was absorbed within two hours at all dose levels after oral administration.
-Food had no relevant effect on the pharmacokinetics of bifeprunox.

In these analyses, the most common side effects reported with bifeprunox (incidence of greater than or equal to five percent and twice the placebo rate) were gastrointestinal in nature including nausea, vomiting, constipation and abdominal discomfort.

“These analyses of Phase 2 and Phase 3 studies point out the favorable weight and metabolic profile of patients who received bifeprunox,” says Earl Sands, M.D, Vice President, Research and Development at Solvay Pharmaceuticals, Inc. “Patients with schizophrenia have a high risk of developing metabolic side effects, including obesity and high cholesterol.” Philip Ninan, M.D., Vice President, Neuroscience at Wyeth Pharmaceuticals, says, “Through our partnership, Wyeth Pharmaceuticals and Solvay Pharmaceuticals are committed to developing investigational medications for mental health conditions. There is a significant need to expand treatment options and to offer individualized therapy for patients with schizophrenia.”

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 codevelop and co-commercialize bifeprunox and two 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 with the potential to be used as antipsychotic medications. Any compounds discovered under this research collaboration will be co-owned and co-patented by Solvay Pharmaceuticals and Wyeth and could be selected for co-development and co-commercialization by Solvay Pharmaceuticals and Wyeth.


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