–Additional Data Show Fewer Metabolic Side Effects for Bifeprunox Versus Studied Comparators–
Marietta, Ga. – December 6, 2006 -Solvay Pharmaceuticals, Inc., Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE) and Lundbeck A/S presented clinical study results for bifeprunox at a major medical conference this week. Bifeprunox is an investigational treatment for schizophrenia studied as a once-daily regimen. Results of these efficacy and safety studies showed 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. Additionally, bifeprunox showed a favorable weight and metabolic profile in both short- and long-term studies versus placebo or active references. Weight gain and metabolic disturbances are common and important side effects of some antipsychotic medications, which can cause some patients with schizophrenia to stop taking their medication.
“Based on the data from Phase 2 and 3 trials, including its metabolic profile, if approved, bifeprunox may be a valuable treatment option for stable patients with schizophrenia,” says Daniel Casey, M.D., Professor, Psychiatry and Neurology, Oregon Health and Science University. “These are important new findings because some obstacles, including side effects associated with current treatments, can derail the optimal long-term care of patients with schizophrenia.”
The research presented includes investigational data on bifeprunox in adult patients with acute exacerbations of schizophrenia and stable schizophrenia. A synopsis of the abstract objectives and conclusions follows.
Six-Month Maintenance of Stability Study in Stable Schizophrenia
o Abstract: Long-Term Efficacy and Safety of Bifeprunox in Patients With Schizophrenia: A Six- Month, Placebo-Controlled Study
In this Phase 3 study, researchers investigated the long-term efficacy of bifeprunox in patients with stable schizophrenia by assessing the time to deterioration with bifeprunox, compared to placebo, over a period of up to six months. In addition, the study investigated whether clinical effect, as assessed by the Positive and Negative Syndrome Scales (PANSS), after six weeks of treatment with bifeprunox, is superior to placebo. Bifeprunox was superior to placebo in preventing deterioration over six months in patients with stable schizophrenia. A favorable metabolic profile was also seen for bifeprunox, based on weight changes, lipids and the presence or absence of metabolic syndrome.
Metabolic Profile of Bifeprunox
o Abstract: The Metabolic Profile of Bifeprunox in the Treatment of Patients With Schizophrenia
The purpose of this analysis was to examine the metabolic effects of bifeprunox, compared with placebo or active references, in patients with acute and stable schizophrenia. In the analysis of six-week trials, decreases in body weight and improvement in lipid profiles were observed in patients treated with bifeprunox, with minimal changes in plasma glucose. Weight, triglyceride, total cholesterol and triglyceride: HDL ratios also were reduced in patients receiving six months of treatment.
Short-Term Studies in Acute Exacerbation of Schizophrenia
o Abstract: Efficacy and Safety of Bifeprunox Versus Placebo in the Treatment of Patients With Acute Exacerbations of Schizophrenia
In this Phase 3 study, researchers investigated whether bifeprunox treatment is superior to placebo in patients with acute exacerbations of schizophrenia. Researchers also evaluated the safety and tolerability of bifeprunox as compared with placebo. Bifeprunox was superior to placebo in improving the symptoms of schizophrenia. Treatment was also associated with a decrease in body weight and improvements in the lipid profiles compared to placebo and active reference.o Abstract: Efficacy and Safety of Bifeprunox in the Treatment of Patients With Acute Exacerbations of Schizophrenia: Results of a Dose-Finding Study
In this Phase 2 study, researchers evaluated the efficacy and safety of bifeprunox in the treatment of patients with acutely exacerbated schizophrenia. Bifeprunox showed significant improvement compared to placebo in these patients. Bifeprunox was also associated with a decrease in weight and improvement in the lipid profile compared to placebo.o Abstract: A Randomized, Double-Blind, Placebo-Controlled Study of Bifeprunox, a Partial Dopamine D2 Receptor Agonist, in Patients With Acute Exacerbations of Schizophrenia
In this Phase 3 study, researchers evaluated the efficacy, safety and tolerability of bifeprunox versus placebo in patients with acute exacerbations of schizophrenia. Although investigators observed no statistically significant improvement in PANSS score for bifeprunox compared with placebo, the metabolic profiles of subjects treated with bifeprunox were favorable and comparable with placebo.
In these studies, 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.
“We are pleased to report these promising findings that show the potential for bifeprunox to add value to the management and treatment of schizophrenia,” says Earl Sands, M.D., Vice President, Research and Development at Solvay Pharmaceuticals, Inc. “We are especially encouraged by the favorable weight and metabolic profile shown in both short- and long-term studies.”
In October 2006, Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) 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 agreed to co-develop and co-commercialize bifeprunox and two other compounds, which are in earlier stages of development, as treatments for schizophrenia and other psychiatric conditions.
“As the government-sponsored CATIE [Clinical Antipsychotic Trials in Intervention Effectiveness] study showed, a significant need remains for treatment alternatives with improved safety and tolerability profiles to ensure optimal care of individuals with schizophrenia,”says Philip Ninan, M.D., Vice President, Neuroscience at Wyeth Pharmaceuticals.
About Schizophrenia
Schizophrenia is a chronic form of psychosis that affects approximately 1.1 percent of the population in the United States in one year. It is characterized by positive and negative symptoms such as hallucinations, delusions, poverty of speech, disorganized thought and emotional blunting. Severity of the symptoms and the long-term pattern of schizophrenia often cause a high degree of disability for patients and place a burden on families, caregivers and communities.
While atypical antipsychotics help reduce positive and negative symptoms, to varying degrees, some may be associated with weight gain, glucose and triglyceride elevations and altered lipids, which may increase risk of diabetes and heart disease. These side effects are compounded by the fact that individuals with schizophrenia are more likely than the general population to be overweight or obese, and they have a two-to-four-times higher risk of diabetes than the general population.
About Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc., of Marietta, Georgia is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit www.solvaypharmaceuticals-us.com
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: SOLBt.BR) is listed on the Euronext stock exchange in Brussels. Details are available at www.solvay.com.