Safety Analyses of Clinical Data for Bifeprunox in Patients withSchizophrenia Showed a Favorable Weight and Lipid Profile, Similarto Placebo
COLLEGEVILLE, Pa., March 30, 2007 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , Solvay Pharmaceuticals, Inc. 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, similar to 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 and low-density lipoprotein, similar to placebo. * Bifeprunox patients experienced decreases in body weight, body mass index (BMI) and prolactin and had an extrapyramidal side effects 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 5 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, Wyeth Pharmaceuticals and Solvay Pharmaceuticals, Inc. 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, Wyeth Pharmaceuticals and Solvay Pharmaceuticals agreed to co-develop 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 Wyeth, Solvay Pharmaceuticals and Lundbeck.
Under a new agreement that was announced in January 2007, Wyeth Pharmaceuticals and Solvay 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 co-patented by Wyeth and Solvay Pharmaceuticals as well as co-developed and co-commercialized by the two companies.
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 the 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 higher risk of diabetes than the general population.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors." The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Posted: March 2007