New Long-Term Data Analyses for Bifeprunox Show Favorable Effects Versus Placebo in Stabilized Patients with Schizophrenia
Six-Month Data Show Bifeprunox Maintained Stability Significantly Longer than Placebo and had a Favorable Weight and Lipid Profile Comparable with Placebo
MARIETTA, Ga. and COLLEGEVILLE, Pa., May 22, 2007 - Solvay Pharmaceuticals, Inc., Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), and Lundbeck A/S presented clinical study results on bifeprunox, an investigational treatment for adult patients diagnosed with schizophrenia, today 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:
o 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.
Schizophrenia is a chronic form of psychosis that affects approximately 1 percent of the adult population in the United States. 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 chronic 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 lipid abnormalities, 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 Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc., of Marietta, Georgia is the U.S. subsidiary of Solvay Pharmaceuticals.
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, and men's and women's health. Its 2006 sales were EUR 2.6 billion and it employs approximately 10,000 people worldwide.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs some 30,000 people in 50 countries. In 2006 its consolidated sales amounted to EUR 9.4 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.
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.
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Posted: May 2007