Solvay
Pharmaceuticals, Inc. and Wyeth Pharmaceuticals, a division of Wyeth (NYSE:
WYE), announced today that a New Drug Application (NDA) was submitted to
the U.S. Food and Drug Administration (FDA) for bifeprunox, an
investigational atypical antipsychotic for the treatment of schizophrenia.
"The NDA submission of bifeprunox is an important milestone in our
commitment to develop and commercialize compounds that potentially address
the long-term treatment outcomes of patients with mental illnesses," says
Laurence Downey, M.D., President and CEO of Solvay Pharmaceuticals, Inc.
"In addition to our research in schizophrenia, we're also exploring other
treatments for other psychiatric disorders."
The NDA submission is based on safety and efficacy studies that
evaluated bifeprunox for the treatment of schizophrenia in approximately
2,550 patients. Patients were evaluated with acute exacerbations for six
weeks, and stable patients were evaluated for six months.
"One recent U.S. government-sponsored study, CATIE (Clinical
Antipsychotic Trials of Intervention Effectiveness), showed a significant
need for new treatment options, especially over the long-term," says Joseph
Camardo, M.D., Senior Vice President of Global Medical Affairs, Wyeth
Pharmaceuticals. "We are pleased that our collaboration with Solvay
Pharmaceuticals has resulted in an application with proposed indications
for both initial therapy and maintenance, which is an important feature for
an atypical antipsychotic."
In March 2004, Solvay Pharmaceuticals and Wyeth entered into a
collaboration agreement exclusively dedicated to neuroscience research and
development. Under the terms of the agreement, the partners will codevelop
and cocommercialize bifeprunox and two other compounds, currently known as
SLV-313 and SLV-314, which are in earlier stages of development as
treatments for schizophrenia, bipolar disorder, major depressive disorder
with psychotic features and other indications.
About Schizophrenia
Schizophrenia is a chronic form of psychosis that affects approximately
three million North Americans. 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.
Medications for schizophrenia can help reduce and control the distressing
symptoms of the illness.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of women's health care, cardiovascular disease, 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.
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from time to time in our periodic reports filed with the Securities and
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reports on Form 10-Q and annual report on Form 10-K, particularly the
discussion under the caption "Item 1A, Risk Factors." We assume no
obligation to publicly update any forward-looking statements, whether as a
result of new information, future developments or otherwise.
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