Wyeth (NYSE: WYE)
announced today it was notified by the U.S. Food and Drug Administration
(FDA) of the Agency's decision to cancel its September 7, 2006
Psychopharmacologic Drugs Advisory Committee meeting. The meeting was
originally scheduled to provide a forum for FDA advisors to discuss and
review data included in Wyeth's New Drug Application (NDA) for
desvenlafaxine succinate extended release for the treatment of major
depressive disorder. After further review of the data, the FDA decided it
was no longer necessary to hold the advisory committee meeting before
issuing its action letter, which is expected in October 2006.
Wyeth is encouraged by this development and believes that its
comprehensive clinical trials program for desvenlafaxine succinate supports
the product's approval. The Company submitted its NDA to the FDA for
desvenlafaxine succinate, a dual serotonin-norepinephrine reuptake
inhibitor, in December 2005.
Facts About Depression
Depression is the most common serious mental disorder worldwide.
-- Depression affects approximately 121 million people worldwide and is the
fourth leading cause of disability and premature death.
-- The World Health Organization projects that by the year 2020, depressive
disorders will become the second-leading cause of disability worldwide.
-- Depression is one of the most prevalent mental health conditions in the
United States, affecting approximately 14.8 million American adults each
year.
-- Women suffer from depression twice as often as men.
More treatment options are needed.
-- Researchers estimate that approximately 50 to 60 percent of patients
suffering from depression respond to antidepressant therapy, leaving a
large percentage of patients with unresolved depression.
-- Patients who experience one episode of depression have a 50 to 60
percent chance that it will recur.
Wyeth Is Committed to Neuroscience Research and Development
As a leader in neuroscience, Wyeth's discovery and development of
desvenlafaxine succinate demonstrates its commitment to developing
pharmaceutical products to help address the unmet needs of patients living
with mental illness. In addition to the investigational compound
desvenlafaxine succinate for major depressive disorder, the Company also
has active research programs in other mental health areas, including
bipolar disorder, schizophrenia, and Alzheimer's disease.
About Wyeth
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 nonprescription 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 risks associated with the inherent
uncertainty of the timing and success of product research, development and
commercialization (including with respect to our pipeline products), drug
pricing and payment for our products by government and third- party payors,
manufacturing, data generated on the safety and efficacy of our products,
economic conditions including interest and currency exchange rate
fluctuations, changes in generally accepted accounting principles, the
impact of competitive or generic products, trade buying patterns, global
business operations, product liability and other types of litigation, the
impact of legislation and regulatory compliance, intellectual property
rights, strategic relationships with third parties, environmental
liabilities, 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." We assume no
obligation to publicly update any forward-looking statements, whether as a
result of new information, future developments or otherwise.
Wyeth
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