Wyeth Receives Approvable Letter From FDA For Pristiq (Desvenlafaxine Succinate) For The Treatment Of Major Depressive Disorder

Wyeth Pharmaceuticals,
a division of Wyeth (NYSE: WYE), announced today that the Company has
received an approvable letter from the U.S. Food and Drug Administration
(FDA) for Pristiq(TM) (desvenlafaxine succinate), a
serotonin-norepinephrine reuptake inhibitor (SNRI) studied as a treatment
for adult patients with major depressive disorder (MDD). The letter was
received January 22.



"The approvable letter is in line with Wyeth's expectations and we
remain on track with our plans for Pristiq," says Joseph Mahady, President,
Wyeth Pharmaceuticals -- North America and Global Businesses. "We are
working toward resolution of all outstanding issues at our manufacturing
site in Guayama, Puerto Rico and have already made significant progress in
meeting previously established commitments."



According to the approvable letter, FDA approval of Pristiq is subject
to several conditions, including the following:



-- A satisfactory FDA inspection of the Company's Guayama, Puerto Rico
facility, which is where Pristiq will be manufactured



-- Several post-marketing commitments, including submission of long-term
relapse prevention, low dose and pediatric studies



-- Additional clarity around the Company's product education plan for
physicians and patients



-- Confirmation by the FDA of the acceptability of the proprietary name,
Pristiq



As the Company has already communicated, launch timing for the MDD
indication is predicated on three elements -- final FDA approval for
Pristiq as a treatment for adult patients with MDD, the results of ongoing
MDD studies at lower dosage levels, and the progress of FDA review of
Wyeth's separate New Drug Application (NDA) for vasomotor symptoms (VMS)
associated with menopause. Importantly, while the approvable letter
requires some post-marketing commitments, the FDA does not require that any
additional clinical studies be submitted prior to the approval of Pristiq.



"Given the importance of Pristiq, we are committed to ensuring the most
complete profile and product information is available to physicians and
patients at the time of this product's launch," Mahady says.



About Pristiq



Pristiq is an SNRI studied as a potential treatment for adult men and
women with MDD. Wyeth submitted a NDA for MDD on December 22, 2005. The
Company has also filed a NDA for VMS associated with menopause and expects
an FDA action letter in the second quarter of 2007. If approved, Pristiq
will be the first and only non-hormonal medicine for the treatment of VMS
associated with menopause. Wyeth is a leader in both neuroscience and
women's health care.



Wyeth discovered and developed the first SNRI approved by the FDA,
which is currently the most widely used antidepressant in the world.
Pristiq represents Wyeth's latest efforts and continued commitment to
developing therapies to help improve the lives of patients suffering from
mental health disorders.
















According to a large depression trial funded by the National Institute
of Mental Health, only 28 percent of patients with depression achieved
remission with initial antidepressant treatment. This leaves a large
percentage of patients still suffering from depression. Clearly, additional
medicines are needed for treating MDD.



About Antidepressants



Antidepressants increased the risk of suicidal thinking and behavior
(suicidality) in short-term studies in children and adolescents with major
depressive disorder and other psychiatric disorders. Anyone considering the
use of any antidepressant in a child or adolescent must balance this risk
with the clinical need. Patients who are on such therapy should be observed
closely for clinical worsening, suicidality or unusual changes in behavior.
Families and caregivers should be advised of the need for close observation
and communication with their prescriber.



About Major Depressive Disorder



Major depressive disorder is a serious medical condition that is
different from "feeling blue" and is not something that people just "get
over." Criteria for major depressive disorder include five or more of the
following symptoms that have been present for at least two weeks, and at
least one of the symptoms must be either depressed mood or loss of interest
or pleasure.



-- Depressed mood



-- Loss of interest or pleasure



-- Changes in appetite or weight



-- Changes in sleeping patterns



-- Psychomotor agitation or retardation



-- Fatigue or low energy



-- Feeling worthless or guilty for no reason



-- Difficulty thinking or concentrating



-- Thoughts of death or suicide



Further, people with major depressive disorder may experience
clinically significant distress or impairment in social, occupational or
other important areas of functioning. If a person experiences these
symptoms, he or she should speak with a health care professional.



Major depressive disorder is a common mental disorder, affecting about
121 million people worldwide. In the United States, it is estimated that
depression affects about 19 million American adults each year. The lifetime
risk of major depression has been assessed from 10 to 25 percent for women
and five to 12 percent for men. Research has shown that hormonal changes,
including estrogen decline, or life stressors experienced by women may
contribute to a major depressive episode.



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, hemophilia, oncology and vaccines. 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.



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