Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that it
received an approvable letter from the U.S. Food and Drug Administration
(FDA) for PRISTIQ(TM) (desvenlafaxine), a serotonin-norepinephrine reuptake
inhibitor (SNRI), currently under review as a treatment for
moderate-to-severe vasomotor symptoms (hot flashes and night sweats)
associated with menopause.
In its letter, the FDA said that before the application could be
approved, it would be necessary for Wyeth to provide additional data
regarding the potential for serious adverse cardiovascular and hepatic
effects associated with the use of PRISTIQ in this indication. The Agency
requested that these data come from a randomized, placebo-controlled
clinical trial of a duration of one year or more conducted in
postmenopausal women. The Agency also requested that Wyeth address certain
CMC (Chemistry, Manufacturing and Controls) deficiencies prior to approval.
The FDA also made additional clinical and chemistry requests, which the
Agency stated were not approvability issues.
"Wyeth remains committed to the development of PRISTIQ as a potential
treatment for moderate-to-severe vasomotor symptoms associated with
menopause," says Gary L. Stiles, M.D., Executive Vice President and Chief
Medical Officer, Wyeth Pharmaceuticals. "We will work with the Agency to
satisfy its requests for additional data and move the medicine forward in
the FDA review process."
On January 22, 2007, the Company received an approvable letter for
PRISTIQ for the treatment of Major Depressive Disorder (MDD), which did not
require submission of additional clinical studies prior to approval for
this indication. As previously announced, Wyeth intends to submit its
complete response to the MDD approvable letter at the end of August, and
the Agency is expected to act on the application during the first quarter
of 2008.
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. In
particular, the statements in this press release regarding our expectations
for PRISTIQ are based on a preliminary analysis of the FDA action letter
received on July 23, 2007, regarding the vasomotor symptoms indication and
our expectations as to the future regulatory approval process, all of which
are subject to risks and uncertainties. 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 and pipeline products (including PRISTIQ); 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.
Wyeth Pharmaceuticals
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