Separate Retrospective Analysis of Phase 3 Data Offers Additional
Information on Bazedoxifene Alone
COLLEGEVILLE, Pa., Sept. 25 /PRNewswire/ -- A retrospective analysis of
Phase 3 two-year data presented at the annual meeting of the North American
Menopause Society (NAMS) suggest that postmenopausal women treated with
bazedoxifene/conjugated estrogens (BZA/CE) may experience incidence of
breast tenderness and abnormal mammograms no greater than those treated
with placebo. BZA/CE is an investigational compound being studied by Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), for the treatment of
moderate-to-severe menopausal vasomotor symptoms such as hot flashes and
night sweats, and for the prevention of postmenopausal osteoporosis. Wyeth
describes this compound as a tissue selective estrogen complex (TSEC).
In a retrospective analysis of data from another phase 3 study,
treatment with Wyeth's investigational compound bazedoxifene (BZA) alone
did not appear to increase mammographic breast density in postmenopausal
women with osteoporosis compared to raloxifene (the active comparator) or
placebo over two years. BZA is an investigational selective estrogen
receptor modulator (SERM) under development for the treatment and
prevention of postmenopausal osteoporosis.
Data Highlights
NAMS Poster Titled: Breast Effects of Bazedoxifene/Conjugated Estrogens
in a Randomized, Controlled Trial of Postmenopausal Women
In the phase 3 study involving 3,397 postmenopausal women, primarily
designed to evaluate the effects of BZA/CE on the endometrium and bone
mineral density, mammograms were taken at baseline, and again at years one
and two as part of the safety evaluation. Breast tenderness was reported in
daily diaries. A retrospective analysis suggested no significant
differences in the incidence of breast tenderness or abnormal mammograms
between the BZA/CE groups at any of the doses studied and placebo or
raloxifene.
In this study, the incidence of treatment-emergent adverse events,
serious adverse events, and withdrawals due to adverse events were similar
among the active treatment groups and placebo.
NAMS Poster Titled: Effects of Bazedoxifene on Mammographic Breast
Density in Postmenopausal Women with Osteoporosis
A retrospective study examined mammograms in a subset representing 726
postmenopausal women from a primary phase 3 fracture reduction study of
BZA, raloxifene, and placebo. The objective was to evaluate the
quantitative changes in mammographic breast density after 24 months of
treatment. This study indicated treatment with BZA over 24 months did not
affect mammographic breast density in postmenopausal women with
osteoporosis. Changes in breast density with BZA were similar to those with
raloxifene and placebo.
Also presented at the NAMS meeting were data on the effects of BZA/CE
on sleep and overall menopausal symptoms.
About TSEC
Wyeth describes the pairing of a selective estrogen receptor modulator
(SERM) and one or more estrogens as a TSEC. The TSEC concept is based on
the blended tissue-selective activity of the components, which is
hypothesized to yield different clinical results than those provided by
either the SERM or estrogen(s) alone.
About Menopause
According to the U.S. Census Bureau, in 2006, there were approximately
20 million women of menopausal age (45-54 years) in the United States. As
many as 50 percent to 90 percent of women going through menopause
experience vasomotor symptoms, such as hot flashes, which can greatly
impact a woman's life. Furthermore, between 10 percent and 40 percent of
postmenopausal women experience symptoms of vulvar and vaginal atrophy,
which typically do not subside without treatment.
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, nutritionals 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. For additional information about the company, please
visit http://www.wyeth.com.
The statements in this press release that are not historical facts are
forward-looking statements that are subject to risks and uncertainties that
could cause actual results to differ materially from those expressed or
implied by such statements. In particular, clinical trial data are subject
to differing interpretations, and the views of regulatory agencies, medical
and scientific experts and others may differ from ours. In addition, there
can be no assurance that bazedoxifene/conjugated estrogens or bazedoxifene
will ever receive regulatory approval or be successfully developed and
commercialized. Other risks and uncertainties that could cause actual
results to differ materially from those expressed or implied by
forward-looking statements include, without limitation, 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; government cost-containment initiatives;
restrictions on third-party payments for our products; substantial
competition in our industry, including from branded and generic products;
emerging data on our products and pipeline 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" in
our Annual Report on Form 10-K for the year ended December 31, 2007, which
was filed with the Securities and Exchange Commission on February 29, 2008.
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.
SOURCE Wyeth Pharmaceuticals
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Related links:
http://www.wyeth.com
CONTACT:
Media: Gwen Fisher of Wyeth Pharmaceuticals,
+1-484-865-5160, or Douglas Petkus of Wyeth, +1-973-660-5218; or
Investors: Justin Victoria of Wyeth, +1-973-660-5340
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