Wyeth Presents Data from Five-Year Vertebral Fracture Prevention Study with Bazedoxifene
September 15 2009 - 8:00AM
PR Newswire (US)
COLLEGEVILLE, Pa., Sept. 15 /PRNewswire-FirstCall/ -- Wyeth
Pharmaceuticals, a division of Wyeth (NYSE:WYE), announces findings
from a placebo-controlled Phase 3 study of bazedoxifene 20 mg
extended to five years, which indicated a significant reduction
versus placebo in new vertebral fractures in postmenopausal women
with osteoporosis. These and other data were presented at the
American Society for Bone and Mineral Research (ASBMR) Annual
Meeting in Denver, Colo. Bazedoxifene, a selective estrogen
receptor modulator (SERM), is under clinical investigation for the
prevention and treatment of postmenopausal osteoporosis. "These new
data are important in that they suggest the reduction in vertebral
fracture risk with bazedoxifene seen at five years is comparable to
that seen at three years," says Stuart Silverman, M.D., Clinical
Professor of Medicine at the University of California, Los Angeles
and Cedars-Sinai Medical Center, and the study's lead investigator.
About Study 301 The results being presented are from a two-year
extension of a three-year Phase 3 trial, which enrolled 7,492
generally healthy postmenopausal women aged 55 to 85 years with
osteoporosis. The primary endpoint of the three-year Phase 3 study
was the incidence of new vertebral fractures. Eligible subjects
were randomized to daily treatment with bazedoxifene 20 mg or 40
mg, raloxifene (RLX) 60 mg, or placebo. At the conclusion of the
pivotal three-year study, a total of 4,216 subjects were enrolled
in the extension to five years. Patients receiving bazedoxifene 20
mg continued on that dosage, while the RLX 60 mg treatment arm was
discontinued (as prespecified in the protocol) after the three-year
database was finalized, and subjects receiving bazedoxifene 40 mg
were transitioned to bazedoxifene 20 mg after all subjects
completed four years of treatment. At five years, the study showed
that the incidence of new vertebral fractures was significantly
reduced in the bazedoxifene 20 mg group (4.5%) and in the group
transitioned from bazedoxifene 40 mg to 20 mg (3.9%) compared with
placebo (6.8%). This corresponds to relative risk reductions of 35%
(P=0.014) and 40% (P=0.005), respectively. The incidence of venous
thromboembolic events in this Phase 3 clinical trial was higher in
bazedoxifene-treated subjects when compared with placebo. This
finding is consistent with what was seen at three years. Additional
New Bazedoxifene Data Presented at ASBMR Assessment of the Effect
of Bazedoxifene on Non-Vertebral Fracture Risk (McCloskey EV, et
al) Data were also presented from a post-hoc analysis performed
using the Fracture Risk Assessment Tool (FRAX ), which was
developed by the World Health Organization to calculate a woman's
10-year risk of experiencing an osteoporotic fracture. This
post-hoc analysis indicated that the higher a woman's risk of a
fracture, the greater the reduction in non-vertebral fractures when
receiving bazedoxifene therapy based on her FRAX score. Safety and
Tolerability of Bazedoxifene in Postmenopausal Women with
Osteoporosis: Results of a 5-Year, Randomized, Placebo-controlled
Phase 3 Trial (de Villiers TJ, et al) Bazedoxifene five-year safety
and tolerability data in postmenopausal women with osteoporosis
were also presented. The incidence of adverse events (AEs), serious
AEs and discontinuations due to AEs was similar to that seen in the
placebo group. The incidence of cardiac or cerebrovascular events,
including myocardial infarction and stroke, in the bazedoxifene
treatment groups was similar to that seen in the placebo group.
Subjects treated with bazedoxifene had a higher incidence of deep
venous thrombosis, hot flushes and leg cramps compared with
placebo-treated subjects. The effect of bazedoxifene on the breast
and endometrium was comparable to placebo. Cost-effectiveness of
Bazedoxifene in the US Incorporating the FRAX Algorithm (Strom, et
al) Data from an analysis performed using a Marcov cohort model and
published U.S. cost and epidemiological data evaluated the
potential cost-effectiveness and intervention thresholds of
bazedoxifene treatment (20 mg and 40 mg doses combined) compared to
placebo. Cost-effective scenarios were projected for women with
strong risk factors and with a T-score above the threshold for
osteoporosis. When effect was modeled for non-vertebral fractures,
the data suggested that potential cost effectiveness improved
further in women from the age of 60 years with prior fracture and
at the threshold of osteoporosis (T-score=-2.5 SD). About
Bazedoxifene Wyeth is pursuing regulatory approval of bazedoxifene
for the prevention and treatment of postmenopausal osteoporosis in
the United States and other countries worldwide. In April 2009, the
European Commission granted marketing authorization for
CONBRIZA(TM) (bazedoxifene) for the treatment of postmenopausal
osteoporosis in women at increased risk of fracture. Wyeth intends
to introduce CONBRIZA in certain European markets following receipt
of necessary reimbursement authorizations in those markets.
Bazedoxifene paired with conjugated estrogens (BZA/CE) is also
being studied by Wyeth for the treatment of moderate-to-severe
menopausal vasomotor symptoms such as hot flushes, night sweats and
vulvar and vaginal atrophy, and for the prevention of
postmenopausal osteoporosis. About Osteoporosis Osteoporosis
affects an estimated 75 million people in the United States, Europe
and Japan. In the United States, the condition is a major public
health threat for an estimated 44 million Americans, or 55 percent
of the people 50 years of age and older. Osteoporosis is
characterized by low bone mass and structural deterioration of bone
tissue, leading to bone fragility and an increased risk of
fractures. Up to 20 percent of a woman's expected lifetime bone
loss can occur in the years immediately following menopause. The
treatment of postmenopausal osteoporosis could lead to significant
improvement in the overall health for millions of women worldwide
as well as reduce costs associated with postmenopausal
osteoporosis-related fractures. 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. 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 will be commercially successful in the
markets where approved or that bazedoxifene will be approved in the
future in other formulations or indications and/or in other
countries, including the United States. Other risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by forward looking statements
include, among others, risks related to our proposed merger with
Pfizer, including satisfaction of the conditions of the proposed
merger on the proposed timeframe or at all, contractual
restrictions on the conduct of our business included in the merger
agreement, and the potential for loss of key personnel, disruption
in key business activities or any impact on our relationships with
third parties as a result of the announcement of the proposed
merger; 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; the outcome of
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and regulatory compliance with respect to, manufacturing of our
products; risks associated with our strategic relationships; global
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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, 2008, which was filed with the Securities and Exchange
Commission on February 27, 2009. 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. DATASOURCE: Wyeth Pharmaceuticals CONTACT: for Media,
Gwen Fisher of Wyeth Pharmaceuticals, +1-484-865-5160 or Douglas
Petkus of Wyeth, +1-973-660-5218; or for Investors, Justin Victoria
of Wyeth, +1-973-660-5340
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