New Analysis of WHI Data Shows Reduced Levels of Coronary Artery Calcification, a Predictor of Cardiovascular Events, in Women a
21 Juin 2007 - 2:00PM
Business Wire
BioSante Pharmaceuticals, Inc. (AMEX:BPA) today provided comment on
the Women's Health Initiative (WHI) Coronary Artery Calcium Study
published yesterday in The New England Journal of Medicine (NEJM).
The study found that younger menopausal women (aged 50-59) who
received a standard dose of estrogen therapy had significantly less
coronary artery calcification at the end of the study period
compared with those taking placebo. Coronary artery calcification
is a marker of plaque in the arteries and a predictor of future
cardiovascular events. These findings are consistent with a recent
re-analysis of pooled estrogen alone and estrogen plus progestin
data from the WHI study, published April 4, 2007, in the Journal of
the American Medical Association (JAMA). This study found no
apparent increase in coronary heart disease for women who initiated
hormone therapy within 10 years of menopause; and a statistically
significant reduction in total mortality among women aged 50-59 in
the group receiving hormone therapy compared with those in the
placebo group. �Recent analysis of the data from the WHI study have
consistently clarified the initial data, to show that in the newly
diagnosed population of menopausal women, estrogen therapy does not
increase cardiovascular disease and that there actually is a
statistically significant reduction in total mortality among women
50-59 in the group receiving hormone therapy compared with those in
the placebo group,� said Stephen M. Simes, president & CEO of
BioSante. �These data should aid women in their consideration of
hormone therapy,� Simes continued. The authors state, "The current
recommendations from many organizations that hormone therapy be
limited to the treatment of moderate to severe menopausal symptoms,
with the lowest effective dose used for the shortest duration
necessary, remain appropriate." The authors conclude, "Hormone
therapy should not be initiated (or continued) for the express
purpose of preventing cardiovascular disease in either younger or
older postmenopausal women." Elestrin�, developed by BioSante and
marketed by Bradley Pharmaceuticals (NYSE:BDY) provides the lowest
dose of estradiol currently available for the treatment of hot
flashes. Elestrin is an effective, ultra-low dose transdermal
estrogen therapy that was approved by the U.S. Food and Drug
Administration (FDA) in December 2006 for the treatment of
moderate-to-severe vasomotor symptoms (hot flashes) associated with
menopause. About Estrogens Estrogen products today are approved for
the treatment of menopausal symptoms, including hot flashes.
Estrogen products are not approved for and should not be used for
the treatment or prevention of heart disease, breast cancer or
dementia. The Women's Health Initiative (WHI) study reported
increased risk of stroke and deep vein thrombosis in postmenopausal
women (50 to 79 years of age) during 6.8 years of treatment with
0.625 mg of oral conjugated equine estrogens alone per day,
relative to placebo. The WHI study reported increased risk of
myocardial infarction, stroke, invasive breast cancer, pulmonary
emboli and deep vein thrombosis in postmenopausal women (50 to 79
years of age) during five years of daily treatment with 0.625 mg of
oral conjugated equine estrogens combined with 2.5 mg of
medroxyprogesterone acetate per day. Although studies involving
hormone use and breast cancer risk have produced varied results,
newly reported estrogen-only data provide strong evidence that
estrogen alone does not increase the risk of breast cancer, and in
fact may decrease the risk. The North American Menopause Society
(NAMS), the American College of Obstetricians and Gynecologists and
the FDA all recommend women use the lowest effective dose of
estradiol for the shortest period of time. About BioSante
Pharmaceuticals, Inc. BioSante is developing a pipeline of hormone
therapy products to treat both men and women. These hormone therapy
products are gel formulations for transdermal administration that
deliver bio-identical estradiol and testosterone. BioSante's lead
products include Elestrin (estradiol gel) developed through FDA
approval by BioSante indicated for the treatment of
moderate-to-severe vasomotor symptoms associated with menopause,
marketed in the U.S.�by Bradley Pharmaceuticals, Inc., BioSante's
licensee, and LibiGel� (transdermal testosterone gel) in Phase III
development by BioSante for the treatment of female sexual
dysfunction (FSD). Also in development is Bio-T-Gel�, a
testosterone gel for male hypogonadism, and an oral contraceptive
using BioSante patented technology. The current market in the U.S.
for estrogen and testosterone products is approximately $2.5
billion and for oral contraceptives approximately $3.0 billion. The
company also is developing its calcium phosphate nanotechnology
(CaP) for novel vaccines, including hepatitis B, avian flu and
biodefense vaccines for toxins such as anthrax, as well as a system
for delivering drugs via alternative routes of administration.
Additional information is available online at
www.biosantepharma.com. This news release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. The statements regarding BioSante contained in
this news release that are not historical in nature, particularly
those that utilize terminology such as �may,� �will,� �should,�
�likely,� �expects,� �anticipates,� �estimates,� �believes,�
�plans,� �hopes,� or comparable terminology, are forward-looking
statements. Forward-looking statements are based on current
expectations and assumptions, and entail various risks and
uncertainties that could cause actual results to differ materially
from those expressed in such forward-looking statements. Important
factors known to BioSante that could cause actual results to differ
materially from those expressed in such forward-looking statements
include the difficulty of developing pharmaceutical products,
obtaining regulatory and other approvals and achieving market
acceptance, the success of clinical testing, and other factors
identified and discussed from time to time in BioSante's filings
with the Securities and Exchange Commission, including those
factors discussed in BioSante's most recent annual report on Form
10-K and subsequent quarterly reports on Form 10-Q, which
discussions also are incorporated herein by reference. All
forward-looking statements speak only as of the date of this news
release. BioSante undertakes no obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise.
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