Bradley Pharmaceuticals to Feature Elestrin(TM) at North American Menopause Society Annual Meeting
28 Septembre 2007 - 1:45PM
PR Newswire (US)
FAIRFIELD, N.J., Sept. 28 /PRNewswire-FirstCall/ -- Bradley
Pharmaceuticals, Inc. (NYSE:BDY) today announced that its Kenwood
Therapeutics division will feature Elestrin(TM) (estradiol gel
0.06%) at the 18th Annual North American Menopause Society (NAMS)
Annual Meeting to be held in Dallas, Texas from October 3-6, 2007.
Elestrin(TM) is an effective, low dose transdermal estrogen
therapy, available by prescription, for the treatment of
moderate-to-severe vasomotor symptoms associated with menopause.
Elestrin(TM) was approved by the Food and Drug Administration (FDA)
in December 2006, and launched in June by the Kenwood Therapeutics
division. "We are increasing support for women's healthcare, and
are pleased to feature Elestrin(TM) at the leading North American
scientific organization dedicated to promoting the health and
quality of life of women through an understanding of menopause,"
stated John Knoop, Executive Vice President and General Manager of
Bradley's Kenwood Therapeutics division. "Since the Women's Health
Initiative (WHI) study findings were released in July 2002 detailed
potential health risks associated with estrogen therapy, women have
been looking for new alternatives." Menopause therapy is shifting
toward transdermal, low-dose regimens, and Elestrin(TM) offers
women a new, effective low-dose, transdermal treatment option.
Elestrin(TM) addresses the guidelines set forth by the FDA, North
American Menopause Society (NAMS), American College of
Obstetricians and Gynecologists (ACOG), and the New England Journal
of Medicine that hormone therapy should be used at a low effective
dose for the shortest duration of time. In addition to being an
effective low-dose estrogen therapy, Elestrin(TM) dries quickly
within five minutes and is applied once-daily over a small area of
the upper arm and/or shoulder. "Elestrin(TM) offers physicians
another treatment option for patients who choose to manage their
hot flashes," stated Dr. Michelle Warren, Medical Director of The
Center for Menopause, Hormonal Disorders and Women's Health at
Columbia University. There are approximately 14,000 OB/GYN
physicians in the U.S. who account for the majority of
prescriptions in the $1.3 billion U.S. estrogen therapy market,
which consists of oral and topical products. The topical market
segment is about $300 million. Important Product Safety Information
About Elestrin(TM): Close clinical surveillance of all women taking
estrogens is important. Adequate diagnostic measures should be
undertaken to rule out malignancy in cases of undiagnosed
persistent or recurring abnormal vaginal bleeding. Long-term
continuous administration of estrogen, with or without progestin,
has shown an increased risk of endometrial, breast and ovarian
cancers. Estrogens with or without progestins should not be used
for the prevention of cardiovascular disease or dementia. An
increased risk of developing probable dementia in postmenopausal
women 65 years of age or older was reported with estrogen-alone
use, as well as, in combination with progestin. Estrogen-alone
therapy has been associated with an increased risk of stroke and
deep vein thrombosis. Estrogen plus progestin therapy has been
associated with an increased risk of myocardial infarction, stroke,
invasive breast cancer, pulmonary emboli and deep vein thrombosis.
Estrogens should be discontinued immediately if any of these events
occur or are suspected. Estrogen with or without progestin should
be prescribed at the lowest effective doses and for the shortest
duration consistent with treatment goals and risks for the patient.
An increase in gallbladder disease requiring surgery in
postmenopausal women receiving estrogens has been reported.
Estrogen therapy may lead to severe hypercalcemia in patients with
breast cancer and bone metastases. Retinal vascular thrombosis has
been reported in patients receiving estrogens. Estrogen products
should not be used in women with undiagnosed abnormal genital
bleeding; known, suspected or history of breast cancer; known or
suspected estrogen-dependent neoplasia; active or history of deep
vein thrombosis or pulmonary embolism; active or recent (within the
past year) arterial thromboembolic disease (e.g., stroke,
myocardial infarction); liver dysfunction or disease; known or
suspected pregnancy. Blood pressure should be monitored during
estrogen use. Caution should be exercised in patients with
hypertriglyceridemia, impaired liver function or a history of
cholestatic jaundice, conditions that might be influenced by fluid
retention, hypocalcemia, asthma, diabetes mellitus, epilepsy,
migraine, porphyria, systemic lupus erythematosus, and hepatic
hemangiomas. Patients dependent on thyroid hormone replacement
therapy may require increased doses of such therapy. The addition
of progestin should be considered in patients with residual
endometriosis post-hysterectomy. Concomitant application of
sunscreen and Elestrin(TM) to the same site for more than 7 days
should be avoided. The most frequently reported adverse events in
clinical trials were nasopharyngitis, breast tenderness, upper
respiratory tract infection, and metrorrhagia. For additional
important information about Elestrin(TM), please view full
prescribing information at http://www.bradpharm.com/ or request
full prescribing information by contacting Bradley Pharmaceuticals
at 973-882-1505. Please visit Bradley Pharmaceuticals web site at:
http://www.bradpharm.com/. About Bradley Pharmaceuticals, Inc.
Bradley Pharmaceuticals, Inc. was founded in 1985 as a specialty
pharmaceutical company and markets to niche physician specialties
in the U.S. and international markets. Bradley's success is based
upon its core strengths in marketing and sales, which enable the
company to Commercialize brands that fill unmet patient and
physician needs; Develop new products through life cycle
management; and In-License phase II and phase III drugs with
long-term intellectual property protection that upon approval
leverage Bradley's marketing and sales expertise to increase
shareholder value. Bradley Pharmaceuticals is comprised of Doak
Dermatologics, specializing in therapies for dermatology and
podiatry; Kenwood Therapeutics, providing gastroenterology, OB/GYN,
respiratory and other internal medicine brands; and A. Aarons,
which markets authorized generic versions of Doak and Kenwood
therapies. Safe Harbor for Forward-Looking Statements: This release
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements include statements that address activities, events or
developments that Bradley expects, believes or anticipates will or
may occur in the future, such as Bradley's plans to in-license,
develop and launch new and enhanced products with long-term
intellectual property protection or other significant barriers to
market entry, sales and earnings estimates, other predictions of
financial performance, timing of payments on indebtedness, launches
by Bradley of new products, market acceptance of Bradley's
products, and the achievement of initiatives to enhance corporate
governance and long-term shareholder value. Forward-looking
statements are based on Bradley's experience and perception of
current conditions, trends, expected future developments and other
factors it believes are appropriate under the circumstances and are
subject to numerous risks and uncertainties, many of which are
beyond Bradley's control. These risks and uncertainties include
Bradley's ability to: launch VEREGEN(TM) at the end of 2007;
predict the safety and efficacy of ELESTRIN(TM) and VEREGEN(TM) in
a commercial setting; estimate sales; maintain adequate inventory
levels; implement the returns and inventory optimization plan
timely, if at all; reduce product returns; comply with the
restrictive covenants under its credit facility; refinance its
credit facility; access the capital markets on attractive terms or
at all; favorably resolve the pending SEC informal inquiry;
maintain or increase sales of its products; or effectively react to
other risks and uncertainties described from time to time in
Bradley's SEC filings, such as fluctuation of quarterly financial
results, estimation of product returns, chargebacks, rebates and
allowances, concentration of customers, reliance on third party
manufacturers and suppliers, litigation or other proceedings
(including the pending class action and shareholder derivative
lawsuits), government regulation and stock price volatility.
Further, Bradley cannot accurately predict the impact on its
business of the approval, introduction, or expansion by competitors
of generic or therapeutically equivalent or comparable versions of
Bradley's products or of any other competing products. In addition,
actual results may differ materially from those projected. Bradley
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. DATASOURCE: Bradley Pharmaceuticals, Inc. CONTACT:
Cecelia C. Heer, Investor-Public Relations of Bradley
Pharmaceuticals, Inc., +1-973-882-1505, ext. 252 or Web site:
http://www.bradpharm.com/
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