Bradley Pharmaceuticals Announces Launch of Elestrin(TM)
June 13 2007 - 8:45AM
PR Newswire (US)
FAIRFIELD, N.J., June 13 /PRNewswire-FirstCall/ -- Bradley
Pharmaceuticals, Inc. (NYSE:BDY) today announced the launch of
Elestrin(TM) (estradiol gel 0.06%) by the Company's Kenwood
Therapeutics Division. Elestrin(TM) is an effective, low dose
transdermal estrogen therapy that was approved by the Food and Drug
Administration (FDA) in December 2006 for the treatment of
moderate-to-severe vasomotor symptoms associated with menopause.
Bradley in-licensed the product from BioSante Pharmaceuticals
(AMEX:BPA) late last year and has exclusive marketing rights for
Elestrin(TM) in the U.S. Elestrin(TM) is patent protected until
2022. 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. In
order to support the launch of Elestrin(TM) to the OB/GYN specialty
market, the Company will immediately increase Kenwood's sales
representatives and expects Kenwood to have up to 60
representatives. "After the Women's Health Initiative (WHI) study
in July 2002 detailed potential health risks associated with
estrogen therapy, women have been seeking new alternatives," stated
John Knoop, Vice President and General Manager of Bradley's Kenwood
Therapeutics division. "Elestrin(TM) will enter the market as an
effective, low dose estrogen therapy that follows dosing
recommendations by the FDA and leading women's health organizations
such as the American College of Obstetrics and Gynecologists (ACOG)
and the North American Menopause Society (NAMS) to use the lowest
effective dose of estrogen therapy." In addition to being an
effective low dose estrogen therapy, Elestrin(TM) is an elegant,
fast-drying gel that is applied once-daily over a small, easy-
to-reach area of the upper arm and/or shoulder. Elestrin(TM)
delivers a consistent supply of estrogen to the bloodstream over
24-hours and in clinical trials patients experienced no endometrial
hyperplasia during the twelve week study. "The lower dose regime of
Elestrin(TM) offers physicians a new and different treatment option
for patients suffering from climacteric symptoms of menopause,"
stated Dr. Ruby Huttner, Chairman of the OB/GYN department at
Hunterdon Medical Center, Flemington, New Jersey. "Elestrin(TM)
will provide physicians with an important treatment option for
patients who choose to manage their hot flashes. We are confident
that Elestrin(TM) will make a significant contribution to women's
healthcare and look forward to working with key OB/GYN physicians
to make Elestrin(TM) a success," stated Daniel Glassman, President
and CEO of Bradley Pharmaceuticals. The launch of Elestrin(TM)
marks the execution of an important part of Bradley's strategic
plan to in-license Phase II and Phase III drugs with long- term
intellectual property protection, develop these licensed drugs into
successful products and bring to market brands that fill unmet
patient needs. 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.
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 these products 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, Web site: http://www.bradpharm.com/
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