Bradley Pharmaceuticals' Elestrin(TM) Receives New Patent to 2022
11 Avril 2007 - 2:45PM
PR Newswire (US)
FAIRFIELD, N.J., April 11 /PRNewswire-FirstCall/ -- Bradley
Pharmaceuticals, Inc. (NYSE:BDY) today announced that its partner,
BioSante Pharmaceuticals (AMEX:BPA) was issued a new formulation
patent for Elestrin(TM) (estradiol gel 0.06%). Elestrin(TM) was
approved in December 2006 by the FDA for the treatment of
moderate-to-severe vasomotor symptoms associated with menopause.
This new formulation patent covers gel formulations into 2022.
Bradley has exclusive marketing rights for Elestrin(TM) in the U.S.
and expects to launch the product through its Kenwood Therapeutics
division in June 2007. "Elestrin(TM) will offer the lowest
effective dose of estradiol approved by FDA for the treatment of
moderate to severe vasomotor symptoms. This dosage is a 50 percent
lower daily dose than the next lowest competitive dose of
estradiol," stated Daniel Glassman, President and CEO of Bradley
Pharmaceuticals. "We believe that Elestrin(TM) will provide
physicians with an important treatment option for patients who
suffer from and choose to manage their menopausal symptoms." "An
important part of Bradley's strategic plan is to in-license Phase
II and Phase III drugs with long-term intellectual property
protection, develop these products and bring to market brands that
fill unmet patient needs. The additional patent on Elestrin(TM)
demonstrates Bradley's ability to effectively target new therapies
with long-term intellectual property protection," added Mr.
Glassman. Important Product Safety Information: Elestrin(TM) is
indicated for the treatment of moderate-to-severe vasomotor
symptoms associated with menopause. 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 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. Please request Package Insert
for full Prescribing Information by contacting the Company. Please
visit Bradley Pharmaceuticals web site at:
http://www.bradpharm.com/ Bradley Pharmaceuticals common stock is
listed on the NYSE under the symbol BDY. 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 enables 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, OBGYN, respiratory and other internal
medicine brands; and A. Aarons, which markets authorized generic
versions of Doak and Kenwood therapies. Important announcement:
Bradley Pharmaceuticals will present at the 2007 UBS Global Generic
and Specialty Pharmaceuticals Conference to be held at the Grand
Hyatt in New York, NY, May 8-9, 2007. Bradley Pharmaceuticals will
present at the Robbins Emerging Opportunities Investment
Conference, to be held at The University Club in New York, NY, May
24, 2007. Bradley Pharmaceuticals will present at 9:20 a.m. at the
Banc of America Securities Health Care Conference 2007, to be held
at The Four Seasons Hotel in Las Vegas, Nevada, May 30, 2007. 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) and ELESTRIN(TM) during
2007; predict the safety and efficacy of these products in a
commercial setting; estimate sales; maintain adequate inventory of
levels; 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, stock
price volatility and ability to achieve strategic initiatives to
enhance long-term shareholder value. 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 Relations, Bradley Pharmaceuticals, Inc.,
+1-973-882-1505, ext. 252 Web site: http://www.bradpharm.com/
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