Bradley Pharmaceuticals to Preview New Products at ACOG Meeting
04 Maggio 2007 - 2:45PM
PR Newswire (US)
FAIRFIELD, N.J., May 4 /PRNewswire-FirstCall/ -- Bradley
Pharmaceuticals, Inc. (NYSE:BDY) today announced that it will
preview two new FDA-approved products at the annual clinical
meeting of the American College of Obstetricians and Gynecologists
(ACOG) to be held in San Diego, California, from May 5-9, 2007. The
Company's Kenwood Therapeutics division will be offering package
inserts and product information about Elestrin(TM) (estradiol gel
0.06%), and Veregen(TM) (sinecatechins) Ointment 15%, both of which
are scheduled to be launched this year. Elestrin(TM) is an
estradiol transdermal gel to be prescribed for the treatment of
moderate-to-severe hot flashes in menopausal women and is available
at two dosage levels. Approved by the FDA in December 2006, and
patent protected until 2022, the lower dose level of Elestrin(TM)
offers the lowest effective dose of estradiol approved by the FDA
for treatment of this condition. Bradley in-licensed the product
from BioSante Pharmaceuticals (AMEX:BPA) in November 2006. The
Company's Kenwood Therapeutics division will begin promoting
Elestrin(TM) in June 2007. Veregen(TM) is a topical ointment used
for the treatment of external genital and perianal warts.
Veregen(TM)'s novel active ingredient, sinecatechins, is derived
from the extract of green tea. Veregen(TM), approved in October
2006, is the first botanical and one of 18 new molecular entities
approved by the FDA last year. The product is patent protected
until 2017. Bradley in-licensed Veregen(TM) from MediGene AG
(TecDax: MDG) of Frankfurt, Germany. Both Bradley's Kenwood
Therapeutics division and Doak Dermatologics subsidiary are
currently scheduled to begin detailing Veregen(TM) to OB/GYN
physicians, dermatologists, college health departments, planned
parenthood organizations, and public health programs during the
fourth quarter of this year. "We are pleased to have the
opportunity to preview both Elestrin(TM) and Veregen(TM) at ACOG.
This conference offers the largest exhibition in the country for
obstetricians and gynecologists and related health care
professionals," said John Knoop, Vice President and General Manager
of Bradley's Kenwood Therapeutics division. "Part of Bradley's
expanded business strategy is to in-license Phase II and Phase III
drugs and develop and bring to market products with long-term
intellectual property protection. We accomplished this quickly last
year after signing agreements for Elestrin(TM) and Veregen(TM) and
receiving FDA approval for both products during the fourth quarter.
We are looking forward to successful launches as we progress
through the year," commented Daniel Glassman, President and CEO of
Bradley Pharmaceuticals. Please visit Bradley Pharmaceuticals web
site at: http://www.bradpharm.com/. Bradley Pharmaceuticals common
stock is listed on the NYSE under BDY. Important Product Safety
Information About Elestrin(TM): 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(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, please request full prescribing information
for Elestrin(TM) by contacting Bradley Pharmaceuticals. Important
Product Safety Information About Veregen(TM): Veregen(TM) is
indicated for the topical treatment of external genital and
perianal warts (Condylomata acuminata) in immunocompetent patients
18 years and older. Veregen(TM) is for external use only. Skin
reactions including erythema, erosion, edema, itching, and burning
at the application site are common. Should a severe local skin
reaction occur, the ointment should be removed and further doses
held. Veregen(TM) has not been evaluated for the treatment of
urethral, intra- vaginal, cervical, rectal, or intra-anal human
papilloma viral disease and should not be used for these
conditions. The safety and efficacy of Veregen(TM) in
immunosuppressed patients, in the treatment of external genital and
perianal warts beyond 16-weeks, or for multiple treatment courses
have not been established. Veregen(TM) is not a cure and new warts
might develop during or after therapy. If new warts develop during
the 16-week treatment period, these should also be treated with
Veregen(TM). The effect of Veregen(TM) on the transmission of
genital/perianal warts is unknown. Sexual (genital, anal or oral)
contact should be avoided while the ointment is on the skin.
Veregen(TM) may weaken condoms and vaginal diaphragms. Therefore
the use in combination with Veregen(TM) is not recommended. In
clinical trials, the incidence of local adverse events leading to
discontinuation or dose interruption included: application site
reactions (local pain, erythema, vesicles, skin
erosion/ulceration), phimosis, inguinal lymphadenitis, urethral
meatal stenosis, dysuria, genital herpes simples, vulvitis,
hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in
the urethral meatus, and superinfection of warts and ulcers. For
additional important information, please request full prescribing
information for Veregen(TM) by contacting Bradley Pharmaceuticals.
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 announcements: 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 the Banc of America Securities
Health Care Conference 2007, to be held at The Four Seasons Hotel
in Las Vegas, Nevada, May 30 - June 1, 2007. Bradley
Pharmaceuticals will present at the FTN Midwest Securities Health
Care Conference 2007, to be held at the Four Seasons Hotel in New
York, NY, June 5, 2007. Safe Harbor for Forward-Looking Statement
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 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
of Bradley Pharmaceuticals, Inc., +1-973-882-1505, ext. 252 Web
site: http://www.bradpharm.com/
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