Bradley Pharmaceuticals Launches Veregen(TM) (sinecatechins) Ointment, 15%
14 12월 2007 - 9:45PM
PR Newswire (US)
FAIRFIELD, N.J., Dec. 14 /PRNewswire-FirstCall/ -- Bradley
Pharmaceuticals, Inc. (NYSE:BDY) today announced its launch of
Veregen(TM) (sinecatechins) Ointment, 15%, indicated for the
topical treatment of external genital (EGW) and perianal warts
(Condylomata acuminata) in immunocompetent patients 18 years and
older. Veregen(TM) is the first new prescription treatment for
external genital warts in ten years. Bradley licensed the product
from MediGene AG (Frankfurt: MDG) and has exclusive marketing
rights in the United States. Veregen(TM) is the first botanical
drug approved for prescription use in the United States and is
patented through 2017, with additional applications pending which,
if approved, would extend patents beyond 2020. The active
ingredient in Veregen(TM) is sinecatechins, a proprietary mixture
of 8 catechins, the primary phenols found in green tea leaves. The
health benefits associated with catechins are attributed in part to
their antioxidant properties. In two Phase III randomized,
double-blind, vehicle-controlled studies, Veregen(TM) proved
effective in clearing both baseline and newly emerging external
genital and perianal warts, with complete clearance in 53.6% of all
patients studied who received Veregen(TM) (as compared to 35.3% of
those patients receiving vehicle). Veregen(TM) also demonstrated
low recurrence rates during these trials. When treated with
Veregen(TM), only 6.8% of the patients experienced recurrence. The
majority of adverse reactions reported during these studies were
mild to moderate skin and application site reactions, and there
were no systemic side effects reported. External genital warts are
one of the most common and fastest spreading venereal diseases
worldwide. More than 1 million new cases of EGW are seen each year
in the United States and nearly 1.4 million sexually active adults
have visible genital warts at any point in time. Current treatment
for this condition primarily consists of cryosurgery and the
topical therapy Aldara(R) (imiquimod). Both the Doak Dermatologics
and Kenwood Therapeutics divisions of Bradley will promote
Veregen(TM) to specialty markets including dermatology and female
healthcare providers. "EGW is a condition that is both emotionally
and physically distressing for patients," stated Gerald Wachs,
M.D., Medical Director of Bradley Pharmaceuticals. "We believe that
Veregen(TM), an effective and safe alternative in the treatment of
this condition, will enhance patient care." "Investigations of
catechins have shown wide-ranging effects on mechanisms where HPV
infection progresses to genital warts," stated Warner K. Huh, M.D.,
Associate Professor, Division of Gynecologic Oncology, University
of Alabama at Birmingham. "Veregen(TM) has been shown to be
efficacious and generally well tolerated in patients with genital
warts. There was also a relatively low rate of recurrence." "We are
pleased to launch Veregen(TM) as a new therapeutic option," stated
Daniel Glassman, President and CEO of Bradley Pharmaceuticals, Inc.
"The manufacture of this product is very complex, and I would like
to commend everyone involved on achieving our goal of bringing
Veregen(TM) to market in 2007. We are all very proud of this
therapy and the steps we will be taking in advancing the treatment
of EGW." Veregen(TM) will begin shipping to wholesalers and be
available in drugstores within a few weeks. 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) has not been evaluated to treat urethral,
intra-vaginal, cervical, rectal, or intra-anal human papilloma
viral disease and should not be used to treat these conditions.
Avoid use of Veregen(TM) on open wounds. Safety and efficacy of
Veregen(TM) have not been established in immunosuppressed or
pediatric patients, or pregnant women, or for the treatment of
external genital and perianal warts beyond 16 weeks or for multiple
treatment courses. In clinical trials, local adverse events leading
to discontinuation or dose interruption included: application site
reactions, phimosis, inguinal lymphadenitis, urethral meatal
stenosis, dysuria, genital herpes simplex, vulvitis,
hypersensitivity, pruritis, pyodermitis, skin ulcer, erosions in
the urethral meatus, and superinfection of warts and ulcers. For
additional important information about Veregen(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/. Aldara(R)
is a registered trademark of Graceway Pharmaceuticals, LLC. 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. On October 29, 2007, Bradley signed a merger
agreement with Nycomed US Inc. Additional Information About the
Proposed Merger Transaction and Where You Can Find It In connection
with the proposed merger with Nycomed US Inc. and its wholly owned
subsidiary, Phase Merger Sub Inc., the Company intends to file a
proxy statement and other relevant materials with the Securities
and Exchange Commission ("SEC"). BEFORE MAKING ANY VOTING DECISION
WITH RESPECT TO THE PROPOSED MERGER TRANSACTION, STOCKHOLDERS OF
BRADLEY PHARMACEUTICALS ARE URGED TO READ THE PROXY STATEMENT, WHEN
IT BECOMES AVAILABLE, AND THE OTHER RELEVANT MATERIALS FILED BY THE
COMPANY WITH THE SEC BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION ABOUT THE PROPOSED TRANSACTION. The proxy statement and
other relevant materials, when available, and any other documents
filed by the Company with the SEC, may be obtained free of charge
at the SEC's website at http://www.sec.gov/. In addition, Company
stockholders may obtain free copies of the documents filed with the
SEC on the Company's website (http://www.bradpharm.com/) or by
contacting the Company at Bradley Pharmaceuticals, Inc., Investor
Relations at 383 Route 46 West, Fairfield, NJ 07004, Telephone:
(973) 882-1505, ext 252. You may also read and copy any reports,
statements and other information filed by the Company with the SEC
at the SEC public reference room at 100 F Street, N.E. Room 1580,
Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 or
visit the SEC's website for further information on its public
reference room. The Company and its directors, executive officers
and other members of its management may be deemed to be soliciting
proxies from the Company's stockholders in favor of the merger.
Investors and stockholders may obtain more detailed information
regarding the direct and indirect interests in the merger of
persons who may, under the rules of the SEC, be considered
participants in the solicitation of the Company's stockholders in
connection with the merger by reading the preliminary and
definitive proxy statements regarding the merger, which will be
filed with the SEC. Information about the Company's directors and
executive officers may be found in the Company's proxy statement
disseminated in connection with the Company's 2006 Annual Meeting
that was filed with the SEC on May 17, 2007. These documents will
be available free of charge once available at the SEC's web site at
http://www.sec.gov/ or by directing a request to the Company as
provided above. Other Information: For more detailed information,
please see Bradley's SEC filings, including its recently filed
Quarterly Report on Form 10-Q for the quarter ended September 30,
2007, by visiting http://www.bradpharm.com/ and clicking on the
Investor Relations link, then on SEC Filings. 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 the proposed merger with Nycomed US Inc., 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, 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: predict the safety and efficacy of ELESTRIN(TM) and VEREGEN(TM)
in a commercial setting; estimate sales; maintain adequate
inventory levels; complete the returns and inventory optimization
plan timely; reduce product returns; comply with the covenants
under its new 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. 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, Bradley
Pharmaceuticals, Inc., +1-973-882-1505, Ext. 252, Web site:
http://www.bradpharm.com/ http://www.sec.gov/
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