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
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
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 www.bradpharm.com or request full
prescribing information by contacting Bradley Pharmaceuticals at
Please visit Bradley Pharmaceuticals web site at: 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 www.sec.gov. In addition, Company stockholders may
obtain free copies of the documents filed with the SEC on the Company's
website (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 www.sec.gov or by directing a request to the Company as
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 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
SOURCE Bradley Pharmaceuticals, Inc.