FAIRFIELD, N.J., Jan. 31 /PRNewswire-FirstCall/ -- Bradley
Pharmaceuticals, Inc. (NYSE: BDY) announced today that the Company has entered
into a collaboration and license agreement with MediGene AG
(Frankfurt: TecDax: MDG), to commercialize POLYPHENON(R) E Ointment in the
United States through Bradley's Specialty Sales and Marketing Teams.
The United States Food and Drug Administration recently accepted for
filing MediGene's New Drug Application (NDA) for POLYPHENON(R) E Ointment. The
active ingredient in the ointment is a defined mixture of catechins extracted
from green tea patented for use as an Rx product for the treatment of
hyperplasias caused by papilloma viruses such as external genital and perianal
warts. Genital warts appear as benign but contagious skin tumors in the
genital and anal areas. This disease is one of the most common and fastest
spreading venereal diseases worldwide. It is estimated that approximately 14
million people in the United States are infected with the strains of human
papilloma virus that cause genital warts, making the US the largest market for
this indication.
Bradley and MediGene together will decide whether to develop POLYPHENON(R)
E for other dermatological indications based on a joint clinical development
plan.
Bradley President and CEO, Daniel Glassman, stated, "Bradley
Pharmaceuticals is excited to enter this collaboration with MediGene. This
agreement marks Bradley's expansion into new specialty healthcare markets, and
is an important milestone for the Company. Management feels strongly that this
endeavor will bring the individual strengths of both Bradley and MediGene
together and will result in a synergistic relationship that fuels the growth
of both companies."
MediGene CEO, Peter Heinrich, stated, "MediGene looks forward to
collaborating with Bradley Pharmaceuticals and to the successful
commercialization of one of our most important products. Bradley's ability to
successfully promote prescription products has been demonstrated time and time
again."
About Bradley Pharmaceuticals, Inc.
Bradley Pharmaceuticals, Inc. (NYSE: BDY) was founded in 1985 as a
specialty pharmaceutical company and markets to niche physician specialties in
the U.S. and 38 international markets. Bradley Acquires non-strategic brands,
Enhances these brands with line extensions and improved formulations and Grows
the products through promotion, advertising and selling activities to optimize
life cycle management. Bradley Pharmaceuticals is comprised of Doak
Dermatologics, specializing in topical therapies for dermatology and podiatry,
and Kenwood Therapeutics, providing gastroenterology, respiratory and other
internal medicine brands.
About MediGene
MediGene AG (Frankfurt: TecDax MDG), is a German-American biotechnology
company located in Martinsried, Germany and San Diego, California. MediGene
was the first German biotech company with a drug on the market, and has the
most mature drug development pipeline in the German biotech industry.
MediGene's core competence lies in research and development of novel
approaches for the treatment of cancer.
MediGene(TM) is a trademark of MediGene AG, Polyphenon(R) E is a trademark
of Mitsui Norin.
Bradley Pharmaceuticals, Inc. (NYSE: BDY) was founded in 1985 as a
specialty pharmaceutical company and markets to niche physician specialties in
the U.S. and 38 international markets. Bradley's success is based on the
strategy of Acquire, Enhance and Grow. Bradley Acquires non-strategic brands,
Enhances these brands with line extensions and improved formulations and Grows
the products through promotion, advertising and selling activities to optimize
life cycle management. Bradley Pharmaceuticals is comprised of Doak
Dermatologics, specializing in topical therapies for dermatology and podiatry;
Kenwood Therapeutics, providing gastroenterology, respiratory and other
internal medicine brands; and A. Aarons, which will market authorized generic
versions of Doak and Kenwood therapies.
Please visit Bradley Pharmaceuticals web site at:
http://www.bradpharm.com
Bradley Pharmaceuticals common stock is listed on the NYSE under the
symbol BDY.
Important announcement:
Doak Dermatologics continues its dedicated support of the American Academy
of Dermatology that dates to the organization's inception. Doak will be an
Emerald sponsor of the 64th Annual Meeting of the AAD, to be held in San
Francisco, CA, March 3-7, 2006.
Daniel Glassman will present at the Raymond James & Associates 27th Annual
Institutional Investors Conference, Hyatt Regency Grand Cypress in Orlando,
FL, March 5-8th, 2006.
Daniel Glassman will present at the CIBC World Markets Annual Specialty
Pharmaceutical & Biotechnology Conference, to be held at the Millenium
Broadway Hotel in New York City, April 4-5, 2006.
Daniel Glassman will present at the Banc of America Securities LLC, Health
Care Conference 2006, to be held at The Four Seasons Hotel in Las Vegas, NV,
May 16-18th, 2006.
Daniel Glassman will present a case study on Optimizing Lifecycle
Management for a Product with Limited Patent Protection at the MedAd News'
Specialty Pharmaceuticals Summit, June 6-8, 2006 at 8:45 AM at the Park Hyatt,
Philadelphia, PA.
This press 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 sales and earnings estimates, other predictions
of financial performance, timing of payments on indebtedness, launches by
Bradley of new products and market acceptance of Bradley's products.
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 estimate sales, ability
to comply with the restrictive covenants under its credit facility; ability to
refinance its credit facility, if necessary; ability to access the capital
markets on attractive terms or at all; ability to favorably resolve the
pending SEC informal inquiry and file required financial statements with the
SEC in accordance with the Company's announced timetable, maintain sales of
its products, successfully acquire, develop, integrate, or sell new products,
including POLYPHENON(R) E ointment when and if approved by the FDA, 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
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.
SOURCE Bradley Pharmaceuticals, Inc.
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Related links:
http://www.bradpharm.com
CONTACT:
Anthony Griffo, Investor Relations, of
Bradley Pharmaceuticals, Inc., +1-973-882-1505, ext. 313
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