FAIRFIELD, N.J., May 30 /PRNewswire-FirstCall/ -- Bradley Pharmaceuticals, Inc. announced today that two brands marketed by the Company’s Doak Dermatologics subsidiary were presented recently at the 16th European Academy of Dermatology and Venerology (EADV) Conference in Vienna, Austria.
TX Systems(R) B-Lift(R), licensed from Drs. Albert and Douglas Kligman, is a cosmetic formulation of salicylic acid that is used for epidermal skin peeling to improve appearance. The product was presented in a scientific session conducted by Dr. Aleksandar Krunic, Clinical Assistant Professor of Dermatology, University of Illinois College of Medicine. His study entitled, “Salicylic Acid Peels for Dyschromia, Photoaging and Acne-Related Conditions -- Our Experience,” assessed the effect of salicylic acid peels in patients with darker skin types and conditions including acne, rosacea, postinflammatory hyperpigmentation, melasma, enlarged pores and photoaging.
Thirty-six adult patients participated voluntarily in the study. All other systemic and topical treatments were prohibited. The patients had undergone facial peels with 20-30% salicylic acid in a hydroethanolic solution bi-weekly for three months. They were pre-treated for two weeks with hydroquinone 4% prior to undergoing a series of five salicylic acid chemical peels. Two investigators independently evaluated patients by physical examination and comparison of pre-treatment and post-treatment photos. Paired comparisons revealed moderate to significant improvement in 80.6% of the patients, and it was concluded that salicylic acid peels are beneficial in improving the appearance of acne, dyschromia rosacea and photoaging in patients with darker skin tones.
Solaraze(R) Gel (diclofenac sodium - 3%), indicated for the topical treatment of actinic keratosis, was featured in a scientific poster exhibit. Dr. Boni E. Elewski, professor and Director of Clinical Research, Department of Dermatology, at the University of Alabama at Birmingham and past president of the American Academy of Dermatology, presented a poster entitled, “Disseminated Superficial Actinic Porokeratosis (DSAP) Treated with Diclofenac Sodium 3% Gel.” DSAP is a hereditary disorder of keratinization causing numerous dry patches on sun-exposed areas of the arms and legs.
An open-label, multi-center pilot study was initiated with 15 adult patients enrolled across four sites. Diclofenac sodium 3% gel was applied to the left or right forearm, twice daily and patients were followed monthly for 12 weeks. If lesions were still present, patients continued medication for an additional 12 weeks. Target area lesion counts were performed at each visit to objectively measure efficacy. The primary endpoint was a decrease in the number of DSAP lesions from baseline. Preliminary data from the study indicates treatment with diclofenac sodium 3% gel lead to a stable or reduced number of DSAP lesions in 5 out of 9 patients at 12 weeks. The study is still ongoing and not all patients have completed 24 weeks.
“We at Bradley are fully committed to supporting our brands with data from clinical studies,” stated Daniel Glassman, President and CEO of Bradley Pharmaceuticals. “Currently there are four additional dermatology studies in progress and we look forward to the results because such studies further validate the benefits of our products and support the importance of the specialty markets we serve.”
Important Product Safety Information About Solaraze(R) Gel:
SUN AVOIDANCE IS INDICATED DURING SOLARAZE(R) GEL THERAPY. As with other NSAIDs, anaphylactoid reactions may occur in patients without prior exposure to diclofenac. Diclofenac sodium should be given with caution to patients with the aspirin triad. In clinical trials, the most common adverse reactions involved the skin and included contact dermatitis, rash, dry skin and exfoliation. The majority of these reactions were mild to moderate, and resolved upon discontinuation of therapy. SOLARAZE(R) Gel should not be applied to open skin wounds, infections, or exfoliative dermatitis.
For additional important information about Solaraze(R) Gel, please view full prescribing information at www.bradpharm.com or request full prescribing information by contacting Bradley Pharmaceuticals.
Please visit Bradley Pharmaceuticals web site at: 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, OB/GYN, respiratory and other internal medicine brands; and A. Aarons, which markets authorized generic versions of Doak and Kenwood therapies.
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) at the end of 2007 and ELESTRIN(TM) at the end of the second quarter 2007; predict the safety and efficacy of these products in a commercial setting; estimate sales; maintain adequate inventory levels; implement the returns and inventory optimization plan timely, if at all; reduce product returns; 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 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.
Bradley Pharmaceuticals, Inc.
CONTACT: Cecelia C. Heer, Investor-Public Relations of BradleyPharmaceuticals, Inc., +1-973-882-1505, ext. 252
Web site: http://www.bradpharm.com/
