FAIRFIELD, N.J., Feb. 5 /PRNewswire-FirstCall/ -- Bradley Pharmaceuticals, Inc. announced today that Solaraze(R) Gel (diclofenac sodium 3%), a topical actinic keratosis therapy marketed by the Company’s Doak Dermatologics subsidiary, was featured in a scientific poster at the 65th Annual Meeting of the American Academy of Dermatology.
The poster, titled “Evaluation of the Efficacy and Safety of Diclofenac Sodium 3% Gel in the Treatment of Actinic Keratosis Lesions Post Cryosurgery: Prospective, Double-Arm, Multi-Center, Open Label, Phase IV Study,” presented the results of a recently completed multicenter study comprised of 521 patients at 82 sites. Two hundred forty-four patients were treated with cryosurgery followed by 90 days of therapy with Solaraze(R) Gel, while 277 patients received cryosurgery alone. At the completion of the study, patients receiving sequential therapy of cryosurgery followed by Solaraze(R) Gel experienced, on average, an 80% reduction in cumulative lesions vs. a 43% reduction in the cryosurgery alone group. The difference between the two groups was statistically significant (p<0.0001). Cumulative lesions are defined as target lesions identified at baseline plus new lesions appearing during the study. A total of 52 adverse events, mostly application site reactions, were reported for the study, consistent with those listed in the full Prescribing Information, and resulted in 35 patients discontinuing the study.
Investigators Darrell S. Rigel, M.D. of New York, NY and Joshua M. Berlin, M.D. of Boynton Beach, FL concluded that sequential treatment with Solaraze(R) Gel post cryosurgery is a therapeutic modality that provides a successful outcome. In fact, sequential treatment in this study proved to be almost twice as effective as cryosurgery alone. As noted in the study, it is estimated that more than 90% of actinic keratosis lesions in the US are treated with destructive therapies, principally cryosurgery, representing the most common treatment modality for this condition. This clinical evaluation demonstrating the effectiveness of Solaraze(R) Gel following cryosurgery is a significant confirmation of the value of this therapy in patient care.
President and CEO, Daniel Glassman, stated, “Bradley Management was very pleased with the study results presented at the AAD which provided significant confirmation of the benefits of Solaraze(R) Gel, a patent protected therapy. Bradley plans to further increase promotional support of the Solaraze(R) Gel brand in line with the Company’s evolving strategic plan to focus on brands with intellectual property protection.”
Important Safety Information Solaraze(R) Gel is available by prescription only.
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. Please see full Prescribing Information at www.bradpharm.com
Bradley Pharmaceuticals, Inc. 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 upon strategically expanding from an Acquire, Enhance and Grow to an In-License, Develop and Bring to Market business model: In-license phase II and phase III drugs with long-term intellectual property protection; Develop these products and submit completed clinical studies to the FDA for NDA approvals and commercialization; Bring to Market these patent-protected brands to fill unmet needs and 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 announcement:
Bradley Pharmaceuticals will present at the Roth Capital Partners 19th Annual OC Conference, at 12 noon at the Ritz Carlton, Laguna Niguel, CA, February 21, 2007.
Bradley Pharmaceuticals will present at the Raymond James & Associates 28th Annual Institutional Investors Conference, at 11 A.M. at the Hyatt Regency Grand Cypress in Orlando, FL, March 5, 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 through June 1, 2007.
Please visit Bradley Pharmaceuticals web site at: www.bradpharm.com
Bradley Pharmaceuticals common stock is listed on the NYSE under the symbol BDY.
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 sales and earnings estimates, other predictions of financial performance, 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: successfully acquire, develop, integrate or sell new products, estimate sales; favorably resolve the pending SEC informal inquiry; remediate its material weaknesses in its internal controls; or effectively react to other risks and uncertainties described from time to time in Bradley’s SEC filings. 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. 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: Anthony Griffo, Investor Relations of Bradley Pharmaceuticals,Inc., +1-973-882-1505, ext. 313
Web site: http://www.bradpharm.com/
