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Bradley pharmaceuticals trading was very uneventful as of midday Friday December 14th. Shares were holding close to neutral ground on average volume.
Bradley Pharmaceuticals, Inc. 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 - News) 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 (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 973-882-1505.
Please visit Bradley Pharmaceuticals web site at: www.bradpharm.com.
Aldara is a registered trademark of Graceway Pharmaceuticals, LLC.
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