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CDC Recommends VEREGEN® as Therapeutic Option for External Genital Warts in the 2010 Sexually Transmitted Diseases Treatment Guidelines
Date:1/5/2011

FLORHAM PARK, N.J., Jan. 5, 2011 /PRNewswire/ -- PharmaDerm, a division of Nycomed US Inc., announced today that VEREGEN® (sinecatechins) Ointment, 15%, a topical medication for the treatment of external genital and perianal warts (EGWs), has been added as a new therapeutic option in the 2010 Centers for Disease Control and Prevention (CDC) Sexually Transmitted Diseases (STD) Treatment Guidelines.(1) The new report, developed by the CDC after consultation with a group of professionals knowledgeable in the field of STDs, was published recently in the December 17 issue of Morbidity and Mortality Weekly Report.

VEREGEN® is now listed as a patient-applied option as part of the "Recommended Regimens for External Genital Warts" section of the guidelines. Consistent with the product label, the updated guidelines provide recommendations for the use of VEREGEN® in immunocompetent patients ages 18 years and older and instructs patients to apply the ointment three times daily until complete clearance of warts, but no longer than 16 weeks.

EGWs, which appear on the outside of the genitals or around the outside of the anus (perianal warts), are the most common STD in the U.S.(2) Caused by the human papillomavirus (HPV), if left untreated, EGWs can grow larger, interfering with bowel movements, urination and sexual intercourse.(3) Approximately 20 million Americans are currently infected with HPV and another 6.2 million people become newly infected each year.(4)

"The CDC STD Treatment Guidelines provide an important source of clinical guidance on both the prevention and management of HPV in the U.S.," stated Theodore Rosen, MD, Professor of Dermatology at Baylor College of Medicine. "Based on the latest scientific evidence, the updated guidelines provide clear direction on how VEREGEN® can routinely be incorporated into medical practice as a safe and effective option for patients seeking treatment for external genital warts."

Approved by the U.S. Food and Drug Administration (FDA) in October 2006, VEREGEN® is the first prescription botanical drug approved for use in the U.S., and the first new prescription treatment for EGWs in more than a decade.(5) VEREGEN® is derived from green tea leaves from the plant Camellia sinensis (L.) O Kuntze, and contains a proprietary mixture of catechins and other green tea components. The health benefits associated with green tea catechins, which comprise 85 to 95 percent of the drug substance in VEREGEN®, are attributed in part to their antioxidative, immunostimulatory and antiviral properties.(6) However, the mode of action of VEREGEN® involved in the clearance of EGWs is unknown.  Future studies are necessary to fully understand the role of catechins in human health.(7)

VEREGEN® has demonstrated to be effective in clearing both existing and newly emerging EGWs, with complete clearance in 53.6 percent of all patients treated in two pivotal, randomized, double-blind, vehicle-controlled, Phase 3 studies. VEREGEN® also demonstrated low recurrence rates (6.8%) at 12 weeks post treatment during these trials.(8)

"EGWs can be distressing for patients," said Ralph N. Landau, Ph.D., Senior Vice President, Research and Development of Nycomed US Inc. "We are pleased that experts in the field of STDs acknowledge VEREGEN® as a proven intervention for EGWs that meets the goals of treatment – complete clearance in both existing and newly emerging warts, with a low rate of recurrence."

Important Product Safety Information About VEREGEN®VEREGEN® Ointment, 15% is a medicine for skin use only (topical) for the treatment of warts on the outside of the genitals and around the outside of the anus. It is not a treatment for warts in the vagina, cervix, or inside the anus. Your doctor may recommend examination and screening tests (such as a Pap smear) to evaluate these areas.

VEREGEN® 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® on open wounds. Do not expose skin that has been treated with VEREGEN® to the sun or ultraviolet light because VEREGEN® has not been tested in these conditions. Safety and efficacy of VEREGEN® 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.

The most common adverse reactions that occurred in more than 20% of patients in studies with VEREGEN® were reactions of the skin and application site. These included reddening of the skin, itching, burning, pain or discomfort, skin ulcers, wearing down of the skin, swelling, hard spots, and rash with blisters.

For more information about VEREGEN®, please refer to the full Prescribing Information and associated medication guide at http://www.veregen.com

About Nycomed USNycomed US Inc. is a subsidiary of Nycomed and operates two divisions in the United States focused on specialty pharmaceuticals in dermatology.  Founded in 1849, Fougera is a division of Nycomed US Inc. and is the leading manufacturer and distributor of a wide range of topical products.  The PharmaDerm division is dedicated to developing and commercializing novel prescription products to treat diseases and conditions of the skin – the largest organ of the human body.  For more information on Fougera's complete line of products, please call Fougera Customer Service at (800) 645-9833 or visit the company online at www.fougera.com.  Information on PharmaDerm products can be found online at www.pharmaderm.com.  More information is also available at www.nycomedus.com.(1) Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2010. MMWR 2010;59(No. RR-12):70-74.(2) Rubano E, Shah BR. Genital warts. eMedicine. http://emedicine.medscape.com/article/763014-overview. Updated Aug 16, 2010. Accessed October 15, 2010.(3) Genital warts. American Academy of Dermatology website. http://aad.org/public/publications/pamphlets/viral_genital.html. Accessed December 30, 2010.(4) CDC Fact Sheet – Genital HPV. CDC website. http://www.edcp.org/pdf/hpv_fact_sheet.pdf. Accessed October 15, 2010.(5) Bradley Pharmaceuticals, Inc. (2007, December 14). Bradley Pharmaceuticals Launches Veregen™ (sinecatechins) Ointment, 15% [Press release]. http://www.prnewswire.com/news-releases/bradley-pharmaceuticals-launches-veregentm-sinecatechins-ointment-15-58729832.html. Accessed October 15, 2010.(6) Meltzer SM, Monk BJ, Tewari KS. Green tea catechins for treatment of external genital warts. Am J Obstet Gynecol. 2009;200:233.e1-233.e7.(7) Cabrera C, Artacho R, Gimenez R. Beneficial effects of green tea—a review. J Am Coll Nutr. 2006;25(2):79-99.(8) Veregen Ointment, 15% [package insert]. Melville, NY: PharmaDerm, a division of Nycomed US, Inc.; 2008.
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