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New Study Confirms ARESTIN

WARMINSTER, PA, March 9, 2006 – A new study highlighting the antimicrobial effectiveness of ARESTIN® (minocycline hydrochloride) 1 mg Microspheres in the treatment of periodontal disease will be presented at the first joint annual session of the American Dental Education Association (ADEA) and the American Association for Dental Research (AADR), March 8 -11, 2006 in Orlando, Florida.

The study reveals a significant reduction in Red Complex Bacteria among patients with periodontal disease who were treated with ARESTIN® plus scaling and root planing (SRP) compared with patients who were treated with SRP alone. In addition, the study shows that ARESTIN® + SRP is more effective than SRP alone in:

•Reducing periodontal pocket depth
•Reducing bleeding on probing
•Increasing clinical attachment level
•Reducing periodontal pocket depth and bleeding on probing in smokers

Red Complex Bacteria (RCB) includes three pathogens associated with microbial infection in people with periodontal disease: Porphyromonas gingivalis, Tannerella forsythensis and Treponema denticola. More than 50 million adults across many demographic categories are affected by periodontal disease.1 Advanced periodontal disease is marked by tender, swollen and painful gums that bleed easily. After initial development of the disease, the gums may ulcerate and then become necrotic, leading to tooth loss.2

Scaling and Root Planing (SRP) is the removal of hard and soft deposits from the root surfaces of the teeth using mechanical or ultrasonic devices, thereby permitting healing and potential reduction in depth of the periodontal pocket, which is the space that forms at the gum line around teeth. The study, to be presented at the joint ADEA and AADR annual session, shows that, in comparison to SRP alone, a statistically significant reduction in the numbers of infection-causing Red Complex Bacteria is achieved when ARESTIN® is administered as an adjunct to SRP. The ARESTIN® Microspheres are placed into the periodontal pockets, to which they adhere and deliver therapeutic drug concentrations for up to 14 days after administration.3

“We know that scaling and root planing is effective for gross removal of bacterial plaque and calculus in patients with periodontal disease,” states Dr. J. Max Goodson, Senior Member of the Staff and Director of Clinical Research at The Forsyth Institute. “These studies, however, are important because they demonstrate that when SRP was followed by administration of ARESTIN®, there was a significant added reduction in bacteria that are thought to cause periodontal disease. Hence, the inclusion of ARESTIN® with mechanical treatment more effectively controlled these bacteria and created a measurably better clinical outcome.”

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