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| |  Atridox Periodontal Disease Treatment Approved In Europe FORT COLLINS, CO -- January 4, 2000 -- Atrix Laboratories, Inc. announced that it has received approval in 11 European countries to market Atridox(TM) (doxycycline) 8.8% in the Atrigel(R) delivery system, an innovative antibiotic therapy for periodontal disease, through the Decentralized Mutual Recognition procedure of the European Union (EU).
"The addition of European countries essentially doubles this tremendous market opportunity for Atridox, and we are pleased to receive this broad approval through the Decentralized Mutual Recognition procedure, which is binding in the 11 countries involved," said David Bethune, vice chairman and chief executive officer of Atrix. He said the company anticipates introducing this important new weapon in the fight against periodontal disease in a number of the EU-member countries beginning in June 2000 after individual country marketing authorizations are issued. In addition, approval in the remaining three countries is expected to occur before the end of the year. The Atridox product combines the company's Atrigel drug delivery system with the antibiotic doxycycline to dramatically reduce the bacteria associated with periodontal disease. The innovative treatment is applied as a gel to the affected area, where it conforms to the shape of the periodontal pocket and solidifies, releasing doxycycline over a period of about seven days as it bioabsorbs. Anesthesia is not needed. In a recently reported multi-center, controlled clinical study of 105 patients with moderate to advanced periodontal disease, pocket depths of 5 and 6 mm were reduced to 4 mm or less after three months in nearly 70 percent of those who received routine tooth cleaning and treatment with Atridox. Of those treated with scaling and root planing -- the traditional mechanical removal of bacteria associated with periodontal disease -- pocket depths of 5 and 6 mm were reduced to 4 mm or less in 60 percent of the cases after three months. "Currently only a small percentage of those effected with periodontitis are receiving treatment. Using Atridox at the time of routine dental procedures, such as thorough cleaning, is virtually painless and should dramatically increase the number of patients receiving care," said Dr. Steven Garrett, Atrix vice president of clinical research. Atridox was approved by the U.S. Food and Drug Administration in late 1998 as the first and only locally delivered antibiotic treatment for periodontal disease that has been proven effective as a stand-alone therapy to achieve significant improvements in both pocket depth and attachment level, the primary indications of healing. In addition, the advanced therapy was recently awarded the American Dental Association Seal of Acceptance, an important symbol to dentists and consumers of a dental product's safety, effectiveness and the scientific validity of its health benefits. "Atridox gives dental professionals and their patients a practical, highly effective and pain-free therapeutic option for treating moderate to severe disease before more costly and invasive treatment is necessary, and for improving patient compliance in treating maintenance patients," Dr. Garrett said. Periodontal disease is believed to be the most common infectious disease after the common cold, and is a leading cause of tooth loss in adults. It begins as a painless infection of the gums, caused by a buildup of bacteria known as dental plaque. As the disease progresses, the gums increasingly separate from the teeth to form pockets, allowing the continued accumulation of plaque below the gumline. Without treatment, the bacterial buildup and resulting inflammation destroys the soft tissue and bone that hold the teeth.
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