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| |  Atridox Approved In Europe For Periodontal Disease FORT COLLINS, CO -- April 28, 1999 -- Atrix Laboratories, Inc. has received approval of Atridox® (doxycycline) 8.5%, an advanced site-specific antibiotic therapy for the treatment of periodontal disease, from the Medicines Control Agency in the United Kingdom. "This is the first European approval of Atridox, and is especially significant because it opens the door for subsequent regulatory approvals throughout Europe under the Mutual Recognition procedure," said John Urheim, vice chairman and chief executive officer of Atrix Laboratories. "We are particularly pleased that all variations to the original Product License granted last November were approved and that label claims support both stand-alone and adjunctive use. Dentists and patients in the U.K. can now benefit from this easy-to-use, highly effective and virtually pain-free treatment option, and we look forward to receiving approvals in additional countries during the year." Atridox received U.S. Food and Drug Administration approval in late 1998, and is gaining wide acceptance in the dental community as an important weapon in the fight against one of the most prevalent infectious diseases, and the leading cause of tooth loss in adults. The company will launch Atridox in the United Kingdom during the second quarter, and the new product will be unveiled at the Jubilee Congress of the British Society of Periodontology this May in London. 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 is bioabsorbed; anesthesia is not needed. "Inflammatory periodontal diseases are one of the most widespread and undertreated groups of chronic conditions worldwide, including in the U.K., and are increasingly associated with potentially serious health risks," said Professor Hubert N. Newman, Director of the Clinical Research Centre of the Eastman Dental Institute in London, who conducted clinical trials with the new therapy. "Atridox is a welcome addition that may help result in wider treatment because it is quick, non-invasive and relatively painless." The new therapy has been approved for use in treating patients at early to late stages of the disease and during maintenance therapy, as well as to improve the outcomes of cases that fail to respond to traditional procedures. Atrix has begun initial shipments of Atridox to the United Kingdom, and will market the product through Atrix Laboratories Limited, its U.K. subsidiary based in London, using a contract sales organization with experience in selling dental products in the United Kingdom. European regulations require the Atridox product lots to be tested and released for marketing within the European Union upon importation. This process is underway and is expected to be completed in the next few weeks. "We are continuing discussions with large multinational pharmaceutical companies as well as regional dental product marketing companies in various European countries to develop distribution channels that will maximize product sales throughout the continent," said Rees Orland, Atrix vice president of sales and marketing. "We expect European sales of Atridox to become increasingly significant as the product is approved in additional countries." Periodontal disease has been estimated to affect as many as three out of four adults over age 35. 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. While periodontal disease is a chronic disorder, its progression can usually be arrested and its symptoms reversed with professional treatment, good dental hygiene and continued visits to the dentist for maintenance therapy to prevent recurrence and further deterioration. Individuals with outward signs of periodontal disease, including bleeding or inflammation of the gums, are urged to see a periodontist or general dentist for diagnosis and appropriate treatment.
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