News article received, Friday, November 13, 1998 1:02:38 PM EST
ATRIX LABORATORIES: Innovative ATRIDOX therapy now available in fight against periodontal disease
NOV 13, 1998, M2 Communications - Atrix Laboratories, Inc. (Nasdaq NM: ATRX) today announced that ATRIDOX (doxycycline hyclate, 10.0%) in the ATRIGEL delivery system, an important new weapon in the fight against periodontal disease, is now available to dental professionals and their patients nationwide. Recently approved by the U.S. Food and Drug Administration, this advanced site-specific antibiotic therapy provides a fast, easy, virtually painless and highly effective treatment option for the most common infectious disease after the common cold.
Periodontal disease affects an estimated 50 million Americans, including three out of four people over age 35. However, only 7.5 million (15 percent) are currently receiving treatment for this common gum disorder, which is well known as the leading cause of adult tooth loss.
"The new ATRIDOX product offers unique advantages that should encourage wider treatment of periodontal disease and play a vital role in the overall management of this widespread and potentially serious condition," said John Urheim, vice chairman and chief executive officer of Atrix. "ATRIDOX gives dental professionals and their patients a highly effective and exceptionally easy option for treating periodontal disease before it reaches advanced stages, and for improving compliance with maintenance therapy following extensive periodontal treatment."
Atrix has earned a total of $24 million in milestone payments from Block Drug Corporation (Nasdaq NM: BLOCA), and will receive manufacturing margins and royalties on all product sales. Under terms of a licensing agreement, Block markets ATRIDOX in North America. An estimated $6.5 billion is spent annually to treat periodontal disease in the United States alone.
An original development of Atrix research, the ATRIDOX product combines the company's proprietary 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.
ATRIDOX is 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 long-term healing, as well as to reduce bleeding on probing. As a result, scaling and root planing -- the traditional mechanical treatment for periodontal disease -- is still an important and often critical procedure, but is not required with each ATRIDOX application.
"Because it is site-specific, ATRIDOX delivers far more antibiotic to the affected area than can be delivered by an oral tablet or capsule, providing potent action directly against the bacteria that cause periodontal disease," said Dr. Lee Southard, president and chief scientific officer of Atrix. He noted that oral medications distribute drugs throughout the body and are often associated with systemic side effects.
The Phase III clinical studies that led to this product's approval were the largest trials ever conducted for the treatment of periodontal disease, including data from 822 patients at 20 study centers across the United States. The studies showed that ATRIDOX when used alone resulted in a 1.2 millimeter (mm) reduction in pocket depth and a 0.8 mm gain in attachment, the two most commonly used criteria to assess clinical effectiveness. Scaling and root planing -- the standard mechanical removal of bacterial buildup to treat periodontal disease -- resulted in a 1.1 mm pocket depth reduction and 0.7 mm attachment gain. Data from another clinical trial confirmed a significant decrease in disease-causing bacteria at sites treated with ATRIDOX without an increase in resistance to doxycycline.
In clinical trials, the most common side effects associated with ATRIDOX included tooth sensitivity, gum soreness and infections of the respiratory system. ATRIDOX should not be used by patients hypersensitive to doxycycline or any other drug in the tetracycline class.
"In light of its potentially serious nature, the management of periodontal disease is taking on increased significance," said Dr. Norman Stoller, professor of periodontics at the University of Colorado School of Dentistry, one of the clinical researchers for ATRIDOX. "ATRIDOX antibiotic therapy is a quick, easy, relatively painless, non-invasive treatment which can be used by dentists to help manage periodontal disease. It is particularly useful for those patients with moderate to advanced disease and for patients who are manifesting recurrence of disease at the time of routine maintenance visits."
Periodontal disease 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 growth of plaque below the gumline. Without treatment, the bacterial buildup 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 home care and continuing 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.
"We hope the availability of ATRIDOX will help lead more patients with periodontal disease not only to seek treatment, but to be compliant regarding maintenance visits," said Dr. Southard. He cited a study showing that after initial treatment most patients failed to comply fully with suggested maintenance schedules. In fact, 34 percent did not return to the dentist at all for maintenance therapy following completion of their initial treatment.
"The patient-friendly attributes of ATRIDOX should help attract patients to treatment and, once in treatment, help them to be retained," Dr. Southard said. "The product's effectiveness, comfort and ease of use should be embraced by the dental profession."
Atrix Laboratories, Inc. develops, manufactures and markets dental, medical and veterinary products based on its proprietary ATRIGEL biodegradable polymeric technology, which can be used for a broad range of drug delivery and biomaterial applications. Additional information is available on the Atrix Laboratories, Inc. Web site at atrixlabs.com.
Forward-looking statements in this release involve a number of risks and uncertainties including, but not limited to, product demand, pricing, market acceptance, changing economic conditions, risks in product and technology development, the effect of the company's accounting policies and other risk factors detailed in the company's SEC filings.
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