OraPharma presents data

Nov. 14, 2001
Study further establishes a potential link between cardiovascular disease and periodontal disease, other findings

OraPharma, Inc., a specialty pharmaceutical company with an initial focus on the emerging field of oral health care, presented data from a retrospective study that further establish a potential link between cardiovascular disease and periodontal disease. Data were also presented indicating that smokers being treated for periodontal disease respond more favorably to a combined treatment of scaling and root planing ("SRP"), together with Arestin�, than to SRP alone. Arestin�, OraPharma�s initial product, is a locally delivered antibiotic (Minocycline Microspheres), which is administered to patients with periodontitis. The studies were presented at a symposium sponsored by OraPharma, The Treatment Paradigm for Periodontal Disease in the New Millennium, held during the International Academy of Periodontology Annual Meeting and The New Zealand Society of Periodontology 50th Anniversary Meeting in Auckland.

The study, "Are Cardiac Patients More Likely to Have Periodontitis?", presented by Jan Lessem, M.D., Ph.D., FACC, Chief Medical Officer, Vice President Clinical Research, OraPharma, Inc. retrospectively examined the prevalence and severity of periodontal disease among 78 heart transplant patients and suggests there is a possible relationship between periodontitis and heart disease leading to transplantation. The study explores how infections and inflammations in the mouth could be an additional risk factor for the development of ischemic heart disease. The results infer that secondary infections such as periodontal disease may be a trigger factor for such diseases and therefore could play a much more significant role in overall health.

"The association between periodontal disease and such conditions as heart disease, stroke and diabetes has long been suspected, and was a topic addressed in The Surgeon General�s Report on Oral Health Care in 2000" Dr. Lessem said. "This new retrospective case study further explores the issue of periodontal disease among cardiac transplant patients and presents data indicating that a relationship between the two conditions may exist. This study, which was funded by OraPharma, was completed at two centers in the United States; The University of Louisville and The University of Washington, as well as two centers in the United Kingdom; Parkside National Service and Papworth Hospital".

Also, the "Effects of Locally Delivered Minocycline Microspheres in Patients with Periodontitis Who are Smokers," was presented by Thomas Van Dyke, DDS, Ph.D., Director of Clinical Research, Boston University, and explored smokers and treatment of periodontal disease using SRP, together with Arestin�, versus SRP alone. Smokers with periodontitis are likely to have a more acute case of the disease as well as a complicated course of healing. This study examined the efficacy of Arestin�, when used in conjunction with SRP, to treat periodontal disease among this particular population. The findings demonstrate that, among the smoking population, SRP together with Arestin�, provides a much more effective method of treatment than SRP alone.

"These data clearly illustrate that an extremely effective way to treat smokers with periodontitis is a combination of Arestin� plus SRP. Treatment of infected pockets with the locally administered antibiotic, Arestin�, has been shown to be extremely beneficial to these patients," said Dr. Van Dyke.

This study, which was also funded by OraPharma, was conducted at twenty-two dental schools and one private periodontal practice in connection with the Company�s Phase 3 studies on Arestin�.

Both studies will be submitted for publication in the near-term.