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VIPONT's Rx TIMED-RELEASE ANTIMICROBIAL FOR PERIODONTAL DISORDERS

Executive Summary

VIPONT's Rx TIMED-RELEASE ANTIMICROBIAL FOR PERIODONTAL DISORDERS is being developed by Vipont's new subsidiary, Vipont Research Labs. The active ingredient in the new product is sanguinarine, a bloodroot derivative used in a lower concentration in Vipont Labs' OTC tooth gel and mouthrinse, Viadent. In a Dec. 11 release, Vipont President Lawrence Frederick explained that sanguinarine, contained in a polymer-like material, is inserted into a patient's "periodontal pocket" where it slowly dissolves. The company said the new treatment will be effective for up to two weeks and could be used every six months or more as needed, "in the same manner as current fluoride treatments for cavity protection." The new product, Vipont's first prescription drug product, will be administered by dental professionals only. Vipont Research Labs is being funded with $8-9 mil. from investors Periodontal Associates II, a research and development partnership that will hold a minority interest in the business, Vipont stated. Vipont Research president will be George Southard, who has headed Vipont Labs' research department since 1982. The subsidiary's board of directors will include former FDA Commissioner Jere Goyan and Bruce Merrifield, who was awarded the 1984 Nobel Prize for chemistry. Vipont Research will also have its own scientific advisory board. The Fort Collins, Colorado-based Vipont is studying use of the prescription antimicrobial for three stages of periodontal disease progression. "We know that sanguinarine can kill bacteria which cause plaque formation in the earliest stage and has a suppressant effect on the inflammation associated with gingivitis in the second stage," Vipont stated. In addition, the company said, preliminary studies indicate the compound "may also block the loss of bone in the final stage." The firm said it expects approval of the product in international markets in two-and-a-half years and in the U.S. in three years. An NDA has not yet been submitted to FDA. Vipont noted that it has received six patients on sanguinarine for various oral hygiene applications.
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