CollaGenex Pharmaceuticals Inc., a four-year-old company that wentpublic three months ago, has filed its first new drug application withthe FDA for Periostat, a product to treat periodontitis.
Brian Gallagher, president and CEO of CollaGenex, said the Newton,Pa., company will sell the drug itself in the U.S. if Periostat isapproved.
Collagenex has a marketing deal for Italy with Boehringer MannheimItalia SpA, which also will manufacture the drug for sales throughoutEurope when cleared there. The Italian pharmaceutical firm is asubsidiary of Boehringer Mannheim GmbH, of Mannheim, Germany,which is part of Corange Ltd., of Hamilton, Bermuda.
CollaGenex conducted three Phase III studies of Periostat. In eachclinical trial the drug demonstrated statistical significance in reducingand reversing periodontitis, a disease in which gums becomedetached from teeth.
Periostat contains doxycycline, an active ingredient in FDA-approvedantibiotics, used at a dosage level below that required for fightingmicrobial infections. Doxycycline is among the class of tetracyclineantibiotics.
In low doses, doxycycline does not stimulate anti-microbial action,but the molecule does inhibit production of collagenase, an enzymethat breaks down connective tissue, allowing gums to recede fromteeth.
Gallagher said Periostat would be used by dentists in combinationwith their traditional mechanical methods of cleaning away bacteria,which cause inflammation of the gums, resulting in release ofcollagenase.
Current treatments for periodontitis involve scaling and planing toremove bacteria from teeth below the gum line and surgery to removedetached tissue.
While some companies are focused on methods of deliveringantibiotics to attack the bacteria around teeth, CollaGenex developedPeriostat as a means of inhibiting the cause of the tissue breakdown.
Gallagher added that by using doxycycline in sub-antibiotic doses, itcan be administered over long periods of time without fear ofgenerating bacterial resistance to the drug.
CollaGenex, founded in 1992, changed its name to CollaGenexPharmaceuticals just prior to its initial public offering (IPO), whichwas completed in June 1996.
The company's stock (NASDAQ:CGPI) closed Wednesday up 50cents to $10.25, which is 2.5 percent higher than the $10 price of theIPO. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.