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FDA Accepts Filing of NDA for Collagenex Pharmaceuticals' Lead Product

NEWTOWN, Pa., Nov. 25 /PRNewswire/ -- CollaGenex Pharmaceuticals, Inc. (Nasdaq: CGPI) today announced that the U.S. Food and Drug Administration has accepted the filing of the Company's new drug application (NDA) for its lead product, Periostatr. The FDA has informed CollaGenex that it will undertake a substantive review of Periostat. Such a review is the next step in the process by which drugs are approved for prescription sales in the U.S.

Periostat is the first orally administered, systemically delivered drug indicated for the treatment of periodontitis, a leading cause of tooth loss. CollaGenex's NDA included clinically and statistically significant results from three Phase III clinical trials which demonstrated that Periostat can reduce and reverse the progression of adult periodontitis.

"The FDA's acceptance of our first NDA is an important milestone for our company," said Brian M. Gallagher, Ph.D., President and Chief Executive Officer of CollaGenex Pharmaceuticals. "This is an important step in achieving our goal of making CollaGenex a leader in the development and marketing of medical therapies to enhance professional dental practice."

CollaGenex Pharmaceuticals is engaged in the development and commercialization of innovative proprietary medical therapies for the treatment of periodontal disease and other dental pathologies. The Company's core technology involves inhibiting the activity of certain enzymes that destroy the connective tissues of the body. In addition to periodontal disease, the Company and its collaborators are developing other potential applications of the core technology to treat cancer metastasis, wound healing, osteoarthritis, osteoporosis, rheumatoid arthritis and diabetic complications.

To receive additional information on CollaGenex, via fax, at no charge, dial 1-800-PRO-INFO and enter code CGPI.

SOURCE CollaGenex Pharmaceuticals, Inc.
 -0- 11/25/96

/CONTACT: Brian M. Gallagher, Ph.D., President & CEO of CollaGenex Pharmaceuticals, 215-579-7388; or Jerry Meyer, for general information or Brian Gill, for analyst information, or Gil Faggen, for media information, 212-661-8030, all of The Financial Relations Board/


CO: CollaGenex Pharmaceuticals, Inc.; U.S. Food and Drug Administration ST: Pennsylvania IN: MTC SU: PDT

MW -- NYM011 -- 3482 11/25/96 08:30 EST
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Publication:PR Newswire
Date:Nov 25, 1996
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