NEWTOWN, Pa., Sept. 2 /PRNewswire/ -- CollaGenex Pharmaceuticals, Inc.
(Nasdaq: CGPI) announced today that it had received its first action letter
from the U.S. Food and Drug Administration (FDA) regarding its new drug
application (NDA) for Periostat, the Company's drug for the treatment of
periodontal disease.  In its letter and in a subsequent discussion with the
Company,  the FDA indicated that additional information is needed to obtain
marketing clearance, primarily clarification relating to the statistical
methodology used in the NDA.  The FDA has agreed to meet with the Company in
the near future to discuss the outstanding issues.
    Brian M. Gallagher, Ph.D., President and Chief Executive Officer, said,
"Based on previous experiences with the drug approval process, I am not
surprised by the FDA's request for further information at this stage of its
review.  We have already initiated discussions with the FDA to clarify the
remaining issues and are pleased with the FDA's willingness to work with us to
resolve them in a timely manner."
    CollaGenex is an emerging pharmaceutical company which is developing and
commercializing innovative proprietary medical therapies for the treatment of
periodontal disease and other 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 researching and developing other potential
applications of the core technology, including cancer metastasis, wound
healing, osteoarthritis, osteoporosis, rheumatoid arthritis and diabetic
complications.
    To receive additional information on CollaGenex Pharmaceuticals, Inc., via
fax, at no charge, dial 1-800-PRO-INFO and enter code CGPI, or visit the
Company's website at http://www.collagenex.com

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