NEWTOWN, Pa., March 16 /PRNewswire/ -- CollaGenex Pharmaceuticals, Inc.
(Nasdaq: CGPI), announced today that it has reached an agreement with the
U.S. Food and Drug Administration (FDA) with respect to the continuing review
of the Company's new drug application (NDA) for Periostat(R), the Company's
lead drug for the treatment of periodontal disease.
At a recent meeting with the FDA, the Company addressed certain issues
previously raised by the FDA and provided a review of summary clinical results
from the Company's recently completed phase III clinical trial evaluating the
efficacy of Periostat in combination with scaling and root planing (SRP). The
FDA and the Company then agreed that CollaGenex would seek a revised claim
based on the submission of an NDA amendment containing the results from the
completed SRP trial.
SRP is a procedure performed by periodontists and dental professionals
which involves the mechanical removal of bacterial deposits below the gum
line. SRP is the most prevalent therapy for periodontal disease, and more
than 15 million SRP procedures are performed annually in the U.S.
The FDA advised CollaGenex that it would review the NDA amendment within
six months of submission. The Company expects to submit the amendment within
the next few weeks.
"We appreciate the FDA's willingness to work with us and we're very
pleased with the outcome of our meeting," said Brian M. Gallagher, Ph.D.,
President and Chief Executive Officer. "We now have a well-defined and
mutually agreed action plan and time line for the expected completion of their
review of Periostat."
Dr. Gallagher continued, "As we announced in January, the results from our
SRP trial clearly demonstrated that Periostat significantly enhances the
efficacy of SRP, with up to 50% improvements in clinical attachment level gain
and pocket depth reduction compared to SRP alone. These data support the
important role of Periostat in the professional management of periodontal
disease."
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
nephropathy.
Additional information on CollaGenex is available on the Company website
at http://www.collagenex.com.
This news release contains certain forward-looking statements within the
meaning of Section 21E of the Securities and Exchange Act of 1934, as amended.
Investors are cautioned that forward-looking statements involve risks and
uncertainties which may affect the Company's business and prospects, including
without limitation the requirement for regulatory approval of products by the
FDA, the uncertainty in obtaining such approval and uncertainties relating to
clinical trials, all as discussed in the Company's periodic filings with the
U.S. Securities and Exchange Commission.
SOURCE CollaGenex Pharmaceuticals, Inc.
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Related links:
http://www.collagenex.com
CONTACT:
Brian M. Gallagher, President and Chief
Executive Officer of CollaGenex Pharmaceuticals, 215-579-7388; or
for General Info, Jerry Meyer, 212-661-8030, or Analyst Info,
Brian Gill, 212-661-8030, or Media Info, Gil Faggen,
212-661-8030, all of The Financial Relations Board
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