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EdF

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Tuesday, 12/21/2004 12:28:22 PM

Tuesday, December 21, 2004 12:28:22 PM

Post# of 124
CGPI 6.99/7.05 Second quarter 2005
(BSNS WIRE) CollaGenex Pharmaceuticals Announces Completion of Patient Enrollment for Phase II Clinical Studies of Oracea for the Treatment of Rosacea

Pharmaceutical Writers / Business Editors / Healthcare Writers

NEWTOWN, Pa.--(BUSINESS WIRE)--Dec. 21, 2004--


Company is On Track to Complete Study in the Second Quarter of 2005

CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI) today announced
that it has completed patient screening and enrollment of 528 patients
for its two multi-center, double-blinded, placebo-controlled Phase III
clinical studies to evaluate the efficacy of Oracea(TM) for the
treatment of rosacea. CollaGenex anticipates the study to be completed
in the second quarter of 2005.
The study design provides for sixteen weeks of dosing with either
Oracea or placebo and will evaluate the clinical indices of rosacea,
including reductions in inflammatory lesions, erythema and the
Clinician's Global Severity Assessment Score (CGSAS). The two Phase
III studies are being conducted at a total of 28 investigational
centers across the United States.
Colin W. Stewart, president and chief executive officer of
CollaGenex, commented, "We are very pleased that we were able to
complete enrollment for these two Phase III clinical trials for Oracea
ahead of schedule and are on track to complete the study in the second
quarter of 2005. Based on the other clinical studies we've done with
the same active ingredient in rosacea patients, we anticipate
achieving favorable results from these trials in the second quarter of
2005 and remain on track to file an NDA for Oracea in the middle of
2005.
The completion of patient screening and enrollment is an
essential milestone in our plan to become a leading dermatology
company."

Oracea: An IMPACs Compound

Oracea is a once daily, modified-release formulation of
doxycycline, 40 mg, for the treatment of rosacea. Oracea is part of
the IMPACS (Inhibitors of Multiple Proteases And CytokineS) family of
compounds developed by CollaGenex. These compounds have the potential
for multiple therapeutic uses, primarily in the treatment of diseases
that cause inflammation and destruction of the connective tissues.

The Rosacea Market

Rosacea is an increasingly common diagnosis affecting more than 14
million people in the United States. The disease is characterized by
inflammatory lesions and the appearance of erythema, a persistent
redness of the skin, which usually affects the nose, cheeks and
forehead. As rosacea becomes more severe, it is characterized by
stinging, burning and/or telangiectasia, which are tiny spider veins
on the nose and cheeks.

About CollaGenex

CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical
company focused on providing innovative medical therapies to the
dental and dermatology markets. Currently, the company's professional
dental pharmaceutical sales force markets Periostat(R), which is
indicated as an adjunct to scaling and root planing for the treatment
of adult periodontitis. Periostat is the first and only pharmaceutical
to treat periodontal disease by inhibiting the enzymes that destroy
periodontal support tissues, and by enhancing bone protein synthesis.
The dental sales force also promotes Atridox(R), Atrisorb FreeFlow(R)
and Atrisorb-D FreeFlow(R), Atrix Laboratories, Inc.'s products for
the treatment of adult periodontitis, to the dental market. The
Company's professional dermatology sales force markets Pandel(R), a
prescription topical corticosteroid licensed from Altana, Inc.
Research has shown that certain unique properties of the
tetracyclines discovered during the development of Periostat may be
applicable to other diseases involving inflammation and/or destruction
of the body's connective tissues. CollaGenex is further evaluating
Periostat and other IMPACS(R) compounds, including Oracea(TM), to
assess whether they are safe and effective in these other
applications. Oracea is currently in Phase III clinical trials to
evaluate its effectiveness in treating rosacea, a dermatological
condition, and Col-3 is in clinical trials to evaluate its potential
effectiveness in treating acne and Kaposi's sarcoma, an HIV-related
skin condition. In addition, CollaGenex has licensed the
Restoraderm(R) technology, a unique, proprietary dermal drug delivery
system, in order to develop a range of topical dermatological products
with enhanced pharmacologic and cosmetic properties.
To receive additional information on the Company, please visit our
Web site at www.collagenex.com, which does not form part of this press
release.


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