News: CollaGenex Pharmaceuticals Announces Results of Phase 4 …

CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI) today announced
results of a Phase 4 dose-comparison study designed to evaluate the
safety and efficacy of Oracea(R) once daily versus doxycycline 100 mg
once daily for the treatment of rosacea. A presentation of the results
was made yesterday by James Q. Del Rosso, D.O., Clinical Assistant
Professor, Department of Dermatology at the University of Nevada,
School of Medicine, at the 7th Annual Caribbean Dermatology Symposium.

Oracea is a patented, delayed release formulation of doxycycline,
40 mg, that is the only FDA-approved treatment for the papules and
pustules associated with rosacea. Doxycycline at much higher doses is
often prescribed off-label by dermatologists for the treatment of
rosacea. The study demonstrated that the higher, antimicrobial dose
does not provide a greater clinical benefit than the anti-inflammatory
dose of 40 mg, controlled release. However, the higher dose was
associated with a significantly higher incidence of adverse events.

This prospectively randomized, double-blinded, placebo-controlled
clinical study enrolled 91 patients at 7 investigational centers
across the United States. The study had two arms, and patients were
treated once daily with either 100 mg of doxycycline or Oracea (40 mg
doxycycline, controlled release). Both treatments were administered as
an adjunct to topical MetroGel(R) 1%. The treatment duration was 16
weeks, and patients were evaluated for efficacy and adverse events at
baseline and at weeks 4, 8, 12 and 16.

The primary endpoint was mean change in total inflammatory lesion
count from baseline to the week 16 visit. Patients in the Oracea group
had an average of 19.8 inflammatory lesions at baseline and
experienced a decrease in lesion count of 12.5 lesions, compared with
17.7 lesions at baseline and a decrease of 12.2 lesions in the
doxycycline, 100 mg group. The difference between the treatment groups
is neither clinically nor statistically significant (p-value = 0.83).
In addition, there were no differences observed between the treatment
groups regarding the secondary endpoints of Investigators Global
Assessment and Clinician’s Erythema Assessment with (p-values of 0.86
and 0.50, respectively).

In contrast, a clear difference was observed between the two
treatment groups in the incidence of adverse events, primarily
gastrointestinal reactions. Gastrointestinal adverse events, including
nausea, vomiting, diarrhea and stomach discomfort, were observed in
26% of patients administered 100 mg of doxycycline versus only 5% in
the Oracea group.

Klaus Theobald, M.D., Ph.D., chief medical officer of CollaGenex,
said, “We are extremely pleased with the outcome of our Phase 4 study.
The study clearly demonstrates that increasing the dose of doxycycline
above the anti-inflammatory levels provided by Oracea does not provide
any additional benefit but significantly adds to the adverse event
profile.”

“These data are clinically important as clinicians strive to
provide the most effective treatment while reducing the potential for
side effects,” said James Q. Del Rosso, D.O., the lead principal
investigator of the study. “This study has demonstrated that, in
patients with rosacea, increasing the daily dose of doxycycline to 100
mg does not lead to greater efficacy than Oracea, but has a much
greater incidence of gastrointestinal side effects. In addition,
Oracea’s onset of action was not different from the 100 mg doxycycline
dose.”

Colin Stewart, president and chief executive officer of
CollaGenex, stated, “The results of this trial provide sound clinical
evidence that Oracea provides maximum benefit with minimal adverse
events. These data will help clarify the inflammatory nature of
rosacea and the need for the anti-inflammatory dose of doxycycline
that Oracea provides.”

About CollaGenex

CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical
company currently focused on developing and marketing proprietary,
innovative medical therapies to the dermatology market. In July 2006,
CollaGenex launched Oracea(R), the first FDA-approved systemic product
for the treatment of rosacea. CollaGenex’s professional dermatology
sales force also markets Alcortin(R) (1% iodoquinol and 2%
hydrocortisone), a prescription topical antifungal steroid
combination, and Novacort(R) (2% hydrocortisone acetate and 1%
pramoxine HCl), a prescription topical steroid and anesthetic.
Alcortin and Novacort are marketed by the Company under a Promotion
and Cooperation agreement with Primus Pharmaceuticals, Inc. CollaGenex
recently completed a Phase II clinical trial to evaluate COL-118, a
topical compound based on the SansRosa(R) technology, for the
treatment of redness associated with rosacea and other skin disorders.
CollaGenex recently acquired the rights to develop and commercialize
becocalcidiol, a patented Vitamin D analogue developed by QuatRx
Pharmaceuticals Company that is currently in Phase II clinical trials
for the topical treatment of mild to moderate psoriasis.

Research has shown that compounds can be created by chemically
modifying certain tetracyclines and that these new compounds have
properties that may make them effective in treating diseases involving
inflammation and/or destruction of the body’s connective tissues.
CollaGenex is evaluating various chemically modified tetracyclines (so
called “IMPACS”(TM) compounds because they are Inhibitors of Multiple
Proteases And CytokineS) to assess whether they are safe and effective
in these applications. The Company has a pipeline of innovative
product candidates with possible applications in dermatology and other
disease states. In addition, CollaGenex has acquired the SansRosa(R)
technology, which consists of a class of compounds that have shown
promise in reducing the redness associated with rosacea, and the
Restoraderm(R) technology, a unique, proprietary dermal drug delivery
system. CollaGenex plans to leverage these platforms to develop a
range of topical dermatological products with enhanced pharmacologic
and cosmetic properties.

To receive additional information on the Company, please visit our
Website at www.collagenex.com, which does not form part of this press
release.

Forward Looking Statements

Statements in this press release regarding management’s future
expectations, beliefs, intentions, goals, strategies, plans or
prospects, including statements relating to the Company’s revenue,
cost of goods sold, net loss and expenses and future cash position,
including the remainder of fiscal year 2007, and its future research
and development efforts, including the Company’s clinical and
development programs relating to becocalcidiol, incyclinide and
COL-118 and its dermatology franchise, product pipeline and
intellectual, property, may constitute forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements can be identified by terminology such
as “anticipate,” “believe,” “could,” “could increase the likelihood,”
“estimate,” “expect,” “intend,” “is planned,” “may,” “should,” “will,”
“will enable,” “would be expected,” “look forward,” “may provide,”
“would” or similar terms, variations of such terms or the negative of
those terms. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors including those risks,
uncertainties and factors referred to in the Company’s Quarterly
Report on Form 10-Q for the quarter ended June 30, 2007 filed with the
Securities and Exchange Commission under the section “Risk Factors,”
as well as other documents that may be filed by CollaGenex from time
to time with the Securities and Exchange Commission. As a result of
such risks, uncertainties and factors, the Company’s actual results
may differ materially from any future results, performance or
achievements discussed in or implied by the forward-looking statements
contained herein. CollaGenex is providing the information in this
press release as of this date and assumes no obligations to update the
information included in this press release or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.

Restoraderm(R), SansRosa(R) and Oracea(R) are registered
trademarks and IMPACS(TM) is a trademark of CollaGenex
Pharmaceuticals, Inc.

Novacort(R) and Alcortin(R) are trademarks of Primus
Pharmaceuticals, Inc.

Pandel(R) is a trademark of Taisho Pharmaceuticals.

Atridox(R), Atrisorb(R) and Atrisorb-D(R) are registered
trademarks of Tolmar, Inc.

All other trade names, trademarks or service marks are the
property of their respective owners and are not the property of
CollaGenex Pharmaceuticals, Inc. or any of our subsidiaries.