NEWTOWN, Pa.--(BUSINESS WIRE)--Feb. 17, 2004--
Detailed study results to be presented at the Skin Disease
Education Foundation's Phoenix Dermatology Open Seminar on March 21,
2004
CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI) today announced the
positive outcome of a Phase 3 double-blinded, placebo-controlled
clinical study designed to evaluate the safety and efficacy of
Periostat(R) (doxycycline hyclate tablets, 20 mg BID), for the
treatment of rosacea. The study enrolled 134 patients and is the
largest clinical trial ever conducted to evaluate a systemic therapy
for rosacea.
Preliminary data analysis indicates that patients treated with
Periostat showed a continuous improvement during the 16-week course of
the study compared to patients on placebo. In the study, patients on
Periostat had a significantly greater reduction in the number of
inflammatory lesions (papules and pustules) compared to patients on
placebo. This improvement was both clinically and statistically highly
significant (P = 0.009).
Overall clinical disease severity based on the Clinician's Global
Severity Assessment Scale declined significantly in the group of
patients treated with Periostat compared to placebo, with a greater
number of patients on Periostat showing a complete clearing of the
disease at 16 weeks compared to those patients on placebo (P = 0.014).
The erythema in patients in the Periostat group showed a trend towards
greater improvement compared to patients in the placebo group (P =
0.08).
Colin Stewart, president and chief executive officer of
CollaGenex, stated, "The results from this clinical study confirm that
Periostat offers significant benefits for rosacea patients. There are
currently no FDA-approved systemic therapies for this disease. As part
of our plan to extend the indications for Periostat, we will meet with
FDA to review all of the data supporting the approvability of
Periostat for the treatment of rosacea and determine the appropriate
regulatory path."
The detailed results of the study will be presented by Diane M.
Thiboutot, M.D., Professor of Dermatology, Pennsylvania State College
of Medicine and a principal investigator in the study, at the Skin
Disease Education Foundation's Phoenix Dermatology Open Seminar on
March 21, 2004.
"The results of this study show that a non-antimicrobial dose of
doxycycline clearly produces improvement in rosacea," noted James
Leyden, M.D., Professor Emeritus, University of Pennsylvania, and an
investigator in the study. "These results complement the recently
published similar findings in acne and demonstrate that this very low
dose has anti-inflammatory effects. Sub-antimicrobial dose doxycycline
has the additional benefit of not disturbing the microbial ecology of
the body. Antibiotic resistance is not an issue with this dosage." Dr.
Leyden is a consultant for CollaGenex but has no equity position in
the Company.
Rosacea is an increasingly common diagnosis affecting more than 14
million people in the United States. The disease is characterized by
the appearance of erythema, a persistent redness of the skin, and
inflammatory lesions that usually affect the nose, cheeks and
forehead. As rosacea becomes more severe, itching and pain can occur.
The prescription rosacea category is one of the fastest growing
segments of the dermatology market and is estimated to be $500 million
annually.
CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical
company focused on providing innovative medical therapies to the
dental and dermatology markets. Currently, the Company's 115-person
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 sales force also promotes Atridox(R),
Atrisorb(R) FreeFlow(TM) and Atrisorb-D FreeFlow, Atrix Laboratories
Inc.'s products for the treatment of adult periodontitis, to the
dental market and Pandel(R), a prescription topical corticosteriod
licensed form Altana, Inc., to the dermatology market.
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, including acne, rosacea,
meibomianitis and cancer metastasis, among others. CollaGenex is
further evaluating Periostat, as well as the new IMPACS(R) compounds,
to assess whether they are safe and effective in these applications.
In addition, CollaGenex has licensed the Restoraderm(TM) 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.
This press release contains 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. The Company's business of selling, marketing
and developing pharmaceutical products is subject to a number of
significant risks, including risks relating to the implementation of
the Company's sales and marketing plans for Periostat(R) and other
products that the Company markets, the outcome and consequences of the
patent litigation against Mutual and the outcome of litigation
initiated by Mutual, risks that the FDA will approve generic products,
such as Mutual's products, that will compete with and limit the market
for Periostat, risks inherent in research and development activities,
risks associated with conducting business in a highly regulated
environment and uncertainty relating to clinical trials of products
under development, all as discussed in the Company's periodic filings
with the U.S. Securities and Exchange Commission.
Periostat(R), IMPACS(R) and Metastat(R) are registered trademarks,
and Restoraderm(TM) is a trademark, of CollaGenex Pharmaceuticals,
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.
Pandel(R) is a trademark of Taisho Pharmaceuticals.
Atridox(R), Atrisorb(R) and Atrisorb-D(R) are trademarks of Atrix
Laboratories, Inc.
CONTACT:
CollaGenex Pharmaceuticals, Inc.
Nancy C. Broadbent, 215-579-7388
or
In-Site Communications
Lisa Wilson, 212-759-3929
SOURCE: CollaGenex Pharmaceuticals, Inc.
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