NEWTOWN, Pa.--(BUSINESS WIRE)--May 30, 2006--CollaGenex
Pharmaceuticals, Inc. (NASDAQ:CGPI) today announced that the U.S. Food
& Drug Administration (FDA) has approved Oracea(TM) for the treatment
of inflammatory lesions (papules and pustules) of rosacea in adult
patients. Oracea is the first FDA-approved, orally-administered,
systemically-delivered drug to treat rosacea, a dermatologic condition
that affects an estimated 14 million adults in the U.S. CollaGenex
plans to launch Oracea to the dermatology community in July 2006.
Klaus Theobald, M.D., Ph.D., chief medical officer of CollaGenex,
said, "Rosacea is a chronic inflammatory skin condition affecting the
facial appearance of millions of people. Our New Drug Application for
Oracea included highly significant results from two pivotal Phase III
clinical trials that demonstrated the efficacy and safety of this
anti-inflammatory drug in the treatment of the inflammatory lesions of
rosacea in adult patients. Oracea provides dermatologists and
rosacea-sufferers a safe and effective treatment with the convenience
of once-a-day oral administration."
Colin Stewart, president and chief executive officer, stated,
"Oracea is the first of a series of dermatology products we have in
development, and we are very pleased that our NDA was approved by the
FDA within 10 months of submission. Sufficient quantities of Oracea
capsules have been manufactured for launch and can now be packaged for
distribution to the trade in July. Over the past six months, we have
built a first-rate specialty sales force to launch Oracea, and all of
our representatives were fully trained and in their territories by the
end of April. This is an extremely exciting time for CollaGenex, and
we look forward to providing dermatologists and their patients with
this exciting new therapy to treat rosacea."
About Rosacea
Rosacea is a dermatologic condition that affects approximately 14
million adults in the U.S. It affects primarily the face and is
characterized by the appearance of inflammatory lesions (papules and
pustules), erythema (skin redness) and telangiectasia (spider veins).
If allowed to progress to a moderate to severe condition, rosacea can
cause itching, pain and thickening of the skin. The current U.S.
market size for rosacea is estimated to be approximately $500 million.
About Oracea
Oracea is a 40 mg, unique capsule formulation of doxycycline, USP,
dosed once-a-day and containing a combination of immediate and delayed
release beads. The NDA approval was based primarily upon the safety
and efficacy results of two Phase III, double-blinded,
placebo-controlled clinical trials. These studies enrolled a total of
537 patients in 28 centers across the U.S. In the two studies,
patients receiving Oracea experienced a 61% and 46% mean reduction in
inflammatory lesions compared to 29% and 20% mean reduction,
respectively, in patients receiving placebo. The differences were
clinically and statistically highly significant (p less than 0.001 in
each study). Side effects of the drug were similar to placebo.
About CollaGenex
CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical
company currently focused on developing and marketing proprietary,
innovative medical therapies to the dermatology market. CollaGenex's
professional dermatology sales force markets Pandel(R), a prescription
topical corticosteroid licensed from Altana, Inc., Alcortin(TM) (1%
iodoquinol and 2% hydrocortisone), a prescription topical antifungal
steroid combination, and Novacort(TM) (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
is preparing to launch Oracea, the first FDA-approved systemic product
for the treatment of rosacea, and is conducting a 300-patient, Phase
II dose-finding study to evaluate its second dermatology candidate,
incyclinide, for the treatment of acne. CollaGenex is also developing
COL-118, utilizing the technology acquired in the SansRosa
acquisition, as a preclinical topical compound for the treatment of
redness associated with rosacea and other skin disorders.
CollaGenex also currently sells Periostat(R), which the Company
developed as the first pharmaceutical to treat periodontal disease by
inhibiting the enzymes that destroy periodontal support tissues and by
enhancing bone protein synthesis, and Atridox(R), Atrisorb FreeFlow(R)
and Atrisorb-D FreeFlow(R), which are products of QLT Inc., the
successor to Atrix Laboratories, Inc., for the treatment of adult
periodontitis.
Research has shown that certain tetracyclines can be chemically
modified to remove their antibiotic effects while retaining the
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" 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 Restoraderm(R) technology, a unique, proprietary dermal
drug delivery system, and plans 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.
Statements in this press release regarding management's future
expectations, beliefs, intentions, goals, strategies, plans or
prospects, including statements relating to the Company's plans,
timing and success related to the launch of Oracea for the treatment
of inflammatory lesions of rosacea, may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. CollaGenex' actual results could differ materially
from those stated or implied in forward-looking statements due to a
number of factors, including those factors contained in the most
recent Form 10-Q for the quarter ended March 31, 2006 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. Forward-looking statements include statements regarding
CollaGenex' expectations, beliefs, intentions or strategies regarding
the future and can be identified by forward-looking words such as
"anticipate", "believe", "could", "estimate", "expect", "intend",
"may", "should", "will", and "would" or similar words. CollaGenex
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.
Periostat(R) and Restoraderm(R) are registered trademarks and
IMPACS(TM), and Oracea(TM) are trademarks 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.
Novacort(TM) and Alcortin(TM) 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 QLT USA, Inc.
CONTACT: CollaGenex Pharmaceuticals, Inc.
Nancy C. Broadbent, 215-579-7388
or
Financial Dynamics
Investor Relations:
Evan Smith, CFA / Erica Pettit
212-850-5606 / 212-850-5614
or
Media Contact:
Robert Stanislaro, 212-850-5657
SOURCE: CollaGenex Pharmaceuticals, Inc.
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