CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI)announced today that a Marketing Authorization Application (MAA) forOracea(TM), has been filed with the United Kingdom's Medicines &Healthcare Products Regulatory Agency (MHRA). The UK will act asreference member state in this decentralized procedure. The MAA forOracea was submitted to the MHRA on February 24, 2006. A New DrugApplication for Oracea was filed with the U.S. Food and DrugAdministration in August 2005 and has been given a PDUFA date of May31, 2006. If approved, Oracea will be the first orally administered,systemically delivered drug developed to treat rosacea.
The MAA was based primarily upon the safety and efficacy resultsof two Phase 3, double-blinded, placebo-controlled clinical trials forOracea(R). These studies enrolled a total of 537 patients in 28centers across the U.S. In the two studies, patients receiving Oraceaexperienced a 61% and 46% mean reduction in inflammatory lesionscompared to 29% and 20%, 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 weresimilar to placebo.
"This is an important step towards maximizing the worldwideopportunity for Oracea," said Colin Stewart, president and chiefexecutive officer of CollaGenex. "If approved by the MHRA, we intendto seek registration for Oracea in other countries of the EuropeanUnion."
Approximately 25 million adults in the EU suffer from rosacea.Rosacea affects primarily the face and is characterized by theappearance of inflammatory lesions (papules, pustules and nodules),erythema (skin redness) and telangiectasia (spider veins). If allowedto progress to a moderate to severe condition, rosacea can causeitching, pain and thickening of the skin.
CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceuticalcompany currently focused on developing and marketing proprietary,innovative medical therapies to the dermatology market. CollaGenex'sprofessional dermatology sales force markets Pandel(R), a prescriptiontopical corticosteroid licensed from Altana, Inc., Alcortin(TM) (1%iodoquinol and 2% hydrocortisone), a prescription topical antifungalsteroid combination, and Novacort(TM) (2% hydrocortisone acetate and1% pramoxine HCl), a prescription topical steroid and anesthetic.Alcortin and Novacort are marketed by the Company under a Promotionand Cooperation agreement with Primus Pharmaceuticals, Inc. Inaddition, CollaGenex has filed an NDA for Oracea(TM), the firstsystemic compound for the treatment of rosacea, which is currentlyunder evaluation by the FDA, and is conducting a 300-patient, Phase IIdose-finding study to evaluate its second dermatology candidate,incyclinide, for the treatment of acne. CollaGenex also currentlysells Periostat(R), which the Company developed as the firstpharmaceutical to treat periodontal disease by inhibiting the enzymesthat destroy periodontal support tissues and by enhancing bone proteinsynthesis, and Atridox(R), Atrisorb FreeFlow(R) and Atrisorb-DFreeFlow(R), which are products of QLT Inc., the successor to AtrixLaboratories, Inc., for the treatment of adult periodontitis.
Research has shown that certain tetracyclines can be chemicallymodified to retain non-antibiotic properties that may make themeffective in treating diseases involving inflammation and/ordestruction of the body's connective tissues. CollaGenex is evaluatingvarious chemically modified tetracyclines (so called "IMPACS"compounds because they are Inhibitors of Multiple Proteases AndCytokineS") to assess whether they are safe and effective in theseapplications. The Company has a pipeline of innovative productcandidates with possible applications in dermatology and other diseasestates. In addition, CollaGenex has acquired the Restoraderm(R)technology, a unique, proprietary dermal drug delivery system, andplans to develop a range of topical dermatological products withenhanced pharmacologic and cosmetic properties.
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Statements in this press release, including statements regardingfuture revenues, gross profits, margins, operating expenses and anyother statements about management's expectations, beliefs, goals,plans or prospects, may constitute forward-looking statements withinthe meaning of the Private Securities Litigation Reform Act of 1995.CollaGenex' actual results could differ materially from those statedor implied in forward-looking statements due to a number of factors,including those factors contained in CollaGenex' most recent AnnualReport on Form 10-K for the year ended December 31, 2004 and the mostrecent Form 10-Q for the Quarter ended September 30, 2005 under thesections "Additional Factors That May Affect Future Results" and"Additional Risks That May Affect Results" as well as other documentsthat may be filed by CollaGenex from time to time with the Securitiesand Exchange Commission. Forward-looking statements include statementsregarding CollaGenex' expectations, beliefs, intentions or strategiesregarding the future and can be identified by forward-looking wordssuch as "anticipate", "believe", "could", "estimate", "expect","intend", "may", "should", "will", and "would" or similar words.CollaGenex assumes no obligations to update the information includedin 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 andOracea(TM) is a trademark of CollaGenex Pharmaceuticals, Inc.
All other trade names, trademarks or service marks are theproperty of their respective owners and are not the property ofCollaGenex Pharmaceuticals, Inc. or any of our subsidiaries.
Novacort(TM) and Alcortin(TM) are trademarks of PrimusPharmaceuticals, Inc.
Pandel(R) is a trademark of Taisho Pharmaceuticals.
Atridox(R), Atrisorb(R) and Atrisorb-D(R) are registeredtrademarks of QLT USA, Inc.