21.03.2006 12:30:00
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CollaGenex Pharmaceuticals Reports Notice of Allowance for European Patent Covering Oracea(TM)
Colin W. Stewart, president and chief executive officer ofCollaGenex, stated, "This notice of allowance by the European PatentOffice is another important milestone as we seek to maximize the valueof Oracea both in the United States and abroad. As we engage indiscussions with potential European partners for rights to marketOracea in Europe, we are working to enhance the value of this asset byseeking intellectual property protections and pursuing regulatorymarketing approval."
CollaGenex filed a Marketing Authorization Application (MAA) forOracea, with the United Kingdom's Medicines & Healthcare ProductsRegulatory Agency (MHRA) on February 24, 2006. The U.K. will act asreference member state in this decentralized procedure. 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.
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, the first systemiccompound for the treatment of rosacea, which is currently underevaluation 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 is also developingCOL-118, utilizing the technology acquired in the SansRosaacquisition, as a preclinical topical compound for the treatment ofredness associated with rosacea and other skin disorders.
CollaGenex also currently sells Periostat, which the Companydeveloped as the first pharmaceutical to treat periodontal disease byinhibiting the enzymes that destroy periodontal support tissues and byenhancing bone protein synthesis, and Atridox(R), Atrisorb FreeFlow(R)and Atrisorb-D FreeFlow(R), which are products of QLT Inc., thesuccessor to Atrix Laboratories, Inc., for the treatment of adultperiodontitis.
Research has shown that certain tetracyclines can be chemicallymodified to remove their antibiotic effects while retaining theproperties that may make them effective in treating diseases involvinginflammation and/or destruction of the body's connective tissues.CollaGenex is evaluating various chemically modified tetracyclines (socalled "IMPACS" compounds because they are Inhibitors of MultipleProteases And CytokineS") to assess whether they are safe andeffective in these applications. The Company has a pipeline ofinnovative product candidates with possible applications indermatology and other disease states. In addition, CollaGenex hasacquired the Restoraderm(R) technology, a unique, proprietary dermaldrug delivery system, and plans to develop a range of topicaldermatological products with enhanced pharmacologic and cosmeticproperties.
To receive additional information on the Company, please visit ourWeb site at www.collagenex.com, which does not form part of this pressrelease.
Statements in this press release regarding management's futureexpectations, beliefs, intentions, goals, strategies, plans orprospects, including statements relating to the Company's revenue andexpenses, cash burn and future cash position, including the fourthquarter and year ended December 31, 2005 and for fiscal year 2006, andits future development efforts, including clinical and developmentprograms and its dermatology franchise, may constitute forward-lookingstatements within the meaning of the Private Securities LitigationReform Act of 1995. CollaGenex' actual results could differ materiallyfrom those stated or implied in forward-looking statements due to anumber of factors, including those factors contained in the mostrecent Form 10-Q for the Quarter ended September 30, 2005 under thesections "Additional Risks That May Affect Results" as well as otherdocuments that may be filed by CollaGenex from time to time with theSecurities and Exchange Commission. Forward-looking statements includestatements regarding CollaGenex' expectations, beliefs, intentions orstrategies regarding the future and can be identified byforward-looking words such as "anticipate", "believe", "could","estimate", "expect", "intend", "may", "should", "will", and "would"or similar words. CollaGenex assumes no obligations to update theinformation included in this press release or revise anyforward-looking statements, whether as a result of new information,future events or otherwise.
Periostat(R) and Restoraderm(R) are registered trademarks andIMPACS(TM), SansRosa(TM) and Oracea(TM) are trademarks of CollaGenexPharmaceuticals, 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.
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