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Biotech / Medical : CollaGenex (CGPI) FDA PENDING
CGPI 0.00010000.0%Jul 21 5:00 PM EST

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From: nigel bates3/21/2006 9:29:43 AM
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CollaGenex Pharmaceuticals Reports Notice of Allowance for European Patent Covering Oracea(TM)
Tuesday March 21, 7:30 am ET

NEWTOWN, Pa.--(BUSINESS WIRE)--March 21, 2006--CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI - News) today reported that the European Patent Office has published on its web site that patent application 02731267.7 will be allowed. This patent has a priority date of April 5, 2002 and covers the use of sub anti-microbial doxycycline in the treatment of acne and rosacea, including Oracea(TM).

Colin W. Stewart, president and chief executive officer of CollaGenex, stated, "This notice of allowance by the European Patent Office is another important milestone as we seek to maximize the value of Oracea both in the United States and abroad. As we engage in discussions with potential European partners for rights to market Oracea in Europe, we are working to enhance the value of this asset by seeking intellectual property protections and pursuing regulatory marketing approval."

CollaGenex filed a Marketing Authorization Application (MAA) for Oracea, with the United Kingdom's Medicines & Healthcare Products Regulatory Agency (MHRA) on February 24, 2006. The U.K. will act as reference member state in this decentralized procedure. A New Drug Application for Oracea was filed with the U.S. Food and Drug Administration in August 2005 and has been given a PDUFA date of May 31, 2006.

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®, 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. In addition, CollaGenex has filed an NDA for Oracea, the first systemic compound for the treatment of rosacea, which is currently under evaluation by the FDA, 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, 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®, Atrisorb FreeFlow® and Atrisorb-D FreeFlow®, 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® 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.
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