CollaGenex Pharmaceuticals Reports Notice of Allowance for European Patent Covering Oracea(TM).NEWTOWN, Pa. -- CollaGenex Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CGPI CGPI Corporate Goods Price Index (Japan) CGPI Capital Goods Price Index (New Zealand) ) 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 doxycycline /doxy·cy·cline/ (dok?se-si´klen) a semisynthetic broad-spectrum tetracycline antibiotic, active against a wide range of gram-positive and gram-negative organisms; used also as d. calcium and d. hyclate. 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 MAA abbr. macroaggregated albumin ) for Oracea, with the United Kingdom's Medicines & Healthcare Products Regulatory Agency (MHRA MHRA Medicines and Healthcare Products Regulatory Agency MHRA Modern Humanities Research Association (United Kingdom) MHRA Minnesota Human Rights Act MHRA Malta Hotels and Restaurants Association ) 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 PDUFA Prescription Drug User Fee Act of 1992 (USA) 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(R), a prescription topical corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and licensed from Altana, Inc., Alcortin(TM) (1% iodoquinol and 2% hydrocortisone hydrocortisone (hī'drəkôr`tĭzōn'), another name for the steroid hormone cortisol, more especially used to refer to preparations of this hormone used medicinally. ), 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 (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any for Oracea, the first systemic compound for the treatment of rosacea, which is currently under evaluation by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , 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(R), Atrisorb FreeFlow(R) and Atrisorb-D FreeFlow(R), which are products of QLT QLT Quadra Logic Technologies QLT Quick Link Text Inc., the successor to Atrix Laboratories, Inc., for the treatment of adult periodontitis periodontitis Inflammation of soft tissues around the teeth (see tooth). Poor dental hygiene leads to deposition of bacterial plaque on the teeth below the gum line, irritating and eroding nearby tissues. . Research has shown that certain tetracyclines Tetracyclines Definition Tetracyclines are medicines that kill certain infection-causing microorganisms. Purpose Tetracyclines are called "broad-spectrum" antibiotics, because they can be used to treat a wide variety of 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 IMPACS Institute for Media, Policy and Civil Society IMPACS Integrated Manufacturing Planning and Control System IMPACS International Message and Packet Switching Service " 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 revenue and expenses, cash burn and future cash position, including the fourth quarter and year ended December 31, 2005 and for fiscal year 2006, and its future development efforts, including clinical and development programs and its dermatology franchise, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 September 30, 2005 under the sections "Additional Risks That May Affect Results" 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), SansRosa(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. |
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