NDA filed for Oracea(TM), the first orally administered drug to treat rosacea
Aug 1, 2005 - 11:34:00 PM
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"If approved, Oracea(TM) will be the first systemic therapy for this disease, and we believe that the availability of a convenient, safe and effective product will significantly expand the current $500 million market for prescription drugs to treat this potentially disfiguring condition."
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By CollaGenex Pharmaceuticals, Inc.,
[RxPG] CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI) today announced it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Oracea(TM), the first orally administered, systemically delivered drug to treat rosacea. The NDA included highly significant positive outcomes of two Phase 3, double-blinded, placebo-controlled clinical trials designed to evaluate the safety and efficacy of Oracea(TM). The trials enrolled a total of 537 patients in 28 centers across the U.S.
Approximately 13.6 million adults in the U.S. suffer from rosacea. It affects primarily the face and is characterized by the appearance of inflammatory lesions (papules, pustules and nodules), 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.
Colin Stewart, president and chief executive officer of CollaGenex, stated, "The NDA submission is a major step forward in executing the Company's strategy to become a leading dermatology company. We are anticipating a 12-month review period, with a projected market launch in the third quarter of 2006. If approved, Oracea(TM) will be the first systemic therapy for this disease, and we believe that the availability of a convenient, safe and effective product will significantly expand the current $500 million market for prescription drugs to treat this potentially disfiguring condition."
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Additional information about the news article
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CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company that has built its reputation on providing innovative medical therapies to the dental and dermatology markets. 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). Alcortin and Novacort are marketed by the Company under a co-promotion agreement with Primus Pharmaceuticals Inc. 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 QTL, Inc., the successor to Atrix Laboratories, Inc., for the treatment of adult periodontitis.
Research has shown that certain tetracyclines can be chemically modified to retain non-antibiotic 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(TM)" 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(TM) 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.
Forward-Looking Statements
Statements in this press release regarding management's future expectations, beliefs, goals, plans or prospects, including statements relating its revenue and expenses, future cash position and its future development efforts, 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 CollaGenex' most recent Annual Report on Form 10-K for the year ended December 31, 2004 under the section "Additional Factors That May Affect Future 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.
Periostat(R) is a registered trademark and Restoraderm(R), 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 Evan Smith, CFA, 212-850-5606 or Erica Pettit, 212-850-5614
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