CollaGenex Pharmaceuticals Announces Trademark ``ORACEA''; ORACEA is Being Developed as a Once-Daily Oral Treatment for Rosacea.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) ) announced today that it has filed to adopt the trademark of Oracea(TM) for Col-101, the Company's once daily, modified-release formulation of 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. , 40 mg, for the treatment of rosacea Rosacea Definition Rosacea is a skin disease typically appearing in people during their 30s and 40s. It is marked by redness (erythema) of the face, flushing of the skin, and the presence of hard pimples (papules) or pus-filled pimples (pustules), and in the United States. An Intent to Use application for ORACEA was filed on July 14, 2004 with the Patent and Trademark Office (PTO PTO abbr. 1. Parent Teacher Organization 2. or p.t.o. please turn over 3. power takeoff PTO or pto please turn over Noun 1. ) and the Food and Drug Administration. "ORACEA is a compelling brand name for our drug, which is currently under development to be the first FDA-approved oral treatment for rosacea," said Colin Stewart, president and chief executive officer of CollaGenex. "We expect our two Phase III clinical trials to be fully enrolled by the end of this year. The current market for prescription pharmaceuticals to treat rosacea is estimated to be $500 million annually, and we believe the market will expand and grow with the convenience of a once-daily oral treatment. Based on our market research with physicians, we believe ORACEA will achieve strong awareness and recall among our target physicians, facilitating rapid adoption of the product after launch." ORACEA: An IMPACs Compound ORACEA is a once daily, modified-release formulation of doxycycline, 40 mg, for the treatment of rosacea. Two double-blinded, placebo-controlled Phase 3 clinical studies are each enrolling up to 264 patients at a total of 28 investigational centers. The studies will evaluate the clinical indices of rosacea, including reductions in inflammatory lesions and erythema erythema (ĕr'əthē`mə), more or less diffuse redness of the skin due to concentration of an abnormally large amount of blood within the small vessels of the skin (hyperemia), as in burns. , during a 16-week period of administration. The enrollment of these two studies is expected to be completed by the end of 2004. ORACEA is part of the IMPACS (Inhibitors of Multiple Proteases And CytokineS Cytokines Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. ) family of compounds developed by CollaGenex. These compounds have the potential for multiple therapeutic uses, primarily in the treatment of diseases that cause inflammation and destruction of the connective tissues. Col-101 is also in Phase III clinical testing for the adjunctive 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. , which is already known as Periostat MR. The Rosacea Market Rosacea is an increasingly common diagnosis affecting more than 14 million people in the United States. The disease is characterized by inflammatory lesions and the appearance of erythema, a persistent redness of the skin that usually affect the nose, cheeks and forehead. As rosacea becomes more severe, it is characterized by stinging, burning and/or telangiectasia telangiectasia /tel·an·gi·ec·ta·sia/ (tel-an?je-ek-ta´zhah) permanent dilation of preexisting small blood vessels, creating focal red lesions. , which are tiny spider veins on the nose and cheeks. About CollaGenex Pharmaceuticals CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on providing innovative medical therapies to the dental and dermatology markets. Currently, the company's professional dental pharmaceutical sales force markets Periostat, which is indicated as an adjunct to scaling and root planing The objective of scaling and root planing, otherwise known as conventional periodontal therapy, is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus,[1] for the treatment of adult periodontitis. Periostat is the first and only pharmaceutical to treat periodontal disease Periodontal Disease Definition Periodontal diseases are a group of diseases that affect the tissues that support and anchor the teeth. Left untreated, periodontal disease results in the destruction of the gums, alveolar bone (the part of the jaws where by inhibiting the enzymes that destroy periodontal periodontal /peri·odon·tal/ (per?e-o-don´t'l) 1. pertaining to the periodontal ligament or periodontium. 2. near or around a tooth. per·i·o·don·tal adj. 1. support tissues, and by enhancing bone protein synthesis. The dental sales force also promotes Atridox(R), Atrisorb FreeFlow(R) and Atrisorb-D FreeFlow(R), Atrix Laboratories, Inc.'s products for the treatment of adult periodontitis, to the dental market. The Company'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. 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. This press release contains forward-looking statements that involve risks and uncertainties. Our business of selling, marketing and developing pharmaceutical products is subject to a number of significant risks, including risks relating to the implementation of CollaGenex's sales and marketing plans for Periostat and other products that we market, risks associated with our arrangement with Mutual, risks inherent in research and development activities, risks associated with enforcement of our intellectual property rights, risks that 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. will approve products that will compete with and limit the market for Periostat, risks relating to our litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. with the FDA, risks associated with conducting business in a highly regulated environment and uncertainty relating to clinical trials of products under development. CollaGenex's success depends to a large degree upon the market acceptance of Periostat by periodontists, dental practitioners, other health care providers, patients and insurance companies and the success of our dermatology product candidates. There can be no assurance that CollaGenex's product candidates (other than the FDA's approval of Periostat for marketing in the United States, the United Kingdom Medicines and Healthcare Products Regulatory Agency's approval of Periostat for marketing in the United Kingdom and Periostat's marketing approval in Austria, Finland, Switzerland, Ireland, Israel, Italy, Luxembourg, the Netherlands, Portugal and Canada) will be approved by any regulatory authority for marketing in any jurisdiction or, if approved, that any such products will be successfully commercialized by CollaGenex. In addition, there can be no assurance that CollaGenex will successfully promote Pandel, Atridox, Atrisorb-FreeFlow or Atrisorb-D. As a result of such risks and those risks set forth in CollaGenex's filings with the Securities and Exchange Commission, CollaGenex's actual results may differ materially from the results discussed in or implied by the forward-looking statements contained herein. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Periostat(R) and IMPACS(R) are registered trademarks and Oracea(TM) is a trademark 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. Pandel(R) is a trademark of Taisho Pharmaceuticals. Atridox(R), Atrisorb(R) and Atrisorb-D(R) are registered trademarks of Atrix Laboratories, Inc. |
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