CollaGenex Pharmaceuticals Announces that Court Maintains Preliminary Injunction Preventing the FDA from Approving any Generic Versions of Periostat.NEWTOWN, Pa. -- CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI CGPI Corporate Goods Price Index (Japan) CGPI Capital Goods Price Index (New Zealand) ) today announced that the U.S. District Court for the District of Columbia District of Columbia, federal district (2000 pop. 572,059, a 5.7% decrease in population since the 1990 census), 69 sq mi (179 sq km), on the east bank of the Potomac River, coextensive with the city of Washington, D.C. (the capital of the United States). has maintained the preliminary injunction preventing the U.S. Food and Drug Administration from approving any generic versions of Periostat(R). In maintaining the preliminary injunction, Honorable Judge Collyer ordered expedited briefing of the issue of whether or not Periostat was correctly classified as an antibiotic. A motion by IVAX IVAX Industrial Vax (Dec Computer) Pharmaceuticals Inc. and CorePharma LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control to dissolve the preliminary injunction was heard by Honorable Judge Collyer on November 18, 2004. The injunction had originally been ordered pending final resolution of CollaGenex's challenge to the FDA's decision to classify Periostat(R) as an antibiotic, thereby denying CollaGenex the patent and exclusivity protection otherwise available under the Hatch Waxman amendments to the Food, Drug and Cosmetic Act Federal Food, Drug and Cosmetic Act a regulation in the United States which requires all drugs used in animals to be approved by the Food and Drug Administration. . CollaGenex continues to challenge the FDA's decision. Separately, CollaGenex recently filed a complaint for patent infringement against both IVAX Pharmaceuticals Inc. and CorePharma LLC ("Defendants") in the United States District Court for the Eastern District of New York EDNY redirects here, for other uses see EDNY (disambiguation). The United States District Court for the Eastern District of New York is the federal district court whose jurisdiction comprises the entirety of Long Island (including the portion in New York City) and Staten . In that case, CollaGenex alleges that the Defendants' submissions of ANDA's covering their 20mg tablets of doxycycline hyclate infringe United States Patent RE 34,656, of which CollaGenex is the exclusive licensee. CollaGenex is seeking an injunction preventing the Defendants from introducing 20mg tablets of doxycycline hyclate into the market in the United States. "CollaGenex is the exclusive licensee of valid patents that cover, among other things, the use of Periostat to treat 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. . We will vigorously pursue all legal avenues to defend our patent rights," said Colin Stewart, president and chief executive officer of CollaGenex. 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 by inhibiting the enzymes that destroy periodontal 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 corticosteriod licensed from Altana, Inc. Research has shown that certain unique properties of the 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 discovered during the development of Periostat may be applicable to other diseases involving inflammation and/or destruction of the body's connective tissues. CollaGenex is further evaluating Periostat and other IMPACS IMPACS Institute for Media, Policy and Civil Society IMPACS Integrated Manufacturing Planning and Control System IMPACS International Message and Packet Switching Service (TM) compounds, including Oracea(TM), to assess whether they are safe and effective in these other applications. Oracea is currently in Phase III clinical trials to evaluate its effectiveness in treating rosacea, a dermatological condition, and Col-3 is in clinical trials to evaluate its potential effectiveness in treating acne and Kaposi's sarcoma, an HIV-related skin condition. In addition, CollaGenex has acquired the Restoraderm(TM) technology, a unique, proprietary dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. drug delivery system, in order 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, including statements relating to the 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 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 with IVAX and CorePharma, 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 CollaGenex' most recent Annual Report on Form 10-K for the year ended December 31, 2003 and the most recent Form 10-Q for the Quarter ended September 30, 2004 under the sections "Additional Factors That May Affect Future Results" and "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. Periostat, IMPACS and Restoraderm are U.S. 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. Pandel is a trademark of Taisho Pharmaceuticals. Atridox, Atrisorb and Atrisorb-D are registered trademarks of Atrix Laboratories, Inc. |
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