U.S. Patent and Trademark Office Notifies CollaGenex That It Will Conf

    Business Editors/Health/Medical Writers

    NEWTOWN, Pa.--(BUSINESS WIRE)--March 7, 2005--CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI) today announced that the United States Patent and Trademark Office has issued a Notice of Intent to Issue a Reexamination Certificate confirming the patentability of certain amended claims of United States Patent RE 34,656 (the "'656 Patent"), of which CollaGenex is the exclusive licensee. In the reexamination process, CollaGenex successfully demonstrated to the Patent Office that enhancement of bone protein synthesis using Periostat(R), a sub-antimicrobial dose of doxycycline, is patentable over all patents and publications identified in the reexamination. CollaGenex also overcame rejections based on double patenting over subject matter already covered in CollaGenex's earlier '897 patent, which has now expired.
    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. In that case CollaGenex alleges that the Defendants' submissions of ANDA's covering their 20mg tablets of doxycycline hyclate infringe the '656 Patent. CollaGenex is seeking an injunction preventing the Defendants from introducing 20mg tablets of doxycycline hyclate into the market in the United States. CollaGenex is still awaiting the Court's decision with respect to the injunction. Although the reexamination procedure is recognized as extremely rigorous, it is not predictive of the outcome of this decision.
    "This is an important step for us and justifies our decision to seek reexamination as part of our strategy to enforce our patent rights. The Company is the owner or exclusive licensee of a number of issued and pending patents that cover both our marketed and pipeline products, and we will continue to do all that we can to enhance the intellectual property protections of our products. We believe that our intellectual property positions us well to develop our future business in the dental and dermatology markets," 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 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), which are products of QTL, Inc., the successor to Atrix Laboratories, Inc., for the treatment of adult periodontitis. The Company's professional dermatology sales force markets Pandel(R), a prescription topical corticosteroid licensed from Altana, Inc.
    Research has shown that certain unique properties of the tetracyclines 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(R) 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. In addition, CollaGenex has licensed 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.

    Forward-Looking Statements

    Statements in this press release regarding management's future expectations, beliefs, goals, plans or prospects, including statements relating to the Company's intellectual property rights, its ongoing litigation with IVAX and CorePharma, and its future development efforts, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. CollaGenex's 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's 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's 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 is a registered 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 QTL, Inc.

--30--JM/ph*

CONTACT: CollaGenex Pharmaceuticals, Inc. Nancy C. Broadbent, 215-579-7388 or KCSA Worldwide Evan Smith, CFA, 212-896-1251 or Erica Pettit, 212-896-1248

KEYWORD: PENNSYLVANIA INDUSTRY KEYWORD: LEGAL/LAW PHARMACEUTICAL BANKING MEDICAL DEVICES MEDICAL PRODUCT SOURCE: CollaGenex Pharmaceuticals, Inc.

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