CollaGenex Receives UK Medicines Control Agency Marketing Authorization for Periostat Tablets.

Business Editors/Health & Medical Writers

NEWTOWN, Pa.--(BUSINESS WIRE)--Jan. 4, 2001

CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI) today announced that the United Kingdom Medicines Control Agency has granted marketing approval for a new tablet formulation of Periostat(R), which is indicated for the adjunctive treatment of chronic adult periodontitis.

Periostat is the first orally administered, systemically delivered drug targeted for use in conjunction with treatments for adult periodontitis, a major cause of tooth loss in adults.

"UK approval of Periostat tablets is a critical milestone in the development of our European regulatory and marketing strategies," said Brian M. Gallagher, PhD, chairman, president and chief executive officer of CollaGenex. "Not only does this trigger payments from some of our European partner companies, but it also provides the foundation for the submission later this year for approval in other EU countries through the Mutual Recognition Procedure, with the UK acting as Reference Member State."

Periostat tablets will be marketed by CollaGenex in the UK through its subsidiary, CollaGenex International Limited. Periostat tablets represent a significant advance over the current capsule formulation as they are smaller and easier to swallow, may be blister-packed in specially designed packaging to aid and encourage patient compliance, and offer significant reductions in manufacturing costs.

An NDA for Periostat tablets is currently under review by the US Food and Drug Administration.

CollaGenex has already announced Periostat marketing partnerships for Italy with Roche, SpA (a subsidiary of Hoffman La Roche), for Canada with Pharmascience Inc., for Japan with Showa Yakuhin Kako Co. Ltd, for Spain, Portugal and Greece with the Spanish company ISDIN S.A., for Germany with Hain Diagnostika GmbH, for Austria with Willvonseder & Marchesani Ges.m.b.H. & Co. KG., for Switzerland with Karr Dental AG and for Israel with Taro Pharmaceutical Industries Limited.

Discussions are underway with other companies interested in distributing Periostat in the remaining countries of the European Union.

Periostat capsules have been available in the United States for 2 years. In excess of 825,000 prescriptions, written by more than 32,000 dentists, have been dispensed since launch.

The safety and efficacy of the drug were recently highlighted in publications in the Journal of Periodontology, the official journal of the American Academy of Periodontology, and numerous anecdotal reports have confirmed the outstanding benefit afforded by the drug in improving the outcome of traditional periodontal treatment strategies.

CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on providing innovative medical therapies to the dental market.

The company's lead product, Periostat capsules, was approved by the US Federal Food and Drug Administration in September 1998 and by the United Kingdom Medicines Control Agency in February 2000. It is the first and only prescription pharmaceutical product to treat periodontal disease by suppressing the enzymes that destroy the periodontal support tissues.

Periostat is marketed to the dental community in the United States by CollaGenex through a professional pharmaceutical sales force. Currently, the company's sales force is also marketing VIOXX(R), a Merck & Co. drug that the company promotes for the treatment and relief of acute dental pain, and Denavir(R), a Novartis Pharmaceuticals Corporation product for the treatment of cold sores. Periostat is marketed directly to the periodontal profession in the U.K. by CollaGenex International Limited.

Research has shown that the enzyme suppressing technology underlying Periostat may also be applicable to other diseases involving destruction of the body's connective tissues, including cancer metastases (Metastat(R)) and a broad range of inflammatory diseases.

CollaGenex is developing a series of novel, proprietary compounds known as IMPACS(R) (Inhibitors of Multiple Proteases and Cytokines) to address these applications. The company intends to pursue further research and development of these technologies primarily through partnerships with third parties.

For additional information on CollaGenex or on Periostat, please visit the company's websites at www.collagenex.com and www.periostat.com, neither of which are part of this press release.

This news release contains forward-looking statements within the meaning of Section 231E of the Securities and Exchange Act of 1934, as amended. Investors are cautioned that forward-looking statements involve risks and uncertainties, which may affect the company's business and prospects.

The company's business of selling, marketing and developing pharmaceutical products is subject to a number of significant risks, including marketing plans; risks inherent in research and development activities; risks associated with conducting business in a highly regulated environment and uncertainty relating to clinical trials of products under development, all as discussed in the company's periodic filings with the US Securities and Exchange Commission.

Periostat(R), Metastat(R)and IMPACS(R)are trademarks of CollaGenex Pharmaceuticals, Inc. CollaGenex(R)and Periostat(R)are trademarks of CollaGenex International Limited VIOXX(R)is a trademark of Merck & Co., Inc. Denavir(R)is a trademark of Novartis Pharmaceuticals Corporation