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CollaGenex Receives FDA Approval to Market Periostat Tablets.


Business Editors & Health/Medical Writers

NEWTOWN, Pa.--(BUSINESS WIRE)--Feb. 5, 2001

CollaGenex Pharmaceuticals, Inc. (Nasdaq: CGPI CGPI Corporate Goods Price Index (Japan)
CGPI Capital Goods Price Index (New Zealand) 
) today announced that the U.S. Food and Drug Administration has granted marketing approval for a new tablet formulation of Periostat(R), which is indicated 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.
. 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. Periostat tablets will be manufactured by Pharmaceutical Manufacturing Research Services, Inc. of Horsham, PA.

"The approval of Periostat tablets by 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.
 is an important milestone in the development of our regulatory and commercial strategies," said Brian M. Gallagher, PhD, chairman, president and chief executive officer of CollaGenex. "This is our second NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  approval and was achieved less than one year from filing, validating the company's ability to bring prescription products to the market. Periostat tablets offer patients a significant advance over the current capsule formulation, as they are smaller and easier to swallow. Tablets can be manufactured at a lower cost than capsules, and we expect to experience improvements in our gross margin after the tablets are launched later this year."

Periostat tablets were approved for sale in the United Kingdom in December 2000. Periostat capsules have been available in the U.S. for two years. More than 850,000 prescriptions, written by more than 32,000 dentists, have been filled since the launch of Periostat. Periostat is the first and only prescription pharmaceutical product to treat adult periodontitis adjunctively by suppressing the enzymes that destroy the 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.

CollaGenex has initiated a direct-to-consumer advertising direct-to-consumer advertising Drug industry The use of mass media–eg, TV, magazines, newspapers, to publicly promote drugs, medical devices or other products which, by law, require a prescription, which targets consumers, with the intent of having a Pt  campaign in the Philadelphia, Washington, Houston, Chicago, Tampa and St. Louis markets. The company plans a further expansion of this campaign in up to eight additional markets during 2001. "The introduction of Periostat tablets will augment our consumer marketing strategy, providing additional opportunity for growth during 2001," said Dr. Gallagher.

Periostat is marketed to the dental community in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  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 suppression technology underlying Periostat may also be applicable to other diseases involving destruction of the body's connective connective - An operator used in logic to combine two logical formulas. See first order logic.  tissues, including cancer metastases Metastasis (plural, metastases)
A tumor growth or deposit that has spread via lymph or blood to an area of the body remote from the primary tumor.

Mentioned in: Malignant Melanoma
 (Metastat(R)) and a broad range of inflammatory diseases. CollaGenex is developing a series of novel, proprietary compounds known as IMPACS IMPACS Institute for Media, Policy and Civil Society
IMPACS Integrated Manufacturing Planning and Control System
IMPACS International Message and Packet Switching Service
(R) (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.
) 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 relating to relate prepconcernant

relating to relate prepbezüglich +gen, mit Bezug auf +acc 
 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
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Feb 5, 2001
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