UK Medicines Control Agency Grants Marketing Authorization for Periostat
NEWTOWN, Pa.--(BUSINESS WIRE)--Feb. 29, 2000--CollaGenex Pharmaceuticals, Inc. (Nasdaq: CGPI - news) today announced that the United Kingdom's Medicines Control Agency has granted marketing approval for Periostat© 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.
CollaGenex intends to market Periostat capsules in the UK through its subsidiary, CollaGenex International Limited. There are approximately 20,000 dentists in the UK. CollaGenex also plans to seek marketing authorizations for a tablet formulation of Periostat in the UK and other countries within the European Union through the Mutual Recognition Procedure.
CollaGenex has already announced Periostat marketing partnerships for Italy with Roche, SpA (a subsidiary of Hoffman La Roche) and for France with Laboratoires Pharmascience, a subsidiary of Groupe Expanscience. In addition, CollaGenex is currently in advanced discussions with other distributors and licensees to market Periostat in several other European countries.
"UK approval of Periostat is a significant and exciting milestone in our evolution as a commercial enterprise," said Brian M. Gallagher, PhD, president and chief executive officer of CollaGenex. "There has been considerable interest in Periostat in Europe following the launch of Periostat in the United States and we expect to have Periostat available by prescription in the U.K. within six to eight weeks."
"I have reviewed all of the scientific and clinical data on this product in depth," said Professor Denis Kinane of the Department of Adult Dental Care at Scotland's University of Glasgow Dental School, "and I am able to endorse Periostat and its therapeutic benefits in the adjunctive treatment of chronic adult periodontitis."
"Chronic inflammatory periodontal disease may be difficult to treat in some patients and follow-up supportive therapy may be essential for success," said Dr. Hubert Newman, emeritus professor of Periodontology and Preventive Dentistry at the Eastman Dental Institute, London. "Periostat research has shown it to be an effective systemic supplement to subgingival debridement, and it provides an important novel systemic adjunctive therapy in patients undergoing treatment for adult periodontitis."
CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on providing innovative medical therapies to the dental market. The company's lead product, Periostat, was approved by the FDA in September 1998 and is the first and only pharmaceutical to treat periodontal disease by inhibiting the enzymes that destroy periodontal support tissues.
Periostat is marketed to the dental community in the United States by CollaGenex through a professional pharmaceutical sales force composed of approximately 135 sales representatives and managers. Currently, the company's dental sales force is also marketing Vioxx©, a Merck & Co. drug that the Company promotes for the treatment of acute dental pain, and Denavir©, a SmithKline Beecham Consumer Healthcare prescription drug for the treatment of cold sores.
Research has shown that the enzyme-suppression technology underlying Periostat may also be applicable to other diseases involving destruction of the body's connective tissues, including cancer metastasis, osteoporosis, osteoarthritis and wounds. CollaGenex intends to pursue the research and development of these other applications primarily through partnerships with third parties.
To receive information about the availability of Periostat in the United Kingdom, contact CollaGenex International Limited on 01844 216668. For additional information on CollaGenex, please visit the Company's web site at www.collagenex.com, which is not a part of this press release.
This news release contains forward-looking statements within the meaning of section 21E 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 risks relating to the implementation of the Company's sales and 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 U.S. Securities and Exchange Commission.
Periostat© and CollaGenex© are registered trade marks of CollaGenex International Limited.
Contact:
CollaGenex Pharmaceuticals
Robert A. Ashley, Senior V.P.
Nancy C. Broadbent, CFO
215/579-7388 |
