CollaGenex Files NDA for New Periostat Dosage Form.Business Editors NEWTOWN, Pa.--(BUSINESS WIRE)--March 31, 2000 CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI CGPI Corporate Goods Price Index (Japan) CGPI Capital Goods Price Index (New Zealand) ), today announced that it has filed a New Drug Application (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 ) with the US Food and Drug Administration (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. ) for a new dosage form of Periostat(R), the Company's flagship drug 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. . The new dosage form is a small, film-coated tablet, containing the same active ingredient as the current marketed product (20mg doxycycline hyclate doxycycline hyclate (dok´sisī´klēn hī´klāt), n brand names: Doryx, Doxy-Caps, Vibra-Tabs; drug class: tetracycline, broad-spectrum antiinfective; action: ). Clinical trials submitted to FDA for review have demonstrated that the Periostat tablet formulation delivers equivalent blood concentrations of the drug as does the current capsule formulation. "Having Periostat available as a tablet will provide several advantages for both CollaGenex and our customers" said Brian M. Gallagher, PhD, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of CollaGenex "The tablet is smaller than the current capsule formulation, and will therefore be easier to swallow, particularly for older patients and those with swallowing disorders Swallowing Disorders Definition Swallowing disorders include a number of diseases and conditions that cause difficulty in passing food or liquid from the mouth to the stomach. . Because it is more suitable for blister packaging, the tablet allows the Company additional packaging flexibility to better meet the needs of our customers and to facilitate patient compliance. Finally, the tablet formulation allows for cost savings in our manufacturing process, which is expected to improve the Company's gross margins". 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(R), a Merck & Co. drug that the Company promotes for the treatment of acute dental pain, and Denavir(R), 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 metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases 1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to 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 (TM) (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 this technology primarily through partnerships with third parties. 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(R), Metastat(R) and IMPACS(TM) are trade marks of CollaGenex Pharmaceuticals, Inc. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion