CollaGenex Pharmaceuticals Announces Granting of Final Marketing Authorizations for Periostat in the Netherlands and Portugal.Business Editors CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI CGPI Corporate Goods Price Index (Japan) CGPI Capital Goods Price Index (New Zealand) ) today announced that it has received the final Marketing Authorizations for its lead product, Periostat(R) (doxycycline doxycycline /doxy·cy·cline/ (dok?se-si´klen) a semisynthetic broad-spectrum tetracycline antibiotic, active against a wide range of gram-positive and gram-negative organisms; used also as d. calcium and d. hyclate. 20mg tablets), from the Ministries of Health in the Netherlands and Portugal. The company previously announced the granting of provisional Marketing Authorizations in the Netherlands and Portugal, which were gained under the first round of the European Mutual Recognition Procedure. Periostat tablets were approved by the U.K. MCA MCA in full Music Corporation of America Entertainment conglomerate. It was founded in Chicago in 1924 by Jules Stein as a talent agency. In the 1960s it bought Decca Records and Universal Pictures, and today it produces films, music, and television shows. in February 2001 and by the U.S. 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. in April 2001. Both the Netherlands and Portugal will be supplied product by CollaGenex International Limited in the U.K. "The granting of these final Marketing Authorizations in countries of the European Union are pivotal events in the globalization of Periostat," said Brian M. Gallagher, PhD, chairman, president and chief executive officer of CollaGenex. "In Portugal, our partner is the Portuguese affiliate of our Spanish partner, ISDIN S.A. ISDIN is a joint venture between the Spanish pharmaceutical company Dr. Esteve S.A. and the Spanish personal and beauty care products company, Antonio Puig S.A. We are currently in discussion with potential partners in the Netherlands". Nuno de Francisco, International Manager of ISDIN, said, "The approval of Periostat in Portugal significantly strengthens ISDIN's presence in this market and we are looking forward to launching the product in the third quarter through our dedicated 6-person dental sales force". Periostat is an oral adjunctive therapy to scaling and root planing The objective of scaling and root planing, otherwise known as conventional periodontal therapy, is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus,[1] in the 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. , a condition that affects about 12-15% of the adult population in most countries. With increasing life expectancy and a decrease in tooth loss due to caries caries or tooth decay Localized disease that causes decay and cavities in teeth. It begins at the tooth's surface and may penetrate the dentin and the pulp cavity. (tooth decay), more people are at risk of developing periodontitis, resulting in the increasing need for new therapies to treat this chronic and yet unpredictable disease. Periostat is the first oral adjunctive therapy proven in clinical trials to suppress the tissue-destructive enzymes that the body produces in response to the bacterial infection, thereby helping to prevent the breakdown of gum tissue. CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company currently focused on providing innovative medical therapies to the dental and dermatology markets in the United States and internationally. Research has shown that the enzyme suppression technology underlying Periostat may also be applicable to other diseases involving inflammation and/or destruction of the body's connective tissues, including acne, rosacea Rosacea Definition Rosacea is a skin disease typically appearing in people during their 30s and 40s. It is marked by redness (erythema) of the face, flushing of the skin, and the presence of hard pimples (papules) or pus-filled pimples (pustules), and and blepharitis blepharitis /bleph·a·ri·tis/ (blef?ah-ri´tis) inflammation of the eyelids. blepharitis angula´ris inflammation involving the angles of the eyelids. , among others. CollaGenex is further developing Periostat as well as 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 (Inhibitors of Multiple Proteases and Cytokines) to address these and other applications, such as cancer (Metastat(R)). In addition, CollaGenex has licensed the Restoraderm(TM) technology, a unique, proprietary dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin. der·mal or der·mic adj. Of or relating to the skin or dermis. drug delivery system, in order 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. This press 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 that 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 U.S. Securities and Exchange Commission. Periostat(R), Metastat(R), IMPACS(R) and Restoraderm(TM) are trademarks of CollaGenex Pharmaceuticals, Inc. CollaGenex(R), Periostat(R) and Restoraderm(TM) are trademarks of CollaGenex International Limited. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion