CollaGenex Pharmaceuticals Receives Marketing Authorization for Periostat in Switzerland.Business Editors/Health/Medical Writers NEWTOWN, Pa.--(BUSINESS WIRE)--April 1, 2003 CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI CGPI Corporate Goods Price Index (Japan) CGPI Capital Goods Price Index (New Zealand) ) today announced that it has received a Marketing Authorization for its lead product, Periostat (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. tablets 20mg), from the Swiss regulatory authority Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities , SwissMedic. As previously announced, CollaGenex has established an exclusive marketing and distribution agreement with the Zurich based company Karr Dental AG, a specialist supplier of dental pharmaceutical and other products to the Swiss market. As with other European countries and Israel, Periostat will be sourced for the Swiss market from CollaGenex International Limited. It is anticipated that the product will be introduced in Switzerland in approximately 6 months, following completion of product labelling in the German, Italian and French languages. "Approval of pharmaceutical products in Switzerland is not included in the European Mutual Recognition process, but the result of an independent and rigorous review by the Swiss authorities," said Brian M. Gallagher, PhD, chairman, president and chief executive officer of CollaGenex. "It is a testament to the strength of the Periostat submission that another independent authority has granted marketing approval. Our Swiss partner, Karr Dental AG, has a dedicated dental office sales force and considerable experience in the marketing of dental pharmaceuticals, and we anticipate considerable success in this sophisticated new market." "We are excited about the prospect of introducing this unique product to the dental market in Switzerland," said Dr. Hans-Peter Grimm, president and chief executive officer of Karr Dental AG. "Karr Dental has a reputation as innovators 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. , and Periostat represents a new concept in patient care for this challenging disease. We look forward to working with CollaGenex International and its other European partners in maximizing the opportunity for Periostat throughout Europe." In addition to Switzerland, Periostat is approved for sale in the United States, United Kingdom, Austria, Finland, Ireland, Italy, Luxembourg, the Netherlands, Portugal and Israel. The product is marketed in the United Kingdom and Ireland by CollaGenex International, Ltd., in Israel by Taro Pharmaceutical Industries, Ltd., in Austria by Willvonseder and Marchesani, and in Portugal by ISDIN. CollaGenex continues to seek partners for other countries in which the product is approved for sale by the relevant regulatory authorities. CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company currently focused on providing innovative medical therapies to the dental and dermatology markets. Currently, the Company's 115-person professional dental pharmaceutical sales force markets Periostat(R), which is indicated as an adjunct 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] for the treatment of adult periodontitis. Periostat(R) is the first and only pharmaceutical to treat periodontal disease Periodontal Disease Definition Periodontal diseases are a group of diseases that affect the tissues that support and anchor the teeth. Left untreated, periodontal disease results in the destruction of the gums, alveolar bone (the part of the jaws where by inhibiting the enzymes that destroy 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, and by enhancing bone protein synthesis. The sales force also promotes Vioxx(R), a Merck & Co. drug that CollaGenex co-promotes for the treatment of acute dental pain, Denavir(R), a Novartis Group prescription anti-viral medication for the treatment of cold sores, Sirius Laboratories' AVAR(TM) product line for the topical control of acne vulgaris acne vul·gar·is n. An inflammatory eruption affecting the face, upper back, and chest, consisting of blackheads, cysts, papules, and pustules, and occurring primarily during puberty and adolescence. , 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 seborrheic dermatitis Seborrheic Dermatitis Definition Seborrheic dermatitis is a common inflammatory disease of the skin characterized by scaly lesions usually on the scalp, hairline, and face. , and Atridox(R), Atrisorb(R) FreeFlow(TM) and Atrisorb-D(R) FreeFlow(TM), Atrix Laboratories Inc.'s products for the treatment of adult periodontitis. Research has shown that certain unique properties of the tetracyclines Tetracyclines Definition Tetracyclines are medicines that kill certain infection-causing microorganisms. Purpose Tetracyclines are called "broad-spectrum" antibiotics, because they can be used to treat a wide variety of discovered during the development of Periostat may be applicable to other diseases involving inflammation and/or destruction of the body's connective tissues, including acne, rosacea, meibomianitis and 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 , among others. CollaGenex is further evaluating Periostat, as well as the new IMPACS IMPACS Institute for Media, Policy and Civil Society IMPACS Integrated Manufacturing Planning and Control System IMPACS International Message and Packet Switching Service (R), to assess whether they are safe and effective in these applications. 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, which does not form part of this press release. 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, 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 for Periostat(R) and other products that the Company markets, the outcome and consequences of the patent litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. against West-ward, 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), Dermostat(R), Nephrostat(R), Osteostat(R), Arthrostat(R), Rheumastat(R), Corneostat(R), Gingistat(R), IMPACS(R), PS20(TM), The Whole Mouth Treatment(R), Restoraderm(TM) and Dentaplex(R) are United States trademarks of CollaGenex Pharmaceuticals, Inc. Periostat(R), Nephrostat(R), Optistat(R), Xerostat(R) and IMPACS(TM) are European Community trademarks of CollaGenex Pharmaceuticals, Inc. Periostat(R), Nephrostat(R), Optistat(R), Xerostat(R), IMPACS(R), Dentaplex(R), Restoraderm(R), Dermastat(R), Periocycline(R), Periostatus(R) and Periostan(R) are United Kingdom trademarks of our wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. , CollaGenex International Limited. CollaGenex(R), PS20(R), "C" Logo(R) and The Whole Mouth Treatment(R) are European Community and United Kingdom trademarks of CollaGenex International Limited. Periocycline(TM) and Periostan(TM) are European Community Trademarks of CollaGenex International Limited. All other trade names, trademarks or service marks are the property of their respective owners and are not the property of CollaGenex Pharmaceuticals, Inc. or any of our subsidiaries. Pandel(R) is a trademark of Taisho Pharmaceuticals. VIOXX(R) is a trademark of Merck & Co., Inc. AVAR(TM) is a trademark of Sirius Laboratories, Inc. Atridox(R), Atrisorb(R) and Atrisorb-D(R) are trademarks of Atrix Laboratories, Inc. |
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