CollaGenex Pharmaceuticals Begins Patient Screening and Enrollment of Multicenter Phase III Clinical Study of Periostat MR for Adult Periodontitis.Business Editors/Health/Medical Writers NEWTOWN, Pa.--(BUSINESS WIRE)--April 5, 2004 CollaGenex Pharmaceuticals, Inc. (Nasdaq:CGPI CGPI Corporate Goods Price Index (Japan) CGPI Capital Goods Price Index (New Zealand) ) today announced that it has initiated patient screening and enrollment of a multi-center, double-blinded, placebo-controlled Phase III clinical study to evaluate the efficacy of Periostat(R)MR for 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. . Periostat MR is a new, once-daily formulation of Periostat (doxycycline hyclate tablets) 20 mg, CollaGenex's lead product approved in 1998 for the treatment of adult periodontitis. More than 3 million prescriptions have been filled for Periostat, the largest prescription pharmaceutical branded product ever approved and launched for a dental disease. This study, which will enroll more than 200 patients, is being conducted by Dr. Alan Polson, University of Pennsylvania (body, education) University of Pennsylvania - The home of ENIAC and Machiavelli. http://upenn.edu/. Address: Philadelphia, PA, USA. ; Dr. William Giannobile, University of Michigan (body, education) University of Michigan - A large cosmopolitan university in the Midwest USA. Over 50000 students are enrolled at the University of Michigan's three campuses. The students come from 50 states and over 100 foreign countries. ; Dr. M. John Novak, University of Kentucky The University of Kentucky, also referred to as UK, is a public, co-educational university located in Lexington, Kentucky. ; Dr. James Mellonig, University of Texas at San Antonio The main campus is situated on 600 acres (2.4 km²,) at the intersection of Interstate 10 and Loop 1604 near the northern edge of San Antonio, Texas in Bexar County. The university is also one of the UT System's fastest growing schools, maintaining a 12. ; Dr. Ingvar Magnussen, University of Florida University of Florida is the third-largest university in the United States, with 50,912 students (as of Fall 2006) and has the eighth-largest budget (nearly $1.9 billion per year). UF is home to 16 colleges and more than 150 research centers and institutes. ; and Dr. Philip Preshaw, University of Newcastle University of Newcastle can refer to:
"Periostat has been a significant and highly effective adjunctive therapy in the treatment of adult periodontitis," said Dr. Novak. "A new, once-daily formulation of Periostat will improve patient compliance, offering the possibility of greater efficacy." "The initiation of patient screening and enrollment in this Phase III clinical study is an important milestone in our efforts to improve patient compliance and extend the patent life of Periostat for the treatment of adult periodontitis," said Colin Stewart, president and chief executive officer of CollaGenex. "Periostat MR is the result of a collaboration with Shire Laboratories to develop a once-a-day, modified-release formulation of Periostat using a patented technology that has been used successfully to reformulate a number of pharmaceutical products. We anticipate that our clinical program for Periostat MR in periodontitis will be completed and an 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 submitted to 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. during 2005, with an expected approval and launch during 2006." "We recently announced the very positive outcome of our Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the evaluating the use of Periostat to treat rosacea," Mr. Stewart continued. "Our development program relating to the use of Periostat MR for the treatment of rosacea remains on schedule, and we anticipate the start of our Phase III program in rosacea later in the second quarter." About CollaGenex CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company 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 is the first and only pharmaceutical to treat periodontal disease by inhibiting the enzymes that destroy periodontal support tissues, and by enhancing bone protein synthesis. The sales force also promotes Atridox(R), Atrisorb(R) FreeFlow(TM) and Atrisorb-D FreeFlow, Atrix Laboratories Inc.'s products for the treatment of adult periodontitis, to the dental market and Pandel(R), a prescription topical corticosteriod licensed from Altana, Inc., to the dermatology market. 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 metastases, 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) compounds, to assess whether they are safe and effective in these applications. In addition, CollaGenex has licensed the Restoraderm(R) technology, a unique, proprietary dermal 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 Mutual and the outcome of litigation initiated by Mutual, risks that the FDA will approve generic products, such as Mutual's products, that will compete with and limit the market for Periostat, 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), IMPACS(R) and Metastat(R) are registered trademarks, and Restoraderm(R) is a trademark, of CollaGenex Pharmaceuticals, Inc. 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. Atridox(R), Atrisorb(R) and Atrisorb-D(R) are trademarks of Atrix Laboratories, Inc. |
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