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BioSpecifics Technologies Corp. Announces FDA Approval of XIAFLEX(TM) for Treatment of Dupuytren's Contracture
Date:2/2/2010

ill allow health care providers to access XIAFLEX through specialty distributors and specialty pharmacies or in the institutional setting after they have undergone training on XIAFLEX and its administration.

Auxilium plans to market XIAFLEX to physicians who are experienced in injection procedures of the hand and treatment of Dupuytren's contracture and will only provide access to XIAFLEX after physicians have attested to completion of a training program. The training program is available as a video or written manual and demonstrates proper use and administration of XIAFLEX, as well as an overview of both identified and potential risks with XIAFLEX. The FDA has required a risk evaluation and mitigation strategy (REMS) program for XIAFLEX, which consists of a communication plan and a medication guide. This REMS program is designed (1) to evaluate and mitigate known and potential risks and serious adverse events; (2) to inform healthcare providers about how to properly inject XIAFLEX and perform finger extension procedures; and, (3) to inform patients about the serious risks associated with XIAFLEX.

Pfizer, Inc., Auxilium's marketing partner for XIAFLEX in Europe, has stated that the scientific/technical review procedure for the Marketing Authorization Approval (MAA) for XIAFLEX in Europe began in January 2010. Pfizer is responsible for marketing XIAFLEX for Dupuytren's contracture and Peyronie's disease in 27 member countries of European Union and 19 other European and Eurasian countries.

About Dupuytren's Contracture

Dupuytren's contracture is caused by an abnormal accumulation of collagen in the palm characterized by the formation of nodules or lumps in the early stages. As the disease progresses, a cord is formed and the fingers may become progressively contracted.

About BioSpecifics Technologi
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