On March 2, 2009, Auxilium announced that it had submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) on February 27, 2009 seeking approval of XIAFLEX(TM) for the treatment of Dupuytren's disease in the U.S. Auxilium also announced that it has requested a Priority Review designation for the BLA submission from the FDA and that it expects to hear from the FDA on Priority Review designation within approximately 60 days of the filing date.
About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed and partnered injectable collagenase for three clinical indications: Dupuytren's disease, Peyronie's disease, and frozen shoulder (adhesive capsulitis). It has a development and licensing agreement with Auxilium. More information about the company may be found on its website at www.biospecifics.com.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, our expected revenue growth, and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions, are forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including the ability of our partner Auxilium to obtain regulatory approval of XIAFLEX(TM) in the United States for Dupuytren's disease and Peyronie's
|SOURCE BioSpecifics Technologies Corp.|
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