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BioSpecifics Technologies Corp. Announces FDA Acceptance of Biologics License Application With Priority Review for XIAFLEX(TM) for the Treatment of Dupuytren's Disease
Date:4/28/2009

LYNBROOK, N.Y., April 28 /PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) filed by its partner Auxilium Pharmaceuticals, Inc. for the use of XIAFLEX(TM) for the treatment of Dupuytren's disease, a debilitating disorder resulting from excessive collagen deposition that causes contractures of the fingers. The BLA acceptance triggers a milestone payment to BioSpecifics under our agreement with Auxilium.

In addition, Auxilium Pharmaceuticals announced that the application has been granted Priority Review status, indicating that the FDA is expected to take action on the application by August 28, 2009. Priority Review is an FDA designation given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.

"We are delighted with the acceptance of the BLA and grant of Priority Review status, and are now another step closer to getting this non-surgical treatment to the patients who need it," stated Thomas L. Wegman, President of BioSpecifics. "We look forward to supporting the approval process for this exciting therapeutic."

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.

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