Navigation Links
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.

Forward-Looking Statements

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 future action by the FDA or our partner Auxilium, 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 licensee Auxilium to obtain regulatory approval in the United States of the injectable collagenase product XIAFLEX for Dupuytren's and Peyronie's disease, and other factors identified in the company's annual report on Form 10-K for the year ended December 31, 2008. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.


'/>"/>
SOURCE BioSpecifics Technologies Corp.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. BioSpecifics to Present at the 9th Annual Healthcare Conference of Acumen Bio Fin Rodman Renshaw LLC
2. BioSpecifics Technologies Corp. Announces Sale of Stock in Private Placement Offering
3. BioSpecifics Technologies Corp. Announces Repayment of Outstanding Loan
4. BioSpecifics Technologies Corp. Announces Sale of Stock in Private Placement Offering
5. BioSpecifics Technologies Corp. Announces Additional Sales of Stock in Private Placement Offering
6. BioSpecifics Technologies Corp. Reports Second Quarter 2008 Financial Results
7. BioSpecifics Technologies Corp. Buys Down Royalties for Peyronies Disease
8. BioSpecifics Technologies Corp. Announces Appointment of Dr. Matthew Geller to Board of Directors
9. BioSpecifics Technologies Corp. to Present at Piper Jaffray 20th Annual Health Care Conference
10. BioSpecifics Technologies Corp. Announces Listing on NASDAQ Global Market
11. BioSpecifics Technologies Corp. Reports Fourth Quarter and Full Year 2008 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... ... October 11, 2017 , ... ... today it will be hosting a Webinar titled, “Pathology is going digital. Is ... , on digital pathology adoption best practices and how Proscia improves lab economics ...
(Date:10/11/2017)... and LAGUNA HILLS, Calif. , Oct. ... Cancer Research, London (ICR) and University ... SKY92, SkylineDx,s prognostic tool to risk-stratify patients with multiple myeloma ... MUK nine . The University of Leeds ... partly funded by Myeloma UK, and ICR will perform the ...
(Date:10/11/2017)... ... October 11, 2017 , ... A new study ... in frozen and fresh in vitro fertilization (IVF) transfer cycles. The ... IVF success. , After comparing the results from the fresh and frozen transfer ...
(Date:10/10/2017)... (PRWEB) , ... October 10, 2017 , ... San Diego-based ... of its corporate rebranding initiative announced today. The bold new look is part ... as the company moves into a significant growth period. , It will also expand ...
Breaking Biology Technology:
(Date:4/5/2017)... Allen Institute for Cell Science today announces the launch ... dynamic digital window into the human cell. The website ... deep learning to create predictive models of cell organization, ... suite of powerful tools. The Allen Cell Explorer will ... resources created and shared by the Allen Institute for ...
(Date:4/4/2017)... , April 4, 2017   EyeLock LLC , ... that the United States Patent and Trademark Office (USPTO) ... covers the linking of an iris image with a ... and represents the company,s 45 th issued patent. ... is very timely given the multi-modal biometric capabilities that ...
(Date:3/30/2017)... The research team of The Hong Kong ... identification by adopting ground breaking 3D fingerprint minutiae recovery and matching ... and accuracy for use in identification, crime investigation, immigration control, security ... ... A research team led by ...
Breaking Biology News(10 mins):