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:1/19/2017)... LAKES, N.J. , Jan. 18, 2017 BD (Becton, ... technology company, announced today that it will host a live webcast ... at 1 p.m. (ET). The webcast can be ... be available for replay through Tuesday, January 31, 2017. ... About BD BD ...
(Date:1/18/2017)... 2017 Applied BioMath ( www.appliedbiomath.com ), ... research and development, today announced that Dr. ... of Applied BioMath, will present at the next ... Meeting on Thursday January 19, 2017 at the ... MA.   Dr. Burke,s talk "Quantitative Modeling and Simulation ...
(Date:1/18/2017)... ... January 18, 2017 , ... Whitehouse Labs ... Within Albany Molecular Research, Inc. (AMRI), the scientific staff dedicated to Extractables / ... planned for further growth in 2017. Extractable & Leachable evaluations have become increasingly ...
(Date:1/18/2017)... KING OF PRUSSIA, PA (PRWEB) , ... January ... ... to disrupt clinical operations again at the CHI SCOPE Summit for Clinical Ops ... and AstraZeneca in engaging panel discussions to examine vital clinical research issues such ...
Breaking Biology Technology:
(Date:1/6/2017)... 5, 2017  SomaLogic announced today that it ... established by iCarbonX, the China ... "Global Digital Health Ecosystem that can define each ... individual,s biological, behavioral and psychological data, the Internet ... companies, SomaLogic will provide proteomics data and applications ...
(Date:1/3/2017)... VEGAS , Jan. 3, 2017 Onitor, ... the introduction of Onitor Track, an innovative biometric data-driven ... men, showcasing this month at the 2017 Consumer Electronics ... In the U.S., the World Health ... more than two-thirds of adults who are overweight or ...
(Date:12/20/2016)... and GENEVA, Dec, 20, 2016   Valencell ... sensor technology, and STMicroelectronics (NYSE: STM), a ... of electronics applications, announced today the launch of ... for biometric wearables that includes ST,s compact ... Valencell,s Benchmark™ biometric sensor system. Together, SensorTile ...
Breaking Biology News(10 mins):