Navigation Links
FDA Advisory Committee Unanimously Recommends Approval of XIAFLEX(TM) for Treatment of Dupuytren's Disease

LYNBROOK, N.Y., Sept. 16 /PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first-in-class collagenase-based products, today announced that the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration's (FDA) unanimously recommended by a vote of 12 to 0 that XIAFLEX(TM) (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, be granted marketing approval by the FDA for the treatment of Dupuytren's disease, a debilitating disorder resulting from excessive collagen deposition that causes contractures of the fingers.

"We believe that the Advisory Committee's very supportive vote today for XIAFLEX represents a major advance for both the patients suffering from Dupuytren's disease, as well as for BioSpecifics and its shareholders," stated Thomas L. Wegman, President of BioSpecifics. "We congratulate our partner Auxilium on its thorough and thoughtful presentation today and look forward to the FDA's decision regarding the approval of XIAFLEX."

The Advisory Committee's recommendations are not binding, but will be considered by the FDA in its review of the XIAFLEX BLA. Auxilium Pharmaceuticals, Inc. has licensed the rights to XIAFLEX from BioSpecifics for three clinical indications: Dupuytren's disease; Peyronie's disease; and frozen shoulder (adhesive capsulitis). Auxilium filed its BLA for XIAFLEX for the treatment of Dupuytren's disease on February 27, 2009 and received a target date under the Prescription Drug User Fee Act (PDUFA) date of August 28, 2009, which has not been updated.

About BioSpecifics Technologies Corp.

BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for three clinical indications: Dupuytren's disease; Peyronie's disease; and frozen shoulder (adhesive capsulitis). Its strategic partner Auxilium Pharmaceuticals, Inc. has announced the acceptance of the Biologic License Application (BLA) and Priority Review by the U.S. Food and Drug Administration for injectable collagenase XIAFLEX(TM) in the treatment of Dupuytren's disease. Pfizer, Inc. is responsible for marketing XIAFLEX(TM) product in Europe.

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 the company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, its 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 its actual results to differ materially from those indicated by such forward-looking statements, including the ability of its partner Auxilium to obtain regulatory approval of XIAFLEX(TM) in the United States for Dupuytren's disease and Peyronie's disease and the ability of Pfizer to obtain regulatory approval of XIAFLEX(TM) in its territory for these same indications, which will determine the amount of milestone, royalty and sublicense income payments it may receive; the amount of earn out payments it may receive from DFB Biotech Inc. and its affiliates; whether Auxilium exercises its option under the companies' license agreement for additional indications; the potential benefits of its existing license and development agreements; its estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the Company's Form 10-K for the year ended December 31, 2008 and the Form 10-Q for the quarter ended June 30, 2009 and any subsequent reports filed with the SEC. 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 medicine news :

1. Robert Fanning Named to PerfectServe Advisory Board
2. Dr. Stuart Baker Named to PerfectServe Advisory Board
3. William Dwyer Named to PerfectServe Advisory Board
4. Dr. Michael Guthrie Named to PerfectServe Advisory Board
5. Alan Weinstein Named Chairman of PerfectServe Advisory Board
6. Pennsylvania Patient Safety Authority Releases September Advisory
7. Judy Benjamin Named to PerfectServe Advisory Board
8. GENova appoints Dr. Wang Chong to Scientific Advisory Board
9. GENova appoints Dr. Philip Gould to Scientific Advisory Board
10. Dey Issues Advisory
11. Social Security Advisory Board Warns of Consequences of Unsustainable Growth in The Cost of Health Care
Post Your Comments:
(Date:11/24/2015)... ... November 24, 2015 , ... ThirdLove, the fast-growing bra company ... early, offering 40% off select bras and underwear styles, now through Saturday, November ... fit technology and the latest fashion, quickly becoming the next generation of luxury ...
(Date:11/24/2015)... , ... November 24, 2015 , ... ... leaders when it comes to several aspects of orthopedic care. They have received ... orthopedic surgeries and general orthopedic care. , Becker's Hospital Review selected hospitals ...
(Date:11/24/2015)... Berkeley, California (PRWEB) , ... November 24, 2015 ... ... Brillouin Energy's LENR HHT Bolier Reactor System. Brillouin is the developer of renewable ... on controlled low energy nuclear reactions (“LENR”), announced today that its WET™ and ...
(Date:11/24/2015)... VA (PRWEB) , ... November 24, 2015 , ... ... people across the United States to support their local poison centers through donations ... designated as #GivingTuesday: calls it “a day that inspires people to collaborate ...
(Date:11/24/2015)... ... November 24, 2015 , ... Aided by seed funding from the Ron ... designed to yield insights into how to detect and treat pancreatic cancer (PC). ... from small, non-coding RNA molecules (ncRNA), genetic material that is present in the blood ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... CHICAGO , Nov. 24, 2015  Figure 1, ... view and share medical cases, has launched a new ... of the web version allows radiologists, who work primarily ... workstation. To further engage with its radiologist user base, ... Society of North America (RSNA) ...
(Date:11/24/2015)... , Nov. 24, 2015 Teledyne DALSA , ... image sensing technology, will introduce its CMOS X-Ray detector ... , November 29 to December 3, at McCormick Place in ... detectors for diagnostic and interventional imaging will be on display ... family of advanced CMOS X-Ray detectors is the industry ...
(Date:11/24/2015)... Nov. 24, 2015  NuShield, Inc., an industry leader in LCD screen protection and glare-elimination technology, ... technology as part of their patient monitoring or electronic documentation system. ... ... ... A study in 2013 ...
Breaking Medicine Technology: