Navigation Links
FDA Advisory Committee Unanimously Recommends Approval of XIAFLEX(TM) for Treatment of Dupuytren's Disease
Date:9/21/2009

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:
*Name:
*Comment:
*Email:
(Date:2/28/2017)... ... February 28, 2017 , ... The role of females ... from military to civilian life. Body image dissatisfaction is largely unexamined among female ... and greater occurrence of chronic mental health conditions than female civilians. Female veterans ...
(Date:2/27/2017)... ... February 27, 2017 , ... Robert E. Burke, MD, PhD, had a ... impoverished upbringing and life experiences could have led him down a much different path. ... Tales of Parenting, Perseverance and Pediatrics,” Dr. Burke shares a personal account of the ...
(Date:2/27/2017)... ... February 27, 2017 , ... Orange County dentist, ... inflammatory gum condition that occurs when the bacteria in plaque infect the gums and ... as a scaling and root planing or SRP, and can include surgical therapies if ...
(Date:2/27/2017)... ... February 27, 2017 , ... ... alcohol treatment programs in British Columbia, Canada, at https://www.sunshinecoasthealthcentre.ca/ , is proud ... The new hire, Mackenzie Alsager, showcases the Centre's commitment to innovation in drug ...
(Date:2/26/2017)... ... 2017 , ... Today, A' Design Awards & Competition has ... Design Awards. , The 7th A' Social Design Award is open for ... with realized projects and conceptual works. , The first phase of the International ...
Breaking Medicine News(10 mins):
(Date:2/28/2017)... -- The global  pulse oximeters market  is expected to reach USD ... Inc. The pulse oximeters market is anticipated to witness significant growth during the ... such as chronic obstructive pulmonary disease (COPD), sleep apnea, cardiac arrhythmia, and ischemic ... ... Grand View Research Logo ...
(Date:2/28/2017)... -- Nordic Nanovector ASA (OSE: NANO) announces its results ... the results by the company,s senior management team will take place ... - details below. ... 2016 was a very successful year for Nordic Nanovector. We achieved ... with our preclinical candidates and build the foundation of R&D innovation ...
(Date:2/27/2017)... -- Halyard Health, Inc. (NYSE: HYH ) today ... 2017 outlook and related key planning assumptions. Executive Summary ... 2 percent increase compared to the prior year. ... million compared to net income of $15 million in the ... $24 million compared to adjusted net income of $27 million ...
Breaking Medicine Technology: