BioSpecifics Technologies Corp. Announces 30 Month Safety Update for XIAFLEX® in Dupuytren's Contracture

BioSpecifics Technologies Corp. Announces 30 Month Safety Update for XIAFLEX®
                          in Dupuytren's Contracture

− Safety Profile Consistent with Clinical Trials after Approximately 27,000
Injections Administered in the U.S. through July 31, 2012 −

PR Newswire

LYNBROOK, N.Y., Sept. 5, 2012

LYNBROOK, N.Y., Sept.5, 2012 /PRNewswire/ --BioSpecifics Technologies Corp.
(NASDAQ: BSTC), a biopharmaceutical company developing first in class
collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX^® in
Europe and Eurasia, today announced a safety update following 30 months of
post-approval use in the U.S. of XIAFLEX for the treatment of adult
Dupuytren's contracture patients with a palpable cord. As reported by
BioSpecifics' strategic partner Auxilium Pharmaceuticals, Inc. (Auxilium),
after approximately 27,000 injections were administered to approximately
21,000 patients in the U.S., there was no clinically meaningful change in the
nature of events expected relative to the clinical trial safety profile.

"We are very encouraged by the continued low number of adverse events reported
since the U.S. launch of XIAFLEX for Dupuytren's contracture patients, which
we believe reaffirms the excellent safety profile of XIAFLEX," said Thomas L.
Wegman, President of BioSpecifics."These data also demonstrate the success
of Auxilium's physician and sales force training programs and we look forward
to the launch of its pilot program for select rheumatology clinics later this
year."

From February 2, 2010 through July 31, 2012, approximately 1,454 adverse
events have been reported to Auxilium. Of those reported events, the most
commonly reported events were laceration, peripheral edema (swelling) and
contusion (bruising). Adverse event reporting requirements post-approval are
different from requirements for reporting such events during a clinical
trial. See "About Voluntary Safety Reporting to Auxilium" below for more
information.

In Auxilium's Phase III clinical trials for registration, three (0.3%)
subjects experienced a tendon rupture and one (0.1%) subject experienced
ligament damage (pulley rupture) following XIAFLEX treatment of 1,082 subjects
in the safety database. In the U.S. post-marketing period, 19 tendon ruptures
(0.09%) and 3 ligament injuries (0.01%) from approximately 21,000 patients
treated with commercial drug were reported. Additionally, there has been a
single report of complex regional pain syndrome (0.005%), that resolved within
approximately 3 months, and a single case of residual stretch neuropraxia
(numbness without pain) (0.005%) with full finger extension and remote from
the injection site. Since the U.S. launch by Auxilium, nearly 2,000 U.S.
physicians have injected palpable cords in Dupuytren's contracture patients
with XIAFLEX.

About Voluntary Safety Reporting to Auxilium

According to Auxilium, with any voluntary safety reporting system, such as
that in the U.S., there are limitations regarding interpretation of the data.
The system relies on reporting of events from physicians, patients, and other
healthcare providers. Auxilium employees also are trained to report events of
which they are made aware. The above estimates are based upon voluntary
reporting and reflect all information available to Auxilium from February 2,
2010 thru July 31, 2012 for the use of XIAFLEX in adult patients with
Dupuytren's contracture with a palpable cord in the U.S.

About BioSpecifics Technologies Corp.

BioSpecifics Technologies Corp. is a biopharmaceutical company that has
developed injectable collagenase (XIAFLEX®) for twelve clinical indications.
Currently, XIAFLEX is marketed in the U.S. for the treatment of adult
Dupuytren's contracture patients with a palpable cord by Auxilium
Pharmaceuticals, Inc. (Auxilium) and is also in clinical development for the
treatment of several additional promising indications. Auxilium has reported
positive top-line results from two recently completed Phase III clinical
trials for Peyronie's disease and is also testing XIAFLEX for frozen shoulder
syndrome (adhesive capsulitis) and cellulite in Phase IIa and Phase Ib
clinical trials, respectively. BioSpecifics is currently managing the clinical
development of XIAFLEX for the treatment of human lipoma and canine lipoma,
which are both in Phase II clinical trials. Auxilium has entered into three
strategic partnerships for development and commercialization outside the U.S.
of injectable collagenase for Dupuytren's contracture and Peyronie's disease.
Pfizer Inc. has rights in Europe and Eurasia and injectable collagenase is
currently marketed as XIAPEX® for Dupuytren's contracture in select European
countries. Asahi Kasei Pharma Corporation has rights in Japan and Actelion
Pharmaceuticals Ltd. has rights in Canada, Australia, Brazil and Mexico. For
more information, please visit www.biospecifics.com.

Forward Looking Statements

This release includes "forward-looking statements" within the meaning of, and
made pursuant to the safe harbor provisions of, the Private Securities
Litigation Reform Act of 1995. All statements other than statements of
historical fact are "forward-looking statements." The forward-looking
statements include statements concerning, among other things, the potential
for XIAFLEX to become a first-line treatment option for physicians and
patients and the timing for launch of Auxilium's pilot program for select
rheumatology clinics. In some cases, these statements can be identified by
forward-looking words such as "believe," "expect," "anticipate," "plan,"
"estimate," "likely," "may," "will," "could," "continue," "project,"
"predict," "goal," the negative or plural of these words, and other similar
expressions. These forward-looking statements are predictions based on
BioSpecifics' current expectations and its projections about future events.
There are a number of important factors that could cause BioSpecifics' actual
results to differ materially from those indicated by such forward-looking
statements, including the ability of Auxilium to achieve its objectives for
XIAFLEX; and other risk factors identified in BioSpecifics' Annual Report on
Form 10-K for the year ended December 31, 2011, its Quarterly Reports on Form
10-Q for the first and second quarters of 2012, and its Current Reports on
Form 8-K filed with the Securities and Exchange Commission. All
forward-looking statements included in this release are made as of the date
hereof, and BioSpecifics assumes no obligation to update these forward-looking
statements.

SOURCE BioSpecifics Technologies Corp.

Website: http://www.biospecifics.com
Contact: Thomas L. Wegman, President, BioSpecifics Technologies Corp.,
+1-516-593-7000, thomas_wegman@biospecifics.com
 
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