BioSpecifics Technologies Corp. Announces Online Publication in The Journal of Urology of Results from the IMPRESS Trials of

BioSpecifics Technologies Corp. Announces Online Publication in The Journal of
 Urology of Results from the IMPRESS Trials of XIAFLEX® in Peyronie's Disease

PR Newswire

LYNBROOK, N.Y., Feb. 4, 2013

LYNBROOK, N.Y., Feb. 4, 2013 /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 that The Journal of Urology has
electronically published the uncorrected proof of the pivotal IMPRESS (The
Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies)
trials on its website at These Phase III studies were
conducted by BioSpecifics' strategic partner Auxilium Pharmaceuticals, Inc.
(Auxilium) and assessed XIAFLEX for the treatment of Peyronie's disease, an
excess of inelastic collagen causing penile curvature deformity. The full
article may be found at The manuscript
is currently scheduled to appear in print in the July 2013 print version of
The Journal of Urology.

"These results are quite positive and demonstrate the significant therapeutic
opportunity of XIAFLEX for the treatment of Peyronie's disease patients, who
currently have no FDA-approved pharmaceutical treatment options available for
this devastating condition," commented Thomas L. Wegman, President of
BioSpecifics. "We look forward to receiving the potential FDA approval of
XIAFLEX for Peyronie's disease this year and we also plan to announce several
near-term milestones for the broader XIAFLEX pipeline in the coming months."

Auxilium has previously announced positive top-line efficacy and safety
results of the IMPRESS studies' co-primary endpoints. In IMPRESS I and IMPRESS
II at 52 weeks, both co-primary endpoints met statistical significance for
mean percent improvement in penile curvature deformity and mean improvement in
the Peyronie's Disease Questionnaire (PDQ) bother domain for XIAFLEX subjects
vs. placebo patients. Additionally, XIAFLEX was generally well-tolerated.

The publication includes details of the co-primary and secondary families of
endpoints. Statistical significance for the co-primary endpoints and two
families of secondary endpoints was determined by a multiple comparison
algorithm based on gate keeping strategies designed to control the overall
family-wise type 1 error rate to be less than or equal to 0.05. In IMPRESS I
and II individually, the two co-primary endpoints each required a p-value less
than or equal to 0.05, while the algorithm for the first family of secondary
endpoints was equivalent to requiring a p-value less than or equal to 0.0167
and the algorithm for the second family required a p-value less than or equal
to 0.0042. In both IMPRESS I and II, first family secondary endpoints
(improvement from baseline in percentage of global responders, PDQ
psychological and physical symptoms, and IIEF (International Index for
Erectile Function) overall satisfaction) and second family secondary endpoints
(percentage of composite responders, improvement in penile length, plaque
consistency, and penile pain) were measured in XIAFLEX-treated men compared
with placebo.

Based on results from the IMPRESS Phase III program, Auxilium has submitted a
supplemental Biologics License Application (sBLA) to the U.S. Food and Drug
Administration (FDA) for XIAFLEX for the potential treatment of Peyronie's
disease and, under the Prescription Drug User Fee Act (PDUFA), the FDA is
expected to take action on the application by September 6, 2013. If approved,
XIAFLEX is expected to be the first and only biologic therapy indicated for
the treatment of Peyronie's disease.

For more details on the IMPRESS clinical program and the Phase III results
published online in The Journal of Urology, please refer to the press release
issued February 1, 2013, by Auxilium.

About Peyronie's Disease
Peyronie's disease is characterized by the presence of inelastic collagen on
the shaft of the penis, which can cause the penis to curve during erection,
and may make sexual intercourse difficult or impossible in advanced cases.
Significant psychological distress is common among sexually active patients
with Peyronie's disease. Currently, there are no FDA-approved pharmaceutical
therapies for this condition.

About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a biopharmaceutical company that has
developed injectable collagenase for twelve clinical indications. Injectable
collagenase is currently marketed as XIAFLEX® in the U.S. for the treatment of
adult Dupuytren's contracture patients with a palpable cord by Auxilium
Pharmaceuticals, Inc. (Auxilium) and is approved for Dupuytren's contracture
in the European Union, Switzerland and Canada. XIAFLEX is also in clinical
development for the treatment of several additional promising indications:
Auxilium recently submitted a supplemental Biologics License Application
(sBLA) to the FDA for XIAFLEX for the potential treatment of Peyronie's
disease based on positive results reported from its two Phase III clinical
studies. Auxilium 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 is currently partnered with Asahi Kasei
Pharma Corporation for the development and commercialization of injectable
collagenase for Dupuytren's contracture and Peyronie's disease in Japan and
with Actelion Pharmaceuticals Ltd. for these same indications in Canada,
Australia, Brazil and Mexico. Pfizer Inc. has marketing rights to XIAPEX® (the
EU trade name for XIAFLEX) for Dupuytren's contracture in 46 countries in
Eurasia through April 24, 2013. For more information, please visit

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
FDA approval of XIAFLEX for Peyronie's disease and the timing of such
potential FDA approval; the announcement of milestones for the XIAFLEX
pipeline; and the expectation that, if approved, XIAFLEX would be the first
and only biologic therapy indicated for the treatment of Peyronie's disease.
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 timing of
regulatory filings and action; the ability of BioSpecifics' partner, Auxilium,
and its partners, Asahi Kasei Pharma Corporation and Actelion Pharmaceuticals
Canada Inc., to achieve their objectives for XIAFLEX in their applicable
territories; the market for XIAFLEX in, and initiation and outcome of clinical
trials for, additional indications including frozen shoulder, cellulite, human
lipoma and canine lipoma, all of which will determine the amount of milestone,
royalty and sublicense income BioSpecifics may receive; the potential of
XIAFLEX to be used in additional indications; the timing of results of any
clinical trials; the receipt of any applicable milestone payments from
Auxilium; whether royalty payments BioSpecifics is entitled to receive will
exceed set-offs; 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, second and third 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.

Contact: BioSpecifics Technologies Corp., Thomas L. Wegman, President,
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