BioSpecifics Technologies Corp. Announces Positive Top-line Data from XIAFLEX®
Phase IIa Study for Frozen Shoulder
LYNBROOK, N.Y., March 26, 2013
LYNBROOK, N.Y., March 26, 2013 /PRNewswire/ --BioSpecifics Technologies Corp.
(NASDAQ: BSTC), a biopharmaceutical company developing first in class
collagenase-based products marketed as XIAFLEX^® in the U.S., today announced
positive, statistically significant top-line data from the Phase IIa study of
XIAFLEX for the potential treatment of frozen shoulder (adhesive capsulitis).
"We are very encouraged by these positive results and look forward to progress
in this program which Auxilium expects in the second half of this year,"
reflected Thomas L. Wegman, President of BioSpecifics. "We believe there is
strong potential for XIAFLEX in frozen shoulder as there are few optimal
treatment strategies and no approved therapies available. These data further
support the vast potential of XIAFLEX for many conditions and diseases caused
by collagen accumulation, in addition to the five indications in clinical
development and the sBLA under review at the FDA for XIAFLEX for Peyronie's
This open-label, controlled dose-ranging Phase IIa study was conducted by
BioSpecifics' strategic partner Auxilium Pharmaceuticals, Inc. (Auxilium) and
was designed to assess the safety and efficacy of XIAFLEX for the treatment of
Stage 2 unilateral idiopathic frozen shoulder in comparison to an
exercise-only control group.
As reported by Auxilium, this study involved 50 adult men and women at 11 U.S.
sites. Four cohorts of 10 patients each received up to three ultrasound-guided
extraarticular injections of varying doses of XIAFLEX (ranging from 0.29mg to
0.58mg in three different volumes; 0.5, 1.0, or 2.0 mL), separated by a
minimum of 21 days. All patients were instructed to perform home shoulder
exercises. The fifth cohort of ten patients received no XIAFLEX injections and
only performed home shoulder exercises. The study's primary endpoint was the
change (in degrees) from baseline to the day 92 follow-up in active forward
flexion in the affected shoulder compared to the exercise-only cohort. Safety
assessments were made during all study visits and immunogenicity testing was
performed at screening and day 92.
Both the 0.58mg (1mL) and 0.58mg (2mL) dosing arms showed positive,
statistically significant improvement from baseline in forward flexion vs. the
exercise-only group. The 0.58mg (1mL) dosing arm also showed statistically
significant improvement from baseline in shoulder abduction vs. the
exercise-only group. Positive trends with improvement in degrees were also
seen in other active range of motion (AROM) assessments vs. the exercise-only
group. Twenty-nine study patients (72.5%) received three XIAFLEX injections
with 5 subjects receiving two injections and 6 subjects receiving one
Patients were also assessed using the American Shoulder and Elbow Surgeons
(ASES) Scale for function and pain. Both the 0.58mg (1mL) and 0.58mg (2mL)
cohort demonstrated statistically significant improvement in pain and function
over baseline scores vs. the exercise-only group (p<0.05).
There were no drug-related serious adverse events reported and all
treatment-related adverse events were consistent with XIAFLEX use in other
approved and potential indications. For more details on the data reported for
this study, please refer to Auxilium's press release issued yesterday, March
Frozen shoulder (adhesive capsulitis) is an inflammation and thickening of the
shoulder capsule causing a loss of range of motion in the shoulder. It is
known to be caused by trauma but there are other unknown causes. It is
estimated to affect between 20 and 50 million individuals worldwide with a
slightly higher incidence in women. It typically occurs in patients between
40-70 years of age. Auxilium estimates that approximately 300,000 cases of
frozen shoulder are diagnosed annually and approximately 10% are treated with
an invasive intervention (surgery or manipulation under anesthesia) on an
These results follow positive results previously reported by BioSpecifics for
its 60 patient Phase II randomized, placebo-controlled, double-blind
dose-response study in which BioSpecifics reported statistically significant
differences in the highest injectable collagenase dose group compared to
placebo regarding active elevation, passive external rotation and function
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. A
supplemental Biologics License Application is currently under standard review
at the U.S. Food and Drug Administration for XIAFLEX for the treatment of
Peyronie's disease with a Prescription Drug User Fee Act (PDUFA) date of
September 6, 2013. Auxilium is also testing XIAFLEX for frozen shoulder
syndrome (adhesive capsulitis) and cellulite. BioSpecifics is currently
managing the development of XIAFLEX for two indications, human lipoma and
canine lipoma (Chien-804), both of which are expected to report Phase Il data
in the second half of 2013. 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 the 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 and Peyronie's
disease in 46 countries in Eurasia through April 24, 2013. For more
information, please visit www.biospecifics.com.
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 timing of
progress in, and potential success of, the use of XIAFLEX for the treatment of
frozen shoulder (adhesive capsulitis) and the potential market for XIAFLEX in
that indication; and the potential of XIAFLEX as a treatment in many
conditions and diseases caused by collagen accumulation, in addition to the
six indications currently in clinical development. 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 BioSpecifics' partner,
Auxilium to achieve its objectives for XIAFLEX; the market for XIAFLEX in, and
initiation and outcome of clinical trials for, various indications; and other
risk factors identified in BioSpecifics' Annual Report on Form 10-K for the
year ended December 31, 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, (516)
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