Auxilium Pharmaceuticals, Inc. Presented Data At The ASSH Annual Meeting About
XIAFLEX® For The Treatment Of Dupuytren's Contracture
-42 Percent of Joints Previously Treated Successfully with XIAFLEX Exhibited
Disease Recurrence at Year 4-
-Three-Year Post-Approval Safety Reports After Approximately 49,000 Injections
is Consistent with Safety Profile from Clinical Studies-
CHESTERBROOK, Pa., Oct. 7, 2013
CHESTERBROOK, Pa., Oct. 7, 2013 /PRNewswire/ --Auxilium Pharmaceuticals, Inc.
(NASDAQ: AUXL), a specialty biopharmaceutical company, today announced results
from Year 4 of the Collagenase Optimal Reduction of Dupuytren's - Long-term
Evaluation of Success Study ("CORDLESS"). These data indicated that the
overall recurrence rate at Year 4 was 42.1 percent for patients previously
treated successfully with XIAFLEX ("collagenase clostridium histolyticum" or
"CCH") for Dupuytren's contracture. The study assessed 623 joints in adult
Dupuytren's patients with a palpable cord from earlier Auxilium studies,
indicating that 57.9 percent of patients previously successfully treated with
XIAFLEX did not experience disease recurrence based on the study's
In the CORDLESS study, recurrence was defined as a 20 degree change of
contracture with a palpable cord or when the treated joint underwent
medical/surgical intervention. These data were highlighted as an oral
presentation (Clinical Paper 79) on October 5, 2013, at the 68^th Annual
Meeting of the American Society for Surgery of the Hand ("ASSH") in San
Of the 623 joints that were successfully treated with XIAFLEX, only 12.8
percent of those joints received medical or surgical intervention through Year
4. Of the joints that received medical or surgical intervention by Year 4 of
the study, patients were most commonly retreated with XIAFLEX.
CORDLESS is a five-year observational study designed to assess the rates of
recurrence following treatment with XIAFLEX, as well as long-term safety and
progression of disease in patients from earlier Auxilium studies.
Additionally, in order to evaluate recurrence within the context of criterion
referenced in surgical literature,^,, the data were also examined in
a post-hoc analysis using the recurrence definition of 30 degree worsening of
contracture. By this potentially clinically relevant definition, overall,
27.9 percent of patients who had achieved clinical success experienced
recurrence at four years.
"As a doctor who frequently treats patients with Dupuytren's contracture, I am
encouraged by the recurrence rates seen among patients treated with XIAFLEX, a
non-surgical therapy," said Clayton A. Peimer, MD, Clinical Professor of
Surgery,Michigan State UniversityMedical School/ Marquette General
Healthcare. "These data represent an important piece of information
physicians, patients and payers can consider when determining the most
appropriate treatment option for their patients."
Through four years of follow-up, the adverse event ("AE") profile of
Dupuytren's contracture patients successfully treated with XIAFLEX revealed no
new long-term AEs. Of the 86 serious AEs reported through four years of
follow-up, only one was considered related to XIAFLEX (decrease in ring finger
circumference due to Dupuytren's contracture resolution).
Additional highlights from Year 4 of the CORDLESS study include:
oThe overall recurrence rate increased by 15.4 percent between year two and
three (19.6 to 35 percent) and increased by 7.1 percent from year three to
four (35 to 42.1 percent). This represents a slowing of the recurrence
rate in XIAFLEX treated patients over time.
oAt four years, 87.2 percent of the 623 joints that achieved clinical
success did not have a further surgery or other medical intervention.
oHigh severity proximal interphalangeal ("PIP") joints (those with baseline
contractures> 40 degrees) had a higher recurrence rate than low severity
PIP joints (71 percent versus 58 percent, respectively) at four years.
oRecurrence rates in successfully treated metacarpophalangeal ("MP") joints
with low severity (those with baseline contractures< 50 degrees) and high
severity were comparable at four years (36 percent and 29 percent,
Three-Year Post-marketing Surveillance Safety Update
Study authors also presented an update on XIAFLEX safety data following three
years (36 months) of post-approval use at the ASSH Annual Meeting on Saturday,
October 5, 2013 (Clinical Paper 77). After an estimated 49,078 XIAFLEX
injections were administered to approximately 36,500 adult patients in the
U.S. for the treatment of Dupuytren's contracture with a palpable cord, there
was no clinically meaningful change in the nature of events reported relative
to the one year post-marketing safety profile.^ Adverse events were most
commonly localized, non-serious reactions to XIAFLEX injections, including
skin tears, contusion (bruising), peripheral edema (swelling), extremity pain
and injection site reactions.
Reported events in the U.S. post-marketing period through February 2, 2013,
include 26 tendon ruptures (0.05 percent), a single case of A2 pulley injury
(0.002 percent) and one ligament injury (0.002 percent). Additionally, a
single case of stretch neuropraxia (numbness without pain) (0.002 percent) and
two reports of complex regional pain syndrome (0.005 percent) were reported.
In the Phase III clinical trials for registration, three (0.3 percent)
patients experienced a tendon rupture and one (0.1 percent) patient
experienced ligament damage (pulley rupture) following XIAFLEX treatment of
1,082 patients in the safety database.
"The data that were presented at this year's ASSH Annual Meeting add to the
growing body of evidence that support the safety and efficacy profiles of
XIAFLEX as a non-surgical treatment option for patients with Dupuytren's
contracture with a palpable cord," said Adrian Adams, Chief Executive Officer
and President ofAuxilium Pharmaceuticals.
About Voluntary Safety Reporting
Auxilium is committed to patient safety. 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 through February 3, 2013 for the
use of XIAFLEX in adult patients with Dupuytren's contracture with a palpable
cord in the U.S.
About Dupuytren's Contracture
Dupuytren's disease is a progressive condition affecting the hand,
specifically the layer of tissue just under the skin of the palm and fingers.
While this layer of tissue normally contains collagen, in patients with
Dupuytren's there is a change in the types of collagen produced. Abnormal
collagen build-up results in nodule and cord formation that worsens over
time. Eventually, rope-like collagen cords form, thicken and shorten, causing
the fingers to be drawn in toward the palm. Besides causing contracture, the
thickening and shortening of the Dupuytren's cord can reduce the finger's
range of motion (how much a person can move or straighten them). Once the
Dupuytren's collagen cord can be felt, it is referred to as a "palpable cord."
About XIAFLEX (collagenase clostridium histolyticum (CCH)
XIAFLEX (collagenase clostridium histolyticum or CCH) is made up of two
enzymes (AUX I and AUX II) that are thought to work together to break down
collagen. XIAFLEX is approved in the U.S., EU and Canada for the treatment of
adult Dupuytren's contracture (DC) patients with a palpable cord. A sBLA for
XIAFLEX for the treatment of Peyronie's disease (PD) has been submitted to the
FDA. Additionally CCH is currently being studied in clinical trials in the
following collagen-related conditions, frozen shoulder syndrome (Phase II),
cellulite (Phase I), and lipoma (Phase II). XIAFLEX has been granted orphan
status in the U.S. by the FDA for DC and PD.
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a
focus on developing and marketing products to predominantly specialist
audiences. Auxilium markets Testim® (testosterone gel) for the topical
treatment of hypogonadism in the U.S. and XIAFLEX (collagenase clostridium
histolyticum (CCH) for the treatment of adult Dupuytren's contracture patients
with a palpable cord in the U.S. Ferring International Center S.A. markets
Testim in certain countries of the EU and Paladin Labs Inc. markets Testim in
Canada. Swedish Orphan Biovitrium AB has marketing rights for XIAPEX® (the EU
tradename for collagenase clostridium histolyticum) in 71 Eurasian and African
countries. Asahi Kasei Pharma Corporation has development and commercial
rights for XIAFLEX in Japan and Actelion Pharmaceuticals Ltd has development
and commercial rights for XIAFLEX in Canada, Australia, Brazil and Mexico.
Auxilium also markets TESTOPEL®, a long-acting implantable testosterone
replacement therapy, Edex®, the leading branded non-oral drug for erectile
dysfunction, Striant®, a buccal system for testosterone delivery, Osbon
ErecAid®, the leading device for aiding erectile dysfunction, and also has a
non-promoted respiratory franchise, including Theo-24® and Semprex®-D, along
with three other non-promoted products, in the U.S. Auxilium has three
projects in clinical development. XIAFLEX is currently under regulatory
review by the U.S. FDA for the treatment of Peyronie's disease. CCH is in
phase II of development for the treatment of Frozen Shoulder syndrome
(adhesive capsulitis) and phase II of development for the treatment of
cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights
to pursue additional indications for XIAFLEX. For additional information,
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF
This news release contains forward-looking statements as defined by the
Private Securities Litigation Reform Act of 1995, which discuss matters that
are not facts, and may include words to indicate their uncertain nature such
as "believe," "expect," anticipate," "intend," "plan," "could," "estimate,"
"project," "will," and "target." Our forward-looking statements convey
management's expectations, beliefs, plans and objectives regarding future
performance of the Company and are based upon preliminary information and
management assumptions, and include statements about the Company's plans to
present XIAFLEX data at the ASSH annual meeting, the efficacy and safety
profiles of XIAFLEX, continued evaluation of XIAFLEX, and the Company's
product candidates in development. While the Company may elect to update the
forward-looking statements made in this news release in the future, the
Company specifically disclaims any obligation to do so. Such forward-looking
statements are subject to a wide range of risks and uncertainties that could
cause results to differ in material respects, including those relating to
product development, revenue, expense and earnings expectations, intellectual
property rights, results and timing of clinical trials, success of marketing
efforts, the need for additional research and testing, and the timing and
content of decisions made by regulatory authorities, including the U.S. Food
and Drug Administration, and those risks discussed in our reports on file with
the Securities and Exchange Commission (the "SEC"). Our SEC filings may be
accessed electronically by means of the SEC's home page on the Internet at
http://www.sec.gov or by means of the Company's home page on the Internet at
http://www.auxilium.com under the heading "For Investors - SEC Filings."
There may be additional risks that the Company does not presently know or that
the Company currently believes are immaterial which could also cause actual
results to differ from those contained in the forward-looking statements.
James E. Fickenscher / CFO Nichol Ochsner/ Senior Director, IR
Auxilium Pharmaceuticals, Inc. Auxilium Pharmaceuticals, Inc.
(484) 321-5900 (484) 321-5900
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SOURCE Auxilium Pharmaceuticals, Inc.
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