Auxilium Pharmaceuticals, Inc. to Present Data on XIAFLEX® in the Treatment of
Dupuytren's Contracture at the American Society for Surgery of the Hand (ASSH)
- Four-Year Data from CORDLESS Recurrence Study and Three-Year Safety Data to
be Presented as Clinical Papers -
CHESTERBROOK, Pa., Oct. 3, 2013
CHESTERBROOK, Pa., Oct. 3, 2013 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc.
(NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that
data from multiple trials evaluating the use of XIAFLEX ("collagenase
clostridium histolyticum" or "CCH") in adult patients with Dupuytren's
contracture with a palpable cord will be presented at the upcoming 68^th
Annual Meeting of the American Society for Surgery of the Hand ("ASSH") being
held in San Francisco, California, on October 3 – 5, 2013.
Four-year recurrence data from the Collagenase Optimal Reduction of
Dupuytren's - Long-term Evaluation of Success Study ("CORDLESS") evaluating
XIAFLEX in the treatment of adult Dupuytren's contracture patients with a
palpable cord will be featured during Clinical Paper Session 18 on October 5
at 4:00 p.m. PDT. This five-year observational study was designed to assess
the durability of response following treatment with XIAFLEX, as well as
long-term safety and progression of disease in patients from earlier Auxilium
studies. Study authors will also be presenting Clinical Papers on three-year
safety findings based on post-marketing data reported to Auxilium after
treatment with XIAFLEX, as well as an analysis of four Phase III clinical
trials determining the efficacy and safety of XIAFLEX in the treatment of the
proximal interphalangeal ("PIP") joint (middle joint in the finger)
contracture in Dupuytren's disease.
"The data presented at this year's Annual ASSH Meeting help reinforce the
efficacy and safety profiles of XIAFLEX as a non-surgical treatment option for
patients suffering from Dupuytren's contracture," said Adrian Adams, Chief
Executive Officer and President ofAuxilium Pharmaceuticals. "We are pleased
with the data and remain dedicated to the ongoing evaluation of the long-term
use of XIAFLEX, with the goal of providing additional information to
physicians who treat Dupuytren's contracture."
Data to be presented on XIAFLEX include:
oNonsurgical Treatment of Dupuytren's Contracture: 3-Year Safety Results
Using Collagenase Clostridium Histolyticum (Clinical Paper 77, Clinical
Paper Session 18: Dupuytren's Disease, Saturday, October 5, 3:40 - 3:46
p.m. PDT, Moscone West 3001/3003)
oRecurrence of Dupuytren's Contracture After Nonsurgical Treatment With
Collagenase Clostridium Histolyticum: Summary of 4-year CORDLESS Data
(Clinical Paper 79, Clinical Paper Session 18: Dupuytren's Disease,
Saturday, October 5, 4:00 – 4:06 p.m. PDT, Moscone West 3001/3003)
oEfficacy and Safety of Collagenase Clostridium Histolyticum (CCH) in the
Treatment of Proximal Interphalangeal Joints in Dupuytren Contracture:
Combined Analysis of Four Phase 3 Clinical Trials (Clinical Paper 80,
Clinical Paper Session 18: Dupuytren's Disease, Saturday, October 5, 4:10
– 4:16 p.m. PDT, Moscone West 3001/3003)
oImpact of Collagenase Clostridium Histolyticum on Dupuytren's Contracture
Treatment Patterns (E-poster 139; available October 3 – 5 via kiosks in
the meeting hall or online)
oUse of Local Anesthesia Prior to Finger Extension Following Injection of
Collagenase Clostridium Histolyticum for Dupuytren's Contracture
(International Guest Hand Society (IGHS) Poster 9)
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 ratio of 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 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 in
Phase III of development 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.govor 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,
Auxilium Pharmaceuticals, Inc. Auxilium Pharmaceuticals, Inc.
(484) 321-5900 (484) 321-5900
 Luck JV. Dupuytren's contracture: a new concept of the pathogenesis
correlated with surgical management.J Bone Joint Surg Am. 1959;41(4):635-664.
 Desai SS, Hentz VR. Collagenase clostridium histolyticum for Dupuytren's
contracture. Expert Opin Biol Ther. 2010;10(9):1395-1404.
SOURCE Auxilium Pharmaceuticals, Inc.
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