MALVERN, PA, Jun 08, 2010 (MARKETWIRE via COMTEX) --Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty
biopharmaceutical company, today announced two year recurrence data
from the long-term extension study for XIAFLEX(R) (collagenase
clostridium histolyticum) in the treatment of Dupuytren's
contracture. The clinical study was designed to assess the durability
of response following treatment with XIAFLEX as well as long-term
safety and progression of disease in joints. At two years, the
nominal recurrence rate for the 618 joints previously treated
successfully with XIAFLEX was 19.3%.
"Surgery is not a cure for Dupuytren's disease and recurrences are
seen at 12 and 24 months after surgery," said Dr. Clayton Peimer,
Clinical Professor of Orthopedics at the Michigan State University.
"The recurrence rates seen through two years after treatment with
XIAFLEX should be well-received by physicians and patients who have
been looking for a long-term, non-surgical treatment option that
predictably works well."
In order to qualify for the XIAFLEX long-term extension study,
patients must have participated in the phase III XIAFLEX clinical
trials (CORD I, CORD II, JOINT I, JOINT II, or pharmacokinetic study)
and received at least one injection of XIAFLEX. Recurrence in the
long-term extension study was standardized and defined as (a) a joint
contracture that was successfully treated (had previously achieved a
reduction in contracture to five degrees or less at the Day 30
evaluation after the last injection of XIAFLEX) and that subsequently
increases by at least 20 degrees compared with the reference value
having a palpable cord present, or (b) a joint which underwent
surgical correction to treat contracture in that joint.
Data from the XIAFLEX Two Year Follow-up
All Joints MP Joints PIP Joints
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Patients from All Phase III
Studies (n=950) 1,568 920 648
Patients Enrolled in Extension
Study (n=634) 1,065 641 424
Patients Successfully Treated
and Enrolled in Extension
Study (n=474) 619* 449* 170
Joints with Recurrence (n/%) (119/618) (61/448) (58/170)
19.3% 13.6% 34.1%
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* One patient had unrelated hand surgery and post-operative bandaging
prevented an accurate assessment of recurrence at 2 years
Other Top-Line Findings:
-- Patients who experienced a benefit of 20 degrees or more, but did not
achieve success (0-5 degrees), had a higher rate of recurrence than
patients who did achieve 0-5 degrees.
-- Of the 30 adverse events reported, none were considered related to
XIAFLEX and none occurred in the treated finger.
-- No patients in this study have been retreated with XIAFLEX as of the
two year follow-up, of which the majority of visits occurred before
XIAFLEX was commercially available in the United States.
"The recurrence rate at two years following XIAFLEX treatment is
comparable to the published retrospective recurrence rates of up to
34% following fasciectomy and superior to the up to 85% recurrence
rate reported following needle fasciotomy," said Dr. Philip Blazar,
Assistant Professor of Orthopaedic Surgery, Harvard Medical School.
"I believe that first-line treatment with XIAFLEX is a non-surgical
alternative to surgery that can provide comparable outcomes and rates
of recurrence."
Literature on Surgical Recurrence
According to one paper and
depending on the type of surgery performed (fasciectomy, fasciotomy,
or needle aponeurotomy), surgical recurrence rates range from 2% to
60%, with an average of 33% (1). Higher recurrence rates are seen
with surgery in Proximal Intra-Phalangeal (PIP) joints vs. Metacarpal
Phalangeal (MP) joints (1) and with needle aponeurotomy vs.
fasciectomy (2). The earliest reports of recurrence for fasciectomy
were seen in 22% of female and 19% of male Dupuytren's contracture
patients at a mean of 12 months following fasciectomy (3).
Additionally, a rate of up to 34% has been reported within the first
two years following fasciectomy (4). At a recent conference, an
abstract for a prospective trial comparing needle fasciotomy to open
fasciectomy reported a recurrence rate for needle fasciotomy of 85%
at a mean of 2.3 years and 23.8% at a mean of 3.7 years for
fasciectomy, when recurrence was defined as a worsening of joint
contractures by at least 30 degrees compared to the preoperative
measurement (5).
(1) Rayan GM. Dupuytren disease: anatomy, pathology, presentation,
and treatment. J Bone Joint Surg Am. 2007;89A(1):190-198.
(2) A.L.
Van Rijssen, Journal of Hand Surgery (British and European Volume,
2006) 31B: 5: 498-501
(3) Anwar et al., Journal of Hand Surgery,
Vol. 32A No. 9 November 2007 ; 1423-1428
(4) Leclercq C.
Epidemiology. In: Tubiana R, Leclercq C, Hurst LC, Badalamente MA,
Mackin EJ, eds, Dupuytren's disease. Martin Dunitz Ltd, London, 2000;
239-249.
(5) A.L. Van Rijssen, 2010 International Symposium on
Dupuytren's Disease
About Dupuytren's Contracture
Dupuytren's contracture is a condition that affects the connective
tissue that lies beneath the skin in the palm. The disease is
progressive in nature. Typically, skin pits then nodules develop in
the palm as collagen deposits accumulate. As the disease progresses,
the collagen deposits form a cord that stretches from the palm of the
hand to the base of the finger. Once this cord develops, the
patient's fingers contract and the function of the hand is impaired.
The incidence of Dupuytren's disease, inclusive of pits, nodules and
cords, is highest in Caucasians, historically those of Northern
European descent, with a global prevalence of three to six percent of
the Caucasian population. (1) Most cases of Dupuytren's contracture
occur in patients older than 50 years. (2)
The most frequently affected parts of the hand associated with
Dupuytren's contracture are the joints called the Metacarpal
Phalangeal Joint, or MP joint, which is the joint closest to the palm
of the hand and the Proximal Intra-Phalangeal Joint, or the PIP
joint, which is the middle joint in the finger. The little finger and
ring finger are most frequently involved. XIAFLEX is the only drug
approved by the U.S. Food and Drug Administration for treatment of
Dupuytren's contracture, which has historically been treated
primarily by an open surgical procedure.
(1) Hurst, L. C. et al., Injectable Collagenase Clostridium
Histolyticum for Dupuytren's Contracture, New England Journal of
Medicine, (2009;361:968-979)
(2) Badalamente, M. A., Hurst, L. C. et
al., Collagen as a Clinical Target:
Nonoperative Treatment of
Dupuytren's Disease, The Journal of Hand Surgery,
(2002;
27A:788-798)
About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical
company with a focus on developing and marketing products to
predominantly specialist audiences, such as urologists,
endocrinologists, certain targeted primary care physicians, hand
surgeons, subsets of orthopedic, general, and plastic surgeons who
focus on the hand, and rheumatologists. Auxilium markets XIAFLEX(R)
(collagenase clostridium histolyticum) for the treatment of adult
Dupuytren's contracture patients with a palpable cord and Testim(R)
1%, a topical testosterone gel, for the treatment of hypogonadism.
Auxilium has four projects in clinical development. XIAFLEX is in
phase IIb of development for the treatment of Peyronie's disease and
is in phase II of development for treatment of Frozen Shoulder
syndrome (Adhesive Capsulitis). Auxilium's transmucosal film product
candidate for the treatment of overactive bladder (AA4010) and its
fentanyl pain product using its transmucosal delivery system are in
phase I of development. The Company is currently seeking a partner to
further develop these product candidates. Auxilium has rights to
additional pain products and products for hormone replacement and
urologic disease using its transmucosal film delivery system.
Auxilium also has options to all indications using XIAFLEX for
non-topical formulations. For additional information, visit
http://www.auxilium.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
This release contains "forward-looking-statements" within the meaning
of The Private Securities Litigation Reform Act of 1995, including
statements regarding the interpretation of clinical data; the number
of patients with Dupuytren's; and products in development for
Peyronie's disease, Frozen Shoulder syndrome, overactive bladder,
pain, hormone replacement and urologic disease; and all other
statements containing projections, statements of future performance
or expectations, our beliefs or statements of plans or objectives for
future operations (including statements of assumption underlying or
relating to any of the foregoing). Forward-looking statements can
generally be identified by words such as "believe," "appears," "may,"
"could," "will," "estimate," "continue," "anticipate," "intend,"
"should," "plan," "expect," and other words and terms of similar
meaning in connection with any discussion of projections, future
performance or expectations, beliefs, plans or objectives for future
operations (including statements of assumption underlying or relating
to any of the foregoing). Actual results may differ materially from
those reflected in these forward-looking statements due to various
factors, including further evaluation of clinical data, results of
clinical trials, decisions by regulatory authorities as to whether
and when to approve drug applications, and general financial,
economic, regulatory and political conditions affecting the
biotechnology and pharmaceutical industries and those discussed in
Auxilium's Annual Report on Form 10-K for the year ended December 31,
2009 and Auxilium's Quarterly Report on Form 10-Q for the period
ended March 31, 2010 under the heading "Risk Factors," which are on
file with the Securities and Exchange Commission (the "SEC") and may
be accessed electronically by means of the SEC's home page on the
Internet at http://www.sec.gov or by means of Auxilium's home page on
the Internet at http://www.Auxilium.com under the heading "For
Investors -- SEC Filings." There may be additional risks that
Auxilium does not presently know or that Auxilium currently believes
are immaterial which could also cause actual results to differ from
those contained in the forward-looking statements. Given these risks
and uncertainties, any or all of these forward-looking statements may
prove to be incorrect. Therefore, you should not rely on any such
factors or forward-looking statements.
In addition, forward-looking statements provide Auxilium's
expectations, plans or forecasts of future events and views as of the
date of this release. Auxilium anticipates that subsequent events and
developments will cause Auxilium's assessments to change. However,
while Auxilium may elect to update these forward-looking statements
at some point in the future, Auxilium specifically disclaims any
obligation to do so. These forward-looking statements should not be
relied upon as representing Auxilium's assessments as of any date
subsequent to the date of this release.
For More Information, Contact:
James E. Fickenscher
CFO
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
Email Contact
William Q. Sargent, Jr.
V.P., IR
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
Email Contact
SOURCE: Auxilium Pharmaceuticals, Inc.
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