MALVERN, PA, Jun 03, 2008 (MARKET WIRE via COMTEX News Network) -- In the news release, "Auxilium Pharmaceuticals, Inc. Announces
XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p <
0.001) in CORD I Pivotal Phase III Study for Dupuytren's
Contracture," issued earlier today by Auxilium Pharmaceuticals, Inc.
(NASDAQ: AUXL), please be advised that Marketwire incorrectly
replaced the "greater than or equal to" symbol with the phrase "less
than or equal to" and the "less than or equal to" symbol with the
phrase "greater than or equal to" 12 times throughout the text and
the chart of the press release. Marketwire accepts full
responsibility for these errors. Complete corrected text follows.
Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary
Endpoint With Statistical Significance (p < 0.001) in CORD I Pivotal
Phase III Study for Dupuytren's Contracture
XIAFLEX Also Meets Primary Endpoint (p < 0.001) in Australian CORD II
Phase III Study; Pharmacokinetic Study Demonstrates Lack of Systemic
Exposure of XIAFLEX; Serious Adverse Events Occurring at a 0.33% Rate
per XIAFLEX Injection; Conference Call Scheduled for Today, June 3,
at 8:45 a.m. Eastern Time
MALVERN, PA--(June 03, 2008) - Auxilium Pharmaceuticals, Inc.
(NASDAQ: AUXL) today announced positive top-line efficacy and safety
results from the CORD I and CORD II phase III clinical trials for
XIAFLEX(TM) (clostridial collagenase for injection) in the treatment
of Dupuytren's contracture. Each of the CORD I and II trials
successfully met the primary endpoint, a reduction in the angle of a
patient's joint contracture to less than or equal to 5 degrees of
normal, as measured by digital goniometry, 30 days after the last
injection. The Company also released results of a Pharmacokinetic
("PK") Study that demonstrate the lack of systemic exposure of
XIAFLEX in patients treated for Dupuytren's contracture. The most
common adverse events in the CORD I and II and PK studies were
consistent with adverse events reported in previous trials and
included pain, swelling, bruising and pruritis at the injection site
and transient lymph node swelling and pain. In over 2,000 XIAFLEX
injections administered in approximately 850 patients through the end
of May 2008, a total of seven serious adverse events ("SAEs")
possibly related to study drug have been reported, five of which are
related to tendon or ligament injury (rate per injection = 0.24%).
"We believe that this is a great day for the patients who suffer from
Dupuytren's contracture, the physicians who treat the disease, and
Auxilium, as XIAFLEX appears to offer a safe and effective,
non-surgical treatment for Dupuytren's contracture," said Armando
Anido, Auxilium's Chief Executive Officer and President. "We expect
the results of these trials, together with all previous clinical and
pre-clinical data, will enable us to submit a Biologics License
Application for XIAFLEX in Dupuytren's contracture in early 2009. I
wish to thank all the patients, investigators and Auxilium employees
who contributed to these trials."
CORD I Efficacy Results
CORD I is the largest placebo-controlled study ever conducted in
Dupuytren's contracture patients and the second U.S. pivotal phase
III study for XIAFLEX in Dupuytren's contracture. A total of 306
patients evaluable for efficacy enrolled in 16 clinical sites across
the U.S., with 203 patients receiving XIAFLEX and 103 receiving
placebo in the double-blind portion of the study. The joints were
stratified 2:1 Metacarpal Phalangeal Joint, or MP joint, to Proximal
Intra-Phalangeal, or PIP joint. The primary endpoint was met with
64% (130 of 203) of patients' primary joints treated with XIAFLEX
achieving less than or equal to 5 degrees of normal contracture,
compared to only 6.8% (7 of 103) of patients' primary joints treated
with placebo (p < 0.001). On average, Dupuytren's contracture
patients who achieved the primary endpoint received 1.5 XIAFLEX
injections.
In addition to the primary endpoint, there were 26 secondary
endpoints that were measured, each of which was met with statistical
significance. The Company believes two important secondary endpoints
are the difference between the pre- and post-treatment contracture
angles and whether patients achieved at least a 50% reduction in
their contracture compared to baseline. First, the average percent
improvement in contracture from baseline was 79.3% (50.2 degrees
average contracture at baseline down to 12.2 degrees average
contracture after treatment) for primary joints treated with XIAFLEX,
compared to placebo patients, where the average percent improvement
in contracture from baseline was 8.6% (49.1 degrees average
contracture at baseline down to 45.7 degrees average contracture
after placebo treatment) (p < 0.001). Second, 84.7% of patients (172
of 203) treated with XIAFLEX achieved at least a 50% reduction in
their primary joint contracture from baseline, compared with 11.7% of
patients (12 of 103) treated with placebo (p < 0.001).
Dr. Lawrence Hurst, M.D., Professor and Chair, Department of Hand
Surgery, Department of Orthopaedics of the Health Science Center,
State University of New York at Stony Brook, an investigator in the
CORD I clinical trial, said, "I believe these clinical results are
very encouraging for patients with Dupuytren's contracture. As a
surgeon, I am pleased to get contracture improvement to less than or
equal to 5 degrees of normal in 50-60% of patients who undergo
surgery. Based on the risk/benefit profile demonstrated in the data
released today, I would anticipate that XIAFLEX will offer a strong
therapeutic alternative to surgery and could potentially become the
new first-line treatment option for Dupuytren's contracture."
CORD II Efficacy Results
CORD II enrolled a total of 66 Dupuytren's contracture patients in
five clinical sites across Australia. Forty-five patients received
XIAFLEX and 21 received placebo in the double-blind portion of the
study. The joints were stratified 1:1 MP to PIP. The primary
endpoint was met, with 44.4% (20 of 45) of patients' primary joints
treated with XIAFLEX achieving less than or equal to 5 degrees of
normal contracture, compared to only 4.8% (1 of 21) of patients'
primary joints treated with placebo (p < 0.001). On average,
Dupuytren's contracture patients who achieved the primary endpoint
received 1.5 XIAFLEX injections.
Within the CORD II study, average percent improvement in contracture
from baseline was 70.5% (53.2 degrees average contracture at baseline
down to 16.7 degrees average contracture after treatment) for primary
joints treated with XIAFLEX. For placebo patients, the average
percent improvement in primary joint contracture from baseline was
13.6% (50 degrees average contracture at baseline down to an average
44.3 degrees after placebo treatment) (p < 0.001). A greater than or
equal to 50% reduction from baseline in the affected joint's
contracture was achieved in 77.8% of patients (35 of 45) of all
primary joints treated with XIAFLEX compared to 14.3% of patients (3
of 21) for joints treated with placebo (p < 0.001).
Top-line Efficacy Results of CORD I and CORD II
XIAFLEX arm Placebo arm p-value
------------- ------------- -------
CORD I:
Number of evaluable subjects 203 103
Percentage of contractures 64% 6.8% < 0.001
achieving less than or equal (130/203) (7/103)
to 5 degrees of normal
Average percent improvement in 79.3% 8.6%
contracture from baseline (50.2 degrees/12.2 degrees) (49.1 degrees/45.7 degrees) < 0.001
Percentage of contractures 84.7% 11.7%
achieving greater than or equal to (172/203) (12/103) < 0.001
50% reduction
CORD II:
Number of evaluable subjects 45 21
Percentage of contractures 44.4% 4.8%
achieving less than or equal (20/45) (1/21) < 0.001
to 5 degrees of normal
Average percent improvement in 70.5% 13.6%
contracture from baseline (53.2 degrees/16.7 degrees) (50.0 degrees/44.3 degrees) < 0.001
Percentage of contractures 77.8% 14.3%
achieving greater than or equal to (35/45) (3/21) < 0.001
50% reduction
Note: All data applies to primary joint 30 days after last
"As described in the available literature on surgery and as we have
seen in previous XIAFLEX clinical studies, the CORD I and II trials
demonstrate that MP joints generally respond better to treatment than
PIP joints, and joints of lesser severity generally respond better
than joints of higher severity," said Dr. Tony DelConte, Chief
Medical Officer for Auxilium. "We believe these findings will be
well-received by the physician and patient community who have
expressed a desire to treat affected joints earlier than current
surgical practice."
Pharmacokinetic Study Results
An open label study was conducted to assess the pharmacokinetics of a
single injection of XIAFLEX in 16 subjects with Dupuytren's
contracture. Nine patients with MP contractures and seven patients
with PIP contractures were enrolled in the study. No measurable
levels of XIAFLEX were detected in plasma from 5 minutes to 30 days
post injection.
Although the study was not designed to measure efficacy in comparison
to placebo, 12 of the 16 patients achieved less than or equal to 5
degrees of normal contracture after their only injection of XIAFLEX.
Adverse Events
The most common adverse events reported in the CORD I and II and PK
studies were pain, swelling, bruising and pruritis at the injection
site and transient lymph node swelling and pain. These adverse
events were consistent with previous trials. No systemic allergic
reactions were noted.
In data from the CORD I and II studies, the open label JOINT I and II
studies and the PK study, over 2,000 XIAFLEX injections have been
administered to approximately 850 patients through the end of May
2008. There have been seven SAEs possibly related to drug (rate per
injection = 0.33%). There have been a total of three confirmed
tendon ruptures (rate per injection = 0.14%), one reported tendon
rupture remains unconfirmed (rate per injection = 0.05%), and one
pulley ligament injury (rate per injection = 0.05%). Additionally,
one complex regional pain syndrome (rate per injection = 0.05%) and
one deep vein thrombosis ("DVT") (rate per injection = 0.05%)
occurred. Three SAEs occurred in CORD I (two tendon ruptures and the
complex regional pain syndrome), two occurred in JOINT II (DVT and a
tendon rupture), one occurred in CORD II (a pulley ligament injury)
and one tendon rupture occurred in the PK study.
"In summary, we believe that based on all clinical data for XIAFLEX
in Dupuytren's contracture to date, we are positioned to bring a novel
therapeutic to market that has the potential to revolutionize the
treatment of Dupuytren's contracture," stated Mr. Anido. "The data
indicate that approximately 4 out of 5 patients may achieve at least
a 50% reduction in their contractures, and we believe the rate of
reported serious adverse events compares favorably to the
complications of surgery described in the available literature."
Conference Call
Auxilium will hold a conference call today, June 3, 2008 at 8:45 a.m.
ET, to discuss the results of the CORD I and II studies and the PK
study and provide updates on the XIAFLEX programs in general. The
conference call will be simultaneously web cast on Auxilium's web
site and archived for future review until July 3, 2008. Reference
materials for the conference call also will be available on
Auxilium's web site.
Conference call details:
Date: Tuesday, June 3, 2008
Time: 8:45 a.m. ET
Dial-in (U.S.): 800-322-2803
Dial-in (International): 617-614-4925
Password: 59892572
The reference materials that will be utilized by the Company during
the call may be accessed by clicking the "For Investors" tab on the
home page of the Company's web site at http://www.auxilium.com
Web cast: http://www.auxilium.com
To access an audio replay of the call:
Access number (U.S.): 888-286-8010
Access number (International): 617-801-6888
Conference ID#: 29592205
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, painful 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.
Currently, surgery is the only effective treatment. The incidence of
Dupuytren's contracture 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. There are currently no
drugs approved by the U.S. Food and Drug Administration for
Dupuytren's contracture, which is treated primarily by an open
surgical procedure.
(1) American Academy of Orthopaedic Surgeons.
http://orthoinfo.aaos.org/topic.cfm?topic=A00008
(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 CORD I
The U.S. pivotal trial is a double-blind, randomized,
placebo-controlled study of XIAFLEX with 308 patients enrolled in 16
sites throughout the U.S. The primary endpoint of the study is to
determine if XIAFLEX can reduce the contracture angle in
metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints to
less than or equal to 5 degrees of normal. In CORD I, MP and PIP
patients were stratified in a 2:1 ratio.
All patients receiving XIAFLEX in the double-blind portion of the
study will be monitored for a minimum of 12 months following initial
dosing. After finishing the double-blind portion, XIAFLEX and placebo
patients are also eligible to receive additional XIAFLEX injections
for either unsuccessfully treated joints or additional untreated
joints during an open-label, extended treatment period. This
open-label phase was designed to provide further data for the
long-term safety and efficacy of XIAFLEX injections in the treatment
of Dupuytren's contracture.
About CORD II
This Australian study is a supportive double-blind, randomized,
placebo-controlled study with an open-label extension that enrolled
66 patients in five sites. The design of this study is similar to that
of the pivotal U.S. phase III trial (CORD I) and its open-label
extension. The primary endpoint was the reduction of contracture
angle in MP or PIP joints to less than or equal to 5 degrees of
normal. In CORD II, MP and PIP patients were stratified in a 1:1
ratio.
After finishing this double-blind portion, patients from both XIAFLEX
and placebo groups will be permitted to receive additional XIAFLEX
injections for either unsuccessfully treated joints or additional
untreated joints during an open-label, extended treatment period.
This open-label phase was designed to provide further data for the
long-term safety and efficacy of XIAFLEX injections in the treatment
of Dupuytren's contracture.
About JOINT I and II
In addition to the open-label extensions of CORD I and II, the
Company is concurrently conducting two phase III open-label studies
in approximately 600 patients. These studies will provide additional
safety and efficacy data and will contribute to the safety database
that is required for the BLA.
About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical
company with a focus on developing and marketing to urologists,
endocrinologists, orthopedists and select primary care physicians.
Auxilium markets Testim(R) 1%, a topical testosterone gel, for the
treatment of hypogonadism through its approximately 190-person sales
and marketing team. Auxilium has four projects in clinical
development. XIAFLEX(TM) (clostridial collagenase for injection) is
in phase III of development for the treatment of Dupuytren's
contracture and is in phase II of development for the treatment of
Peyronie's disease and Frozen Shoulder syndrome (Adhesive
Capsulitis). Auxilium also has options to all indications using
XIAFLEX for non-topical formulations. Auxilium's transmucosal film
product candidate for the treatment of overactive bladder is in phase
I of development. Auxilium has one pain product using its
transmucosal film delivery system in pre-clinical development and has
rights to seven additional pain products and products for hormone
replacement and urologic disease using its transmucosal film delivery
system. 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
significance of clinical data to Auxilium, the patients suffering
from Dupuytren's contracture and the physicians who treat these
patients and the degree to which these individuals find the clinical
data reported by Auxilium to be compelling; the contribution of the
results of CORD I and CORD II, together with all the previous
clinical and pre-clinical data, to the Biologics License Application
for XIAFLEX for the treatment of Dupuytren's contracture (the "BLA");
the timing of the filing of the BLA; the importance of certain
secondary endpoints in the CORD I trial, including the difference
between the pre- and post-treatment contracture angles and whether
patients achieved at least a 50% reduction in their contracture
compared to baseline; the utility of XIAFLEX in the treatment of
Dupuytren's contracture, including the potential for XIAFLEX as the
first-line treatment option for Dupuytren's contracture; the potential
of XIAFLEX to revolutionize the treatment for Dupuytren's
contracture; the benefits of XIAFLEX compared to surgery for the
treatment of Dupuytren's contracture and the ability of XIAFLEX to
address the medical need for a non-surgical treatment for Dupuytren's
contracture earlier in the disease process; the period of time during
which patients receiving XIAFLEX in the studies will be monitored;
and products in development for Dupuytren's contracture, Peyronie's
disease, Frozen Shoulder syndrome, overactive bladder, pain, hormone
replacement and urologic disease. All statements other than
statements of historical facts contained in this release, including
but not limited to, statements regarding future expectations, plans
and prospects for the Company, statements regarding forward-looking
financial information and other statements containing the words
"believe," "appears," "may," "could," "will," "estimate," "continue,"
"anticipate," "intend," "should," "plan," "expect," and similar
expressions, as they relate to the Company, constitute
forward-looking statements. 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, general financial, economic, regulatory and political
conditions affecting the biotechnology and pharmaceutical industries
and those discussed in the Company's Annual Report on Form 10-K for
the year ended December 31, 2007 under the heading "Risk Factors",
which is 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 the
Company's home page on the Internet at http://www.auxilium.com under
the heading "Investor Relations -- 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. 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 the Company's
expectations, plans or forecasts of future events and views as of the
date of this release. The Company anticipates that subsequent events
and developments will cause the Company's assessments to change.
However, while the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so. These forward-looking statements
should not be relied upon as representing the Company'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 and Corp. Comm.
Auxilium Pharmaceuticals, Inc.
(484) 321-5926
Email Contact
SOURCE: Auxilium Pharmaceuticals, Inc.
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