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Auxilium Pharmaceuticals, Inc. Completes Enrollment in Two Phase III Clinical Trials of XIAFLEX(TM) for Dupuytren's Contracture
| Source: Auxilium Pharmaceuticals, Inc.
MALVERN, PA--(Marketwire - December 17, 2007) - Auxilium Pharmaceuticals, Inc. (NASDAQ : AUXL )
today announced that it has completed patient enrollment in the Company's
second U.S. phase III pivotal trial (CORD I) and its Australian phase III
study (CORD II) of XIAFLEX (clostridial collagenase for injection) for the
treatment of Dupuytren's contracture. In accordance with the study design,
all enrolled patients have received their first injection of either XIAFLEX
or placebo. Due to the high level of interest from patients and
physicians, the Company was able to exceed its enrollment targets in both
studies, with greater than 300 patients enrolled in the CORD I and CORD II
studies combined. The Company had targeted enrolling 216 patients in CORD
I and 60 patients in CORD II.
"We are pleased to achieve this significant milestone within the aggressive
timetable established in advancing what can potentially be the first
non-invasive, non-surgical treatment for patients afflicted with
Dupuytren's contracture," said Mr. Armando Anido, Chief Executive Officer
and President of Auxilium. "We continue to believe that we will report top
line efficacy results from these two trials in the second quarter of 2008
and that we are on track to file a Biologics License Application with the
Food and Drug Administration in early 2009."
The Company also announced that enrollment in the JOINT I and JOINT II open
label studies, which are designed to enroll approximately 450 additional
patients, is progressing as planned, with over 300 patients enrolled to
date.
About CORD I and CORD II
The U.S. CORD (Collagenase Option for Reducing Dupuytren's) I study is a
double-blind, randomized, placebo-controlled study of XIAFLEX. Patients in
the study are randomized on a 2:1 basis in favor of XIAFLEX treatment. To
qualify for the study, patients must have at least 20 degrees of
contracture. The primary endpoint of the study is to determine if XIAFLEX
can reduce the contracture angle of the primary joint to within 0 to 5
degrees of normal after up to three injections of XIAFLEX.
Upon completion of the double-blind study, all patients are eligible to be
enrolled in a separate open label extension study in which the patient will
receive active drug if they were initially given placebo and/or they have
the opportunity to have other affected joints treated. Data from the
double-blind study and the open label extension study will form the basis
of
12-month follow-up information to be used in the Biologics License
Application for marketing approval of XIAFLEX submitted to the U.S. Food
and Drug Administration.
The Australian CORD II study is a double-blind, randomized,
placebo-controlled study and follows a protocol similar to that of the U.S.
CORD I study and its open label extension.
About Dupuytren's Contracture
Dupuytren's contracture is a condition that involves contracture of joints
in the hand that impairs patients' ability to straighten and move their
fingers due to a thickening and shortening of the normal ligaments of the
palm and fingers. As the disease progresses, functionality of the hand is
severely impaired. The incidence of Dupuytren's contracture is highest in
Caucasians, historically those of Northern European descent. Most cases of
Dupuytren's contracture occur in patients older than 50 years.(1)
The most frequently affected joints associated with Dupuytren's contracture
are the joints called the metacarpophalangeal joint, or MP joint, which is
the joint closest to the palm of the hand and the proximal interphalangeal
joint, or the PIP joint, which is the middle joint in the finger. The
little finger and ring finger are most frequently involved.
(1) Badalamente, M. A., Hurst, L. C. et al., Collagen as a Clinical Target:
Non-operative 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 to urologists, endocrinologists,
orthopedists and select primary care physicians. Auxilium markets
Testim® 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 (clostridial
collagenase for injection), formerly referred to as AA4500, 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's transmucosal film
product candidate for the treatment of overactive bladder (AA4010) is in
phase I of development. The Company is currently seeking a partner to
further develop this product candidate. Auxilium has two pain products
using its transmucosal film delivery system in pre-clinical development.
Auxilium has rights to six 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 timing of completion of enrollment in JOINT I and JOINT II;
the timing of reporting of the top line efficacy results for CORD I and
CORD II studies; the timing of the filing of the Biologics License
Application for XIAFLEX for the treatment of Dupuytren's contracture with
the U.S. Food and Drug Administration; 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," "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 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, 2006
and in the Company's Quarterly Report on Form 10-Q for the period ended
September 30, 2007 under the heading "Risk Factors," which are on file with
the Securities and Exchange Commission (the "SEC") and may be accessed
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cause actual results to differ from those contained in the forward-looking
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In addition, forward-looking statements provide the Company's expectations,
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