Auxilium Pharmaceuticals, Inc. Receives Clearance To Resume Clinical Trials For XIAFLEX(TM)

Auxilium
Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that the Company has
received clearance from the U.S. Food and Drug Administration ("FDA") to
resume its phase III clinical trials for XIAFLEX (clostridial collagenase
for injection), formerly referred to as AA4500, in the treatment of
Dupuytren's contracture. The Company will hold a conference call today,
August 16, at 10:00 a.m. Eastern Time to discuss this news.


"We are delighted that we can resume our XIAFLEX phase III trials in
Dupuytren's contracture earlier than anticipated. We expect to begin
enrolling patients into our pivotal trial within the next 30 days," said
Armando Anido, Chief Executive Officer and President of Auxilium. "I would
like to give a special thanks to our employees for their tireless efforts
in making this achievement possible."



The Company plans to initiate a pivotal double-blind trial in the U.S.,
a double-blind trial in Australia, and two open label trials that along
with previously conducted trials will serve as the basis for the Biologics
License Application ("BLA") for marketing approval from the FDA.



The U.S. pivotal trial is a double-blind, randomized,
placebo-controlled study of XIAFLEX involving 216 patients in at least 15
sites throughout the U.S. Patients in the study will be randomized on a 2:1
basis in favor of treatment with XIAFLEX. 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 within
0 to 5 degrees of normal.



Upon completion of the double-blind trial in the U.S., all patients are
eligible to enter a separate open-label extension study in which they will
receive XIAFLEX if they were initially given placebo or have other affected
joints that need treatment. All patients in these studies will be monitored
for a minimum of 12 months following initial dosing for efficacy and safety
parameters.



The Australian study is a double-blind, randomized, placebo-controlled
study with an open-label extension that will enroll 60 patients. The design
of this study is similar to that of the U.S. pivotal phase III trial and
its open-label extension.



In addition to the double-blind studies and their open-label
extensions, the Company plans to concurrently conduct two phase III
open-label studies in approximately 440 patients. These studies will
provide additional safety and efficacy data and will contribute to the
safety database that is required for the BLA.



"As XIAFLEX is ultimately targeted for worldwide markets, we believe
that it is very important to perform well-controlled clinical trials at
sites inside and outside of the U.S.," said Dr. Jyrki Mattila M.D., Ph.D.,
Executive Vice President of R&D, Business Development and Technical
Operations. "The Company is eager to raise global physician and patient
understanding of the potential benefits of XIAFLEX."
















With respect to the clinical program for XIAFLEX for the treatment of
Dupuytren's contracture, Auxilium expects to:


- complete enrollment in the pivotal U.S. trial and the Australian trial
by the end of 2007;


- release top-line results from the double-blind phase III clinical trials
in the second quarter of 2008; and


- file the BLA for approval of XIAFLEX by FDA in early 2009.


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: 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 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), formerly referred to as AA4500, is in phase III development for
the treatment of Dupuytren's contracture and is in phase II 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 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 auxilium.



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 and outcome of the open-label studies, the
utility of the data from the open-label studies in the BLA, the Company's
ability to increase physician and patient understanding of XIAFLEX
overseas; the timing of completion of enrollment in the pivotal U.S. trial
and the Australian trial; the timing of the release of top-line results
from the phase III trials; the timing of the filing of the BLA; 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 June 30, 2007 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
sec or by means of the Company's home page on the Internet
at auxilium 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.


Auxilium Pharmaceuticals, Inc.

auxilium



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