Auxilium Pharmaceuticals, Inc. Announces 30 Month XIAFLEX® Safety Update

   Auxilium Pharmaceuticals, Inc. Announces 30 Month XIAFLEX® Safety Update

−Safety Profile Consistent with Clinical Trials after approximately 27,000
injections administered in U.S. through July 31, 2012−

PR Newswire

MALVERN, Pa., Sept. 5, 2012

MALVERN, Pa., Sept. 5, 2012 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc.
(NASDAQ: AUXL), a specialty biopharmaceutical company, today announced a
safety update following 30 months of post-approval use in the U.S. of XIAFLEX®
for the treatment of adult Dupuytren's contracture patients with a palpable
cord.  After approximately 27,000 injections administered to approximately
21,000 patients in the U.S., there was no clinically meaningful change in the
nature of events expected relative to the clinical trial safety profile. 

(Logo: http://photos.prnewswire.com/prnh/20101202/MM10881LOGO)

From February 2, 2010 through July 31, 2012, approximately 1,454 adverse
events have been reported to the Company. Of those reported events, the most
commonly reported events were laceration, peripheral edema (swelling) and
contusion (bruising). Adverse event reporting requirements post-approval are
different from requirements for reporting such events during a clinical
trial.  See "About Voluntary Safety Reporting" below.

In the phase III clinical trials for registration, three (0.3%) subjects
experienced a tendon rupture and one (0.1%) subject experienced ligament
damage (pulley rupture) following XIAFLEX treatment of 1,082 subjects in the
safety database.  In the U.S. post-marketing period, 19 tendon ruptures
(0.09%) and 3 ligament injuries (0.01%) from approximately 21,000 patients
treated with commercial drug were reported.  Additionally, there has been a
single report of complex regional pain syndrome (0.005%), that resolved within
approximately 3 months, and a single case of residual stretch neuropraxia
(numbness without pain) (0.005%) with full finger extension and remote from
the injection site. Since launch, nearly 2,000 U.S. physicians have injected
palpable cords in Dupuytren's contracture patients with XIAFLEX.

"Based on reported events, we believe that XIAFLEX continues to demonstrate a
safety profile in post-approval use that is potentially better than what we
saw in the clinical trials," said Dr. James P. Tursi, Chief Medical Officer of
Auxilium.   "In particular, we believe that the continuing low numbers of
tendon and ligament damage reported since XIAFLEX has been commercially
available in the U.S. indicate that the training program implemented by the
Company is working and the learning curve for health care providers using
XIAFLEX appears to be short." 

About Voluntary Safety Reporting

Auxilium is committed to patient safety.  With any voluntary safety reporting
system, such as that in the U.S., there are limitations regarding
interpretation of the data. The system relies on reporting of events from
physicians, patients, and other healthcare providers.  Auxilium employees also
are trained to report events of which they are made aware.  The above
estimates are based upon voluntary reporting and reflect all information
available to Auxilium from February 2, 2010 thru July 31, 2012 for the use of
XIAFLEX in adult patients with Dupuytren's contracture with a palpable cord in
the U.S.

About Auxilium

Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a
focus on developing and marketing products to predominantly specialist
audiences. Auxilium markets Testim® 1% (testosterone gel) for the topical
treatment of hypogonadism in the U.S. and XIAFLEX® (collagenase clostridium
histolyticum (CCH)) for the treatment of adult DC patients with a palpable
cord. GlaxoSmithKline LLC co-promotes Testim with Auxilium 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. Pfizer has marketing rights
for XIAPEX® (the EU tradename for collagenase clostridium histolyticum) in 46
countries in Eurasia; 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 has three projects in clinical development. XIAFLEX is in
phase III of development for the treatment of Peyronie's disease. CCH is in
phase IIa of development for the treatment of Frozen Shoulder syndrome
(adhesive capsulitis) and phase Ib of development for the treatment of
cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights
to pursue additional indications for XIAFLEX. 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 potential for adverse events when using XIAFLEX for the
treatment of Dupuytren's contracture in the future;  the potential for the
safety profile of XIAFLEX in post-approval use to be better than in the
clinical trials; the effectiveness of the XIAFLEX training program; products
in development for Peyronie's disease, Frozen Shoulder syndrome and cellulite;
and the potential for XIAFLEX to be used in multiple indications. 

Forward-looking statements often address Auxilium's expected future financial
position or business strategy and plans and objectives of management for
future operations. Forward-looking statements provide Auxilium's current
expectations or forecasts of future events. Auxilium's performance and
financial results could differ materially from those reflected in these
forward-looking statements due to various risks and uncertainties.

A more detailed list and description of the risks and uncertainties that
Auxilium faces may be found under the heading "Risk Factors" in Auxilium's
Annual Report on Form 10-K for the year ended December 31, 2010 and Form 10-Q
for the quarter ended June 30, 2012, which are on file with the Securities and
Exchange Commission. Given these risks and uncertainties, any or all of the
forward-looking statements contained in this release may prove to be
incorrect. Therefore, you should not rely on any such factors or
forward-looking statements. Auxilium undertakes no obligation to update
publicly any forward-looking statement.                        

Auxilium Contacts: 
James E. Fickenscher / CFO                           William Q. Sargent, Jr. /
                                                     V.P., IR
Auxilium Pharmaceuticals, Inc.                       Auxilium Pharmaceuticals,
                                                     Inc.
(484) 321-5900                                       (484) 321-5900
jfickenscher@auxilium.com                            wsargent@auxilium.com

 

SOURCE Auxilium Pharmaceuticals, Inc.

Website: http://www.auxilium.com/