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Auxilium Pharmaceuticals, Inc. Submits Application To The FDA Requesting Approval Of XIAFLEX® For Concurrent Treatment Of

   Auxilium Pharmaceuticals, Inc. Submits Application To The FDA Requesting
   Approval Of XIAFLEX® For Concurrent Treatment Of Multiple Palpable Cords

sBLA Submitted for Dupuytren's Contracture, a Progressive Hand Disease that
Can Present with Multiple Collagen "Cords" That Limit Movement and Function

PR Newswire

CHESTERBROOK, Pa., Dec. 20, 2013

CHESTERBROOK, Pa., Dec. 20, 2013 /PRNewswire/ --Auxilium Pharmaceuticals,
Inc. (NASDAQ: AUXL), a fully integrated specialty biopharmaceutical company,
today announced the submission of a supplemental Biologics License Application
(sBLA) to the U.S. Food and Drug Administration (FDA) requesting approval of
XIAFLEX (collagenase clostridium histolyticum, or CCH) for the treatment of
multiple Dupuytren's contracture (DC) cords concurrently. It is estimated that
35 to 40 percent of annual surgical procedures in the U.S. are performed to
treat more than one DC cord at a time[i]. XIAFLEX is a biologic approved in
the U.S., EU, Canada and Australia for the treatment of adult DC patients with
a palpable cord and, in the U.S. for the treatment of adult men with
Peyronie's disease (PD) with a palpable plaque and curvature deformity of at
least 30 degrees at the start of therapy. XIAFLEX has been granted Orphan Drug
Designation in the U.S. by the FDA for DC and PD.

"We are pleased to present the multicord sBLA filing to the FDA ahead of
schedule, especially given the estimated high prevalence of multiple cords
among patients suffering from Dupuytren's contracture," said Adrian Adams,
Chief Executive Officer and President of Auxilium. "This is an important
milestone for Auxilium and, importantly, for patients, as we believe that a
potential label expansion would provide a non-surgical option for treating
multiple cords during one office procedure."

The sBLA, seeking expansion of the labeling for the concurrent treatment of
multiple palpable cords, is based on positive results from a global,
multicenter Phase 3b trial, together with data from the Company's earlier
MULTICORD (Multiple Treatment Investigation of Collagenase Optimizing the
Resolution of Dupuytren's) studies (AUX-CC-861 and AUX-CC-864).

About Dupuytren's Contracture
Dupuytren's disease is a progressive condition affecting the hand,
specifically the layer of tissue just under the skin of the palm and fingers.
While this layer of tissue normally contains collagen, in patients with
Dupuytren's there is an increase in the amount of collagen produced. Abnormal
collagen build-up results in nodule and cord formation that worsens over time.
Eventually, rope-like collagen cords may form, thicken and shorten, causing
the fingers to be drawn in toward the palm. This thickening and shortening of
the Dupuytren's cord can reduce the finger's range of motion (how much a
person can move or straighten them). Once the Dupuytren's collagen cord can be
felt, it is referred to as a "palpable cord." ^ [ii],[iii]

About XIAFLEX
XIAFLEX (collagenase clostridium histolyticum, or CCH) is a biologic approved
in the U.S., EU, Canada and Australia for the treatment of adult Dupuytren's
contracture patients with a palpable cord and, in the U.S. for the treatment
of adult men with Peyronie's disease with a palpable plaque and curvature
deformity of at least 30 degrees at the start of therapy. XIAFLEX consists of
a combination of two subtypes of collagenase, derived from Clostridium
histolyticum. Together, the collagenase sub-types are thought to work
synergistically to break the bonds of the triple helix collagen structure.
XIAFLEX has been granted Orphan status in the U.S. by the FDA for DC and PD.
Additionally, CCH is currently being studied in clinical trials in the
following collagen-related conditions: frozen shoulder syndrome (Phase 2),
cellulite (Phase 2), and lipoma (Phase 2).

About Auxilium
Auxilium Pharmaceuticals, Inc. is a fully integrated specialty
biopharmaceutical company with a focus on developing and commercializing
products to predominantly specialist audiences. Auxilium markets Testim
(testosterone gel) for the topical treatment of hypogonadism in the U.S. and
XIAFLEX (collagenase clostridium histolyticum (CCH) for the treatment of adult
men with Peyronie's disease with a palpable plaque and curvature deformity of
at least 30 degrees at the start of therapy in the U.S., and XIAFLEX for the
treatment of adult Dupuytren's contracture patients with a palpable cord 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. Swedish Orphan
Biovitrium AB has marketing rights for XIAPEX® (the EU tradename for CCH) in
71 Eurasian and African countries. 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 also markets TESTOPEL®, a
long-acting implantable testosterone replacement therapy, Edex®, the leading
branded non-oral drug for erectile dysfunction, Striant®, a buccal system for
testosterone delivery, Osbon ErecAid®, the leading device for aiding erectile
dysfunction, and also has a non-promoted respiratory franchise, including
Theo-24® and Semprex®-D, along with other non-promoted products, in the U.S.
Auxilium has exclusive marketing rights in the U.S. and Canada for STENDRA™,
an oral erectile dysfunction therapy. Auxilium has two projects in clinical
development. CCH is in Phase 2 of development for the treatment of Frozen
Shoulder syndrome (adhesive capsulitis) and Phase 2 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 news release contains forward-looking statements as defined by the
Private Securities Litigation Reform Act of 1995, including statements made
with respect to: the success of Auxilium's submission of a request for a label
expansion to the FDA regarding concurrent treatment of multiple palpable
Dupuytren's cords; the prevalence of multiple cords among DC patients; the
opportunity to broaden the utilization of XIAFLEX and the importance of and
potential for XIAFLEX to be used to treat multiple cords in one office visit;
the efficacy and safety profiles of XIAFLEX; continued evaluation of XIAFLEX;
Auxilium's other product candidates; and other statements regarding matters
that are not historical facts, and involve predictions. These statements
involve known and unknown risks, uncertainties and other factors that may
cause actual results, performance, achievements or prospects to be materially
different from any future results, performance, achievements or prospects
expressed in or implied by such forward-looking statements. In some cases you
can identify forward-looking statements by terminology such as ''may'',
''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'',
''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'',
''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of
these terms or similar expressions, although not all forward-looking
statements contain these identifying words. Although forward-looking
statements are based on Auxilium's current plans or assessments that are
believed to be reasonable as of the date of this press release, they
inherently involve certain risks and uncertainties. These forward-looking
statements are subject to a number of risks and uncertainties, including those
discussed under ''Risk Factors'' in Auxilium's Annual Report on Form 10-K for
the year ended December 31, 2012 and in other public filings with the SEC,
including, without limitation, as such Form 10-K was updated in Item 8.01 of
the Current Report on Form 8-K filed on April 29, 2013 and Auxilium's
Quarterly Reports for 2013. While Auxilium may elect to update the
forward-looking statements made in this news release in the future, Auxilium
specifically disclaims any obligation to do so. Auxilium's SEC filings may be
accessed electronically by means of the SEC's home page on the Internet at
http://www.sec.gov. 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.

Auxilium Contacts:
Keri P. Mattox / SVP, IR &     Nichol L. Ochsner / Senior Director, IR &
Corporate Communications      Corporate Communications
Auxilium Pharmaceuticals, Inc. Auxilium Pharmaceuticals, Inc.
(484) 321-5900                (484) 321-5900
kmattox@auxilium.com           nochsner@auxilium.com

[i] Ipsos DC Buying Process, Patient survey Aug-Sept'12, HCP survey
Sept-Oct'12, HCP n=496

[ii] Luck JV. Dupuytren's contracture: a new concept of the pathogenesis
correlated with surgical management.J Bone Joint Surg Am. 1959;41(4):635-664.

[iii] Desai SS, Hentz VR. Collagenase clostridium histolyticum for
Dupuytren's contracture. Expert Opin Biol Ther. 2010;10(9):1395-1404.

SOURCE Auxilium Pharmaceuticals, Inc.

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