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Auxilium Receives Notification of XIAFLEX® PDUFA Extension



          Auxilium Receives Notification of XIAFLEX® PDUFA Extension

PR Newswire

CHESTERBROOK, Pa., Aug. 28, 2013

CHESTERBROOK, Pa., Aug. 28, 2013 /PRNewswire/ -- Auxilium Pharmaceuticals,
Inc. (Nasdaq: AUXL), a specialty biopharmaceutical company, announced today
that the U.S. Food and Drug Administration ("FDA") has notified the Company
that it is extending the Prescription Drug User Fee Act ("PDUFA") goal date
for the Company's supplemental biologics license application ("sBLA") for
XIAFLEX^® (collagenase clostridium histolyticum) for the treatment of
Peyronie's disease ("PD") from September 6, 2013 to December 6, 2013.

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

During the course of recent product label discussions, Auxilium submitted
revisions regarding the Company's proposed Risk Evaluation and Mitigation
Strategy (REMS) program and other aspects related to the proposed label. The
FDA determined that this submission qualified as a major amendment filed
during the final three months of the review and extended the PDUFA goal date
to December 6, 2013.  The FDA has not requested that any additional clinical
studies be performed prior to the revised PDUFA action date.

"While we are disappointed in any delay of approval, we remain confident in
the XIAFLEX Peyronie's program and are committed to working with the FDA while
they complete their review," said Adrian Adams, Chief Executive Officer and
President of Auxilium Pharmaceuticals. "We are continuing to prepare for
commercialization in Peyronie's disease, assuming FDA approval by the revised
PDUFA date."

PD is a condition in which collagen scar tissue may develop under the skin of
the penis. The scar tissue, known as a Peyronie's plaque, can feel like a bump
and cause the penis to curve or bend when erect. This curvature deformity of
the penis can impact sexual intercourse, erections and erection appearance,
and can cause affected men to feel bothered, distressed, depressed or
embarrassed.

Auxilium submitted to FDA the safety and efficacy data from the pivotal
IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and
Safety Studies) trials, the Phase III studies that assessed XIAFLEX for the
treatment of PD. In IMPRESS I and IMPRESS II at 52 weeks, both co-primary
endpoints met statistical significance for mean percent improvement in penile
curvature deformity and mean improvement in the PDQ bother domain for XIAFLEX
subjects vs. placebo patients. XIAFLEX was generally well-tolerated.

About Peyronie's Disease
PD can affect men both physically and psychosocially. The disorder can result
in varying degrees of penile curvature deformity, disease bother, sexual
dysfunction, emotional distress, loss of self-esteem and depression. PD often
involves the development of collagen plaque, or scar tissue, on the shaft of
the penis that may harden and reduce flexibility, thus occasionally causing
pain and bending or arcing of the penis during erection. In addition to
difficulty with sexual intercourse, PD is commonly associated with emotional
distress, loss of self-esteem, disease bother and depression. PD is a
heterogeneous disease with an initial inflammatory component. This
inflammatory phase is poorly understood with a somewhat variable disease
course and occasional spontaneous resolutions of not greater than 13%^1. After
approximately 12 months of disease, the disease is reported to often develop
into a more chronic, stable phase^1. The estimated prevalence in adult men of
PD has been reported to be approximately 5%^2; however the disease is thought
to be underdiagnosed and undertreated^1. Based on U.S. historical medical
claims data, it is estimated that between 65,000 and 120,000 PD patients are
diagnosed every year, but only 5,000 to 6,500 PD patients are treated with
injectables or surgery annually^3.

(1)  L.A. Levine Peyronie's Disease: A Guide to Clinical Management. Humana
Press: 10-17, 2007.
(2)  Bella A. Peyronie's Disease J Sex Med 2007;4:1527–1538
(3)  SDI and data on file, Auxilium

About XIAFLEX

XIAFLEX (collagenase clostridium histolyticum; CCH) is a biologic approved in
the U.S., EU, Canada and Australia for the treatment of adult Dupuytren's
contracture (DC) patients with a palpable cord. XIAFLEX is a minimally
invasive treatment for this condition and consists of a highly purified
combination of two subtypes of collagenase, derived from Clostridium
histolyticum, in specific proportion. Together, the collagenase sub-types work
synergistically to break the bonds of the triple helix collagen structure more
effectively than human collagenase. CCH will be entering phase IIb of
development for the treatment of Frozen Shoulder syndrome (adhesive
capsulitis) and phase IIa of development for the treatment of cellulite
(edematous fibrosclerotic panniculopathy).  XIAFLEX has been granted Orphan
status in the U.S. by the FDA for DC and PD.

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 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 collagenase clostridium histolyticum) 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 three other non-promoted products, in the
U.S.  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 II of development for the treatment of Frozen Shoulder syndrome
(adhesive capsulitis) and phase II 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 whether and when XIAFLEX for the treatment of PD will receive
FDA approval,  the efficacy of Auxilium's product candidates, the design of
the REMS program that will be necessary for FDA approval of XIAFLEX for the
treatment of PD, the contents of the label for XIAFLEX for PD, Auxilium's
preparedness for the commercialization of XIAFLEX for PD, if approved by the
FDA, and Auxilium's future operations, financial position, future revenues,
projected costs, prospects, plans and objectives of management 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 Report on Form 10-Q filed on August 1, 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:
James E. Fickenscher / CFO      Nichol L. Ochsner / Senior Director, IR 
Auxilium Pharmaceuticals, Inc.  Auxilium Pharmaceuticals, Inc. 
(484) 321-5900                  (484) 321-5900
jfickenscher@auxilium.com       nochsner@auxilium.com

 

SOURCE Auxilium Pharmaceuticals, Inc.

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