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Auxilium Submits Biologics License
Application for XIAFLEX™ for the Treatment of Dupuytren's
Contracture to the U.S. Food and Drug Administration
MALVERN, PA, Mar 02, 2009 (MARKET WIRE via COMTEX) -- Auxilium
Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty
biopharmaceutical company, today announced that it has submitted
a Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA) for XIAFLEX(TM) (clostridial collagenase
for injection), a novel, first-in-class, orphan-designated
biologic for the treatment of Dupuytren's contracture.
"This BLA submission is a significant regulatory milestone for
XIAFLEX," said Armando Anido, Chief Executive Officer and
President of Auxilium. "There currently are no approved
non-surgical treatments available for Dupuytren's contracture,
which can be a debilitating disease that often affects patients'
quality of life. We believe that XIAFLEX, if approved, would be
the non-surgical treatment choice for the management of
Dupuytren's contracture and could meaningfully improve the lives
of patients diagnosed with the disease. We look forward to
working with the FDA as it reviews the XIAFLEX application."
The BLA submission is based on data from a total of 1082 treated
Dupuytren's contracture patients and over 2600 injections of
XIAFLEX.
Auxilium has requested Priority Review designation for this BLA
submission from the FDA. The Company expects to hear back from
the FDA on Priority Review designation within approximately 60
days from the filing date. If granted, the FDA, per Prescription
Drug User Fee Act guidelines, has up to six months from
submission date to take action on the BLA. Priority Review may
be granted to drug products that provide treatment when no
approved pharmacological treatments exist for a disease.
About Dupuytren's Contracture
Dupuytren's contracture is a condition that affects the
connective tissue that lies beneath the skin in the palm. The
disease is progressive in nature. Typically, nodules develop in
the palm as collagen deposits accumulate. As the disease
progresses, the collagen deposits form a cord that stretches
from the palm of the hand to the base of the finger. Once this
cord develops, the patient's fingers contract and the function
of the hand is impaired. Currently, surgery is the only
effective treatment. The incidence of Dupuytren's contracture is
highest in Caucasians, historically those of Northern European
descent, with a global prevalence of three to six percent of the
Caucasian population.(1) Most cases of Dupuytren's contracture
occur in patients older than 50 years and a hereditary component
exists in approximately 40% of patients.(2,3)
The most frequently affected parts of the hand associated with
Dupuytren's contracture are the joints called the Metacarpal-Phalangeal
Joint, or MP joint, which is the joint closest to the palm of
the hand and the Proximal Intra-Phalangeal Joint, or the PIP
joint, which is the middle joint in the finger. The little
finger and ring finger are most frequently involved and about
half of patients have bilateral disease.(2,3) There are
currently no drugs approved by the U.S. Food and Drug
Administration for Dupuytren's contracture, which is treated
primarily by an open surgical procedure.
(1) American Academy of Orthopaedic Surgeons.
http://orthoinfo.aaos.org/topic.cfm?topic=A00008
(2) 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)
(3) Tubiana, R. Dupuytren's Disease. London: Martin Dunitz Ltd,
2006
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
five projects in clinical development. XIAFLEX(TM) (clostridial
collagenase for injection), formerly referred to as AA4500, has
completed phase III clinical trials for the treatment of
Dupuytren's contracture, is in phase IIb of development for the
treatment of Peyronie's disease and is in phase II of
development for treatment of Frozen Shoulder syndrome (Adhesive
Capsulitis). Auxilium's transmucosal film product candidate for
the treatment of overactive bladder (AA4010) is in phase I of
development. Auxilium also has one pain product (fentanyl) using
its transmucosal film delivery system in phase I of development.
Auxilium has rights to additional pain products and products for
hormone replacement and urologic disease using its transmucosal
film delivery system. The Company is currently seeking a partner
to further develop these transmucosal film product candidates.
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 granting of priority review
for the biologics license application for XIAFLEX for the
treatment of Dupuytren's contracture by the U.S. Food and Drug
Administration and the timing of such priority review, if
granted; the potential benefits and effectiveness of XIAFLEX for
Dupuytren's contracture; the number of people suffering from
Dupuytren's contracture; products in development for Peyronie's
disease, Frozen Shoulder syndrome, overactive bladder, pain,
hormone replacement and urologic disease; and all other
statements containing projections, statements of future
performance or expectations, or statements of plans or
objectives for future operations (including statements of
assumption underlying or relating to any of the foregoing). You
can identify these statements by the fact that they use words
such as "believe," "appears," "may," "could," "will,"
"estimate," "continue," "anticipate," "intend," "should,"
"plan," "expect," and other words and terms of similar meaning
in connection with any discussion of projections, future
performance or expectations, plans or objectives for future
operations (including statements of assumption underlying or
relating to any of the foregoing). Actual results may differ
materially from those reflected in these forward-looking
statements due to various factors, including further evaluation
of clinical data, results of clinical trials, decisions by
regulatory authorities as to whether and when to approve drug
applications, and general financial, economic, regulatory and
political conditions affecting the biotechnology and
pharmaceutical industries and those discussed in Auxilium's
Annual Report on Form 10-K for the year ended December 31, 2008
under the heading "Risk Factors," which is 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
http://www.sec.gov or by means of Auxilium's home page on
the Internet at http://www.Auxilium.com under the heading
"Investor Relations -- SEC Filings." 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. 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 Auxilium's
expectations, plans or forecasts of future events and views as
of the date of this release. Auxilium anticipates that
subsequent events and developments will cause Auxilium's
assessments to change. However, while Auxilium may elect to
update these forward-looking statements at some point in the
future, Auxilium specifically disclaims any obligation to do so.
These forward-looking statements should not be relied upon as
representing Auxilium's assessments as of any date subsequent to
the date of this release.
For More Information, Contact:
James E. Fickenscher
CFO
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
William Q. Sargent Jr.
VP IR
Auxilium Pharmaceuticals, Inc.
(484) 321-5926
Source
Auxilium Pharmaceuticals, Inc.
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