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U.S. Food and Drug Administration's
Arthritis Advisory Committee Confirms Date to Review XIAFLEX™
for the Treatment of Dupuytren's Contracture
MALVERN, PA, Jul 31, 2009 (MARKETWIRE via COMTEX) -- Auxilium
Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty
biopharmaceutical company, today announced that the U.S. Food
and Drug Administration's (FDA) Arthritis Advisory Committee
confirmed it will review XIAFLEX™ during an advisory
committee hearing at the Holiday Inn in Gaithersburg, MD on
September 16, 2009. The Arthritis Advisory Committee is an
official advisory committee of the FDA's Division of Anesthesia,
Analgesia and Rheumatology Products (DAARP). Advisory committees
provide the FDA with independent expert advice on scientific,
technical, and policy matters.
XIAFLEX (collagenase clostridium histolyticum) is a novel,
first-in-class, orphan-designated, biologic for the treatment of
Dupuytren's contracture. Auxilium filed its Biologics License
Application (BLA) for XIAFLEX for the treatment of Dupuytren's
contracture on February 27, 2009. The FDA has not updated the
Prescription Drug User Fee Act (PDUFA) date of August 28, 2009.
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.(1) Most cases of Dupuytren's contracture occur in
patients older than 50 years and a hereditary component exists
in approximately 40% of patients.(1,2)
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.(1) 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) Tubiana, R. Dupuytren's Disease. London: Martin Dunitz Ltd,
2006
(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)
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™ (collagenase
Clostridium histolyticum), formerly referred to as AA4500, has
completed phase III clinical trials for the treatment of
Dupuytren's contracture, and the biologics license application
is under review at the FDA for the treatment of Dupuytren's
contracture. XIAFLEX 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) and its fentanyl
pain product using its transmucosal delivery system are in phase
I of development. The Company is currently seeking a partner to
further develop these product candidates. Auxilium has rights to
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
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 timing of actions to be taken
by the FDA; the date of the FDA Arthritis Advisory Committee
meeting to review XIAFLEX and the participants in such meeting;
the interpretation of data; the potential benefits and
effectiveness of XIAFLEX for 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 "For Investors -- 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
Chief Financial Officer
Auxilium Pharmaceuticals, Inc.
+1-484-321-5900
or
William Q. Sargent Jr.
Vice-President
Investor Relations and Corporate Communications
Auxilium Pharmaceuticals, Inc.
+1-484-321-5926
Source
Auxilium Pharmaceuticals, Inc.
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