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U.S. Food and Drug Administration's
Arthritis Advisory Committee Votes Unanimously 12-0 to Recommend
Approval of XIAFLEX™ for Dupuytren's Contracture
Auxilium to Host Conference Call and Webcast on Thursday,
September 17 at 8:00 a.m. Eastern Time
MALVERN, PA, Sep 16, 2009 (MARKETWIRE via COMTEX) -- Auxilium
Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty
biopharmaceutical company, today announced that the Arthritis
Advisory Committee appointed by the U.S. Food and Drug
Administration (FDA) recommended by a unanimous vote of 12 to 0
that XIAFLEX™ (collagenase clostridium histolyticum), a novel,
first-in-class, orphan-designated, biologic, be granted
marketing approval by the FDA for the treatment of Dupuytren's
contracture.
"We are very pleased with the Advisory Committee's unanimous
recommendation, which supports our view that XIAFLEX has a
favorable benefit to risk profile in the treatment of
Dupuytren's contracture," said Armando Anido, Chief Executive
Officer and President of Auxilium. "XIAFLEX has the potential to
provide an important new non-surgical treatment option for
patients with Dupuytren's contracture, a debilitating hand
condition severely affecting patients' quality of life."
The Advisory Committee's recommendation, although not binding,
will be considered by the FDA in its review of the Biologics
License Application that Auxilium has submitted for XIAFLEX. The
original target Prescription Drug User Fee (PDUFA) action date
for the FDA's decision as to whether to grant marketing approval
for XIAFLEX was August 28, 2009. The FDA has not updated the
target PDUFA action date.
Conference Call
Auxilium will hold a conference call tomorrow, September 17 at
8:00 a.m. EDT, to discuss the outcome of today's FDA's Arthritis
Advisory Committee meeting and other related topics. The
conference call will be simultaneously web cast on Auxilium's
web site and archived for future review until October 17, 2009.
Conference call details:
Date: Thursday, September 17, 2009
Time: 8:00 a.m. EDT
Dial-in (U.S.): 866-543-6407
Dial-in (International): 617-213-8898
Web cast:
http://www.auxilium.com
Passcode: Auxilium
To access an audio replay of the call:
Access number (U.S.): 888-286-8010
Access number (International): 617-801-6888
Replay Passcode #: 99930573
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. (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. 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) Hurst, L. C. et al., Injectable Collagenase Clostridium
Histolyticum for Dupuytren's Contracture, New England Journal of
Medicine, (2009; 361:968-979)
(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 benefit to risk profile of
XIAFLEX for the treatment of Dupuytren's contracture; the timing
of FDA review of the BLA for XIAFLEX and the approval thereof;
the number of patients with 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, our beliefs or
statements of plans or objectives for future operations
(including statements of assumption underlying or relating to
any of the foregoing). Forward-looking statements can generally
be identified by 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, beliefs, 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
and in Auxilium's Quarterly Report on Form 10-Q for the period
ended June 30, 2009 under the heading "Risk Factors", which are
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.
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
+1-484-321-5900
SOURCE:
Auxilium Pharmaceuticals, Inc.
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