Contact Information: 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
U.S. Food and Drug Administration's Arthritis Advisory Committee Sets Tentative Date to Review XIAFLEX(TM) for the Treatment of Dupuytren's Contracture
| Source: Auxilium Pharmaceuticals, Inc.
MALVERN, PA--(Marketwire - June 18, 2009) - Auxilium Pharmaceuticals, Inc. (NASDAQ : AUXL ),
a specialty biopharmaceutical company, today announced that the U.S. Food
and Drug Administration's (FDA) Arthritis Advisory Committee will review
XIAFLEX™ during an advisory committee hearing, tentatively scheduled to
take place 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.
"Since XIAFLEX is a new molecular entity, we have been anticipating an
advisory committee meeting," said Armando Anido, Chief Executive Officer
and President of Auxilium. "Due to administrative issues, the tentative
committee date is just beyond the previously announced PDUFA date of August
28, 2009, but we are encouraged that the FDA advisory committee is looking
at including hand and/or orthopedic surgeons on the panel. We believe that
the XIAFLEX application supports a compelling benefit-risk profile of
XIAFLEX in the treatment of Dupuytren's contracture."
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® 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
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