Contact 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 +1-484-321-5900
XIAFLEX(TM) for the Treatment of Dupuytren's Contracture Receives Priority Review From the U.S. Food and Drug Administration
| Source: Auxilium Pharmaceuticals, Inc.
MALVERN, PA--(Marketwire - April 28, 2009) - Auxilium Pharmaceuticals, Inc. (NASDAQ : AUXL ),
a specialty biopharmaceutical company, today announced that the U.S. Food
and Drug Administration (FDA) has accepted for filing and granted priority
review status to its Biologics License Application (BLA) for XIAFLEX™
(clostridial collagenase for injection), a novel, first-in-class,
orphan-designated, biologic for the treatment of Dupuytren's contracture.
Under the Prescription Drug User Fee Act (PDUFA), the FDA is expected to
take action on the application by August 28, 2009.
"We are pleased that the FDA has granted priority review for our XIAFLEX
BLA. We believe this designation emphasizes the significant need for a
non-surgical treatment alternative for Dupuytren's contracture," said
Armando Anido, Chief Executive Officer and President of Auxilium. "We look
forward to working with the FDA as it reviews the application. If
approved, we are planning for a U.S. launch approximately 60 days following
XIAFLEX approval."
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(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® 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™ (clostridial
collagenase for injection), 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 date on which the U.S. Food and Drug Administration will take
action on the application; the approval of XIAFLEX for the treatment of
Dupuytren's contracture by the U.S. Food and Drug Administration and the
timing of launch of the product in the U.S., if approved; the potential
need of Dupuytren's contracture patients for XIAFLEX; 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.