MALVERN, PA, Sep 17, 2008 (MARKET WIRE via COMTEX News Network) -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty
biopharmaceutical company, today announced that the first patients
have been dosed in the Company's U.S. phase IIb trial of XIAFLEX(TM)
for the treatment of Peyronie's disease. Peyronie's disease is the
development of a collagen plaque, or scar tissue, on the shaft of the
penis that hardens and reduces flexibility, causing the penis to bend
or arc during erection resulting in psychological distress and pain
for the patient and often interfering with or preventing intercourse.
"We believe XIAFLEX is a company-transforming product for Auxilium
and the excitement surrounding this trial in the urological community
that treats Peyronie's patients has been resounding. Additionally,
the response from potential patients has been highly encouraging, and
as a result, we believe we will complete enrollment in this study in
the first quarter of 2009," said Armando Anido, Chief Executive
Officer and President of Auxilium. "We are extremely pleased to
achieve this important development milestone in Peyronie's disease, a
potential second indication for XIAFLEX, and we look forward to
having the results of the trial by the end of 2009."
The Phase IIb study is a randomized, double-blind, placebo-controlled
study that is designed to assess the safety and efficacy of XIAFLEX,
when administered two times a week every six weeks for up to three
treatment cycles (2 x 3), in subjects with Peyronie's disease. The
study will involve at least 120 patients at approximately 11 sites
throughout the U.S., and patients will be monitored for 36 weeks
following the first injection.
The trial is also designed to validate a proprietary Peyronie's
Patient Reported Outcome (PRO) questionnaire, which will measure
several domains of patients' sexual quality of life, over a 36 week
period. The four domains measured by the PRO are penile pain,
Peyronie's disease bother, intercourse discomfort and intercourse
constraint.
"We are encouraged by earlier Phase II clinical trials in Peyronie's
disease which demonstrated a reduction in penile curvature with
XIAFLEX," said Dr. Tony DelConte, Auxilium's Chief Medical Officer.
"Our team, in conjunction with outside experts, has spent a
significant amount of time and effort to develop the Peyronie's PRO
questionnaire and we are eager to validate its use for our Phase III
protocols where it is intended to be the primary endpoint."
To qualify for the study, patients must be able to maintain a rigid
erection and have a penile contracture between 30 and 90 degrees.
Patients will be stratified by the degree of penile curvature (i.e. 30
degrees to 60 degrees versus > 60 degrees) and then randomized into 4
treatment groups to receive either XIAFLEX or placebo with or without
modeling of the penile plaque. Modeling refers to massaging of the
plaque after the second injection of a treatment series and is
intended to maximize the enzymatic effect of the XIAFLEX injection in
the plaque. Patients will be randomized in a 3:1 ratio of XIAFLEX to
placebo and a 1:1 ratio to receive penile plaque modeling or
no
modeling.
Plaque Targeted Number
Arm Study Drug Modeling of Patients
=======================================================
A XIAFLEX yes 45
B Placebo yes 15
C XIAFLEX no 45
D Placebo no 15
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About Peyronie's Disease
Peyronie's disease is the development of collagen plaque, or scar
tissue, on the shaft of the penis that hardens and reduces
flexibility, thus causing pain and forcing the penis to bend or arc
during erection. This often can prevent intercourse. In addition to
difficulty with sexual intercourse, Peyronie's disease may also be
associated with emotional distress, loss of self-esteem and
depression. In certain populations, the estimated number of men
affected by Peyronie's Disease may be as high as 9 percent in men
over 60 years of age and 3 percent in men over 30.(1)
(1) L.A. Levine "Peyronie's Disease: A Guide to Clinical Management."
Humana Press: 10-17, 2007.
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, is in phase III of development for
the treatment of Dupuytren's contracture and is in phase II of
development for the treatment of Peyronie's disease and Frozen
Shoulder syndrome (Adhesive Capsulitis). Auxilium's transmucosal
film product candidate for the treatment of overactive bladder
(AA4010) is in phase I of development. The Company is currently
seeking a partner to further develop this product candidate.
Auxilium also has one pain product using its transmucosal film
delivery system in phase I of development. Auxilium has rights to
seven 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 XIAFLEX as a company-transforming product; the
timing of completion of enrollment of patients in the phase IIb trial
for XIAFLEX for the treatment of Peyronie's disease; the timing of
release of results from the phase IIb trial for XIAFLEX for the
treatment of Peyronie's disease; the ability to use data from the
phase IIb study to further validate the Patient Reported Outcome
questionnaire as a tool to be used as the primary efficacy endpoint
in phase III studies for XIAFLEX for the treatment of Peyronie's
disease; the interpretation of data from earlier phase II clinical
trials for Peyronie's disease; the number of men affected by
Peyronie's disease; and products in development for Dupuytren's
contracture, Frozen Shoulder syndrome, overactive bladder, pain,
hormone replacement and urologic disease. All statements other than
statements of historical facts contained in this release, including
but not limited to, statements regarding future expectations, plans
and prospects for the Company, statements regarding forward-looking
financial information and other statements containing the words
"believe," "appears," "may," "could," "will," "estimate," "continue,"
"anticipate," "intend," "should," "plan," "expect," and similar
expressions, as they relate to the Company, constitute
forward-looking statements. 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, the performance of third-party service providers,
decisions by regulatory authorities regarding whether or when to
proceed to the next phase of clinical trials, general financial,
economic, regulatory and political conditions affecting the
biotechnology and pharmaceutical industries and those discussed in
the Company's Annual Report on Form 10-K for the year ended December
31, 2007 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 the Company's home page on the
Internet at http://www.auxilium.com under the heading "Investor
Relations -- SEC Filings." There may be additional risks that the
Company does not presently know or that the Company currently believes
are immaterial which could also cause actual results to differ from
those contained in forward-looking statements. Given these risks and
uncertainties, any or all of the forward-looking statements contained
in this release may prove to be incorrect. Therefore, you should not
rely on any such factors or forward-looking statements.
In addition, forward-looking statements provide the Company's
expectations, plans or forecasts of future events and views as of the
date of this release. The Company anticipates that subsequent events
and developments will cause the Company's assessments to change.
However, while the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so. These forward-looking statements
should not be relied upon as representing the Company'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
Email Contact
William Q. Sargent Jr.
VP IR
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
Email Contact
SOURCE: Auxilium Pharmaceuticals, Inc.