XIAFLEX® Effective in Nonsurgically Treating MP and PIP Joints with Dupuytren's Contractures in Second Pivotal Study

MALVERN, Pa., Dec. 6, 2010 /PRNewswire-FirstCall/ -- Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL), a specialty biopharmaceutical company, today announced that The Journal of Hand Surgery (JHS) has published in its December online edition the Company's pivotal CORD II phase III clinical trial of XIAFLEX® (collagenase clostridium histolyticum), a novel, first-in-class biologic for the nonsurgical treatment of adult Dupuytren's contracture patients with a palpable cord.  The CORD II study is the second pivotal clinical trial examining the treatment of Dupuytren's contracture with XIAFLEX.  Treatment with XIAFLEX significantly reduced the angle of contracture for patients with Dupuytren's contracture in both their metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints, with clinically meaningful responses in both less severe and more severe contractures.  

"The results for both MP and PIP joints that were treated with XIAFLEX are compelling and compare favorably to surgery from both an efficacy and safety point of view," said Dr. David Gilpin, study investigator and surgeon at the Brisbane Hand and Upper Limb Clinic.  "As noted in the publication, the investigators believe that the limited long-term efficacy and the potential for numerous complications associated with percutaneous needle aponeurotomy, and the serious complications and prolonged recovery associated with surgery, underscore the need for a simpler, less-invasive treatment option that is effective, safe and causes minimal convalescence and rehabilitation.  I believe that XIAFLEX, as a new non-surgical treatment, addresses these needs and could become the standard of care for Dupuytren's contracture."

Auxilium has previously announced top line results of the CORD I and CORD II studies, and findings from CORD II are consistent with those reported for CORD I.  Important findings from CORD II include:

• The proportion of joints that attained the primary endpoint of 0 degrees to 5 degrees of full extension (normal or near normal straightening of the treated finger) at 30 days after the last injection of Dupuytren's cords with collagenase was 44% in CORD II (vs. 64% in CORD I) and when evaluated according to joint type was 65% for MP and 28% for PIP joints (vs. 76.7% and 40% in CORD I, respectively).  The authors noted that lower overall efficacy in CORD II may have resulted from differences in MP to PIP stratification compared with the CORD I study (1:1 stratification by joint [MP to PIP] in CORD II and 2:1 stratification in CORD I) or a greater proportion of high-severity PIP joints studied in CORD II.
• The proportion of joints achieving a reduction of contracture to a clinically meaningful 15 degrees or less was 67%, which was similar to the proportion of joints achieving a reduction of contracture to 15 degrees or less in CORD I (74%).
• Prior surgery for Dupuytren's disease did not affect attainment of the primary end point.  The proportion of patients who had prior surgery for Dupuytren's disease was not statistically different among those who reached the primary end point (9 of 20) and those who did not (15 of 25; p=0.38).
• At the time of the 12-month follow-up, none of the 20 successfully treated cords from the double-blind phase or 48 successfully treated cords from the open-label phase had experienced a recurrence.
• Although all patients had detectable antibodies to collagenase by their third collagenase injection, no systemic allergic reactions were reported.

"We believe that Dupuytren's cords may significantly impact patients at an early stage of contracture and affect many aspects of patient's daily lives," said Dr. Jim Tursi, Auxilium's Vice President of Clinical Research & Development.  "We now have two published studies with XIAFLEX demonstrating that joints with low baseline contracture severity respond better than joints with higher baseline severity, which we believe indicates that earlier nonsurgical intervention with XIAFLEX in adults with palpable cords could generate superior contracture responses versus delayed intervention."

The most commonly reported adverse events were edema peripheral, contusion, upper-extremity pain, injection-site pain, injection-site hemorrhage, injection-site swelling, tenderness, pruritus, lymph-node enlargement, lymph node tenderness on palpation and injection site vesicles.  Most treatment-related adverse events were mild or moderate in intensity and the median resolution time for all adverse events was 10 days, with limited or no medical intervention.  Three treatment-related serious adverse events were reported: one flexion pulley rupture and one patient with both cord proliferation (i.e., rapid thickening of the treated cord without a change in length) and sensory abnormality in the treated hand.  No deaths, systemic allergic reactions, nerve injuries, arterial injuries, tendon ruptures or significant changes in flexion or grip strength were observed during the 12-month study.

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.  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.  XIAFLEX is the only drug approved by the U.S. Food and Drug Administration for treatment of Dupuytren's contracture, which has historically been treated primarily by an open surgical procedure.

About CORD II

The Australian pivotal trial is a double-blind, randomized, placebo-controlled study of XIAFLEX with 66 Dupuytren's contracture patients enrolled in five sites throughout Australia.  The primary endpoint of the study was to determine if XIAFLEX could reduce the contracture angle in a combined analysis of metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints to less than or equal to 5 degrees of normal 30 days after the last injection.  All patients had Dupuytren's contracture of the MP joint between 20 and 100 degrees or of the PIP joint between 20 and 80 degrees in at least one digit (not the thumb).  In CORD II, there were 45 patients randomized to receive XIAFLEX and 21 patients randomized to receive placebo that had primary joints able to be evaluated.  MP and PIP joints were stratified in a 1:1 ratio.  

All patients receiving XIAFLEX in the double-blind portion of the study will be monitored for a minimum of 12 months and potential maximum of five years following initial dosing.  After finishing the double-blind portion, XIAFLEX and placebo patients are also eligible to receive additional XIAFLEX injections for either unsuccessfully treated joints or additional untreated joints during the open-label, extended treatment period.  This open-label phase is designed to provide further data for the long-term safety and efficacy of XIAFLEX injections in the treatment of Dupuytren's contracture.  XIAFLEX is currently approved in the U.S. for the treatment of Dupuytren's contracture in adult patients with a palpable cord.

About Auxilium

Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences, such as urologists, endocrinologists, certain targeted primary care physicians, hand surgeons, subsets of orthopedic, general, and plastic surgeons who focus on the hand, and rheumatologists.  Auxilium markets XIAFLEX® (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord and Testim® 1%, a topical testosterone gel, for the treatment of hypogonadism.  Auxilium has four projects in clinical development.  XIAFLEX is in phase III 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.

AUXILIUM 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 possibility or likelihood of XIAFLEX becoming the standard of care for Dupuytren's contracture; the impact of Dupuytren's cords on patients at an early stage of contracture and the efficacy of earlier nonsurgical intervention with XIAFLEX in adults with palpable cords; the continued monitoring of patients in the CORD II study; and products in development for Dupuytren's contracture, and 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, 2009 under the heading "Risk Factors," and in Auxilium's Quarterly Report on Form 10-Q for the period ended September 30, 2010, 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 the Company's home page on the Internet at http://www.auxilium.com under the heading "For Investors -- 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.

SOURCE Auxilium Pharmaceuticals, Inc.