Auxilium initiates XIAFLEX phase IIa trial in Frozen Shoulder syndrome

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that the first patient has been dosed in its open-label phase IIa trial of XIAFLEX® (collagenase clostridium histolyticum) for the treatment of idiopathic adhesive capsulitis of the shoulder, also known as Frozen Shoulder syndrome.

Frozen Shoulder syndrome is a common, prolonged, painful condition of the shoulder in which increased capsular collagen thickening and subsequent capsular contraction in the shoulder joint is thought to cause a loss of range of motion in the shoulder. The condition is believed to affect approximately two percent of the general adult population and the full duration of the frozen stage of disease can last up to 3.5 years.

"The shoulder joint is crucial for many essential activities and when its function becomes limited, it can have a significant impact on patients' daily living," said Dr. James Tursi, Chief Medical Officer of Auxilium. "We are pleased that the trial is underway and anticipate that the results may demonstrate the potential of XIAFLEX as an innovative acute option for orthopedic surgeons to treat Frozen Shoulder syndrome over approximately six weeks with a minimally invasive treatment option."

"Initiation of the Frozen Shoulder syndrome trial represents another important development milestone for Auxilium and we are excited to advance the third potential indication for XIAFLEX," said Armando Anido, Chief Executive Officer and President of Auxilium Pharmaceuticals. "We believe that XIAFLEX represents a pipeline in a product and expect to develop multiple future indications, in addition to its proven benefit in treating adult Dupuytren's contracture in patients with a palpable cord."

The phase IIa study is an open-label, controlled dose-ranging study designed to assess the safety and efficacy of XIAFLEX for the treatment of Frozen Shoulder syndrome in comparison to an exercise-only control group. The study will involve approximately 50 adult men and women at approximately nine sites throughout the U.S. Topline study results are expected in the first half of 2013.

To qualify for the Frozen Shoulder syndrome study, patients must have unilateral idiopathic adhesive capsulitis of the shoulder with restricted range of motion in the affected shoulder for at least three months, but not more than 12 months. Following screening and determination of study eligibility, subjects will be assigned to four groups that vary in dosing (injection volume and concentration) or a fifth group receiving shoulder exercises only. Patients may receive up to three ultrasound-guided injections of varying doses of XIAFLEX (ranging from 0.29 mg to 0.58 mg in varying concentrations) separated by a minimum of 21 days and all patients will be instructed to perform home shoulder exercises. The study's primary endpoint is the change (degrees) from baseline to the day 92 follow-up in forward flexion (active) in the affected shoulder. Safety assessments, including immunogenicity testing, will be made during all study visits. More information on the study, including study sites participating in this trial, can be found at clinicaltrials.gov.