Additional data from Auxilium XIAFLEX phase III studies on Peyronie's disease

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, announced that additional data will be presented from its IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, the phase III studies that assessed XIAFLEX® (collagenase clostridium histolyticum or CCH), a novel, in-office, first-in-class biologic therapy for the potential treatment of Peyronie's disease (PD). These data will be presented at the Sexual Medicines Society of North America (SMSNA)/International Society for Sexual Medicine (ISSM) Joint Annual Meeting in Chicago, IL.

A baseline analysis from IMPRESS focuses on the psychosocial impact on men with PD, specifically the level of PD bother and distress associated with PD as related to the degree of penile curvature deformity. At baseline, results showed that all degrees of curvature deformity evaluated in the studies may be associated with high levels of bother and distress. Specifically, more than half (58 percent) of patients with lesser levels of curvature deformity (30 to 60 degrees) reported that they were "very bothered" or "extremely bothered" about their condition. Additional results showed that 73 percent of patients with curvature deformity of 60 to 90 degrees were also "very bothered" or "extremely bothered" about their condition.  A high level of patient-reported moderate to severe distress over PD was also noted among subjects with curvature deformity of 30 to 60 or 60 to 90 degrees (80.5 percent and 90.5 percent, respectively).

PD can be a physically and psychosocially devastating disorder that results in varying degrees of curvature deformity, disease bother, sexual dysfunction, emotional distress, loss of self-esteem and depression.  To measure the impact of PD on a patient, the studies utilized an FDA-phase III validated Peyronie's Disease Questionnaire (PDQ). One domain of the PDQ is patient bother, which is the patient-reported bother relating to various aspects of PD including pain or discomfort with erection, appearance of the erect penis, difficulty when attempting intercourse and less frequent intercourse. The analysis to be presented at SMSNA focuses on the level of patient bother associated with PD as related to the degree of curvature deformity. 

"It has long been assumed that the less the penile curvature deformity, the less a PD patient would be bothered by the deformity, but this analysis shows that patients with any degrees of curvature (30 to 90 degrees) may experience high levels of bother and distress," explained Dr. James Tursi, Chief Medical Officer of Auxilium. "This supports that measuring curvature alone would not capture the full impact of the disease and consideration of the psychosexual components should be an important aspect of managing and treating patients with PD."

In June 2012, Auxilium first shared its top-line results from its IMPRESS trials. The trials' co-primary endpoints—percent improvement from baseline in curvature deformity compared to placebo and the change from baseline (improvement) in the bother domain compared to placebo—were both met with statistical significance.

In addition, photographs and data will presented from a subset of IMPRESS patients involved in the first study ever to use 3-D photographic technology for 360 degree assessment of penile curvature deformity in PD patients. The sub-study was conducted as part of an open-label phase III study allowing physicians to visualize the changes in penile curvature deformity for a patient after each XIAFLEX treatment cycle, including images from the patient's perspective.  Patients were followed for 36 weeks and penile curvature deformity was 3-D photographed prior to each treatment cycle and at the end of the study.  The results from this open-label sub-study were consistent with the double-blind placebo-controlled studies.

"Seeing the physical changes in curvature deformity in three dimensions and the improvement over the treatment cycles is extremely impactful for patients and their physicians," said Dr. Tursi.

The data will be presented at the SMSNA/ISSM meeting by Dr. Larry Lipshultz, entitled "Relationship of Baseline Penile Curvature Deformity Severity and Symptom Bother Observed in Patients with Peyronie's Disease" on August 29 and by Dr. Ridwan Shabsigh, entitled "Three-Dimensional Imaging to Document Improvement in Penile Curvature Deformity in Patients with Peyronie's Disease Treated in a Phase III Study With Collagenase Clostridium Histolyticum" on August 27.  Additional details about the presentations and the meeting can be found at www.smsna.org/meetings/2012/default.aspx.

"We continue to uncover information demonstrating the devastating impact of Peyronie's disease, which further increases our commitment, subject to FDA approval, to providing XIAFLEX as a potential solution for these patients," said Adrian Adams, Chief Executive Officer and President of Auxilium. "It is our hope that these data may help physicians further appreciate the psychological and physical symptoms of Peyronie's disease and create greater awareness of this serious medical condition."