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Auxilium Pharmaceuticals (AUXL) Penile Curvature Drug Meets Study Goal


6/4/2012 7:48:43 AM

MALVERN, Pa., June 4, 2012 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced positive top-line results 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).

(Logo: http://photos.prnewswire.com/prnh/20101202/MM10881LOGO )

In IMPRESS I at 52 weeks, the co-primary endpoints met statistical significance with a 37.6% mean reduction in penile curvature deformity for XIAFLEX subjects (p=0.0005) and a 3.3 point (44%) improvement in the Peyronie's Disease Questionnaire (PDQ) bother domain for XIAFLEX subjects (p=0.0451). In IMPRESS II at 52 weeks, the co-primary endpoints met statistical significance with a 30.5% mean improvement in penile curvature deformity for XIAFLEX subjects (p=0.0059) and a 2.4 point (32.4%) improvement in the PDQ bother domain for XIAFLEX subjects (p=0.0496). XIAFLEX was generally well-tolerated. The most common treatment related adverse events reported in the phase III studies were local to the treatment site and consistent with adverse events reported in previous PD trials with XIAFLEX, which included injection site hematoma, pain and swelling. If approved by the U.S. Food and Drug Administration (FDA), XIAFLEX is expected to be the first and only approved biologic therapy indicated for the treatment of PD.

"We believe that XIAFLEX, if approved for the treatment of Peyronie's Disease, has the clinical profile to become a potential breakthrough procedure," said Adrian Adams, Auxilium's Chief Executive Officer and President. "With its current indication in Dupuytren's contracture, positive topline clinical results in Peyronie's Disease, and development ongoing in Frozen Shoulder syndrome and cellulite, XIAFLEX represents a pipeline in a product with potential applications in multiple therapeutic areas that currently have limited options."

PD can be a physically and psychosocially devastating disorder that results in varying degrees of penile curvature deformity, disease bother, sexual dysfunction, emotional distress, loss of self-esteem and depression. A localized connective tissue disorder, PD results from excess collagen deposition on the tunica albugineathe dense tissue under the skin of the shaft of the peniswhich results in an abnormal scar formation. Based on the medical literature, it is estimated that approximately 5% of adult men may have some degree of PD. However, due to the embarrassing nature of the disease and limitations of current treatments, it is also estimated that many PD sufferers remain undiagnosed and untreated. Relying on historical medical claims data and proprietary market research, Auxilium believes that between 65,000 and 120,000 PD patients are diagnosed every year in the U.S., and that approximately 5,000 to 6,500 PD patients are currently treated with injectable therapies or surgery annually in the U.S.

"Obtaining a statistically significant reduction in penile curvature deformity and improvement in Peyronie's disease bother without the risks of surgical intervention represents an enormous advantage for eligible patients suffering from PD," said Dr. Larry Lipshultz, Professor of Urology and Chief of the Division of Male Reproductive Medicine and Surgery at the Baylor College of Medicine. "Currently, surgery is typically a treatment of last resort as there is the potential for complications, including decreased penile length or erectile dysfunction. The most common current PD treatments are non-FDA approved oral, topical and injection therapies that have limited effect and are often not based upon rigorous scientific data."

Efficacy Results









IMPRESS I


IMPRESS II


XIAFLEX (n=199)

Placebo (n=104)

XIAFLEX (n=202)

Placebo (n=107)


Baseline Penile Curvature Deformity (in degrees)

48.8

49.0


51.3

49.6


52 week Penile Curvature Deformity (in degrees)

31.0

39.0

35.1

41.1


Improvement (in degrees; %)

17.8 (37.6%)

10.1 (21.3%)

16.2 (30.5%)

8.5 (15.2%)


p- value

p=0.0005

p=0.0059





Baseline PDQ Bother Domain Score

7.5

7.4


7.4

8.2


52 Week PDQ Bother Domain Score

4.2

5.4

5.0

6.5


Improvement (%)

3.3 (44%)

2.0 (27%)

2.4 (32.4%)

1.6 (20.7%)


p- value

p=0.0451

p=0.0496









Adverse Events

The most common adverse events reported in the IMPRESS phase III trials were hematoma, pain and swelling at the treatment site. These adverse events were comparable to the previous trials and most resolved within 14 days. There have been no systemic hypersensitivity events reported in the phase III trials or any of the previous XIAFLEX PD clinical studies to date. Including data from all XIAFLEX PD clinical studies, over 7,500 XIAFLEX injections have been administered to more than 1,050 PD patients.

Most Common Adverse Events greater than or equal to 5% in XIAFLEX patients








IMPRESS I


IMPRESS II

XIAFLEX

Placebo

XIAFLEX

Placebo


N = 277

N = 140


N = 274

N =141

n (%)

n (%)

n (%)

n (%)

Any non-serious AE

256 (92.4)

81 (57.9)

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