Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - AUXILIUM PHARMACEUTICALS INC | d8k.htm |
| EX-99.1 - PRESS RELEASE - AUXILIUM PHARMACEUTICALS INC | dex991.htm |
 1 Auxilium Pharmaceuticals Auxilium Pharmaceuticals AUX-CC-801 AUX-CC-801 Conference Call Conference Call Top-line Data Review Top-line Data Review December 16, 2009 December 16, 2009 Exhibit 99.2 |
 2 Peyronie’s Disease – Peyronie’s Disease – Background Background • • Etiology remains unknown Etiology remains unknown • • Wide variation in disease Wide variation in disease • • Course of disease Course of disease – – Acute (inflammatory) phase – Acute (inflammatory) phase – 12 to 18 months 12 to 18 months – – Chronic phase Chronic phase • • Spontaneous resolution Spontaneous resolution – – Reports range from 13% to 50% Reports range from 13% to 50% – – Experts report this is more likely with early Experts report this is more likely with early disease disease |
 3 Penile Penile Curvature Curvature – – AUX-CC-801 AUX-CC-801 Overall Overall Change Change from from Baseline Baseline – – Week Week 36 36 54.4 50.6 38.2 45.1 0 10 20 30 40 50 60 Xiaflex Placebo P = 0.001 P = 0.001 -29.7% -11.0% Degrees Xiaflex N = 109 Placebo N = 36 |
 4 Peyronie’s Peyronie’s Disease Bother – Disease Bother – AUX-CC-801 AUX-CC-801 Overall Overall Mean Mean Score Score Change Change from from Baseline Baseline – – Week Week 36 36 -2.6 -0.7 -3 -2.5 -2 -1.5 -1 -0.5 0 Xiaflex Placebo Change From Baseline P = 0.046 Xiaflex N = 100 Placebo N = 34 |
 5 Penile Curvature Penile Curvature 25% Improvement at Week 36 25% Improvement at Week 36 Responder Analysis 60.5 25 0 10 20 30 40 50 60 70 80 90 100 Xiaflex Placebo Overall Overall Percent Of Subjects Xiaflex N = 109 Placebo N = 36 |
 6 Xiaflex Xiaflex With With Modeling Modeling – – AUX-CC-801 AUX-CC-801 Overall Overall Change Change from from Baseline Baseline – – Week Week 36 36 54.7 51.9 37.2 52.5 0 10 20 30 40 50 60 Xiaflex Placebo P < 0.001 P < 0.001 -32.4% 2.5% Degrees Xiaflex N = 54 Placebo N = 20 |
 7 Xiaflex Xiaflex With With Modeling Modeling – – AUX-CC-801 AUX-CC-801 Change Change from from Baseline Baseline – – Peyronie’s Peyronie’s Disease Disease Bother Bother -3.6 -0.2 -4 -3.5 -3 -2.5 -2 -1.5 -1 -0.5 0 Xiaflex Placebo Change From Baseline P = 0.004 Xiaflex N = 50 Placebo N = 18 |
 8 Xiaflex Xiaflex With With Modeling Modeling – – AUX-CC-801 AUX-CC-801 Penile Penile Curvature Curvature 25% 25% Improvement Improvement at at Week Week 36 36 – – Responder Analysis 64.8 10 0 10 20 30 40 50 60 70 80 90 100 Xiaflex Placebo Percent Of Subjects Xiaflex N = 54 Placebo N = 20 |
 9 Xiaflex Without Modeling – Xiaflex Without Modeling – AUX-CC-801 AUX-CC-801 Overall Overall Change Change from from Baseline Baseline – – Week Week 36 36 54.1 48.9 39.1 35.9 0 10 20 30 40 50 60 Xiaflex Placebo P = 0.91 P = 0.91 -27.1% - 27.9% Degrees Xiaflex N = 55 Placebo N = 16 |
 10 Xiaflex Without Modeling – Xiaflex Without Modeling – AUX-CC-801 AUX-CC-801 Penile Penile Curvature Curvature 25% 25% Improvement Improvement at at Week Week 36 36 – – Responder Analysis 56.4 43.8 0 10 20 30 40 50 60 70 80 90 100 Xiaflex Placebo Percent Of Subjects |
 11 AUX-CC-801 AUX-CC-801 – – Duration Duration of of Disease Disease > 1.5 > 1.5 Years Years 1.5 1.5 Years Years Duration Duration % % (N) (N) % % (N) (N) 63% 63% (10) (10) 45% 45% (25) (25) 45% 45% (9) (9) 35% 35% (19) (19) Without Modeling Without Modeling With Modeling With Modeling Placebo Xiaflex Placebo Xiaflex 55% 55% (30) (30) 55% 55% (11) (11) 37% 37% (6) (6) 65% 65% (35) (35) |
 12 AUX-CC-801 AUX-CC-801 – – Top Top Line Line Results Results Efficacy and Safety • • Overall Overall – – Significant Significant Xiaflex Xiaflex effect effect – – Reduction of penile curvature Reduction of penile curvature – – Improvement in Peyronie’s Improvement in Peyronie’s Disease Bother (PRO Domain) Disease Bother (PRO Domain) • • Xiaflex Xiaflex With Modeling With Modeling – – Significant effect in both penile curvature and Peyronie’s Significant effect in both penile curvature and Peyronie’s disease bother endpoints disease bother endpoints • • Xiaflex Xiaflex Without Modeling Without Modeling – – Not significant - Not significant - Due to strong placebo response Due to strong placebo response • • Safety profile consistent with previous Xiaflex Safety profile consistent with previous Xiaflex studies studies – – Well tolerated Well tolerated – – Immunogenicity profile expected Immunogenicity profile expected – – Injection Injection site site bruising, bruising, edema, edema, pain pain – – most most common common – – No drug related SAEs No drug related SAEs – – No systemic immunologic events No systemic immunologic events |