Auxilium and Sobi announce encore presentation of Xiapex data at European Association of urology congress

- Encore data highlighted from trials evaluating Xiaflex/Xiapex, the first and only FDA approved treatment for Peyronie's Disease.

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that encore data were presented from multiple clinical trials evaluating the use of Xiapex/Xiaflex® (collagenase clostridium histolyticum or CCH) in adult patients with Peyronie's disease (PD). These data were presented at the 29^th Annual European Association of Urology (EAU) Congress being held 11-15 April, 2014 in Stockholm, Sweden.

Poster presentations on Xiapex/Xiaflex included analysis from the pivotal Phase 3 IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials which evaluated Xiapex/Xiaflex for the treatment of PD. Xiaflex is the first and only FDA-approved treatment proven effective for PD in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy. Work is on-going by Sobi to potentially file for approval of Xiapex in the EU for the treatment of PD. Xiapex is approved by the EMA for the treatment of Dupuytren's contracture, and as the Market Authorization Holder in Europe, Sobi intends to submit a Variation to the EMA to extend the Xiapex label to include Peyronie's disease.

Highlights of the data related to the use of Xiapex/Xiaflex in PD include:

• A post-hoc analysis of the pooled data from the IMPRESS I and II Phase 3 trials showed improved clinical outcomes following CCH-treatment regardless of subjects' baseline PD treatment history, erectile function scores, and/or prostatectomy history. These data were also presented at the Sexual Medicine Society of North America (SMSNA) 19^th Annual Fall Scientific Meeting held 21-24 November, 2013 in New Orleans.
   
• The global safety analysis of seven clinical trials of CCH for the treatment of PD shows that the adverse events were mostly localized to the penis, non-serious and resolved without intervention before the next injection. Serious adverse events (SAEs) related to treatment were also all localised to the penis in these clinical studies. A total of 60 (5.7%) of CCH-treated subjects experienced at least one treatment-emergent SAE, 0.9% experienced treatment-related SAEs (five penile hematoma and four corporal rupture). These data were also presented at the American Urological Association (AUA) Meeting held 4-8 May, 2013 in San Diego.

Additional details about the presentations and the meeting can be found at: http://www.eaustockholm2014.org/the-congress/.