Auxilium Pharmaceuticals, Inc., a fully integrated specialty biopharmaceutical company, and Swedish Orphan Biovitrum AB (Sobi), an international specialty healthcare company dedicated to rare diseases, have presented encore data from multiple clinical trials evaluating the use of Xiaflex/Xiapex (collagenase clostridium histolyticum or CCH) in adult patients with Peyronie's disease (PD). These data were presented at the 29th Annual European Association of Urology (EAU) Congress being held April 11 – 15, 2014 in Stockholm, Sweden.

Poster presentations on Xiaflex/Xiapex included encore analysis from the pivotal phase 3 IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials which evaluated 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. Xiapex is approved by the EMA for the treatment of Dupuytren's contracture (DC), and as the Market Authorization Holder in Europe, Sobi intends to submit a Variation to the European Medicines Agency (EMA) to extend the Xiapex label to include Peyronie's disease.

Highlights of the data related to the use of Xiaflex/Xiapex 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) 19th Annual Fall Scientific Meeting held November 21-24, 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 localized to the penis in these clinical studies.  A total of 60 (5.7%) of CCH-treated subjects experienced at least one treatment-emergent SAE, nine of whom experienced treatment-related SAEs (five penile hematoma and four corporal rupture). These data were also presented at the American Urological Association (AUA) Meeting held May 4-8, 2013 in San Diego.

PD is a condition that involves the development of collagen plaque, or scar tissue, on the shaft of the penis.  The scar tissue, known as a Peyronie's plaque, may harden and reduce flexibility, which may cause bending or arching of the penis during erection. PD can result in varying degrees of penile curvature deformity and disease "bother" (encompassing concern about erection appearance, erection pain and the impact of PD on intercourse and on frequency of intercourse). PD is a disease with an initial inflammatory component. This inflammatory phase is poorly understood with a somewhat variable disease course and spontaneous resolution occurring in less than 13 percent of casesi. After approximately 12 months of disease, the disease is reported to often develop into a more chronic, stable phase. The incidence of PD is estimated between 3 and 9 percent; however the disease is thought to be underdiagnosed and undertreated. Based on U.S. historical medical claims data, it is estimated that between 65,000 and 120,000 PD patients are diagnosed every year, but only 5,000 to 6,500 PD patients are treated with injectables or surgery annually.

Xiaflex (collagenase clostridium histolyticum or CCH) is a biologic approved in the US, EU, Canada and Australia for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord and for the treatment of adult men with Peyronie's disease (PD) with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy in the US Sobi may now file for market authorization for Xiapex for the treatment of PD and work is ongoing for that filing in the EU. Sobi holds the exclusive rights to commercialize Xiapex for the DC and PD indications in the EU, subject to applicable regulatory approvals. Xiaflex consists of a combination of two subtypes of collagenase, derived from clostridium histolyticum. Together, the collagenase sub-types are thought to work synergistically to break the bonds of the triple helix collagen structure. Xiaflex has been granted Orphan status in the US by the FDA for DC and PD.

Auxilium Pharmaceuticals, Inc. is a fully integrated specialty biopharmaceutical company with a focus on developing and commercializing innovative products for specialist audiences.