Auxilium/Sobi's Xiapex Filed for Label Expansion - Analyst Blog

Auxilium Pharmaceuticals, Inc. AUXL announced that partner, Swedish Orphan Biovitrum AB (Sobi), has filed for an extension of the label for Xiapex in the EU to include the indication of Peyronie's disease.

Xiapex's EU filling was based on positive results from two double-blind, placebo-controlled studies - IMPRESS I and II (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies). The studies evaluated Xiapex in patients with Peyronie's disease. Results from the studies demonstrated a favorable safety and efficacy profile of Xiapex.

Xiapex is marketed in the U.S. under the trade name, Xiaflex. The EU filing of Xiapex in the Peyronie's disease indication comes after the U.S. approval of Xiaflex for the same indication in Dec 2013. Auxilium had mentioned in its press release at that time that Xiaflex is the only approved treatment with proven efficacy for Peyronie's disease in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy in the U.S.

In July last year, Auxilium and Sobi collaborated for the development, supply and commercialization of Xiapex for the treatment of Dupuytren's contracture and Peyronie's disease. As per the collaboration, Sobi enjoys exclusive rights for the commercialization of Xiapex for these indications in 28 EU member countries, Switzerland, Norway, Iceland, 18 Central Eastern Europe/Commonwealth of Independent countries, including Russia and Turkey, and 22 Middle Eastern & North African countries. Auxilium Pharma is entitled to receive significant tiered double-digit royalties on Xiapex sales in Sobi's territories, including payment for product supply.

Xiapex is already approved in the EU for the treatment of Dupuytren's contracture in adults with a palpable cord. The product is also approved in the U.S., Canada and Australia for the indication. Auxilium is looking to expand Xiaflex's label further. Xiaflex is currently under review in the U.S. for the treatment of two Dupuytren's contracture cords concurrently. A final decision on the approval of Xiaflex in this indication is expected by Oct 20, 2014.

Auxilium recorded Xiapex U.S. net sales of $16.6 million in the first quarter of 2014. Successful label expansion of the drug will boost its sales further.

Auxilium Pharma currently carries a Zacks Rank #5 (Strong Sell). Some better-ranked stocks worth considering include Regeneron Pharmaceuticals, Inc. REGN, Biogen Idec Inc. BIIB and The Medicines Company MDCO. All these stocks carry a Zacks Rank #1 (Strong Buy).