Auxilium Pharmaceuticals, Inc. (AUXL) recently finished enrolling patients for its phase III program with Xiaflex. Xiaflex is being studied for the treatment of Peyronie’s disease.

The double-blind, placebo-controlled phase III program (IMPRESS – The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies) consists of four clinical studies. More than 600 patients will be evaluated in the program which is being conducted across 70 sites in the US and Australia.

Auxilium Pharma is also conducting an open label study and a pharmacokinetic study with Xiaflex. While the open-label study will enroll about 250 patients, the pharmacokinetic study will enroll 16 patients. 

Xiaflex, an injectable enzyme (clostridial collagenase for injection), is already approved in the US and the EU for the treatment of Dupuytren’s Contracture, a condition that affects the connective tissue in the palm known as palmar fascia. Xiaflex, which posted sales of $18.4 million in 2010, is expected to post $55 – $67 million in revenues in 2011.

Auxilium Pharma is looking to expand Xiaflex’ label by evaluating the candidate for additional indications like Peyronie’s and adhesive capsulitis (frozen shoulder syndrome). While top-line results from the ongoing phase III Peyronie’s program should be out in the first half of 2012, Auxilium Pharma is looking to conduct additional studies for the frozen shoulder syndrome indication. Other indications for which Xiaflex could be developed include cellulite and lipoma.

Auxilium Pharma has a strategic alliance for the development, commercialization, and supply of Xiapex (EU trade name for Xiaflex) with Pfizer (PFE).

We currently have a Neutral recommendation on Auxilium Pharma, which is supported by a Zacks #3 Rank (short-term “Hold” rating). Auxilium Pharma’s future relies heavily on Xiaflex. While the initial ramp of Xiaflex was slower than expected, performance should improve with the implementation of the J-code.

The implementation of the CPT code, potentially in 2012, should boost sales further. Going forward, we expect investor focus to remain on the successful commercialization of Xiaflex/Xiapex and label expansion of the product for additional indications.

 
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