Auxilium Pharmaceuticals Inc. (AUXL) recently presented long term data on its Dupuytren’s Contracture treatment Xiaflex. Results showed that the recurrence rate in patients treated with Xiaflex was 19.3% at two years. This compares favorably with the recurrence rate seen in patients undergoing other treatment options like fasciectomy and needle fasciectomy, which showed recurrence rates of up to 34% and 85%, respectively.
Auxilium’s Xiaflex is an injectable enzyme that received approval in February 2010 from the US Food and Drug Administration (FDA) for the treatment of Dupuytren’s Contracture, a condition that affects the connective tissue in the palm known as palmar fascia.
Xiaflex’s approval is a major milestone for Auxilium and we believe the product will put Auxilium squarely on the path to sustained profitability. There are currently no treatment options available for Dupuytren apart from surgery.
Encouraging data on the product from two phase III studies, CORD I (Collagenase Option for Reducing Dupuytren’s) and CORD II should give sales reps a talking point. The long-term safety data on the product should also help drive usage of the product.
Auxilium is currently working on the reimbursement process for Xiaflex. Auxilium intends to promote the product to about 7,000 physicians in the US.
Xiaflex is also being studied for the treatment of Peyronie’s disease (phase II completed) and frozen shoulder syndrome (phase II). Auxilium intends to conduct an end-of-phase II meeting with the FDA for the Peyronie’s indication and is looking to move the candidate into phase III studies in the second half of 2010.
The company estimates that there are at least 450,000 potential patients annually in the US and the EU for Dupuytren’s and Peyronie’s. Approval for both indications could help Xiaflex sales cross $1 billion.
Xiaflex is yet to be approved in the EU where it is currently under regulatory review. Auxilium has a development, commercialization and supply agreement with Pfizer, Inc. (PFE) for Xiaflex for the treatment of Dupuytren’s and Peyronie’s in Europe and certain Eurasian countries.
We currently have a Neutral recommendation on Auxilium. Going forward, we expect investor focus to remain on the successful commercialization of Xiaflex, and label expansion of the product for additional indications.
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