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Standard Review for Auxilium's Drug

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Auxilium Pharmaceuticals, Inc. recently announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Xiaflex (clostridial collagenase for injection). Auxilium Pharma is looking to expand Xiaflex’ label and is seeking approval for the treatment of Peyronie's disease (PD).

With the FDA accepting the sBLA for standard review, a response from the agency should be out by September 6, 2013.

Xiaflex is an injectable enzyme that received approval in February 2010 from the FDA for the treatment of Dupuytren’s Contracture (DC), a condition that affects the connective tissue in the palm known as palmar fascia.

Xiaflex, which posted global sales of $56.4 million in 2011, is expected to post global revenues of $153 - $163 million in 2012.

Besides the Peyronie’s indication, Xiaflex is being developed for additional indications like the treatment of cellulite (edematous fibrosclerotic panniculopathy) and frozen shoulder syndrome. Partner BioSpecifics Technologies (BSTC - Free Report) is conducting a phase II study with Xiaflex for the treatment of canine and human lipomas.

Our Take

In our view, Auxilium Pharma’s chances of gaining approval for the Peyronie’s indication are high. The company had reported impressive data from two phase III studies for the Peyronie’s indication earlier this year. If all goes well, Xiaflex could be on the market for the Peyronie’s indication by late 2013. FDA approval would make Xiaflex the first biologic therapy to be approved for Peyronie’s. Auxilium Pharma estimates that about 65,000-120,000 patients are diagnosed with Peyronie’s every year in the US with 5,000-6,500 patients opting for injectable therapies or surgery. This represents significant commercial potential for Auxilium Pharma.

Currently, pharma companies like Astellas Pharma and Valeant Pharma (VRX - Free Report) carry a Zacks #1 Rank (Strong Buy).

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