Auxilium Pharmaceuticals, Inc. (AUXL) recently announced a three-month delay in the Prescription Drug User Fee Act (:PDUFA) goal date for its supplemental biologics license application (sBLA) for Xiaflex.
Xiaflex (in-licensed from BioSpecifics Technologies Corp. (BSTC)) is an injectable enzyme (clostridial collagenase for injection) that is currently approved for the treatment of Dupuytren’s Contracture. Auxilium Pharma is looking to get Xiaflex’ label expanded into the treatment of Peyronie's disease.
The FDA was initially supposed to deliver a decision regarding the label expansion by Sep 6. However, during the process of label discussions with the FDA, Auxilium Pharma made revisions in its proposed Risk Evaluation and Mitigation Strategy (:REMS) program as well as aspects related to the proposed label. The FDA is treating the submitted revisions as a major amendment and has, therefore, extended the review period to Dec 6. Importantly, the FDA has not asked Auxilium Pharma to conduct additional studies.
The extension of the review period is disappointing, though not a setback, as the FDA has not asked for additional studies to be conducted during this period. Expansion into the Peyronie’s indication would boost Xiaflex sales.
Auxilium Pharma has collaboration agreements with Japan’s Asahi Kasei Pharma Corporation, Swiss biopharma company, Actelion (ALIOF) and Swedish Orphan Biovitrum AB for the development, supply and commercialization of Xiaflex (EU trade name: Xiapex) in different territories.
Xiaflex is also being evaluated for the treatment of adhesive capsulitis (frozen shoulder syndrome), with a late-stage study expected to commence in the fourth quarter of 2013, and the treatment of edematous fibrosclerotic panniculopathy with a phase IIa study slated to commence later this year.
Auxilium Pharma currently carries a Zacks Rank #3 (Hold). At present, BioSpecifics, Questcor Pharmaceuticals, Inc. (QCOR) and Actelion look well-positioned with all three being Zacks Rank #1 (Strong Buy) stocks.
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