Auxilium Pharmaceuticals, Inc.
) 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.
)) 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
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
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,
) and Swedish Orphan Biovitrum AB for the development, supply and
commercialization of Xiaflex (EU trade name: Xiapex) in different
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
Questcor Pharmaceuticals, Inc.
) and Actelion look well-positioned with all three being Zacks
Rank #1 (Strong Buy) stocks.
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