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
Besides the Peyronie's indication, Xiaflex is being developed
for additional indications like the treatment of cellulite
(edematous fibrosclerotic panniculopathy) and frozen shoulder
) is conducting a phase II study with Xiaflex for the treatment
of canine and human lipomas.
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
) carry a Zacks #1 Rank (Strong Buy).
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