Auxilium Pharmaceuticals, Inc.
) recently announced that data from the pivotal phase III trials,
IMPRESS (The Investigation for Maximal Peyronie's Reduction
Efficacy and Safety Studies), on Xiaflex, was published online in
The Journal of Urology. We note that the IMPRESS trials were
conducted to evaluate Xiaflex for Peyronie's disease (PD). Both
the co-primary and secondary endpoints of the study were
achieved. Common adverse events included hematoma, pain and
swelling at the treatment site.
Xiaflex is currently under US Food and Drug Administration (FDA)
review for the Peyronie's indication. A response from the agency
should be out by Sep 6, 2013.
Xiaflex is an injectable enzyme that received approval in Feb
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.
Besides the Peyronie's indication, Xiaflex is being developed
for additional indications like the treatment of cellulite and
frozen shoulder syndrome.
) has marketing rights for Auxilium Pharma's Xiapex in 46
Eurasian countries through Apr 24, 2013.
In our view, Auxilium Pharma's chances of gaining approval for
the Peyronie's indication are high. If all goes well, Xiaflex
could be in 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 currently carries a Zacks Rank #3 (Hold).
Furiex Pharmaceuticals, Inc.
) look more attractive with a Zacks Rank #1 (Strong Buy).
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