) currently has two approved products - Testim and Xiaflex (EU
trade name: Xiapex) - in its portfolio in the U.S.
Testim (1% testosterone) is approved for the treatment of
hypogonadism or low testosterone level, whereas Xiaflex is an
injectable enzyme (clostridial collagenase for injection)
currently approved for the treatment of Dupuytren's Contracture
We note that Auxilium Pharma is developing Xiaflex in
BioSpecifics Technologies Corp
). The company is currently working to expand Xiaflex label.
Auxilium Pharma announced encouraging results on Xiaflex from
the MULTICORD (Multiple Treatment Investigation of Collagenase
Optimizing the Resolution of Dupuytren's) study.
Results from the phase III study (n=715) showed that two
concurrent injections of Xiaflex in patients with multiple DC led
to a significant improvement in joint contracture and the range
of motion as compared to single injections administered in a gap
of 30 days.
The study also showed that concurrent injections of Xiaflex
reduced total fixed flexion contracture (FFC) by an average of
74.4% and improved the total range of motion by a combined
average 66.6 degrees.
Hence, Auxilium Pharma intends to submit the planned
supplemental Biologics License Application (sBLA) to the U.S.
Food and Drug Administration (FDA) in the first quarter of 2014,
backed by positive results from various MULTICORD studies. The
company is seeking label expansion of Xiaflex for the concurrent
treatment of multiple palpable cords.
We remind investors that Auxilium Pharma is also seeking FDA
approval for the use of Xiaflex in the treatment of Peyronie's
disease - a sBLA has been submitted for the same. Meanwhile,
Xiaflex is in a phase IIa study for the treatment of
We are encouraged by Auxilium Pharma's efforts to expand
Xiaflex' label. Xiaflex generated sales of $57.1 million in the
first nine months of 2013, up 26.6% from the year-ago period. The
approval of additional indications will further boost sales.
Auxilium Pharma currently carries a Zacks Rank #2 (Buy). Some
other stocks worth considering in the pharma sector include
). Both carry a Zacks Rank #1 (Strong Buy).
AUXILIUM PHARMA (AUXL): Free Stock Analysis
BIOSPECIFICS TE (BSTC): Get Free Report
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
SHIRE PLC-ADR (SHPG): Free Stock Analysis
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