Auxilium Pharmaceuticals, Inc.'s
) Xiaflex recently gained approval in yet another country. Auxilium
Pharma and partner
) said that Xiaflex has been granted approval in Canada for the
treatment of Dupuytren's contracture in adults with a palpable
Actelion, which entered into a collaboration agreement with
Auxilium Pharma earlier this year, intends to launch Xiaflex in
Canada in the first half of 2013. Other countries covered under the
collaboration include Australia, Brazil and Mexico, where
regulatory filings are expected to be submitted by year end.
Under the terms of the agreement, Auxilium Pharma is entitled to
receive $0.5 million on Xiaflex's approval in Canada. The company
is also entitled to receive tiered double-digit royalties on sales
of Xiaflex in Actelion's territories.
Xiaflex is currently approved in the US and the EU (trade name:
Xiapex) for the Dupuytren's contracture indication. It is currently
under development in Japan.
Meanwhile, Auxilium Pharma is set to seek approval for a second
indication for Xiaflex by year end. The company recently presented
much-awaited positive phase III results on Xiaflex from the IMPRESS
(The Investigation for Maximal Peyronie's Reduction Efficacy and
Safety Studies) trials which were conducted to evaluate Xiaflex for
Xiaflex is being studied for other indications as well,
including the treatment of cellulite (edematous fibrosclerotic
panniculopathy) and the treatment of frozen shoulder syndrome.
Auxilium Pharma will most likely succeed in gaining approval for
a second indication for Xiaflex. 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.
The company 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
We are also positive on the company's efforts to drive Testim
sales. Auxilium Pharma recently signed an agreement with
) US subsidiary, GlaxoSmithKline LLC, for the co-promotion of
Auxilium Pharma's Testim (1% testosterone), which is approved for
the treatment of hypogonadism or low testosterone level. We expect
Testim sales to benefit from the additional promotional effort.
We currently have a Neutral recommendation on Auxilium Pharma.
The stock carries a Zacks #2 Rank (short-term Buy rating).
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