) currently has two approved products in its portfolio in the
U.S. - Testim and Xiaflex (EU trade name: Xiapex).
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.
Auxilium Pharma announced encouraging new data on Xiaflex from
the fourth year of the follow-up study, CORDLESS (Collagenase
Optimal Reduction of Dupuytren's - Long-term Evaluation of
CORDLESS is a five-year follow up study on Xiaflex which is
being conducted to assess the rates of recurrence following
treatment. The study will also assess the long-term safety and
progression of disease in patients from earlier studies.
The study further evaluated the use of Xiaflex in adult
patients with DC with a palpable cord. The results from the study
(n=623) indicated that 57.9% of patients previously successfully
treated with Xiaflex did not experience disease recurrence.
We are encouraged by the follow-up data on Xiaflex which
further reinstates its efficacy in DC.
Meanwhile, Auxilium Pharma is looking to get Xiaflex' label
expanded for the treatment of Peyronie's disease.
However, in Aug 2013, Auxilium Pharma announced a three-month
delay in the Prescription Drug User Fee Act (PDUFA) goal date for
its supplemental biologics license application (sBLA) for
The delay is primarily due to some revisions in Auxilium
Pharma's 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 therefore has extended the review period to Dec 6.
Importantly, the FDA has not asked Auxilium Pharma to conduct
additional studies. Expansion into the Peyronie's indication
would further boost Xiaflex sales.
Auxilium Pharma currently carries a Zacks Rank #3 (Hold).
Ironwood Pharmaceuticals, Inc
) look well-positioned with a Zacks Rank #2 (Buy).
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