Auxilium Pharmaceuticals (AUXL - Analyst Report) 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 (DC).
We note that Auxilium Pharma is developing Xiaflex in collaboration with 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 Success Study).
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 Xiaflex.
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). Right now, ViroPharma and Ironwood Pharmaceuticals, Inc. (IRWD - Analyst Report) look well-positioned with a Zacks Rank #2 (Buy).