Auxilium Scores with Xiaflex - Analyst Blog


Auxilium Pharmaceuticals, Inc. ( AUXL ) received a huge boost recently with the company reporting much-awaited positive phase III results on Xiaflex. The company presented top-line results from the IMPRESS (The I nvestigation for M aximal P eyronie's R eduction E fficacy and S afety S tudies) trials which were conducted to evaluate Xiaflex for Peyronie's disease.

While IMPRESS I saw Xiaflex patients experiencing a 37.6% mean reduction in penile curvature deformity and a 44% improvement in the Peyronie's Disease Questionnaire (PDQ) bother domain, IMPRESS II saw Xiaflex patients experiencing a 30.5% mean improvement in penile curvature deformity and 32.4% improvement in the PDQ bother domain.

What Next?

Auxilium Pharma intends to submit a supplemental Biologics License Application (sBLA) by the end of 2012 seeking US Food and Drug Administration (FDA) approval for the potential use of Xiaflex in the treatment of Peyronie's.

Xiaflex is an injectable enzyme (clostridial collagenase for injection) that is already marketed for the treatment of Dupuytren's Contracture (DC), a condition that affects the connective tissue in the palm known as palmar fascia.

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 has a development, commercialization and supply agreement with Pfizer, Inc. ( PFE ) for Xiapex (EU trade name of Xiaflex) for the treatment of Dupuytren's and Peyronie's in Europe and certain Eurasian countries. The company has agreements with Asahi Kasei Pharma Corporation and Actelion for Xiaflex for other territories.

Our Take

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 Peyonie'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 Pharma.

We currently have a Neutral recommendation on Auxilium Pharma. The stock carries a Zacks #2 Rank (short-term Buy rating). Auxilium Pharma is on a roll with positive phase III data on Peyronie's. The stock was up more than 16% on the news.

We are also positive on the company's efforts to drive Testim sales. Auxilium Pharma recently signed an agreement with GlaxoSmithKline's ( GSK ) 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.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.

This article appears in: Investing , Business , Stocks

Referenced Stocks: AUXL , GSK , PFE

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