Auxilium Awaiting FDA Decision

Auxilium Pharma (AUXL - Analyst Report) is currently awaiting a decision from the U.S. Food and Drug Administration (FDA) on its key pipeline candidate, Xiaflex, which is under FDA review for the treatment of Dupuytren’s Contracture. In September, Auxilium received a major boost in the form of a favorable recommendation from the FDA’s Arthritis Advisory Committee for Xiaflex for the treatment of Dupuytren’s Contracture.
 
Dupuytren’s Contracture is a condition that affects the connective tissue in the palm known as palmar fascia. The company estimates that approximately 240,000 Dupuytren’s candidates could exist in the U.S. and the EU. This represents significant commercial opportunity for Auxilium.
 
Xiaflex is also being studied for the treatment of Peyronie’s disease and frozen shoulder syndrome. According to the company, there are at least 450,000 potential patients annually in the U.S. and the EU for Dupuytren’s and Peyronie’s. Approval for both indications could help Xiaflex sales cross $1 billion.
 
Meanwhile, Auxilium is looking to conduct additional studies for the frozen shoulder syndrome indication. Frozen shoulder syndrome is a disorder of diminished shoulder motion and almost 3% of people, especially women, develop this problem over their lifetime.
 
Auxilium has a development, commercialization and supply agreement with Pfizer Inc. (PFE - Analyst Report) for Xiaflex for the treatment of Dupuytren’s and Peyronie’s in Europe and certain Eurasian countries. With the European deal in place, we believe the company will intensify its search for partners for other non-European and non-North American territories.
 
The advisory panel’s unanimous recommendation (12-0) brings Xiaflex a step closer to receiving approval. Although the FDA is not required to follow the advice of the panel, it usually does so. A response from the agency should be out shortly. We have a Neutral rating on the stock.