Auxilium Pharmaceuticals currently has two approved products – Testim and Xiaflex (EU trade name: Xiapex) – in its portfolio in the U.S.
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. (BSTC - Snapshot Report) . The company is currently working to expand Xiaflex label.
Auxilium Pharma announced encouraging results on Xiaflex from the MULTICORD (Multiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytren's) study.
Results from the phase III study (n=715) showed that two concurrent injections of Xiaflex in patients with multiple DC led to a significant improvement in joint contracture and the range of motion as compared to single injections administered in a gap of 30 days.
The study also showed that concurrent injections of Xiaflex reduced total fixed flexion contracture (FFC) by an average of 74.4% and improved the total range of motion by a combined average 66.6 degrees.
Hence, Auxilium Pharma intends to submit the planned supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2014, backed by positive results from various MULTICORD studies. The company is seeking label expansion of Xiaflex for the concurrent treatment of multiple palpable cords.
We remind investors that Auxilium Pharma is also seeking FDA approval for the use of Xiaflex in the treatment of Peyronie’s disease – a sBLA has been submitted for the same. Meanwhile, Xiaflex is in a phase IIa study for the treatment of cellulite.
We are encouraged by Auxilium Pharma's efforts to expand Xiaflex' label. Xiaflex generated sales of $57.1 million in the first nine months of 2013, up 26.6% from the year-ago period. The approval of additional indications will further boost sales.
Auxilium Pharma currently carries a Zacks Rank #2 (Buy). Some other stocks worth considering in the pharma sector include Shire (SHPG - Analyst Report) and Jazz Pharmaceuticals (JAZZ - Analyst Report) . Both carry a Zacks Rank #1 (Strong Buy).