Auxilium Pharmaceuticals has announced plans to invest in an indication for prescription drug Xiaflex (collagenase clostridium histolyticum), which was approved by FDA in February 2010 for adult Dupuytren's contracture patients with a palpable cord, for the treatment of cellulite.
Auxilium is teaming up with BioSpecifics Technologies Corp. (BSTC) to investigate Xiaflex's cellulite indication, in addition to an indication to treat human and canine lipomas. Although Auxilium had filed a law suit against BSTC in February of this year, alleging that the biopharma had commenced pre-clinical trials to test Xiaflex's canine lipomas prior to approval of each of the companies' Joint Development Committee, with the announcement of the shared new indication investments, Auxilium has dismissed all pending ligation against BSTC, according to a note to investors penned by Collins Stewart analyst Salveen Richter.
By early 2012, Auxilium plans to have initiated P1b pre-clinical studies for Xiaflex's cellulite indication, with data expected in Q4 of next year. BSTC already conducted a single-center study in which “10 women with cellulite received a total of 0.58mg of Xiaflex administered through five injections,” and the preliminary evidence showed positive results, with a physician-reported reduction in the appearance of cellulite by 76%.
It would be advantageous for Auxilium to receive approval on a cellulite indication for Xiaflex, as such a procedure would likely be ruled cosmetic, which would allow the company to avoid the issues of reimbursement that were encountered with the drug's Dupuytren's indication. Notwithstanding, the company reported worldwide net revenues of $15.4 million for Xiaflex for its current approved indication, $9.9 million of which was accounted for in US sales.
According to Collins Stewart, Auxilium plans to file an investigational new drug (IND) application for the cellulite indication of Xiaflex by the end of 2011, and the company will take responsibility for all development costs.