Auxilium, BioSpecifics Technologies to invest in cellulite indication for Xiaflex

Share this article:

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.

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...