Lipomas are benign fatty tumors often detected as bulges under the skin. Surgery is the only proven treatment option for both humans and canines and there are currently no FDA-approved pharmaceutical therapies for lipomas in humans or in canines. BioSpecifics carried out preclinical research and discovered that collagenase injections can reduce fat deposits. Based on that observation, BioSpecifics initiated clinical trials for treatment of lipoma as the Company believes that there is a great need for a minimally-invasive approach to treat this indication. As of July 29, 2016, Endo is managing the development of XIAFLEX for human lipoma in addition to canine lipoma.

Human Lipoma

Lipomas are encapsulated deposits of benign fat, often detected as bulges under the skin. According to Endo, there are approximately 600,000 patients in the U.S. annually. CCH potentially offers an alternative for those patients that may choose to avoid surgery, and as a result, potentially avoid surgically related complications, i.e. hematomas, sutures, restricted activity and general or local anesthesia. CCH may also address more moderate-to-severe cases in which patients are unwilling or unable to undergo surgery and more severe patients with challenging or multiple lipomas for which surgery carries a significantly elevated risk or is not a practical treatment. If approved, CCH could potentially become the first FDA-approved therapy for lipoma, offering a safe and effective alternative to surgery.

In June 2016, BioSpecifics announced positive, statistically significant, top-line results from its Phase 2 placebo-controlled double-blind study of collagenase clostridium hystolyticum (CCH) for the treatment of human lipoma. The trial met its primary endpoint of reduction in the visible surface area of the target lipomas relative to placebo, as determined by caliper, at six months post injection (p<0.0001). There were no serious adverse events reported during the trial.

The study was conducted at two centers in the U.S. and enrolled 19 adult men and women who presented with at least two benign lipomas of similar size. Subjects were randomized to have two lipomas treated in immediate succession, one with CCH and one with placebo.

In July 2016, Endo exercised its right to opt-in for this indication.