Auxilium expands licensing agreement with BioSpecifics

Auxilium will now receive exclusive global rights to develop and commercialize AA4500 (adhesive capsulitis) for the new indication of frozen shoulder syndrome. Auxilium already has an exclusive global license to develop and commercialize the drug for the treatment of Dupuytren’s and Peyronie’s diseases. Both these indications have been granted orphan drug status by the FDA.

BioSpecifics has conducted a phase II clinical trial using the injectable enzyme in the treatment of frozen shoulder syndrome. Three different doses of the enzyme were compared to placebo in this prospective, randomized trial in 60 subjects. The results from this trial suggest that local injection of the enzyme is well-tolerated and may be effective in patients suffering from frozen shoulder syndrome.

“AA4500 is a very important product candidate for Auxilium, and we believe the addition of a third indication for this development program enhances the commercial potential of AA4500,” said Gerri Henwood, CEO of Auxilium.

Frozen shoulder syndrome is a disorder of diminished shoulder motion, characterized by restriction in both active and passive range of motion of the shoulder joint. Auxilium suggests that 3% of people develop frozen shoulder syndrome over their lifetime and that women tend to be affected more frequently than men.