Auxilium gets frozen shoulder syndrome rights for AA4500 from BioSpecifics

By Ted A. Knutson

Washington, Dec. 20 - Auxilium Pharmaceuticals, Inc. announced Tuesday it has exercised its option to expand its rights with BioSpecifics Technologies Corp. to an additional indication of AA4500, Auxilium's injectable enzyme, to include frozen shoulder syndrome (adhesive capsulitis).

Under the terms of the development and license agreement, Auxilium receives exclusive global rights to develop and commercialize AA4500 for the frozen shoulder indication having exercised its option. Auxilium also has an exclusive global license to develop and commercialize AA4500 for the treatment of Dupuytren's and Peyronie's diseases, and both indications have been granted orphan drug status by the Food and Drug Administration.

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. It is estimated that 3% of people develop frozen shoulder syndrome over their lifetime and that women tend to be affected more frequently than men.

BioSpecifics said it has conducted a phase 2 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. The company said additional studies are needed to assess the optimal dose and dosing regimen of AA4500 in this indication.

"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, chief executive officer of Auxilium, in a news release.

Malvern, Pa.-based Auxilium Pharmaceuticals is a specialty pharmaceutical company with a current focus on urology and sexual health.

Lynbrook, N.Y.-based BioSpecifics Technologies is a pharmaceutical company with a major focus on wound healing and tissue remodeling.

The announcement was made in an 8-K filing with the Securities and Exchange Commission.

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