Mallinckrodt's Synacthen Depot sublicense approved by FTC
The Federal Trade Commission said it approved a sublicense submitted by Mallinckrodt granting West Therapeutic Development certain rights to develop and market the specialty drug Synacthen Depot in the United States. Synacthen Depot contains a synthetic version of adrenocorticotropic hormone, or ACTH, and is approved in Europe and elsewhere to treat infantile spasms, nephrotic syndrome, and other disorders. "Mallinckrodt currently has a monopoly in the U.S. ACTH market with its drug H.P. Acthar Gel, which contains naturally derived ACTH," the FTC added. The agency's January order against Mallinckrodt settled charges that the company violated the antitrust laws when its Questcor unit acquired rights to Synacthen Depot. The FTC complaint alleged that Questcor's acquisition stifled competition by preventing any other company from using the Synacthen Depot assets to develop a synthetic ACTH drug for the United States, preserving Questcor's monopoly and allowing it to maintain extremely high prices for Acthar Gel. Under the January order, the FTC approved Marathon Pharmaceuticals as the sublicensee. Marathon has since spun off the assets and personnel related to the development of a synthetic ACTH drug to West Therapeutic Development.