FTC approves sub-license for Synacthen Depot submitted by Mallinckrodt

The USA’s Federal Trade Commission has approved a sub-license submitted by UK-incorporated Mallinckrodt (NYSE; MNK), granting West Therapeutic Development certain rights to develop and market the specialty drug Synacthen Depot (tetracosactide) in the USA.

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 US ACTH market with its drug HP Acthar Gel, which contains naturally-derived ACTH.

The FTC’s January 2017 order against Mallinckrodt settled charges that the company, formerly known as Questcor Pharmaceuticals, and its parent company, Mallinckrodt, violated the antitrust law Saves when Questcor 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 USA, preserving Questcor’s monopoly and allowing it to maintain extremely high prices for Acthar Gel.