FTC Approves Sublicense for Synacthen Depot Submitted by Mallinckrodt ARD Inc.

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The Federal Trade Commission has approved a sublicense submitted by Mallinckrodt ARD Inc. granting West Therapeutic Development, LLC 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’s January 2017 order against Mallinckrodt settled charges that the company, formerly known as Questcor Pharmaceuticals, Inc., and its parent company, Mallinckrodt plc, violated the antitrust laws 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 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, LLC 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, LLC.          

The Commission vote to approve the sublicense was 2-0. (FTC File No. 1310172; the staff contact is David J. Gonen, Bureau of Competition, 202-326-3129.)

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