Approved forms In the US, available forms of animal-derived corticotrophin have included: • Corticotrophin derived from
pituitary glands from pigs, in a
gel formulation as well as in a zinc hydrochloride formulation, each first approved in the US in 1955 and subsequently discontinued. In September 2015 ANI Pharmaceuticals and
Merck & Co. agreed that ANI would purchase NDA 009854 and NDA 008975 and related trademarks and other assets related to these two versions of corticotrophin from Merck for $75M and ongoing royalties; the transaction closed in January 2016. As of November 2016 ANI was preparing its supplemental NDA to get approval to re-introduce this formulation; in 2015 ANI estimated that the US market for these products was about $1 billion per year, based on sales of Acthar gel. • Corticotrophin branded as "Acthar", was first approved in 1950 and was subsequently discontinued; as of January 2017 this NDA was under control of
Sanofi. • A corticotrophin was approved in 1957 under NDA 010831, was subsequently discontinued, and as of January 2017 was under control of Organics/Lagrange, a subsidiary of
Abbvie via Abbott's acquisition of
Solvay's drug business. A
generic version under this NDA was approved under ANDA 088772 and was subsequently discontinued, and as of January 2017 was under the control of
Actavis. • A corticotrophin called H.P. Acthar Gel was approved in 1952 and as of January 2017 was under the control of
Mallinckrodt. A repository version of H.P. Acthar gel was approved in 2010 and as of January 2017 was also under the control of Mallinkrodt. Synthetic forms were created as a replacement for the animal-derived products. In the US, available forms of tetracosactide/cosyntropin, the synthetic form of corticotrophin, have been approved only for diagnostic uses, and there were three generic versions under ANDAs, one for
Mylan approved in 2009, one for Sandoz/
Novartis, approved in 2012, and another for Amphastar under ANDA 016750. • A version of cosyntropin in solution (as opposed to powder) was developed by Sandoz/
Novartis and was approved under the 505b(2) pathway in 2008; as of January 2017 it had been discontinued. In the UK, available forms of tetracosactide/cosyntropin, the synthetic form of corticotrophin, have been approved for both therapeutic and diagnostic uses, and have included: • A version branded Synacthen and provided in solution 250 mcg ampoules, for diagnostic uses, approved in 2008 and as of January 2017 controlled by Mallinckrodt. • A version branded Synacthen, absorbed on to zinc phosphate, provided in milky white suspension, approved in 2008 and as of January 2017 controlled by Mallinckrodt.
Doping As of 2007, it was widely reported that tetracosactide had been used as an illegal performance-enhancing drug by professional cyclists. It is known to be used as a doping agent to increase the secretion of glucocorticoids by adrenal glands.
Pricing Mallinckrodt acquired the US rights to the animal-derived form via its acquisition of Questcor Pharmaceuticals in 2014. In 2013, Questcor acquired the US rights to a competing product, Synacthen Depot, from Novartis. The
Federal Trade Commission and attorneys general from five states sued Mallinckrodt for anti-competitive behavior with regard to the acquisition of Synacthen Depot and the monopolistic pricing of Acthar, and in January 2017 the company settled, agreeing to pay $100 million and to license Synacthen Depot to a competitor. According to Kaiser Health News, Mallinckrodt responded by increasing its Congressional lobbying to $610,000, and its contributions to Congress members to $44,000, in the first quarter of 2017. In Canada, Synacthen Depot's pricing increased by 2000% in 2015, causing some provincial single payer authorities to delist the drug from funded medications. The increase in the drug's price came after
Mallinckrodt acquired Questcor and its drug portfolio, which included the worldwide rights to Synacthen Depot. Prior to the price increase, Mallinckrodt claims that the drug was manufactured at a loss. Some have claimed that the price increase is abusive. The drug had been priced at $33 but rose to $680 per vial. As an off-patent pharmaceutical, a similar drug, differing in formulation, available in Europe, made by a different manufacturer, sells for $8 per vial. == Research ==