Acthar is dead… long live Acthar

Mallinckrodt’s efforts to expand beyond its best-seller, H.P. Acthar gel, have again come up against a brick wall. The company has abandoned CPP-1X plus sulindac after the combination failed a phase III trial in familial adenomatous polyposis. The project had been seen as the group’s most promising pipeline prospect, but that is not saying much: EvaluatePharma sellside consensus forecast sales of $49m in 2024. No matter, Mallinckrodt has other important readouts approaching, but a couple of these feature a familiar name: Acthar. First-quarter sales of the product disappointed, but Mallinckrodt still reckons it can hit $1bn this year, helped by upcoming data in rheumatoid arthritis and multiple sclerosis. Beyond Acthar, Mallinckrodt is looking to phase III projects including its skin substitute Stratagraft and terlipressin. And it has not given up on its Nieman-Pick C disease candidate VTS-270, despite a pivotal trial failure last year. During yesterday’s earnings call Mallinckrodt said it had conducted various post-hoc analyses and would meet the FDA to discuss the project’s next steps. With the DOJ still investigating alleged improper sales practices at Acthar’s originator, Questcor, Mallinckrodt could do with something more promising to turn to.

Key Mallinckrodt readouts in 2019
Project Indication Trial Data due 2024e sales ($m)
H.P. Acthar Gel Rheumatoid arthritis Phase IV, NCT02919761 Jun 2019 273*
  Multiple sclerosis Phase IV, NCT03126760 H2 2019 229*
Stratagraft Partial thickness burns Phase III, NCT03005106 Late 2019 32
Xenex Neuroprotection post-cardiac arrest Phase III, NCT03176186 H2 2019 26
Terlipressin Hepato-renal syndrome Phase III, NCT02770716 Late 2019
*Indication sales. Source: EvaluatePharma.

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