Although 2021 has been a period of significant regulatory and commercial progress for Diurnal, this performance has been overshadowed by the recent decision of the Scottish Medicines Consortium (SMC) not to recommend automatic reimbursement of Efmody in CAH. This is disappointing and has blunted Efmody's immediate UK wide potential despite its clear benefits. Efforts are underway to address the SMC's concerns, with two trials ongoing in both AI and CAH. Elsewhere, despite the impact of the pandemic, the increase in Alkindi sales has demonstrated the effectiveness of the existing European commercial infrastructure, with some operating leverage already evident. Efmody pricing discussions are ongoing in Europe, and there have been successful conclusions in several geographies, including Germany and Norway.
Our note highlights the additional Efmody studies underway, which should provide more confirmatory data for bodies such as the SMC. The recently started CHAMPAIN study compares Efmody to Plenadren in the treatment of adrenal insufficiency. The study is expected to take six months to complete, and we should see a data readout in H2 2022. A successful outcome will allow a filing for Efmody's approval in AI, a $1.9bn market in Europe alone. Our report outlines the reasons why the trial should deliver a successful result. An approval for AI in Europe will dwarf the CAH opportunity and should remove any concerns arising from the Scottish decision
