- Diurnal Group said initial sales of its Alkindi adrenal insufficiency treatment in Germany were line with its expectations, while a final pricing decision was expected by May.

The company noted that a dossier published Wednesday by the German Institute for Quality and Efficiency in Health Care stated that Alkindi's benefit over generic hydrocortisone had not been proven -- as the appropriate comparator therapy was not implemented in any of its studies.

'This assessment is as anticipated since Diurnal did not include a hydrocortisone comparator arm in its pivotal studies with Alkindi, due to the lack of a specific paediatric dose appropriate licensed form of hydrocortisone,' the company said.

'This assessment does not impact Diurnal's commercial expectations for Alkindi in Europe.'

Diurnal announced the launch of Alkindi in Germany in May 2018, following submission of a pricing and reimbursement dossier to the Gemeinsame Bundesausschuss. It was now stocked at over 40 wholesaler depots and available to pharmacies across Germany.

The next scheduled step in the assessment procedure was a hearing with a Gemeinsame Bundesausschuss committee, which would give experts and other stakeholders an opportunity to contribute their viewpoints to the process.

The assessment process, and therefore the determination of the final price in Germany, was expected to be completed by May 2019. 'As part of the pan-European commercialisation programme for Alkindi, Diurnal is in discussions with various health authorities across Europe to ensure timely launches in all major European countries,' chief executive Martin Whitaker said.

'Diurnal believes that Alkindi represents a cost-effective and major breakthrough for patients with adrenal insufficiency, being the first licensed hydrocortisone treatment in Europe specifically designed for use in children.'

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