LONDON (Alliance News) - Diurnal Group PLC said Wednesday a German body published a study which says that the benefit of the company's product Alkindi over generic hydrocortisone has not been proven.
Alkindi is used to treat children whose adrenal glands cannot produce enough cortisol, a hormone used to control many body processes,
The pharmaceutical company, which focuses on chronic hormonal diseases, noted the clinical benefit dossier published by the German Institute for Quality and Efficiency in Health Care which states that "Alkindi's benefit over generic hydrocortisone has been not proven as the appropriate comparator therapy was not implemented in any of the studies".
Diurnal said that the assessment is "as anticipated" and will not have an impact of its commercial expectations for Alkindi in Europe.
The company said that the next step in the assessment process for Alkindi is a hearing with the Gemeinsame Bundesausschuss committee, a group of German public health agencies, which is 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 Officer Martin Whitaker said.
He added: "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".
Diurnal Group shares were untraded at 172.50 pence on Wednesday.