Diurnal soars after securing Nordic distribution deal

Diurnal, which is a specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, returned a loss before tax of £9.6m for the six-month period ended 31 December, an increase of 23% compared to the same period the year before, as research and development costs increased by 62% to £7.6m.

Sales increased from £0.1m to £0.2m after the company launched Alkindi in the UK in September, its second launch following introduction in Germany in May, while it also entered into a marketing and distribution agreement that covers the commercialisation of Alkindi in Sweden, Denmark, Norway, Finland and Iceland with Anthrop Pharma.

Martin Whitaker, chief executive of Diurnal, said: "The company has made excellent progress with Alkindi with sales performance in line with the board's expectations, following successful launches in the UK and Germany, and with continued growth after the period end. Further Alkindi launches are planned for 2019 in Europe. We have also clarified the US regulatory path for Alkindi, facilitating the company's first New Drug Application to the US Food and Drug Administration in Q4 2019."

The increase in research costs came as the AIM traded company undertook activities to initiate a Chronocort US Phase 3 trial in congenital adrenal hyperplasia and a US Phase 2 trial in paediatric adrenal insufficiency, in addition to completion of the Chronocort Phase 3 registration trial in Europe and the transition of patients completing this study into the European long-term follow-on study.

"Despite the initially disappointing top-line analysis of data from the Chronocort European Phase 3 study in CAH, following further in depth analysis of the study results we continue to believe that Chronocort represents a valuable treatment option for patients based on multiple important clinical parameters. We have requested scientific advice from the EMA in order to clarify the regulatory path for a potential Marketing Authorisation Application (MAA) and we expect to receive this advice in Q2 2019," said Whitaker.

The company said it expects further Diurnal country launches during 2019 to accelerate growth of revenues, along with a planned NDA submission in the US during Q4 2019, while it added that strong US interest in Alkindi and Chronocort has been received and will licensing discussions will continue.

Diurnal's shares were up 19.15% at 28.00p at 1058 GMT.