Portfolio news 0

Strong launches for Alkindi® in Germany and UK with further launches planned for 2019

Company on track for two major regulatory filings during 2019

Continued progress in emerging early-stage pipeline

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its results for the six months ended 31 December 2018 (the "Period"). 

Operational highlights (during the Period and post the Period end)

Alkindi® (hydrocortisone granules in capsules for opening)

• Launch of Alkindi® in the UK as the first specifically developed and licensed replacement therapy of paediatric adrenal insufficiency and positive Scottish Medicines Consortium pricing and reimbursement decision
• Confirmation of the current clinical and regulatory path for Alkindi® with the US FDA, facilitating NDA submission in Q4 2019
  • Partnering discussions for Alkindi® in the US initiated following confirmation of regulatory path

Chronocort® (modified release hydrocortisone)

• Completion of European Phase 3 study in congenital adrenal hyperplasia, the largest ever treatment study in this disease, and subsequent announcement of headline data:
  • Study missed primary endpoint of superiority of Chronocort® to conventional therapy in control of androgens (17-OHP) over the 24-hour period
  • Chronocort achieved significantly better control of androgens (17-OHP) in the period 07:00-15:00
  • Chronocort® achieved 24-hour control on a lower overall dose of glucocorticoid with fewer patients requiring rescue therapy (sick day rules)
  • Scientific Advice sought from European Medicines Agency with a view to filing a Marketing Authorisation Application in Q4 2019

Financial overview

• Alkindi® revenues of £186k (H1 2017/18: £nil) following initial launches, in Germany and UK, in line with Board's expectations; continued progress post-Period end with sales for the two months ended 28 February 2019 of £190k
• Operating loss of £9.7m (H1 2017/18: £7.7m) reflecting increased investment in clinical development activities
• Held-to-maturity financial assets, cash and cash equivalents at 31 December 2018 of £6.9m (31 December 2017: £14.0m); 30 June 2018 of £17.3m

Martin Whitaker, PhD, Chief Executive Officer of Diurnal, commented:

"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.

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. If the EMA agrees that our existing clinical data could support a regulatory submission, Diurnal anticipates filing an MAA for Chronocort® in Q4 2019."

In the Interim Results:

"H1" refers to the six-month period ended 31 December

"m" and "k" represent million and thousand, respectively

"Group" is the Company and its subsidiary undertakings, Diurnal Limited and Diurnal Europe B.V.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

For further information, please visit www.diurnal.co.uk or contact:

Diurnal Group plc	+44 (0)20 3727 1000
Martin Whitaker, Chief Executive Officer Richard Bungay, Chief Financial Officer
Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker)	+44 (0) 20 7886 2500
Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: James Stearns
Cantor Fitzgerald Europe (Joint Broker)	+44 (0)20 7894 7000
Corporate Finance: Phil Davies, Will Goode, Michael Boot Healthcare Equity Sales: Andrew Keith
FTI Consulting (Media and Investor Relations)	+44 (0)20 3727 1000
Simon Conway Victoria Foster Mitchell

 

Notes to Editors

About Diurnal Group plc

 Founded in 2004, Diurnal is a UK-based specialty pharma company developing high quality products for the global market for the life-long treatment of chronic endocrine conditions, including Congenital Adrenal Hyperplasia and Adrenal Insufficiency. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.

For further information about Diurnal, please visit www.diurnal.co.uk