9 Jan 2018 07:00
9 January 2018
Diurnal Group plc
("Diurnal" or the "Company")
End of Year Business Update and Notice of Interim Results
Imminent European approval of first product, Alkindi®, highlights Diurnal's ability to realise its vision of becoming a world-leading endocrinology specialty pharma company
Clear registration pathway now established for Chronocort® in the US
Transformational year ahead
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, today provides a business update ahead of the release of its interim financial results for the six months ended 31 December 2017 on Monday, 12 March 2018.
Highlights:
European Commission Marketing Authorisation (MA) of Alkindi® (development programme name: Infacort®; hydrocortisone granules in capsules for opening), the Company's first product, anticipated in February 2018
· Approval timeline expected to be in accordance with the 67-day timeline following the recently announced adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP)
o Anticipated indication as replacement therapy for paediatric adrenal insufficiency (AI) in children up to 18 years of age
· Robust supply chain in place in anticipation of launch
o Commercial supply agreement in place with Glatt Pharmaceutical Services, a specialist global manufacturer of multi-particulate pharmaceutical products
o Agreements in place with Ashfield Healthcare and Sharp Packaging Services to facilitate supply chain requirements
o Wholly-owned subsidiary Diurnal Europe BV established in The Netherlands to mitigate Brexit risk
Alkindi® US Phase III registration programme progresses - approval anticipated in 2020
· Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) successfully opened
o Alkindi® food matrix compatibility study meets primary endpoint with high statistical significance (see separate announcement issued today)
o Alkindi® continued to be well tolerated in adult volunteers
o Proposed package of registration studies expected to be completed during 2018
Chronocort® European pivotal Phase III trial expected to complete enrolment by end of January 2018
· Study now scheduled to complete in Q3 2018 and potential market authorisation in Europe in 2020
o Phase III open label study in which adult patients with congenital adrenal hyperplasia, currently treated with a single or combination of generic steroids (standard-of-care), randomised to receive Chronocort® on a twice daily "toothbrush" regimen or continue on their standard-of-care regimen
o The primary endpoint of the trial is the control of androgens on the same or lower total daily dose of steroid when treated with Chronocort® compared to standard-of-care treatment, similar to the previous successful Phase II clinical trial for Chronocort®
Written feedback received from FDA on Chronocort® US Phase III pivotal trial design
· Company finalising study design and plans selection of specialist global CRO; now expect to start US study in mid-2018
Strong financial position with cash and cash equivalents and held-to-maturity financial assets (unaudited) at 31 December 2017 of £14.0m (31 December 2016: £25.6m)
Martin Whitaker, PhD, Chief Executive Officer of Diurnal, commented:
"We are delighted to have ended a very productive 2017, with our first product, Alkindi®, receiving a positive opinion from the EMA. This positive momentum continues into 2018 as we expect to receive the formal Marketing Authorisation from the European Commission in February, followed by our first European launch of this product with our own salesforce in the second quarter of 2018.
We are also making good progress elsewhere in the pipeline. Notably, we have successfully opened an Investigational New Drug Application for Alkindi® in the US and our recently completed food matrix compatibility study (a prerequisite for a registration package for this product) successfully met its primary endpoint. We expect to complete enrolment of the European pivotal trial for Chronocort® by the end of January. If successful, we could see market approval in Europe for this product in 2020. In addition, we expect to initiate the US Chronocort® Phase III pivotal trial in mid-2018."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 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 | |
Numis Securities Ltd (Nominated Adviser) | +44 (0)20 7260 1000 |
Nominated Adviser: Michael Meade, Paul Gillam, Freddie Barnfield | |
Corporate Broking: James Black | |
Panmure Gordon (UK) Limited (Joint Broker) | +44 (0) 20 7886 2500 |
Corporate Finance: Freddy Crossley | |
Corporate Broking: Tom Salvesen | |
FTI Consulting | +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