Posted on Wednesday, 15/Aug/2018 Posted by admin

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, notes the publication of a clinical benefit dossier assessment of Alkindi® (hydrocortisone granules in capsules for opening) by the German Institute for Quality and Efficiency in Health Care (IQWiG) released today on the Gemeinsame Bundesausschuss (G-BA) website, which states that Alkindi®’s benefit over generic hydrocortisone has been not proven, as the appropriate comparator therapy (hydrocortisone) was not implemented in any of the 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. 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 G-BA. Alkindi® is now stocked at over 40 wholesaler depots and is available to pharmacies across Germany, with initial Alkindi® pricing and commercial sales to date in line with the Company’s expectations.

Diurnal submitted an Added Benefit dossier for Alkindi® to the G-BA in May 2018. Part of the multi-faceted early benefit assessments procedure according to the Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) process is a clinical benefit dossier assessment performed by the IQWiG. The Alkindi® marketing authorisation was underpinned by the statistically significant data previously reported from the Company’s pivotal open-label Phase III clinical trial. In this study, as agreed with the European Medicines Agency (EMA), a comparator was not included due to the lack of a regulated and licensed paediatric formulation. The findings of IQWiG are non-binding on the G-BA.

The next scheduled step in the assessment process is a hearing with the G-BA committee, which provides an opportunity for experts in medical science and practice, physicians' associations, self-help groups and patient representatives, as well as manufacturers to contribute their expertise or their viewpoints to the process. The assessment process, and therefore the determination of the final price in Germany, is expected to be completed by May 2019 by the G-BA.

Martin Whitaker, Chief Executive Officer of Diurnal, said, “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. 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”.

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)
Corporate Finance: Phil Davies, Will Goode, Michael Boot
Healthcare Equity Sales: Andrew Keith

FTI Consulting +44 (0)20 3727 1000
Simon Conway 
Victoria Foster Mitchell

Notes to Editors

About Der Gemeinsame Bundesausschuss (G-BA)
The G-BA is the highest decision-making body of the joint self-government of physicians, dentists, hospitals, and health insurance funds in Germany. The G-BA’s assessment procedures are as follows:
• A request for consultation must be submitted before the start of consultation.
• The methods assessment is conducted according to specified criteria.
• A hearing must take place before a resolution is drafted on changes that affect third parties.
• The G-BA requires scientific support, e.g. from IQWiG, to fulfil its duties
• The G-BA drafts a resolution after consultations are completed.
• Resolutions are submitted for review by the Federal Ministry of Health, which has legal supervision over the G-BA.

The G-BA hearing procedure provides an opportunity for experts in medical science and practice, umbrella organisations of physicians' associations, central organisations of self-help groups and patient representatives, as well as manufacturers to contribute their expertise or their viewpoints as affected parties to the decision-making process. The results of the hearing procedure are evaluated by the subcommittee. For further information about G-BA, please visit: www.english.g-ba.de/legalmandate/

About IQWIG
IQWiG is the independent Germany agency responsible for the assessment of medical treatments based on their quality and efficacy.

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

About Adrenal Insufficiency
Adrenal insufficiency (AI) is a condition characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. The primary symptoms of AI are chronic fatigue and patients are at risk of adrenal crisis and death if they do not have adequate cortisol replacement. AI is either primary or secondary, with primary AI resulting from diseases intrinsic to the adrenal gland and secondary AI resulting from pituitary diseases where there is a failure of stimulation of the adrenal by the pituitary of the signalling hormone ACTH (adrenocorticotropic hormone). In Europe, AI has been identified as a rare condition, where there are estimated to be approximately 4,000 sufferers younger than the age of six, where the need for an effective replacement therapy is greatest. Prior to the European approval of Diurnal’s product, Alkindi®, paediatric AI was treated by compounding hydrocortisone or crushing/splitting tablets of hydrocortisone (the synthetic version of cortisol) as there was no licensed formulation available specifically designed for children.

About Alkindi® (hydrocortisone granules in capsules for opening)
Alkindi® is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric AI. Alkindi® is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than eighteen years of age suffering from diseases due to cortisol deficiency including paediatric AI and CAH. AI requires life-long treatment and Diurnal’s novel approach to product development has the potential to significantly improve these young patients’ lives. On 9 February 2018, the European Commission granted a paediatric use marketing authorisation (PUMA) for Alkindi® as replacement therapy of AI in infants, children and adolescents (from birth to <18 years old), following the positive opinion issued by the European Medicines Agency in December 2017. The PUMA affords 10 years market and data exclusivity for Alkindi® in Europe.

 

Date of Preparation: August 2018 Code: Inf EU-EU-0080