1 Sep 2021 07:00
01 September 2021
Diurnal Group plc
("Diurnal" or the "Company")
Diurnal launches Efmody® in Germany and Austria
Represents Diurnal's second marketed product in Europe
Provides a new treatment option for adult and adolescent patients suffering from CAH
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces the launch of Efmody® (hydrocortisone modified-release hard capsules) in Germany and Austria as treatment of adult and adolescent patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH), following approval by the European Commission in May 2021.
Following the launch of Alkindi® (hydrocortisone granules in capsules for opening) in Germany in 2018, Efmody® is now the second product that Diurnal has brought to market in Europe. Efmody® pricing has been published today in the LAUER-TAXE® (the reference for all German pharmacies, insurers and wholesalers) and is in line with the Company's expectations. In addition, the pricing for Efmody® in Austria has also been published in the Warenverzeichnis (the reference for all Austrian pharmacies, insurers and wholesalers) managed by the Apotheker-Verlages.
As part of the pan-European commercialisation programme for Efmody®, Diurnal is currently in discussions with various health authorities across the European Economic Area to ensure timely launches in other major European countries. As previously announced, the Company intends to mirror its strategy for Alkindi® by commercialising the product itself in core European markets given the concentrated prescribing base, relationships already established from Alkindi®, and to retain the full value of the product.
Efmody® is a preparation of hydrocortisone that has been specifically designed for patients with CAH, a rare condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 36,000 people in the European Economic Area.
Martin Whitaker, Chief Executive Officer of Diurnal, commented:
"With the launch of Efmody® in Germany and Austria, Diurnal has achieved a significant milestone through the commercialisation of our second product. Importantly, the launch of Efmody® alongside our first product Alkindi®, means that patients in Europe with CAH will now have the option of lifelong treatment with products specifically designed for their disease. We look forward to expanding our reach within Europe in the coming months and helping to provide treatment to these patients where there is a significant unmet need."
This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions.
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 Sole Broker) | +44 (0)20 7886 2500 |
Corporate Finance: Freddy Crossley, Emma Earl | |
Corporate Broking: Rupert Dearden | |
FTI Consulting (Media and Investor Relations) | +44 (0)20 3727 1000 |
Simon Conway | |
Victoria Foster Mitchell | |
Alex Davis | |
Notes to Editors
About Congenital Adrenal Hyperplasia
Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. The cortisol deficiency and over-production of male sex hormones can lead to increased mortality, infertility and issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis.
Current therapy for CAH uses a variety of generic glucocorticoid (steroid) preparations including hydrocortisone, dexamethasone, prednisolone and prednisone in the US, with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe and the United Kingdom, with over 400,000 in the rest of the world.
About Efmody® (hydrocortisone modified release hard capsules)
Efmody® is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first indication for Efmody® is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents (children older than 12 years of age). Efmody® has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US.
The European Commission approval of Efmody® was based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, the largest ever interventional clinical trial completed in CAH. The Phase 3 data was supported by detailed analysis of data from an open-label safety extension study for patients completing treatment in the Phase 3 study, which is assessing the impact of treatment with Efmody® over an extended period, with a number of patients on this trial having been treated for over five years.
The human medicine European public assessment report (EPAR) for Efmody® can be viewed here and the Summary of Product Characteristics (SmPC) here.
About Diurnal Group plc
Diurnal Group plc is a European, UK-headquartered, specialty pharmaceutical company dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, hypogonadism and hypothyroidism. 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
Date of Preparation: September 2021 Code: CORP-GB-0148