DNL.L Regulatory News (DNL)

6 September 2017

Diurnal Group plc

("Diurnal" or the "Company")

Diurnal announces grant of first US patent for Chronocort®

Composition of matter patent provides protection until 2033 in key US market where Chronocort® has already received Orphan Drug Designation

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces the grant by the US Patent and Trademark Office (USPTO) of its first US patent for Chronocort®, the Company's second late-stage product.

US 9,750,704, entitled "Delayed and Immediate Release Formulation", is a pharmaceutical composition of matter patent protecting the Chronocort® proprietary formulation as a treatment for congenital adrenal hyperplasia (CAH) and adrenal insufficiency (AI).  The patent provides in-market protection until 2033.

This patent expands the Company's exclusivity position in the US, where Chronocort® has already received Orphan Drug Designation for the treatment of both CAH and AI from the US Food and Drug Administration (FDA), which provides the potential for seven years of market exclusivity awarded on approval.

The US is expected to be a major territory for sales of Chronocort®, with CAH and AI collectively estimated to affect 140,000 patients and have an addressable market of approximately $1bn. In addition to the on-going European Phase III trial, Diurnal has submitted a proposed Phase III pivotal US registration study design and supporting data package for Chronocort® for the treatment of CAH to the FDA and, subject to their agreement, expects to commence this study around the end of 2017.

Martin Whitaker, CEO of Diurnal, commented: 

"This new patent for Chronocort® provides in-market protection until 2033 in the US, a key target market for Diurnal, in addition to the potential for market exclusivity provided by the award of Orphan Drug Designation for both CAH and AI. With patents now extending protection in the US for both Chronocort® and Infacort® to 2033 and 2034, respectively, we are confident that, if approved, these products will enjoy a long period of exclusivity in the US market."

Notes to Editors

About Congenital Adrenal Hyperplasia

Congenital Adrenal Hyperplasia (CAH) is an orphan condition usually caused by deficiency of the enzyme 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 severe development defects including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis.

Approximately two thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect approximately 71,000 patients in Europe (51,000) and the US (20,000), with approximately 405,000 in the rest of the world.

Current therapy for CAH uses a combination of generic steroids (hydrocortisone, dexamethasone and prednisolone) and, at best, these adequately treat approximately one third of CAH patients. Other therapies being developed are at an early stage of development and not expected to receive approval in the short-term.

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. AI is either primary or secondary with primary AI resulting from diseases intrinsic to the adrenal gland (e.g. Addison's diseases where auto-immune destruction of the adrenal glands occurs) and secondary AI resulting from pituitary diseases (e.g. hypopituitarism) where there is a failure in signalling and stimulation of cortisol secretion. AI has been identified as an orphan disease in Europe and the US where there are estimated to be approximately 400,000 patients. Currently there are no optimal hydrocortisone preparations in the US specifically designed to treat these patients where patients are often administered a variety of non-physiological steroid therapies. These often result in poor control of disease can result in chronic fatigue leading to a poor quality of life in adulthood resulting in increased morbidity and mortality.

About Chronocort®

Chronocort® is a modified release hydrocortisone preparation that has been designed to mimic the natural circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (last thing at night before sleep and first thing in the morning on waking). Chronocort has been granted Orphan Drug Designations in Europe and the US in the treatment of Congenital Adrenal Hyperplasia (CAH) and Adrenal Insufficiency (AI). The first planned indication for Chronocort® is CAH. Chronocort® has completed three Phase I trials in 2011, 2012 and 2015 (food effects study), a Phase II trial in CAH patients in 2014 in the US and is currently in Phase III trials in Europe.

In Europe, Chronocort® already benefits from Orphan Drug Designations for both CAH and AI, providing the potential to be granted market exclusivity for 10 years post market authorisation. The pivotal Phase III trial for Chronocort® in Europe continues to progress well, with over 75% of patients recruited at the end of the financial year, and is scheduled to complete in the first half of 2018, implying a potential market authorisation in Europe could be forthcoming around the end of 2019.

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