Diurnal announces grant of first US patent for lead product, Infacort®
Composition of matter patent in this key territory provides protection to 2034
Company also announces receipt of Notice of Allowance for second US Infacort® patent application, covering a method of treatment for all forms of adrenal insufficiency
Emerging patent portfolio significantly strengthens in-market protection in US where Infacort® already has 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 Infacort®, the Company’s lead product.
US 9,649,280, entitled “Composition Comprising Hydrocortisone”, is a pharmaceutical composition-of-matter patent protecting Infacort®’s proprietary formulation as a treatment for all forms of adrenal insufficiency (AI). The patent provides in-market protection until 2034.
The Company also announces that it has received a Notice of Allowance from the USPTO for a second patent (application no. US14/354651) entitled “Treatment of Adrenal Insufficiency”. This patent application claims methods of treatment of all forms of AI using Infacort® and will also expire in 2034.
Together, this emerging patent portfolio significantly bolsters the Company’s exclusivity position in the US, where Infacort® has already received Orphan Drug Designation in the treatment of paediatric AI from the Food and Drug Administration (FDA), providing seven years of market exclusivity awarded on approval. The US is expected to be a major territory for sales of Infacort® and, as previously announced, the drug is set to begin a US pivotal trial in the second half of 2017, subject to Diurnal completing discussions with the FDA, with approval anticipated for 2019.
In Europe, Infacort® is currently under regulatory review in the European Medicines Agency (EMA) for the treatment of paediatric AI having successfully completed a European pivotal trial in July 2016, with approval anticipated in late 2017.
Martin Whitaker, CEO of Diurnal, commented:
“The US is a key target market for Diurnal. Establishing a robust Infacort® US patent portfolio is a significant milestone for Diurnal for market entry in this territory, where the drug has already been awarded Orphan Drug Designation for paediatric adrenal insufficiency. With these patents extending protection to 2034 and US approval for Infacort® anticipated in 2019, we are confident that, if approved, Infacort® should enjoy a long period of exclusivity on the US market.”
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, Freddie Barnfield, Paul Gillam
Corporate Broking: James Black
Panmure Gordon (UK) Limited (Joint Broker) +44 (0) 20 7886 2500
Corporate Finance: Freddy Crossley / Duncan Monteith
Corporate Broking: Tom Salvesen
FTI Consulting +44 (0)20 3727 1000
Victoria Foster Mitchell
Notes to Editors
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 has been identified as an orphan disease in the US where there are estimated to be approximately 4,500 sufferers younger than the age of sixteen, with a similar number in Europe. Currently there are no licensed hydrocortisone preparations in the US or Europe specifically designed to treat these young patients. These children are often administered compounded adult tablets or other unlicensed products. Poor control of disease can result in precocious puberty in young children, virilisation in girls and chronic fatigue leading to a poor quality of life in adulthood resulting in increased morbidity and mortality.
Infacort® represents the first preparation of hydrocortisone specifically designed for use in children suffering from AI. It is a patented, immediate-release, oral, paediatric formulation of hydrocortisone that allows for age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than sixteen years of age suffering from diseases due to cortisol deficiency including adrenal insufficiency and congenital adrenal hyperplasia. AI requires life-long treatment and Diurnal’s novel approach to product development has the potential to significantly improve these young patients’ lives. Diurnal has already submitted for market authorisation in Europe to the European Medicines Agency via the Paediatric Use Marketing Authorisation (PUMA) route in late 2016.
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