Diurnal Group PLC Market Authorisation Application in Australia (2407E)

TIDMDNL

RNS Number : 2407E

Diurnal Group PLC

03 July 2019

3 July 2019

Diurnal Group plc

("Diurnal" or the "Group")

Alkindi(R) Market Authorisation Application Submitted in Australia

Significant opportunity to address unmet medical need in paediatric adrenal insufficiency in Australia

Continuation of strategy to expand global presence of lead products

Second market authorisation submission for Alkindi(R) in 2019 following Israeli application

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that an application for market authorisation for Alkindi(R) (hydrocortisone granules in capsules for opening) has been submitted to the Australian Therapeutic Good Administration (TGA) for the indication "replacement therapy of adrenal insufficiency (AI) in infants, children and adolescents (from birth to <18 years old)". Alkindi(R) was recently granted Orphan Drug Designation in Australia, a valuable regulatory privilege that provides significant benefits, including waiver of application, evaluation and annual registration fees.

Diurnal's marketing and distribution partner in Australia and New Zealand for Alkindi(R) and the Company's second product, Chronocort(R) (modified release hydrocortisone), is Emerge Health Pty Limited. Emerge Health is pursuing registration for Alkindi(R) in Australia and New Zealand, which represent significant market opportunities for Diurnal, with around 1,750 patients in these territories suffering from paediatric AI and the genetic condition congenital adrenal hyperplasia (CAH), providing an estimated total market opportunity for Alkindi(R) and Chronocort(R) of approximately $10 million per annum (USD).

Alkindi(R) is already approved and marketed in Europe and is the first preparation of hydrocortisone (the synthetic version of cortisol) specifically designed for use in children suffering from AI, including the related condition CAH. In February 2019, Diurnal announced its partner, Medison Pharma Ltd, had submitted an application for market authorisation for Alkindi(R) to the Ministry of Health in Israel.

Martin Whitaker, Chief Executive Officer of Diurnal, added:

"We are pleased that our partner, Emerge Health, has successfully submitted the market authorisation application for Alkindi(R) in Australia. This builds on the grant of orphan drug designation for Alkindi(R) in Australia received earlier in 2019, which highlights the importance of this product as the first specifically developed and licensed replacement therapy of paediatric adrenal insufficiency designed to address the unmet need in these young patients. We look forward to developing our already successful relationship with Emerge Health as we continue to build our marketing and distribution capabilities in high value markets outside our core territories."

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: 
 
                                                       [phone] 
 Diurnal Group plc                                      1000 
 Martin Whitaker, Chief Executive Officer 
 Richard Bungay, Chief Financial Officer 
 
 Panmure Gordon (UK) Limited (Nominated Adviser        [phone] 
  and Joint Broker)                                     2500 
 Corporate Finance: Freddy Crossley, Emma Earl 
 Corporate Broking: James Stearns 
 
                                                       [phone] 
 Cantor Fitzgerald Europe (Joint Broker)                7000 
 Corporate Finance: Phil Davies, Will Goode, 
  Michael Boot 
 Healthcare Equity Sales: Andrew Keith 
 
                                                       [phone] 
 FTI Consulting (Media and Investor Relations)          1000 
 Simon Conway 
 Victoria Foster Mitchell 
 

Notes to Editors

About Alkindi(R) (hydrocortisone granules in capsules for opening)

Alkindi(R) is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric adrenal insufficiency (AI). Alkindi(R) is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate 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 congenital adrenal hyperplasia (CAH). AI requires life-long treatment and Diurnal's novel approach to product development has the potential to significantly improve these young patients' lives. The European Commission has granted a paediatric use marketing authorisation (PUMA) for Alkindi(R) as replacement therapy of AI in infants, children and adolescents (from birth to <18 years old) in Europe.

About Paediatric Adrenal Insufficiency

Paediatric AI, including the genetic condition CAH 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).

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 Emerge Health

Emerge Health Pty Limited is an innovative, specialised Australian pharmaceutical company focused on the marketing and sales of niche, high quality medicines to the hospital sector. Emerge Health is dedicated to providing exceptional products and support to ensure it meets its customers and partners needs and priorities.

For more information, please visit http://www.emergehealth.com.au

Date of Preparation: July 2019 Code: Inf EU-AUS-0002

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July 03, 2019 02:00 ET (06:00 GMT)