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® (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® 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® and the Company’s second product, Chronocort® (modified release hydrocortisone), is Emerge Health Pty Limited. Emerge Health is pursuing registration for Alkindi® 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® and Chronocort® of approximately $10 million per annum (USD).
Alkindi® 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® 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® in Australia. This builds on the grant of orphan drug designation for Alkindi® 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.”
diurnal-grp