Diurnal partner submits marketing authorisation for 'Alkindi' in Australia
Diurnal Group
27.30p
16:57 31/10/22
Speciality pharmaceutical company Diurnal Group announced on Wednesday 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 “replacement therapy of adrenal insufficiency (AI) in infants, children and adolescents”.
FTSE AIM All-Share
755.15
11:35 25/04/24
Pharmaceuticals & Biotechnology
22,806.76
11:35 25/04/24
The AIM-traded firm noted that Alkindi was recently granted orphan drug designation in Australia, which it described as a “valuable regulatory privilege” that provided “significant” benefits, including waiver of application, evaluation and annual registration fees.
It said its marketing and distribution partner in Australia and New Zealand for Alkindi and its second product, ‘Chronocort’ - modified release hydrocortisone - was Emerge Health.
Emerge Health was pursuing registration for Alkindi in Australia and New Zealand, which represented “significant” market opportunities for Diurnal, with around 1,750 patients in those two territories suffering from paediatric AI, and the genetic condition congenital adrenal hyperplasia (CAH).
That would provide an estimated total market opportunity for Alkindi and Chronocort of approximately $10m per annum.
Diurnal said Alkindi was already approved and marketed in Europe, and was the first preparation of hydrocortisone specifically designed for use in children suffering from AI, including the related condition CAH.
In February, the company announced that its partner Medison Pharma had submitted an application for market authorisation for Alkindi to the Ministry of Health in Israel.
“We are pleased that our partner, Emerge Health, has successfully submitted the market authorisation application for Alkindi in Australia,” said chief executive officer Martin Whitaker.
“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.”