Diurnal Group (DNL) , told investors on Wednesday that its partner submitted an application for market authorisation of Alkindi® in Australia.
The AIM listed specialty pharmaceutical company develops products for the life-long treatment of chronic endocrine conditions.
Emerge Health Pty Limited, Diurnal's marketing and distribution partner in Australia and New Zealand for Alkindi® and Chronocort®, submitted an application to the Australian Therapeutic Good Administration (TGA) on Wednesday.
The indication listed was for the "replacement therapy of adrenal insufficiency (AI) in infants, children and adolescents (from birth to <18 years old)".
Shares in Dirunal were trading 5% higher on Wednesday following the announcement
Martin Whitaker, Chief Executive Officer of Diurnal, said: “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."
Alkindi® was recently granted Orphan Drug Designation in Australia, a regulatory privilege that allowed the company to waive application, evaluation and annual registration fees.
Around 1,750 patients in Australia and New Zealand suffer from paediatric AI and the genetic condition congenital adrenal hyperplasia (CAH).
Alkindi® is already approved and marketed in Europe and in February, its partner Medison Pharma, submitted an application to the Ministry of Health in Israel.
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