24th Apr 2019 10:44
LONDON (Alliance News) - Diurnal Group PLC on Wednesday said its adrenal insufficiency drug Alkindi has been granted a second patent and orphan drug designation in Australia.
Shares in pharmaceutical company were up 11% at 30.00 pence on Wednesday.
The orphan designation was given by the Therapeutic Goods Administration and gives a number of benefits in Australia, including the waiver of application, evaluation, and annual registration fees relating to the drug.
The TGA granted the designation to Alkindi as a replacement therapy for adrenal insufficiency in infants, children, and adolescents below 18 years of age. Paediatric adrenal insufficiency is characterised by a lack of the hormone cortisol. It causes chronic fatigue and can be fatal without treatment.
A second Australian patent for Alkindi has also given to Diurnal. It is a composition-of-matter patent and protects Alkindi's formulation as a treatment for adrenal insufficiency. In combination, the two patents protect Alkinidi in Australia until 2034.
Diurnal Chief Executive Martin Whitaker said: "We are pleased to have obtained orphan drug designation for Alkindi in Australia, highlighting 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. This continued progress exemplifies Diurnal's ambition to build our marketing and distribution capabilities in high value markets outside our core territories."
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