Shield Therapeutics is hopeful it will be able to sell its lead drug product in Canada after health authorities in the country accepted it for regulatory review.
The Gateshead firm told investors that Health Canada, the government department responsible for national health policy, will review its Accrufer drug following a 'New Drug Submission' by its licensing partner KYE Pharmaceuticals Inc. An outcome is expected mid-2023 and if successful will allow KYE.
Shield said it is due to receive a £250,000 milestone payment if it gets regulatory approval, and the firm is eligible for a further £600,000 in milestone payments when it meets sales targets. Through its licensing deal with KYE announced earlier this year, Shield will also receive double-digit royalties on net sales of Accrufer.
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In June, Shield reported it had secured a $10m shareholder loan following a strong start to the year on the back of a "transformational" 2021. At the time, the firm said it had gained FDA approval to raise Accrufer’s product shelf life from 24 to 36 months, giving additional flexibility in manufacturing and storage timelines.
Last year it launched Accrufer in the US following a four-year build up in which included FDA challenges.
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