Commercial-stage pharmaceutical company focused on treating iron deficiency Shield Therapeutics (STX:AIM) said its lead product Accrufer had been submitted for regulatory review in Canada.
If approved the drug would become the first prescription-only iron oral therapy approved by Health Canada with marketing expected to begin in 2023. Investors welcomed the submission, marking the shares up 3.5% to 19.7p.
EXCLUSIVE AGREEMENT
Shield signed an exclusive agreement in January with KYE Pharmaceuticals Inc to undertake clinical and regulatory activities to achieve marketing authorisation and commercialisation of Accrufer in Canada.
On approval the company will receive £150,000 from KYE, adding to the £150,000 upfront payment already received.
Shield is eligible for a further £600,000 in milestone payments dependent on certain sales targets being met as well as 10%-to-15% royalties on net sales.
Chief medical officer for Shield Jose A. Menoyo commented: ‘Both organisations have demonstrated excellent collaboration and are driven to make Accrufer® available to patients in Canada with iron deficiency as quickly as possible.
‘Shield Therapeutics is committed in bringing Accrufer®/Feraccru® to patients with iron deficiency around the world, and Canada is an important element of that mission.’
The US market is the biggest opportunity for Accrufer and management have made good progress building brand awareness.
There are around 1.3 million annual prescriptions for oral therapy in the US worth around $350 million a year.
