Shield's Canadian partner files new drug submission for Accrufer

Commercial-stage pharmaceutical company Shield Therapeutics announced on Monday that KYE Pharmaceuticals has submitted a new drug submission to Health Canada, for the regulatory review and approval of the iron therapy ‘Accrufer’.

The AIM-traded firm said if approved, Accrufer would be the first prescription-only oral iron therapy approved by Health Canada.

Marketing approval for Accrufer was expected to be confirmed in the first half of 2023.

Shield said it would be eligible to receive £0.85m in development and sales milestones, consisting of £0.25m on regulatory approval of Accrufer by Health Canada, and up to £0.6m in milestone payments on achieving specified calendar net sales targets.

For the term of the agreement, Shield would also receive “double-digit” royalties on net sales of Accrufer.

“We are delighted with the rapid progress made in partnership with KYE since the signing of the licence agreement in January,” said Shield chief medical officer José Menoyo.

“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 to bringing Accrufer/Feraccru to patients with iron deficiency around the world, and Canada is an important element of that mission.”

At 1129 GMT, shares in Shield Therapeutics were up 3.34% at 19.63p.