LONDON: Shield Therapeutics plc (LSE: STX), a commercial stage pharmaceutical company with a focus on treating iron deficiency with its lead product Accrufer/Feraccru (ferric maltol), announces that KYE Pharmaceuticals Inc. (‘KYE’) has submitted a New Drug Submission (‘NDS’) to Health Canada for the regulatory review and approval of Accrufer, for treatment of iron deficiency.
If approved, Accrufer would be the first prescription only oral iron therapy approved by Health Canada. Marketing approval for Accrufer is expected to be during first half of 2023.
Doug Reynolds, President of KYE, said: “The Shield and KYE teams worked tremendously hard to compile the Canadian NDS in a matter of months and I am extremely pleased to have achieved this milestone.”
José A. Menoyo, MD, Chief Medical Officer for Shield, added: “We are delighted with the rapid progress made in partnership with KYE since the signing of the license agreement in January 2022. 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.”
Shield is eligible to receive £850,000 in development and sales milestones comprised of a payment of £250,000 upon regulatory approval of Accrufer by Health Canada and up to £600,000 in milestone payments upon the achievement of specified calendar net sales targets. For the term of the agreement, Shield will also receive double-digit royalties on net sales of Accrufer.