Shield Therapeutics (STX ), a commercial stage pharmaceutical company, has successfully made a New Drug Submission to Canadian regulator Health Canada through its Canadian licensing partner KYE Pharmaceuticals.
Health Canada has screened and accepted the submission for the company's flagship product Accrufer, and is expected to complete its review by mid-2023. Accrufer is an iron deficiency oral treatment that uses a novel absorption mechanism. It has been shown effective in treating anemia and other iron deficiency-related conditions.
Upon regulatory approval by Health Canada, Shield will receive a £250K milestone payment. Additionally, Shield will be eligible for a further £600K, conditional on reaching certain sales targets. For the term of the agreement, Shield will also receive royalties on those sales.
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Accrufer has already launched in the US, UK, and EU to much success. Shield announced last month that subscriptions grew 100% in the US in just the first 3 months of 2022. Accrufer sales reached c. 2,500 prescriptions in the 6 months following its US launch in July 2021, with 40% of eligible Americans now having coverage for the treatment in both private and Medicaid segments.
In Europe, where the treatment's brand name is Feraccru, volume was up 60% in 2021, mostly due to increased demand in Germany. Shield also licensed Accrufer to Korea Pharma in the Republic of Korea last year. And in China, Shield's partner Beijing Aosaikang Pharmaceutical (ASK Pharma) has completed a pharmacokinetics study requirement and started enrolment in a Phase 3 registrational trial.
Today's news represents a continuation of Shield's global rollout strategy. If success in Canada and Asia mirrors results in the US and Europe, the company will be well-positioned for future growth.
Greg Madison, CEO, said in last month's update: "Based on all our collective insights, we are even more confident today about Accrufer becoming the oral iron of choice, and the potential for significant value creation. The team here at Shield will continue to work tirelessly in our pursuit to ensure the millions of patients seeking treatment for their iron deficiency, will have the opportunity to experience the benefits of Accrufer."
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