Shield Therapeutics PLC's (AIM:STX, OTCQX:SHIEF) partner, Korea Pharma, has filed a New Drug Application (NDA) for Accrufer with the country's Ministry of Food and Drug Safety.
This filing is a crucial step toward making Accrufer available to patients with iron deficiency anaemia in Korea. If approved, Shield Therapeutics will receive a $1.9 million milestone payment upon the first sale. The regulatory green light is anticipated next year.
The NDA submission follows a successful pharmacokinetic study. The study confirmed that Accrufer's iron absorption in Korean patients is comparable to that of previous clinical studies. This supports Shield drug's effectiveness and safety.
Shield will also receive additional commercial sales milestone payments based on net sales targets. For the duration of the intellectual property, the UK group will earn double-digit percentage royalties on net sales of its product in South Korea. Shield will manage the initial manufacturing and supply.
Shield's CEO Greg Madison said: "Iron deficiency anaemia is a global issue. Shield is committed to working with valued partners, such as Korea Pharma, to enable global access to Accrufer and advance the care of patients with iron deficiency anaemia around the world.
"Completion of the MFDS filing by Korea Pharma marks the first filing for Accrufer in Southeast Asia. We are thrilled to work with our partner to reach this important milestone. We look forward to supporting Korea Pharma as they continue the pathway to making Accrufer available to patients in Korea."