New Drug Application for Accrufer® in South Korea

Pending successful review, approval in Korea anticipated in 2025

London, UK, 28 May 2024: Shield Therapeutics plc (LSE: STX), a commercial stage pharmaceutical company that delivers Accrufer®/Feraccru® (ferric maltol), an innovative and differentiated specialty pharmaceutical product, to address a significant unmet need for patients suffering from iron deficiency (with or without anaemia), today announces that its Accrufer® partner for Korea, Korea Pharma Co., Ltd (Korea Pharma) has submitted a New Drug Application (NDA) to the Korean Ministry of Food and Drug Safety (MFDS) for the review and approval of Accrufer® to treat patients with iron deficiency anaemia in Korea. Pending a successful review, approval of Accrufer® in Korea is anticipated in 2025.

Korea Pharma's MFDS filing follows the successful completion of a pharmacokinetic (PK) study in Korea. The PK study confirms that the absorption of iron from Accrufer® is comparable between patients in Korea and the patient population enrolled in the key clinical studies supporting Accrufer® effectiveness and safety.

Shield is eligible to receive a development milestone payment of c.$1.9 upon the first sale of Accrufer® in the territory, as well as future commercial sales milestone payments upon the achievement of specified net sales targets. For the duration of the intellectual property, Shield will also receive double-digit royalties on net sales of Accrufer® in Korea. Shield will be responsible for the initial manufacturing and supply to Korea Pharma.

Greg Madison, CEO of Shield, commented: "Iron deficiency anaemia is a global issue. Shield is committed to working with valued partners, such as Korea Pharma, to enable global access of 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."

Eun-Hee Park, Korea Pharma CEO, commented: "We are pleased by the positive results for the local PK study. These data enabled us to successfully complete a regulatory filing for Accrufer® with the MFDS. There are an estimated 5.2 million people in the Republic of Korea with iron deficiency and iron deficiency anaemia in need of novel treatment options. Pending approval of the NDA, we look forward to providing Accrufer® to the people of Korea as a potential first choice for the treatment of iron deficiency anaemia."

Clinically low iron levels (aka iron deficiency, ID) can cause serious health problems for adults of all ages, across multiple therapeutic areas. Together, ID and ID with anaemia (IDA) affect about 20 million people in the U.S. and represent a $2.3B market opportunity. As the first and only FDA approved oral iron to treat ID/IDA, Accrufer® has the potential to meet an important unmet medical need for both physicians and patients.

About Korea Pharma Co.,Ltd

Korea Pharma is a prescription pharmaceutical company focusing on CNS (central nervous system) and GI (gastro-intestinal) products. Korea Pharma has previously signed an exclusive distribution agreement With Norgine BV, a global PEG-based bowel cleansing agent development company, for distribution of PLENVU®, the world's first one-litre PEG (polyethylene glycol) bowel preparation drug, and is developing a liquid type PEG laxative.