Licence Agreement in Japan for ACCRUFeR®

Shield to receive an initial payment of ~$665,000 plus regulatory and sales milestones, and double-digit royalties on net sales

London, UK, 22 April, 2025: Shield Therapeutics plc (LSE: STX), a commercial stage pharmaceutical company specialising in iron deficiency with or without anemia ("ID/IDA"), announces that it has entered into an exclusive licence agreement ("the Agreement") for ACCRUFeR® with VITAL-NET, Inc. ("VITAL-NET") in Japan. VITAL-NET will undertake and be responsible for all costs, including clinical and regulatory, related to activities required to achieve marketing authorisation and commercialisation of ACCRUFeR® in Japan.

Shield will receive an initial payment of circa $665,000 and is eligible to receive additional milestone payments related to the regulatory approval of ACCRUFeR® and upon the achievement of specified net sales targets by VITAL-NET. For the term of the agreement, Shield will also receive double-digit royalties on net sales of ACCRUFeR®. VITAL-NET to be responsible for, and cover costs of all development and regulatory activity.

Anders Lundstrom, Chief Executive Officer for Shield, commented: "This partnership aligns with our commitment to keep expanding our global footprint for ACCRUFeR®. Japan, the third largest pharmaceutical market in the world, is an important market to enter as Iron deficiency is a prevalent health concern in Japan, especially among women, children, and the elderly. ACCRUFeR® offers a new option for those who need a more effective treatment to restore their iron levels and improve their overall health. We look forward to working together with VITAL-NET to making ACCRUFeR® available to the people of Japan."

Takeshi Ichijo, CEO of VITAL-NET, commented: ""We are excited to have entered into the agreement with Shield Therapeutics for the supply, development and marketing of ACCRUFeR®. Iron deficiency (ID) patients in pulmonary hypertension (PH) and inflammatory bowel disease (IBD) are our important areas, we believe that our experience will be of great use. We will endeavour to provide the drug to Japanese patients suffering from ID."

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 anemia (IDA) affect about 20 million people in the US 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.

Iron deficiency and iron deficiency anemia (ID/IDA) poses a significant health challenge in Japan, with the country accounting for approximately 39% of ID cases among the seven major markets, which include the USA, EU5 (the UK, Italy, Spain, France, and Germany), and Japan[1]. The ID/IDA treatment landscape in Japan primarily consists of oral and intravenous (IV) iron supplements. Oral iron products, including both over-the-counter and prescription formulations, dominate the market in terms of volume[2].

The Japanese iron deficiency therapy market is poised for growth. This growth is attributed to factors such as the introduction of novel therapies, an increasing IDA prevalence, and heightened awareness regarding anemia management[3]. Japan's ID/IDA market is characterized by a robust demand for both oral and IV iron supplements, influenced by regional demographics and recent pharmaceutical innovations2. The market is expected to expand steadily, driven by ongoing advancements in treatment options and a growing focus on addressing iron deficiency and iron deficiency anemia3.

[1] Anemia Market Insight, Epidemiology and Market Forecast

[2] Clinical management of iron deficiency anemia in Japan: iron prescription patterns, treatment effectiveness, and assessments - PMC

[3] Iron Deficiency Anemia Therapy Market Size Report, 2030