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FDA Grants Approval of IND to Commence a Phase 3 Pivotal Study for ST10 for the Treatment of Iron Deficiency Anaemia in Chronic Kidney Disease
Date:12/16/2013

utive Officer of Shield Therapeutics, stated:  "I am delighted that FDA has approved this IND and we can now move forward with our plans to test ST10 in this second major indication and at the same time introduce ST10 to clinicians in the world's largest and most important pharmaceutical market. ST10 has the potential to be the only effective oral iron-replacement therapy without significant GI side effects and we believe this novel and convenient product has the potential to become a market leader for IDA in the established CKD patient population worldwide."

About Shield Therapeutics

Shield Therapeutics (http://www.shieldtherapeutics.com), founded in 2008, is an independent specialty pharmaceutical company focused on the development and commercialisation of late-stage, mineral-derived hospital pharmaceuticals which address areas of high unmet medical need.  Shield is currently conducting pivotal Phase 3 studies of its lead asset, ST10, for the treatment of iron deficiency anaemia associated with inflammatory bowel disease and is soon to commence a Phase 3 study of ST10 for the treatment of iron deficiency anaemia in patients with chronic kidney disease.

About IDA and the CKD Therapeutics Market

Epidemiology data suggests the current total IDA patient population in the EU, USA and Japan is approximately 34m, with an addressable population of 2.6m (IBD and CKD in the EU and US) in the first instance.  The company estimates that the core market in IDA is worth at least $3.0bn. In addition, the global CKD therapeutics market is forecast to grow at a compound annual growth rate (CAGR) of 6.4% to reach $11.6billion by 2018[1].

[1]Chronic Kidney Disease (CKD) Therapeutics - Pipeline Assessment and Market Forecasts to 2018, GlobalData, S
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SOURCE Shield Therapeutics
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