Shield Thera Regulatory News (STX)

Shield Therapeutics plc

("Shield" or the "Group")

Shield receives EU Commission approval for the broadening of the indication for Feraccru® (Ferric Maltol) to the treatment of Iron Deficiency in adults

London, UK, 27 March 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs, today announces that the European Commission (EC) has adopted the Decision to extend the approved indication for Feraccru to include treatment of all adults with iron deficiency (ID) with or without anaemia.

This decision, which follows the recent positive opinion of the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) to adopt this extension of Feraccru's marketing authorisation approval, will provide Feraccru with a much broader commercial opportunity, as previously it was only approved and marketed in Europe for the treatment of iron deficiency anemia (IDA) in adult patients with inflammatory bowel disease (IBD).

Carl Sterritt, Chief Executive Officer of Shield Therapeutics, said: "We are extremely pleased that following the CHMP positive opinion in February, the EU Commission has so rapidly ratified the expansion of the indication for Feraccru. This decision confirms a significantly broader patient population target opportunity for Feraccru in Europe, where 40 million* people are estimated to be iron deficient."

The European Commission approval governs the marketing of Feraccru in all 28 EU member countries, as well as Iceland, Norway and Liechtenstein.

*Levi, M., Rosselli, M., Simonetti, M., Brignoli, O., Cancian, M., Masotti, A., Pegoraro, V., Cataldo, N., Heiman, F., Chelo, M., Cricelli, I., Cricelli, C. and Lapi, F. (2016), Epidemiology of iron deficiency anaemia in four European countries: a population-based study in primary care. Eur J Haematol, 97: 583-593. doi:10.1111/ejh.12776

Other Feraccru pipeline events:

Feraccru AEGIS-H2H non-inferiority EU Phase 3b study

The AEGIS-H2H Phase 3b study is designed as a non-inferiority trial comparing the efficacy and safety of Feraccru to the market-leading latest generation form of IV iron (Ferinject/Injectafer, ferric carboxymaltose). Primary endpoint data from the AEGIS-H2H study is expected to be available in the second half of 2018.

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For further information please contact:

Shield Therapeutics plc +44 (0)207 186 8500

Carl Sterritt, Chief Executive Officer

Dr Karl Keegan, Chief Financial Officer

Fleur Wood, Director, Investor Relations

Nominated Advisor and Joint Broker +44 (0)203 100 2222

Liberum Capital Limited

Christopher Britton/Steve Pearce

Joint Broker +44 (0)207 418 8900

Peel Hunt LLP

James Steel/ Dr Christopher Golden

Financial PR Advisor +44 (0)203 709 5700

Consilium Strategic Communications

Mary-Jane Elliott/Matthew Neal

About Iron Deficiency, Anemia and Iron Deficiency Anemia:

Iron deficiency occurs when a body does not have enough iron to supply its needs. Iron is present in all cells in the human body and has several vital functions, such as: carrying oxygen to the tissues from the lungs as a key component of the hemoglobin protein; acting as a transport medium for electrons within the cells in the form of cytochromes; facilitating oxygen enzyme reactions in various tissues. Before iron deficiency causes anaemia the iron stores in the reticuloendothelial system must be completely depleted, leading to symptoms including fatigue, irritability, lack of concentration, hair loss, brittle nails and impaired immune function. Many women in the reproductive age group have very limited or no storage iron due to menstrual blood loss.

Total body iron averages approximately 3.8g in men and 2.3g in women. In blood iron is carried tightly bound to the protein transferrin. There are several mechanisms that control human iron metabolism and safeguard against iron deficiency with the main regulatory mechanism situated in the gastrointestinal tract.

Untreated iron deficiency can lead to iron deficiency anemia, a common type of anemia. Anemia occurs when you have a decreased level of haemoglobin (Hb) in your red blood cells (RBCs). Haemoglobin is the protein in RBCs that is responsible for carrying oxygen to tissues. Iron deficiency anemia is the most common type of anemia, and it occurs when the body doesn't have enough iron as the body needs iron to make haemoglobin. When there isn't enough iron in the blood, the rest of the body cannot get the amount of oxygen it needs. While the condition can be common, many people don't know they have iron deficiency anemia and it is possible to experience the symptoms for years without ever knowing the cause.

For men, anemia is typically defined as having an Hb level of less than 13.0g/dL and in women anemia is typically defined as having an Hb level of less than 12.0g/dL.

The primary causes of IDA are inadequate dietary iron, excess loss of iron usually attributable to some form of bleeding and loss of red blood cells or reduced iron absorption, most commonly due to chronic inflammation caused by a significant disease such as IBD, CKD congestive heart failure and cancer. IDA commonly causes rapid heartbeat, chest pain, diminished cognitive function, depression, fatigue, trouble breathing, dizziness, headache, inability to concentrate, light-headedness, difficulty staying warm and loss of sex drive. Severe IDA, if untreated, can ultimately lead to death.

About Feraccru®

Feraccru is a novel, stable, non-salt, oral formulation of ferric iron, which has a differentiated mechanism of action compared to salt-based oral iron therapies. When salt-based oral iron therapies are ingested, the iron must dissociate from the salt in the GI tract to allow the iron to be absorbed and treat the iron deficiency or the anaemia. This free iron readily chelates to form insoluble clumps as well as producing damaging free radicals that together cause a range of mild-to-severe GI adverse events including nausea, bloating and constipation; leading to poor tolerability, reduced patient compliance and ultimately treatment failure. In addition, many patients are concurrently treated with medicines that raise the pH in the gut, which further reduces the effect of salt-based oral iron therapies as they require highly acidic conditions to be absorbed. Feraccru is not an iron salt, iron can be absorbed from the ferric maltol molecule and as a result, it does not routinely cause the same treatment-limiting intolerance issues. Feraccru has been shown in clinical trials to be well-tolerated by patients even when they had previously failed treatment with salt-based oral iron therapies, which should lead to increased patient compliance and better patient outcomes.

Currently, the only treatment option for patients with iron deficiency with or without anaemia who cannot tolerate salt-based oral iron therapies, is IV iron therapy. IV iron therapies quickly increase iron stores via direct administration of very large doses of iron, causing an increase in Hb levels that is physiologically controlled and occurs over a period of weeks, as is the case with Feraccru. IV iron therapies, however, are invasive, costly, inconvenient, complex to administer and also come with potentially life-threatening, spontaneous hypersensitivity reactions.

About Shield Therapeutics plc

Shield is a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs. Our clear purpose is to help our patients become people again, by enabling them to enjoy the things that make the difference in their everyday lives. The Group has a marketed product, Feraccru®, for the treatment of IDA in adult patients with IBD which has exclusive IP rights until the mid-2030's. For more information please visit www.shieldtherapeutics.com. 

Forward-Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements are based on management's current expectations and include statements related to the timing of future results of Feraccru trials and the timing and success of the Group's regulatory plans and commercial strategy for Feraccru. These statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties, many of which are beyond our control, that may cause actual results, performance or achievements to be materially different from management's expectations expressed or implied by the forward-looking statements, including, but not limited to, risks associated with the regulatory approval process, the Group's business and results of operations, competition and other market factors. The forward-looking statements made in this press release represent management's expectations as of the date of this press release, and except as required by law, the Group disclaims any obligation to update any forward-looking statements contained in this release, even if subsequent events cause our views to change.