Shield Thera Regulatory News (STX)

Shield Therapeutics plc

("Shield" or the "Group")

Shield receives CHMP positive opinion for Feraccru® (Ferric Maltol) for the treatment of Iron Deficiency in adults

Recommendation for broad label in EU

London, UK, 23 February 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs, with an initial focus on addressing iron deficiency anaemia, today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorisation approval of Feraccru (Ferric Maltol) to be extended to include treatment of all adults with iron deficiency (ID) with or without anaemia, which will provide Feraccru with a much broader commercial opportunity. This recommendation will now go forward to the European Commission for ratification and implementation over the next two to three months. Feraccru, the Company's lead asset, is currently approved and marketed in Europe for the treatment of iron deficiency anemia (IDA), initially in patients with inflammatory bowel disease (IBD).

Dr Mark Sampson, Chief Medical Officer of Shield Therapeutics, said: "We are pleased to receive this positive opinion from the CHMP for Feraccru and it is an important step for Shield and for patients suffering with iron deficiency be that with or without anaemia. Iron deficiency causes significant morbidity and failure to be able to treat it adequately with current therapies can cause the disease to progress to iron deficiency anaemia. The WHO has identified that iron deficiency is a globally important health issue significantly impacting the lives up to 2 billion people."

Carl Sterritt, Chief Executive Officer of Shield Therapeutics, said: "As we announced yesterday, the Board has initiated a complete review of the various strategic options available to the Company, particularly the options for Feraccru to deliver significant value to shareholders. Once this recommendation is ratified by the European Commission in the near term, the market opportunity for Feraccru in Europe significantly expands from the current 300,000 patients with IDA in IBD, to a much broader patient population opportunity, with over 40 million* people in the EU estimated to be iron deficient. With Feraccru being protected by a composition of matter patent through to 2035, this a valuable step forward for the Company as it considers its strategic options. We look forward to the European Commission's ratification and approval of the CHMP's positive opinion."

The positive opinion from the CHMP will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 EU member countries, Iceland, Norway and Liechtenstein. The EC generally follows the recommendation of the CHMP two to three months following CHMP opinion.

*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.

- Ends -

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 plasma, iron is carried tightly bound to the protein transferrin. There are several mechanisms that control human iron metabolism and safeguard against iron deficiency. The main regulatory mechanism is 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 hemoglobin in your red blood cells (RBCs). Hemoglobin is the protein in your RBCs that is responsible for carrying oxygen to your tissues. Iron deficiency anemia is the most common type of anemia, and it occurs when your body doesn't have enough of the mineral iron. Your body needs iron to make hemoglobin. When there isn't enough iron in your blood stream, the rest of your body can't get the amount of oxygen it needs. While the condition may be common, many people don't know they have iron deficiency anemia. It's 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 13g/dL and in women anemia is typically defined as having an HB level of less than 12.0 g/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, and 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 IDA. This free iron readily chelates to form insoluble clumps and produces 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 with IDA 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, and iron can be absorbed from the ferric maltol molecule, 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 IDA patients 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 and 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.