Positive decision on Feraccru®'s process patent

Shield Therapeutics plc

("Shield" or the "Group")

European Patent Office reaches positive decision on Feraccru®'s process patent 

London, UK, 14 March 2019: Shield Therapeutics plc (LSE: STX), a commercial stage pharmaceutical company with a focus on addressing iron deficiency with or without anaemia via its lead product Feraccru®, announces that, further to Shield's announcement on 24 January 2019 and in relation to the Group's patent #2 668 175, which covers a "Process for preparing an iron hydroxypyrone", the Opposition Division of the European Patent Office (EPO) has today decided in favour of Shield.

The decision by the EPO, which was reached having taken into account Shield's first and preferred minor amendment, follows a hearing in relation to the opposition that had been filed against the patent by a third party.  This means that the patent as amended and the invention to which it relates meet the requirements of the European Patent Convention and they will continue to provide protection to Feraccru® through to 2032.

Customary rights of appeal apply to the third-party opposition and Shield will continue to proactively and robustly defend its intellectual property.

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About Shield Therapeutics plc

Shield is a de-risked, commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs.  The Company's clear purpose is to help its 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 iron deficiency in adults which has exclusive IP rights until the mid-2030s.  Feraccru® is commercialised in the European Union by Norgine BV and the US Food and Drug Administration (FDA) is currently considering a New Drug Application (NDA), with a PDUFA (Prescription Drug User Fee Act) date of 27^th July 2019.  For more information please visit www.shieldtherapeutics.com. 

About Feraccru®

Feraccru® is a novel, stable, non-salt oral treatment for iron deficiency with or without anaemia which offers a compelling alternative to IV Iron for those patients that cannot tolerate salt-based oral iron therapies.  When salt-based oral iron therapies are ingested they can cause a range of mild-to-severe gastrointestinal tract (GI) adverse events, including nausea, bloating and constipation, leading to poor tolerability, reduced patient compliance and ultimately treatment failure.  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.

Previously, the only treatment option for patients who could not tolerate salt-based oral iron therapies was IV iron therapy, which is invasive, costly, inconvenient and complex to administer as well as being associated with potentially life-threatening and spontaneous hypersensitivity reactions. 

Feraccru® is approved and marketed in the European Union for the treatment of ID in adults and in Switzerland for the treatment of IDA in adults with IBD.

About Iron Deficiency

The WHO state that ID is the most common and widespread nutritional disorder in the world.  As well as affecting a large number of children and women in non-industrialized countries, it is the only nutrient deficiency which is also significantly prevalent in virtually all industrialized nations. There are no current global figures for ID, but using anaemia as an indirect indicator it can be estimated that most preschool children and pregnant women in non-industrialized countries, and at least 30-40% in industrialized countries, are iron deficient.

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.