Shield Thera Regulatory News (STX)

Shield Therapeutics plc

("Shield" or the "Group")

Business Update

London, UK, 06 January 2017: Shield Therapeutics plc (LSE:STX), a specialty pharmaceutical company focused on secondary care, is pleased to provide a progress update on the initial stages of the launch of Feraccru, our recently approved, well-tolerated oral iron product for the treatment of iron deficiency anaemia (IDA), in addition to a corporate update as the Group continues to transition to a fully-fledged commercial business.

Feraccru early commercialisation overview

The Group is seeing very encouraging signals of demand after only six months since commercial launch of Feraccru in England and less than three months since launch in Germany. The Board remains extremely positive about the broader commercial opportunity for Feraccru and the prospects this will provide for the long-term success of the Group.

Since raising funds in our IPO in February 2016, as well as commercially launching Feraccru, we have also taken steps to further our transition from a pure research and development focused business into a fully-fledged commercial pharmaceutical company. We have continued to build out the appropriate central resources to support the Group, at the same time as building a commercial product distribution function as well as the beginnings of a European sales and marketing infrastructure.

Commercially, our focus has been on building solid foundations from which we can actively scale and maximise the Feraccru business. To that end, we have made positive progress against a number of strategic goals including achieving very attractive pricing for Feraccru in the key reference markets of England and Germany, as well as starting to see increasing numbers of regional and local formulary and pricing and reimbursement (P&R) approvals in England, a key gating activity to enable prescriber demand to be fulfilled in that key market.

With such positive pricing now entrenched in these key markets, together with a recently extended patent life position, we are considering the best regulatory strategy to provide early access to the wider commercial opportunity that a broader label would provide to Feraccru. We have also made our first commercial sales to AOP, our Central and Eastern European partner, as it commences its commercial activities related to Feraccru. Towards the end of 2016 we also filed a new drug approval application with the Swiss authorities and this should translate to commercialisation in Switzerland during 2018.

UK launch, June 2016

Feraccru became available to the UK market in June 2016, as expected. Our initial focus has been on achieving the demand-enabling formulary access with hospitals and P&R agreements with the budget-holding clinical commissioning groups (CCGs). Whilst substantial resource was deployed as quickly as possible post the IPO and capital raise, review processes within hospital formularies and budget-holding CCGs were slower than initially hoped through the summer months immediately after the product became available commercially. In these early stages of commercialisation we have strategically focused our P&R activities on achieving successful access at the key prescriber locations. Formulary and P&R approvals are now coming through and it is pleasing to see demand follow and to note that our sales team is not encountering any significant push back from patient stakeholders. Month on month we are now beginning to see an increasing number of prescribers being able to make use of the product in their adult inflammatory bowel disease patient population suffering from IDA.

Germany launch, October 2016

Germany is the most important pharmaceutical market opportunity in Europe for Feraccru and we have achieved more attractive pricing in this key market compared to the UK. We are still at a very early stage in the commercial launch as first sales only occurred as planned towards the end of October 2016, once the product became commercially available. However, in the German market, clinician demand for Feraccru becomes visible to the Group much more rapidly because with a national P&R system, there is not the need to gain approvals via local P&R processes. The Group also benefits from a bigger pre-launch footprint for Feraccru due to the Group's close involvement with approximately 20 trial centres during Feraccru's development over the past few years. These factors are enabling us to already see some very positive demand-led uptake in Germany.

Out-licensing strategy set to yield near-term revenues

As planned, the Group continues to make progress in pursuing an out-licensing strategy with highly regarded licensing partners in a number of relevant, although non-core, territories. We are confident that these negotiations will translate into meaningful validations of the technology of, and opportunity for, Feraccru and will yield significant additional revenue in due course. Having recently recruited Georg Buchner (formerly of Amgen) as Senior Director of Business Development and Licensing, we are confident we will see an expansion of the licensing opportunities for Feraccru in additional non-core markets.

Feraccru clinical trial update

Together with existing data on Feraccru, the two Phase 3 studies we are running are designed to further increase the product's commercial opportunity by achieving a broader label in Europe and giving access to the US market via an NDA from the US Food and Drug Administration (US FDA). These data will also facilitate marketing approvals in additional geographies.

AEGIS-CKD Phase 3 study

Timely progress continues to be made with this important trial of Feraccru that is being conducted exclusively with approximately 30 US-based expert nephrology centres. Initial feedback on the product from the involved centres has been positive and, as forecast, the first patients were randomised to treatment during Q4 2016. We continue to anticipate that top line data will be available towards the end of 2017 and, if positive, this will facilitate an NDA submission of Feraccru to the US FDA shortly thereafter.

AEGIS-H2H Phase 3 study

Due to the complex nature of this head to head study,  recruitment has been slower than initially expected. To expedite the process, centres have now been opened by the Group in the US and the progress this study expansion was anticipated to create has started to be seen with first US subjects now randomised to treatment. We expect these newly initiated US centres will provide a material boost to the recruitment process however, at the historic recruitment rate, we anticipate data from this study will now be available in H2 2017, as compared to H1 2017 as indicated in our preliminary results issued in June 2016.

PT20

Good progress has been made with PT20 and, following a recent end of Phase 2 meeting with US FDA, the key work streams towards a potential NDA approval are now clearly understood.

Financial update

We continue to maintain tight control of our finances, selectively investing in the broadening out of the Group's operational capabilities whilst directly supporting the commercial launch of Feraccru and our ongoing product development activities. Booked revenue in 2016 will be in line with market expectations and costs will be below market expectations, largely reflecting a lower level of activity during the period in the AEGIS-H2H study. Preliminary audited results for the year ended 31 December 2016 will be announced in April 2017.

Carl Sterritt, Chief Executive Officer of Shield Therapeutics, said: "The focus for the Group is to drive significant sales growth of Feraccru via our own salesforce or licensing partners and generate additional compelling clinical trial data that can be proactively used to increase and extend the unique commercial opportunity we are creating. The extensive formulary access and P&R process in the UK is undoubtedly frustrating and time consuming, however with Feraccru now becoming increasingly available to prescribers, I am encouraged at the signals of demand we are seeing in England. With no such P&R requirements in Germany, whilst it is early days, I am further encouraged that the opportunity we know exists for Feraccru is beginning to materialise in this very large pharmaceutical market. With a newly launched product, Shield remains well positioned to capitalise on this interest and deliver growth, initially through Feraccru, and, in the near to medium term, through our other pipeline assets as well as the planned acquisition or in-licensing of other complimentary products."

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About Shield Therapeutics plc

Shield Therapeutics is a specialty pharmaceutical company focused on the commercialisation and development of late-stage, hospital-focused pharmaceuticals which address areas of unmet medical need. The Group has a marketed product, Feraccru®, for the treatment of iron deficiency anaemia (IDA) which has exclusive IP rights until 2034. In addition, the Group is developing PT20, a late-stage pharmaceutical for the treatment of systemic phosphate accumulation (hyperphosphatemia). Shield Therapeutics, headquartered in London, is listed on LSE's AIM under the ticker STX. For more information please visit www.shieldtx.com.