TIDMSTX TIDMSTXW
RNS Number : 4912T
Shield Therapeutics PLC
06 January 2017
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."
- Ends -
For further information please contact:
Shield Therapeutics plc +44 (0)20 7186 8500
Carl Sterritt, Chief Executive
Officer
Nominated Adviser and Broker
Liberum Capital Limited
Christopher Britton/Steve
Pearce +44 (0)20 3100 2222
Financial PR Advisor +44 (0)20 3709 5700
Consilium Strategic Communications shieldtherapeutics@consilium-comms.com
Mary-Jane Elliott/Matthew
Neal
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(R), 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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