TIDMSTX
RNS Number : 9416N
Shield Therapeutics PLC
24 January 2019
This announcement contains inside information for the purposes
of Article 7 of Regulation 596/2014
Shield Therapeutics plc
("Shield" or the "Group")
Business and trading update
London, UK, 24 January 2019: Shield Therapeutics plc (LSE:STX),
a commercial stage, pharmaceutical company delivering innovative
specialty pharmaceuticals to address patients' unmet medical needs,
today provides a business and unaudited trading update for the year
ended 31 December 2018.
Operational highlights
-- Norgine commences promotion of Feraccru(R) in UK and Germany
-- Following the positive result from the Feraccru(R) AEGIS-CKD
study, a US NDA was filed and accepted by FDA and the 27 July 2019
has been set as the PDUFA date
Financial highlights in line with market expectations
-- Revenues for year ended 31 December 2018 are expected to be
c. GBP11.9 million (2017: GBP637,000)
-- Cash position as at 31 December 2018 was GBP9.8 million (2017: GBP13.3 million)
Business update
The Group announced on 19 September 2018 that it had entered
into an exclusive licence agreement with Norgine BV for the
commercialisation of Feraccru(R) in Europe, Australia and New
Zealand. The financial terms included an GBP11 million upfront
licence payment which was recognised in 2018, up to an additional
EUR54.5 million in development and sales milestones, and royalties
on sales which range from 25% to 40%. With a positive working
relationship, the transition process progressed smoothly through
the last three months of 2018 and Norgine began to promote
Feraccru(R) in both the UK and Germany in December as these are
markets where the product was already commercially available and
being reimbursed.
Across these two markets Norgine already has approximately 80
sales representatives promoting Feraccru, representing more than
four times the number of sales representatives Shield had
previously been able to deploy. These sales representatives are
further supported in the field by dedicated pricing and
reimbursement-focused staff, and also medical support staff.
Feraccru(R) will be launched by Norgine in the other major
European markets when pricing and reimbursement negotiations are
concluded, with these launches not expected before 2020. During
2018 Feraccru(R) also achieved attractive levels of reimbursement
in Sweden and Finland, enabling further commercial rollout by AOP
in those markets. 2018 also saw a major broadening of the approved
marketing authorisation of Feraccru(R) in Europe, which
significantly expanded the market opportunity from a few hundred
thousand patients with IBD-IDA to many millions of patients, as
Feraccru(R) can now be used in all adults to treat iron deficiency
with or without anaemia, whatever the patient's primary
disease.
The Group also announced on 1 October 2018 that it had submitted
a New Drug Application (NDA) for Feraccru(R) for the treatment of
iron deficiency with the US Food and Drug Administration (FDA).
Since then the FDA has accepted the filing and confirmed that the
target date for completion of the NDA review is 27 July 2019.
However, with the prolonged shutdown of federal government
operations in the USA, there may be some risk of delay to this
review. As previously indicated, as with European
commercialisation, the Board is assessing options for the
commercialisation of Feraccru(R) in the USA, including identifying
a suitable commercial partner for whom Feraccru(R) would be an
important asset and who would be able to deploy significantly more
resources than the Group could in support of the successful
commercialisation of Feraccru(R).
Discussions are also underway with third parties for the
licensing of Feraccru(R) commercial rights in certain other
countries.
Recruitment of patients into the AEGIS-H2H study, comparing
Feraccru(R) with Ferinject (the leading intravenous iron therapy)
was completed in September 2018 and the Group expects that results
of this study will be available by the end of March 2019. In the
event that the study achieves the primary endpoint of
non-inferiority a milestone payment would become receivable by the
Group under the terms of the Norgine agreement.
The Group has been made aware that a 3rd party has raised
objections with the European Patent Office (EPO) to the Group's
patents (#2 668 175 and # 3 160 951) which cover "Process for
preparing an iron hydroxypyrone" and "Crystalline forms of ferric
maltol" respectively. On the basis of specialist advice received
and the fact both patents went through an extensive examination
process prior to grant, the Group continues to have full confidence
in the validity of the patents which expire in 2032 and 2035, and
intends to robustly defend its intellectual property, if required.
Further information is available on the website of the European
Patent Office (EPO) (www.epo.org) and the Group will provide
updates in due course.
Financial update
Expected revenues of c. GBP11.9 million in 2018 are dominated by
the GBP11.0 million upfront received from Norgine on the signing of
the licence agreement. The remaining expected c. GBP0.9m comprised
(a) c. GBP0.6 million Shield sales in the UK and Germany prior to
the signing of the licence agreement, (b) c. GBP0.1 million
royalties from Norgine on their sales in the UK and Germany since
the September 2018 signing of the licence agreement, and (c) c.
GBP0.2 million sales to AOP Orphan Pharmaceuticals AG and Ewopharma
AG, Shield's licence partners for Scandinavia and Switzerland.
Following the receipt of the GBP11.0 million upfront from
Norgine, the Group had a cash balance of GBP9.8 million as at 31
December 2018. Taking into account expected royalty income from
Norgine during 2019, which is anticipated to grow steadily based on
sales in the UK and Germany, but excluding any development or sales
milestones which may be received from Norgine, and the planned
expenditure on R&D, the Board is confident that the Group's
cash runway currently extends into 2020.
Board change
The Group has previously announced that James Karis, a
non-executive director since 2016, has been appointed as Chairman
of the Board.
Carl Sterritt, Chief Executive Officer of Shield Therapeutics,
said: "Shield has entered 2019 in good shape. I have been
encouraged by the sales performance of Feraccru(R) in the UK and
Germany, where upward sales momentum has been maintained through
the last twelve months despite the lack of active sales promotion
since February 2018 and I believe that Norgine, with its much
larger field-based sales team and readily available resources, is
well placed to build on the positive momentum we saw in 2018 and
drive the Feraccru business forwards in Europe. In the USA I am
looking forward to the 27 July 2019 PDUFA date for Feraccru(R) and
the opportunity for Feraccru(R) to be commercialised in the world's
largest prescription pharmaceutical market. To enable this we are
focused on identifying a suitable US commercial partner at the
earliest opportunity, and, based on ongoing discussions I believe
we also have the potential to out-license Feraccru(R) for
commercialisation in other parts of the world".
- Ends -
For further information please contact:
Shield Therapeutics plc +44 (0)207 186 8500
Carl Sterritt, Chief Executive Officer
Tim Watts, Interim Chief Financial Officer
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 +44 (0)203 709 5700
Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal
About Feraccru(R)
Feraccru(R) is a novel, stable, non-salt, oral formulation of
ferric iron, which has a differentiated mechanism of absorption
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(R) is not an iron salt, and 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(R)
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(R). 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(R), for the treatment of iron deficiency in adult
patients with or without anaemia. Feraccru(R) 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.
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END
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