TIDMSTX
RNS Number : 0739K
Shield Therapeutics PLC
06 April 2018
Shield Therapeutics plc
("Shield" or the "Company")
Shield Therapeutics Announces Results of its Pre-Submission
Meeting with FDA
Confirms plans to submit a New Drug Application for Feraccru(R)
as soon as possible, provides a strategic review update and
announces the appointment of a Non-Executive Director
London, UK, 6 April 2018: Shield Therapeutics plc (LSE:STX), a
commercial stage, pharmaceutical company with an initial focus on
addressing iron deficiency with its novel therapy, Feraccru,
announces it has received final minutes from the US Food and Drug
Administration (FDA) of its recent pre-New Drug Application (NDA)
submission meeting. These minutes form the official record of this
meeting with the FDA and they have provided Shield with the
necessary guidance to progress submission of an NDA for Feraccru
without conducting additional pivotal clinical trials. The NDA will
be submitted as soon as possible in 2018 and the work will be
funded within the Company's current cash resources.
Background
On 16 March 2018 the Company provided an update on the AEGIS-CKD
Phase III study following detailed analyses of the data from the
double-blind period of this study of Feraccru. At the same time
Shield also confirmed it had met with the FDA for a previously
scheduled pre-NDA submission meeting. In this meeting Shield shared
the data and findings from all available analyses of the AEGIS-CKD
Phase III trial, including key safety and efficacy parameters.
Based on the minutes of the meeting provided to the Company by FDA
and Shield's own review of the data, the Company now intends to
finalise and submit an NDA for Feraccru as soon as possible.
Strategic review update
Europe licensing options:
With the recent significant expansion of Feraccru's European
marketing authorisation to include all adult patients with iron
deficiency, the Company is evaluating ways of more rapidly
leveraging the value of Feraccru in Europe and has engaged a third
party to facilitate this process. Shield is considering a range of
partnering structures that could likely include upfront payments,
which would further extend the Company's cash runway, along with
sales-based royalties that would provide revenue throughout the
life of a partnering agreement.
US market opportunity for Feraccru:
Following feedback from the FDA, Shield is now progressing with
the submission of an NDA for Feraccru as soon as possible and the
Company will continue to update the market in the normal course of
business as the submission progresses. Shield will now also fully
re-assess the options for Feraccru's commercialisation in the
US.
Appointment of Non-Executive Director
A separate announcement by the Company today confirms the
appointment of Rolf Hoffmann, as a Non-Executive Director of the
Company. Rolf's extensive experience and knowledge of the
pharmaceutical industry and his deep commercial experience will be
helpful in assessing the specific decisions the Company is
considering in relation to the commercial strategy for Feraccru, as
well as part of its ongoing strategy assessment.
Cash runway
There have been no material changes to Shield's cash runway as
stated in the business update announcement of 22(nd) February 2018.
The Company will provide a further update in its upcoming
preliminary results announcement due on 11(th) April 2018.
Carl Sterritt, Chief Executive Officer of Shield Therapeutics,
said: "As I said at the time, we were surprised and disappointed by
the initially reported top-line findings of the AEGIS-CKD study, as
Feraccru had previously consistently demonstrated positive efficacy
and safety, which facilitated its approval in Europe and where it
has continued to gain commercial traction. The discussions with and
feedback received from FDA, together with our own review of the
AEGIS-CKD data, provides us with the confidence to submit
Feraccru's NDA as soon as possible and without conducting
additional pivotal trials. If approved, the NDA would permit this
novel product to be marketed in the world's most important
pharmaceutical market.
"The US geographic expansion we hope this positive data will
facilitate, would hugely increase Feraccru's commercial
opportunity, further increasing the attractiveness of an asset that
already has broad approval in Europe and gold standard composition
of matter protection through 2035 in the two most important
pharmaceutical markets in the world. At the same time, we are
encouraged by the level of interest shown in the initial stages of
our European partnering activities for Feraccru and we will
continue to diligently work towards finalising a suitable agreement
at the earliest opportunity.
"Finally, on behalf of the Board, I would like to extend a warm
welcome to Rolf Hoffmann and I look forward to benefitting from his
highly relevant and extensive knowledge of the global
pharmaceutical market."
Webcast and conference call for analysts at 1pm BST today
Carl Sterritt, Chief Executive Officer, Dr Karl Keegan, Chief
Financial Officer and Dr Mark Sampson, Chief Medical Officer, will
host a live conference call and webcast for analysts at 1pm BST
today, 6 April 2018, to discuss this announcement.
The presentation and access to the live webcast will be on
Shield's website at www.shieldtherapeutics.com.
Dial in details:
Location Purpose Phone Number
--------------- ------------ -------------------
United Kingdom Participant +44 (0)330 336 9105
--------------- ------------ -------------------
United States Participant +1 646-828-8156
--------------- ------------ -------------------
The participation code is: 8668739
To access the audio webcast, please follow this link or
alternatively visit Shield's investor relations page.
An audio replay file will be made available shortly afterwards
via Shield's website: www.shieldtherapeutics.com.
- 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
This announcement contains inside information for the purposes
of Article 7 of Regulation 596/2014. The person who arranged for
the release of this announcement on behalf of Shield Therapeutics
was Carl Sterritt, Chief Executive Officer.
About Feraccru(R)
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 iron
deficiency or the anaemia. This free iron readily chelates to form
insoluble clumps as well as producing 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 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,
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.
Currently, the only treatment option for patients with iron
deficiency with or without anaemia 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, complex to administer and also come with potentially
life-threatening, spontaneous hypersensitivity reactions.
About Non-Dialysis Dependent Chronic Kidney Disease and Iron
Deficiency Anaemia
The National Institute of Diabetes and Digestive and Kidney
Diseases suggests the overall prevalence of CKD in the United
States is approximately 14%, and in Europe, the European Renal
Association has reported that CKD has a prevalence of 10%.
There are five stages of CKD; in stages 1 and 2 people are
typically under the care of a primary care physician and have a
mild loss of kidney function. As people progress to stage 3
haemoglobin levels begin to fall, the patient experiences moderate
to severe loss of kidney function and is generally referred to a
nephrologist. Stage 4 is characterised as advanced disease with
multiple complications and by stage 5 a patient is in kidney
failure and dialysis would be initiated.
Standard of care currently only consists of measures to help
control signs and symptoms and reduce the impact of the many
complications, thereby making a patient more comfortable and
slowing disease progression.
Anaemia is a major complication of CKD with an average of 15.4%
of patients having anaemia, although this prevalence increases with
the stage of CKD, rising from around 10% at stage 1 to
approximately 55% at stage 5 and is associated with fatigue,
lethargy, decreased quality of life and is also believed to be
associated with cardiovascular complications, hospitalisations and
increased mortality. As with IDA due to other diseases, currently
available salt-based oral iron supplements are associated with
limited efficacy and dose-limiting tolerability issues.
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 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 Company'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 Company'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 Company disclaims any
obligation to update any forward-looking statements contained in
this release, even if subsequent events cause our views to
change.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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