N4 Pharma PLC Sildenafil PCT Update (1130T)
October 10 2017 - 2:00AM
UK Regulatory
TIDMN4P
RNS Number : 1130T
N4 Pharma PLC
10 October 2017
10 October 2017
N4 Pharma Plc
("N4 Pharma" or the "Company")
Sildenafil PCT Update
N4 Pharma Plc (AIM: N4P), a specialist pharmaceutical company
which reformulates existing drugs and vaccines to improve their
performance, is pleased to announce the publication of the PCT
Patent Application ("Patent Application") in respect of its
proposed reformulation of sildenafil.
The Patent Application deals specifically with N4 Pharma's plans
to reformulate sildenafil to allow for an initial faster onset of
drug in plasma, followed by a further release where the sildenafil
is delivered into plasma more steadily and over a longer time
period.
N4 Pharma's reformulation of sildenafil would see a faster
acting and longer lasting version of current market leader Viagra.
In addition it is expected that, unlike Viagra, the new formulation
can be taken with or without food. The Company believes that these
innovations would make its reformulation attractive to both the end
consumer and pharmaceutical partners in the final development and
commercialisation of the drug. This is supported by market research
undertaken by Black Swan Analysis earlier this year with clinicians
in the UK and US who are currently prescribing sildenafil and
competing products Vardenafil and Tadalafil which suggested that
between 12% and 25% of clinicians in the UK (depending on the
product) would switch patients to N4 Pharma's product and between
19% and 28% of clinicians in the US would do the same.
Following formal publication of the Patent Application, which
has a priority date of 2 June 2016, the next stage in granting the
final patent is 2 October 2018. This is the deadline for entry of
the patent application into national phases and the start of the
detailed review in each key territory.
Further to its announcement on 15 May 2017 regarding its patent
application for Paroxetine, after further reviewing the clinical
and commercial potential for this product, the Board has decided
not to continue with this application and focus the Company's
resources in its other areas of generic reformulation and
vaccines.
Nigel Theobald, CEO of N4 Pharma, commented: "The publication of
the Patent Application marks another important step in our lead
product sildenafil as we head towards our initial human pilot
clinical trials within the next few months. With the Patent
Application now formally published, we can talk more freely with
investors and other interested parties about what our reformulated
sildenafil will hope to achieve in terms of its pharmacokinetic
properties and where it might sit amongst competitors in this
highly lucrative market."
Enquiries:
N4 Pharma Plc
Nigel Theobald, Via Alma PR
CEO,
Stockdale Securities
Tom Griffiths Tel: +44(0)207 601
6100
Beaufort Securities
Elliot Hance Tel: +44(0)207 382
8300
Alma PR
Josh Royston Tel: +44(0)778 090
Robyn Fisher 1979
Tel: +44(0)754 070
6191
About N4 Pharma
N4 Pharma is a specialist pharmaceutical company which
reformulates existing drugs and vaccines to improve their
performance.
N4 Pharma's reformulation work falls under two divisions:
-- generic, already commercialised, drugs; and
-- delivery of novel and existing vaccines.
N4 Pharma has identified a number of established drugs that
could be improved upon through its reformulation techniques. N4
Pharma's most advanced reformulation is for sildenafil, widely
marketed as Viagra, where N4 Pharma is seeking to improve the speed
at which the drug takes effect whilst also extending its duration
of action.
N4 Pharma's reformulation approach should take approximately
three years to obtain regulatory approval as opposed to the
traditional process for new drugs of on average ten years. The cost
and risk profile of this model is also significantly less than the
traditional process. N4 Pharma's business model is to take
reformulated drugs from its portfolio through to the stage where it
will license its newly reformulated drugs to pharmaceutical
companies to commercialise them. N4 Pharma's revenues should be
derived from up front milestone and royalty payments associated
with the licence.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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