N4 Pharma PLC Filing of Patents and Sildenafil Update (0666F)
15 May 2017 - 4:00PM
UK Regulatory
TIDMN4P
RNS Number : 0666F
N4 Pharma PLC
15 May 2017
15 May 2017
N4 Pharma Plc
("N4 Pharma" or the "Company")
Filing of Patents and Sildenafil 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 filing of its Patent
Cooperation Treaty ("PCT") patent application for its sildenafil
reformulation and provide an update on the work done by the Company
in the year to date as it moves towards clinical trials. In
addition, the Company is pleased to announce the filing of two new
patents expanding its potential reformulation product pipeline to
five.
Sildenafil Update
Since the start of this year, work has continued on the
Company's sildenafil reformulation and the Company has now filed
its PCT patent application seeking worldwide protection of the
Company's reformulation methodology. This follows the successful
completion of the laboratory dissolution testing of the formulation
to establish the correct dissolution profile required for the
reformulated product.
The next phase for the sildenafil product is to move into
clinical trials with healthy volunteers to determine the precise
level of the drug in blood plasma to then take those results to the
relevant regulatory authorities, such as the Food and Drug
Administration ("FDA") in the USA and the Medicines and Healthcare
Regulatory Agency ("MHRA") in the UK. The Company is in the process
of discussing the parameters for these trials as well as working
through all the regulatory requirements and necessary approvals
before they can formally commence and will make further
announcements in due course as and when the timing of commencement
of the trials becomes clearer.
New Product Patent Filings
N4 Pharma has also filed two new patent applications in respect
of the reformulation of two other drugs.
The first is for a reformulation of the anti-depressant drug,
paroxetine, to develop a new product for the treatment of hot
flashes and night sweats in menopausal women. Paroxetine has
already been approved for these treatments by the FDA.
The second is for a reformulation of another anti-depressant
drug, duloxetine, for the treatment of premature ejaculation
("PE"). This product differs slightly to our standard approach in
that, although duloxetine has been researched to show its efficacy
for PE, no clinical trials have been performed to date since there
is no patent protection for the generic drug. Our reformulation
will provide patent protection, thereby allowing a partner to
undertake the required trials knowing that the final product will
be commercially protected.
Both of these conditions ideally require the product to be
faster acting and longer lasting and our formulations will give us
strong patent protection if granted in this area. The market for
menopausal hot flashes drugs is forecast to grow annually from
$3.8bn in 2014 to $5.3bn by 2023(1). In the case of duloxetine, PE
is believed to affect up to 30 per cent of American males,
equivalent to approximately 20 million adults per year.
Nigel Theobald, CEO of N4 Pharma, commented: "Our reformulation
work has progressed positively over the last few months and, with
the completion of our lab work on sildenafil, all our efforts will
be focused on finalising the scope of work and deliverables for our
clinical trials.
"Our new patent applications take our potential product pipeline
to five, with each product addressing significant established
markets for a range of complications from erectile dysfunction to
hypertension and the side effects of menopause.
"With the funds raised from the recent share placing, we are
well placed to take our programme forward and I look forward to
providing further updates on our various projects as and when
appropriate."
Enquiries:
N4 Pharma Via Alma PR
CEO, Nigel Theobald
Stockdale Securities Tel: +44(0)207 601
Tom Griffiths 6100
Beaufort Securities Tel: +44(0)207 382
Elliot Hance 8300
Alma PR Tel: +44(0)778 090
Josh Royston 1979
Robyn Fisher Tel: +44(0)754 070
6191
About N4 Pharma
N4 Pharma was formed in 2014 by Nigel Theobald, the former Chief
Executive of AIM quoted Oxford Pharmascience Group plc. It 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.
(1)
http://www.prnewswire.com/news-releases/menopausal-hot-flashes-market-to-reach-us528-bn-by-2023-estrogen-leads-hormonal-products-in-revenue-and-prescription-volume-564235661.html
This information is provided by RNS
The company news service from the London Stock Exchange
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