N4 Pharma PLC Strategic Review (3150B)
20 September 2018 - 4:00PM
UK Regulatory
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RNS Number : 3150B
N4 Pharma PLC
20 September 2018
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the Market Abuse Regulations (EU) No. 596/2014. Upon the
publication of this announcement via Regulatory Information
Service, this inside information is now considered to be in the
public domain
20 September 2018
N4 Pharma Plc
("N4 Pharma" or the "Company")
Strategic Review
N4 Pharma Plc (AIM: N4P), the specialist pharmaceutical company,
today announces that, following the receipt of the final report of
the clinical trial for its reformulation of sildenafil, the Board
has undertaken a strategic review of the business. The findings and
implications are as follows:
Results of the full clinical data:
As announced on 9 July 2018, the Company received the
preliminary results of the pharmacokinetic ("PK") data from its
clinical trial for the reformulation of sildenafil, which showed
that the formulation had not met the key target endpoints of the
trial.
The Board has since received the full clinical data report,
analysis of which shows that the technical difficulty in achieving
the required fast onset product profile for sildenafil as set out
in our patent application is much higher than originally
anticipated and, therefore, there can be no guarantee that any
subsequent new reformulation would be covered by the patent
application. Having considered the options to address the PK
profile the directors have concluded that the cost and time for
subsequent reformulation and clinical work on this product will be
much higher than previously anticipated and the chances of success
considerably lower. The Board considers that this also has similar
implications for other patents within the Company's generics
portfolio, namely aprepitant and duloxetine, which are based on a
similar PK approach to sildenafil and so, it is likely that their
cost and risk will also increase.
Nuvec(R) opportunity:
Nuvec(R), as a delivery system, gives N4 Pharma many
opportunities to explore in what is a highly attractive market,
with many major pharmaceutical companies seeking delivery system
solutions for projects in which they are investing significant sums
of money.
Since admission to trading on AIM, N4 Pharma has undertaken and
continues to undertake research to identify the exciting potential
for Nuvec(R) and has already secured a collaboration with a major
player, MedImmune UK, to evaluate its potential applications. N4
Pharma is now beginning the relevant Chemisty Manufacturing and
Controls ("CMC") work needed, including technology transfer, scale
up and Good Manufacturing Practice ("GMP") in order to be well
placed to work with partners to undertake clinical trials as and
when needed. The Company has also recently recruited Dr Allan Hey
former Vice President of Pharmaceutical services at Circassia Ltd
as the new Head of CMC Development to lead this work. Allan brings
considerable expertise in the field of CMC Biologics having also
held senior CMC posts at Takeda and Lundbeck.
Result of Strategic Review:
In light of the results of the full sildenafil clinical data
report, the Board has given careful consideration to the chances of
success for sildenafil and consequently aprepitant and duloxetine.
The Board has concluded that the increased risk and much higher
costs of undertaking any further clinical trials has significantly
altered the risk reward profile and that pursuing these
opportunities would not be a good use of the funds available to the
Company and, therefore, not in the long-term interest of
shareholders. In light of this, the Company will discontinue
further development of these assets and will not continue with the
patent applications for these generic reformulations.
This therefore leaves the generic division with valsartan as the
only opportunity with the potential risk reward ratio sought by the
Company. Keeping this opportunity active due to patent obligations
would still involve significant investment and therefore the Board
has taken the difficult decision to close the generics division and
focus management's time and Company funds on Nuvec(R).
By making the decision to stop further investment into the
generics division, the Company maintains sufficient funds to
continue to invest in undertaking the required work on Nuvec(R)
well into 2019. As announced on 18 June 2018 the first results of
the existing research will be available in Q4 2018, which the Board
believes will provide further compelling data to present to other
collaborators as well as MedImmune UK and identify specific
opportunities for the Nuvec(R) system.
Nigel Theobald, CEO of N4 Pharma commented: "Whilst the decision
to close the generic division is clearly disappointing, it has not
been taken lightly and the Board remains very optimistic about the
potential for Nuvec(R) and believes it is right to focus on this,
as we increasingly believe, bigger opportunity. The Board believes
this will deliver the exciting opportunities that the Company was
set up to achieve and the Company should not chase opportunities
where the risk profile has changed for the negative.
"Rather than narrowing our approach, I firmly believe that by
focusing our resources on Nuvec(R) we are in fact giving N4 Pharma
the greatest chance to achieve multiple commercial opportunities
given the revised risk profile we faced with our generics division
following the data obtained from our clinical trial.
"On behalf of the Board, I would like to thank all of our
shareholders for their continued support and look forward to
providing further updates on Nuvec(R) in the near future."
Enquiries:
N4 Pharma Plc
Nigel Theobald, CEO Via Alma PR
Allenby Capital Limited Tel: +44(0)203 328 5656
James Reeve/Virginia Bull/Asha
Chotai
Alma PR
Josh Royston Tel: +44(0)778 090 1979
Robyn Fisher Tel: +44(0)754 070 6191
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END
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