TIDMIMM
RNS Number : 0607A
Immupharma PLC
07 September 2018
7th September 2018
ImmuPharma PLC
("ImmuPharma" or the "Company")
CORPORATE UPDATE
ImmuPharma PLC (LSE: IMM), the specialist drug discovery and
development company today announces a corporate update.
Key highlights:
-- Lupuzor(TM)
o Agreement signed to enter Lupuzor(TM) into a 'Managed Access
Programme'
o Open Label extension study completes recruitment
-- Nucant (cancer) programme: Clinical Development Collaboration with Incanthera Limited
-- Ureka subsidiary: Divestment process to commence
Lupuzor(TM)
Lupuzor(TM) is the Company's late stage asset for Lupus, a
potential life threatening auto-immune disease. Lupuzor(TM)
concluded a pivotal Phase III trial earlier this year. Key
announcements providing top line data of the results were announced
on 17 April 2018 and 29 May 2018 (please see full announcements on
IMM's website - www.immupharma.com).
Managed Access Programme
ImmuPharma has signed an agreement with a specialist provider to
distribute Lupuzor(TM) via a Managed Access Programme ("MAP").
The key objectives of the MAP, based on the clinical and safety
data received from the recently announced Phase III trial, are to
promote the use of Lupuzor(TM) by allowing Lupus patients early
access to Lupuzor(TM), whilst continuing to engage with Lupus
specialists and practitioners.
This will allow Lupus patients ongoing access to Lupuzor(TM)
prior to any regulatory filing. In addition, the Company will be
collecting valuable data from these patients, which the Company
believes will add significantly to the existing data package.
It's currently envisaged that up to 500 patients will be
recruited for the MAP and that these patients will be granted
access to Lupuzor(TM) for a minimum of two years. Based on these
parameters, the programme will be funded from current cash
resources.
Further updates will be announced as appropriate.
Extension Study
The Lupuzor(TM) open label extension study, initially announced
on 18 January 2018, has completed enrolment with a total of 62
eligible patients from the original Phase III trial, who were
recruited throughout the US and Europe. The study is anticipated to
report results in Q2 2019.
Nucant Cancer Programme - Clinical Development Collaboration
A number of options have been under review to develop the
Company's Nucant cancer programme, which has demonstrated promising
results in two Phase I trials (safety and dose-finding
studies).
In order to progress this programme, ImmuPhama has signed Heads
of Terms on a clinical development collaboration for the Nucant
cancer programme, with Incanthera Limited ("Incanthera"), a
specialist oncology development company.
Key highlights of the Heads of Terms are summarised below:
-- Incanthera, based on its positive due-diligence on the
Company's Nucant technology, will licence in and take up the
continued clinical development of the Nucant cancer programme as an
integral part of its own cancer development portfolio.
-- As an integral part of the collaboration, upon signing the
Heads of Terms, ImmuPharma has invested GBP2m into Incanthera by
subscribing for 363,637 new ordinary Incanthera shares at a price
of GBP5.50 per share. This investment values Incanthera at a
pre-money valuation of approximately GBP10m and is consistent with
the most recent funding round that Incanthera completed in March
2018. Following this investment, ImmuPharma will have a circa 16%
shareholding in Incanthera.
-- ImmuPharma has granted Incanthera a period of exclusivity
until 31(st) December 2018, during which the Company and Incanthera
will finalise the terms of a Definitive Licence Agreement for the
Nucant technology. These terms are expected to include, but will
not be limited to the following:
o Incanthera will pay a licence payment to ImmuPharma of GBP1m,
with this payment to be made via the issuance of new ordinary
shares in Incanthera. This payment in shares is separate and will
be in addition to the shareholding which Immupharma currently holds
as described above;
o Incanthera will be responsible for all of the development
costs for the Nucant programme; and
o All future commercialisation revenues will be shared equally
between the two companies.
Tim McCarthy, the Company's Chairman, is also Chairman and
minority shareholder in Incanthera. As such, Tim McCarthy is
precluded from voting on any matters relating to the Heads of Terms
between ImmuPharma and Incanthera and will be precluded from voting
on any matters relating to the future Definitive Licence Agreement
between the two companies.
Further updates will be announced as appropriate.
Ureka : Divestment Process
Ureka, ImmuPharma's wholly owned subsidiary, based in Bordeaux,
which is carrying out research into treatments for Type II diabetes
and NASH (Non-Alcoholic-Steato-Hepatitis) has recently demonstrated
success in recognised preclinical studies.
Following an extensive review by ImmuPharma's Board of
directors, it has been decided that Ureka, whilst having exciting
and innovative technologies, is not part of the ongoing strategy of
ImmuPharma, which is now fully focused on utilising its resources
to develop late stage assets.
Hence, ImmuPharma, with its advisors, will now commence a
process of considering all opportunities to divest Ureka. The
intention is to allow ImmuPharma to divest Ureka, whilst still
retaining an interest in any future commercial success.
Further updates will be announced as appropriate.
Commenting, Tim McCarthy, Chairman, said:
"The Board has been focused on delivering a business strategy
which provides the optimum route forward for ImmuPharma and its
shareholders, based on its current assets, resources and knowhow.
We believe that the strategy outlined today provides the most
effective route to create shareholder value going forward.
"We are excited as a team to be progressing the MAP programme
which allows Lupus patients early access to Lupuzor(TM). In the
medium term, we remain focussed on achieving the full regulatory
approval of Lupuzor(TM) which we believe has the potential to be a
ground breaking drug for Lupus patients and in turn has blockbuster
potential in commercial terms.
"Our Nucant programme and Ureka subsidiary have been part of our
portfolio for a number of years. We are equally excited by the
potential of both. We believe the strategy we have announced today
for both, will create enhanced value for shareholders going
forward.
"As part of our continued proactive investor relations
communications, we look forward to further updating the market and
shareholders as and when appropriate."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014. ("MAR")
For further information please contact:
+ 44 (0)20 7152
ImmuPharma plc (www.immupharma.com) 4080
Tim McCarthy, Chairman
+ 44 (0) 7721
Lisa Baderoon, Head of Investor Relations 413496
Northland Capital Partners Limited
(NOMAD & Joint Broker)
David Hignell, Dugald Carlean, Jamie
Spotswood, Corporate Finance +44 (0)20 3861
Rob Rees, Corporate Broking 6625
Bryan, Garnier & Co. (Joint Broker)
Phil Walker, Corporate Finance +44 (0)20 7332
Dominic Wilson, Sales 2500
About Incanthera Limited
Incanthera Limited was formed in 2010 as a spin-out from the
Institute of Cancer Therapeutics at Bradford University and is
targeting the treatment of cancer through a portfolio of unique
technologies. Having successfully commercialised its lead product
in 2017, it is actively acquiring technologies to further enhance
its portfolio of cancer therapeutics. Incanthera is currently
preparing for an IPO on AIM.
For more information, please visit www.incanthera.com
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END
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