Immupharma PLC LupuzorT Gears Up To Start Pivotal Phase III trial (9352S)
September 30 2014 - 2:02AM
UK Regulatory
TIDMIMM
RNS Number : 9352S
Immupharma PLC
30 September 2014
30 September 2014
ImmuPharma
Lupuzor(TM) Gears Up To Start Pivotal Phase III trials
ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the
specialist drug discovery and development company, is delighted to
announce that Phase III activities of its lead compound Lupuzor(TM)
will soon commence.
Following advanced discussions and after completing detailed due
diligence with a potential partner, ImmuPharma has started the
preparatory steps for Lupuzor's (TM) pivotal phase III clinical
trials. Before these initial activities are completed, it is
expected that a further agreement to develop Lupuzo(TM) will be
finalised and signed which will see Immupharma and the potential
partner fund the phase III trials. This agreement will also allow
the partner to run the phase III pivotal programme based on the
strengthened study protocol agreed between ImmuPharma and the
FDA.
Commenting on the announcement, ImmuPharma's Chairman, Richard
Warr, said: "Taking Lupuzor(TM) into pivotal Phase III trials
represents a significant milestone in the history of ImmuPharma.
Our strategy remains focused on maximising the full value of
Lupuzor(TM) on behalf of our shareholders as we progress the
compound through phase III and beyond."
Dr Robert Zimmer, ImmuPharma's President and Chief Scientific
Officer, further commented: "The entry of Lupuzor(TM) into pivotal
Phase III trials involves a potential partner with strong
credentials and expertise in late stage clinical development.
Furthermore they provide an independent validation of Lupuzor's(TM)
potential to become a leading treatment for lupus patients
world-wide. We are commencing Lupuzor's(TM) phase III activities
immediately and look forward to providing further guidance on
progress as soon as possible."
For further information please contact:
+ 44 (0) 20 7152
ImmuPharma plc 4080
Dimitri Dimitriou, Chief
Executive Officer
Dr Robert Zimmer, President
and Chief Scientific Officer
Richard Warr, Chairman
Lisa Baderoon, Head of Investor
Relations + 44 (0) 7721 413496
Panmure, Gordon & Co., NOMAD
& Broker +44 (0) 20 7886 2500
Hugh Morgan
Fred Walsh
Duncan Monteith
Notes to Editors
ImmuPharma PLC is a pharmaceutical company listed since 2006 on
AIM of the London Stock Exchange (LSE:IMM), focusing on developing
novel medicines with high sales potential in specialist markets
with serious unmet need. ImmuPharma has five drug candidates in
development, two platform technologies and a multitude of patents
and IP. ImmuPharma is led by a commercially focused Board and
management team with extensive experience. For more information
please go to: www.immupharma.com
-- Lupuzor(TM)
Lupuzor(TM) also referred to as rigerimod or P140 is
ImmuPharma's lead compound and a potential treatment for lupus (or
Systemic Lupus Erythematosus), a chronic, potentially
life-threatening auto-immune disease, Lupuzor(TM) has a novel
mechanism of action aimed at modulating the body's immune system so
that it does not attack healthy cells, without causing adverse side
effects. It has the potential to halt the progression of the
disease in a substantial proportion of patients.
Lupuzor(TM) has been granted Fast Track status by the US FDA and
approved to start Phase III under Special Protocol Assessment
(SPA). This SPA was subsequently amended due to its strong safety
and efficacy profile to allow for a reduced number of patients in
the pivotal Phase III trial thereby reducing the projected cost of
development considerably. ImmuPharma has been in discussions with a
number of possible partner companies to progress Lupuzor(TM) 's
development and commercialisation. The GBP50m equity finance
facility from Darwin Strategic allows ImmuPharma further
flexibility in structuring the further development of
Lupuzor(TM)
Commercial Opportunity
Current drugs either have serious side effects or have limited
effectiveness
GSK's Benlysta's approval paves the way for Lupuzor(TM) (first
Lupus drug approved in over 50 years)
There are an estimated 1.5 million patients in US, Europe and
Japan
The target price per patient is estimated to be around $10,000
-$20,000 per year
For more information on Lupuzor(TM) please visit:
(www.lupuzor.com)
This information is provided by RNS
The company news service from the London Stock Exchange
END
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