TIDMIMM
RNS Number : 8187C
Immupharma PLC
22 January 2015
FOR IMMEDIATE RELEASE 22 JANUARY 2015
IMMUPHARMA
Landmark Collaboration Agreement & Commencement of Pivotal
Phase III Lupuzor(TM) Study
with Simbec-Orion
Deal provides powerful validation for Lupuzor(TM)
ImmuPharma PLC (AIM: IMM) ("ImmuPharma") and Simbec-Orion Group
Limited ("Simbec-Orion") announce that they have today entered into
a Collaboration Agreement for the execution of ImmuPharma's Pivotal
Phase III clinical study of Lupuzor(TM).
Lupuzor(TM) (also known as Rigerimod, IPP-201101 and P140), is
ImmuPharma's lead compound for the treatment of Lupus, (Systemic
Lupus Erythematosus or "SLE"), a chronic, potentially
life-threatening autoimmune disease. Lupuzor(TM) has been granted
Fast Track status by the US FDA and approved to start Phase III
trials under a Special Protocol Assessment (SPA) due to its strong
safety and efficacy profile. The multi-centre study will commence
immediately and will recruit patients across Europe, the United
States and other regions.
Simbec-Orion is a full service international Clinical Research
Organisation ("CRO") specialising in Rare & Orphan conditions
and has previous direct experience in Lupus trials.
Simbec-Orion was created in 2014 through the merger between
Simbec Research Limited ("Simbec"), one of the most established and
specialist CROs in Early Stage Clinical Development and ORION
Clinical Services Limited ("ORION"), the specialist CRO in Late
Stage Clinical Development. The merger was completed through the
provision of funds raised from the Wales Life Sciences Fund LP,
managed by Professor Sir Christopher Evans' Arthurian Life Sciences
Limited. Sir Christopher, a highly successful scientist and
entrepreneur, is also a Non-Executive Director of Simbec-Orion. The
combined Group has revenues of approximately GBP25 million, employs
approximately 250 staff and has operations across Europe, Australia
and the United States, together with capabilities in multiple other
territories.
Simbec-Orion has agreed that it will reinvest a significant
proportion of its fees in new ordinary shares at a fixed price of
150p per share, representing a premium of 206% to the closing
mid-market price on 21 January 2015. It is expected that over the
duration of the study Simbec-Orion will subscribe for approximately
900,000 new ordinary shares.
The clinical study is titled "A 52-Week, Randomized,
Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate
the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus
Standard of Care in Patients With Systemic Lupus Erythematosus". It
is a pivotal study designed to demonstrate the safety and efficacy
of IPP-201101 and as a last step prior to the filing of the drug
for approval with the US Food & Drug Administration ("FDA") and
the European Medicines Agency ("EMA").
Commenting on the agreement, Dimitri Dimitriou, Chief Executive
Officer said: "This deal is very attractive for ImmuPharma because
it allows us to retain rights to Lupuzor(TM) until
commercialisation. This opens many options for the Company for
further corporate deals including following in the path of all "big
biotechs" by generating our own sales. We are delighted to have
chosen to work with Simbec-Orion for a number of key clinical and
commercial reasons. We are confident in their abilities and
credentials and particularly appreciate their investment and
commitment to Lupuzor's(TM) success."
Richard Warr, Executive Chairman, commented: "This is a landmark
deal for ImmuPharma. Lupuzor(TM) has been recognised as a
significant asset by distinguished organisations. To enter phase
III under the terms agreed for our partnership with Simbec-Orion
demonstrates the commercial magnitude of our Lupuzor(TM) asset.
Simbec-Orion are providing a powerful validation of Lupuzor(TM) by
investing in our partnership. The transaction represents a
groundbreaking structure which maximises shareholder value while
Lupuzor(TM) is monetised. This vindicates our stated strategy of
achieving the highest margins on behalf of our shareholders."
Dr Robert Zimmer, ImmuPharma's President and Chief Scientific
Officer, further commented: "We are delighted to be working with
such an established CRO as Simbec-Orion as we commence Lupuzor(TM)
pivotal Phase III trials. Importantly they provide an independent
validation of Lupuzor's(TM) potential in becoming a leading
treatment for lupus patients world-wide. We look forward to
providing further guidance on progress over the coming months."
Ronald Openshaw, CEO, Simbec-Orion said: "We are delighted to be
working with ImmuPharma. Lupuzor(TM) results to date are highly
impressive and this has given us the confidence to invest in
ImmuPharma. It is a key part of our strategy to use the deep
know-how in our therapeutic areas of expertise and to make
strategic investments in our clients thereby building long-term
partnerships."
END
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
Simbec-Orion Group
Ronald Openshaw, Chief Executive
Officer +44(0)1753 578080
Consilium Strategic Communications
(Simbec-Orion) +44 (0)20 3709 5700
Mary-Jane Elliott SimbecOrion@consilium-comms.com
Ivar Milligan
NOTES TO EDITORS
ImmuPharma PLC
ImmuPharma 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.
The pivotal Phase III clinical study is titled "A 52-Week,
Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study
to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101
Plus Standard of Care in Patients With Systemic Lupus
Erythematosus". It is a pivotal study designed to demonstrate the
safety and efficacy of IPP-201101 and as a last step prior to the
filing of the drug for approval with the US Food & Drug
Administration ("FDA") and the European Medicines Agency
("EMA").
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)
Simbec-Orion
Simbec-Orion is a full service CRO operating from first in human
Phase I clinical studies through to pivotal Phase III studies and
Phase IV post marketing studies. The Company has expertise in all
drug types, dosage forms and delivery mechanisms and in later stage
development has particular expertise in oncology, rare and orphan
diseases. Simbec-Orion supports its clients with its own in-house
full service central laboratories, pharmacovigilance, data
management and statistics, pharmacy, medical management. For more
information please visit: www.simbec.com and www.orioncro.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
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