Cephalon initiates critical steps in development
June 23 2010 - 2:00AM
UK Regulatory
TIDMIMM
RNS Number : 0764O
Immupharma PLC
23 June 2010
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| For Immediate Release | 23 June 2010 |
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ImmuPharma PLC
Cephalon, ImmuPharma license partner for Rigerimod (Lupuzor) initiates critical
steps in its development program
US Recruitment commences
ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug
discovery and development company, is pleased to announce today that Cephalon
Inc., its license partner for IPP-201101 (Rigerimod; Lupuzor) has started the
recruitment of lupus patients for a Phase IIb trial in the US. This study was
designed to allow US based investigators and the FDA to evaluate Rigerimod
(Lupuzor) as a treatment for lupus before commencing a Phase III clinical trial.
A large number of centres are involved and the study is expected to be extended
to EU sites within a few months. The data generated from this trial will be part
of the package to be submitted to the FDA and other regulatory authorities for
approval.
In addition to the US trial and in order to prepare for the commercial
development in Japan, Cephalon has entered into a separate sub-licence agreement
with Symbio Pharmaceuticals. Under the agreement, Cephalon retains all
commercialisation rights to Rigerimod (Lupuzor) in Japan, and Symbio is granted
an exclusive right to conduct a Japanese-based Phase I clinical study which is
mandatory for a future filing of Rigerimod (Lupuzor) with the Japanese
regulatory bodies.
Dimitri Dimitriou, Chief Executive Officer of ImmuPharma said: "We are extremely
encouraged with the progress Cephalon is making with regards to the US trials,
first steps into Japan and importantly their commitment to the Lupuzor
programme."
For further information please contact:
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| ImmuPharma PLC: | |
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| Dimitri Dimitriou, Chief | +44 20 7152 4080 |
| Executive Officer | |
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| Dr Robert Zimmer, President | + 33 389 32 76 50 |
| & Chief Scientific Officer | |
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| Richard Warr, Chairman | +44 20 7152 4080 |
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| | |
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| Buchanan Communications | + 44 20 7466 5000 |
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| Lisa Baderoon | |
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| Catherine Breen | |
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| Panmure Gordon & Co | + 44 20 7459 3600 |
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| Andrew Burnett | |
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| Rakesh Sharma | |
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Notes to Editors:
About ImmuPharma
ImmuPharma PLC is a drug discovery and development company headquartered in
London, UK and quoted on AIM of the London Stock Exchange (LSE:IMM). It has
research operations in France (ImmuPharma (France) SA) and Switzerland
(ImmuPharma AG). ImmuPharma is dedicated to the development of novel drugs,
largely based on peptide therapeutics, to treat serious medical conditions such
as autoimmune diseases characterised by:
· blockbuster potential in niche markets
· low promotional costs in few specialised physicians and centres and
· lower risk of drug development and lower development costs
ImmuPharma is a currently developing drug candidates for three different medical
conditions, each of which would represent a significant breakthrough in its
field. The furthest advanced drug candidate targets Lupus, a disease for which
there is currently no cure or specific treatment. The other two address moderate
to severe pain (such as that experienced by cancer sufferers and post-operative
patients), and MRSA and similar severe hospital-acquired resistant infections.
All three have significant sales potential as well as low marketing costs and a
relatively low risk of development failure. One or more have the potential to be
fast-tracked by the US Food and Drug Administration according to "Guidance for
Industry: Fast Track Drug Development Programs - Designation, Development and
Application Review" issued July 2004 and could therefore obtain their market
authorization by 2010.
Key to the potential success of ImmuPharma is its unique collaborative agreement
with Centre National de la Recherche Scientifique, France's scientific research
institution. This agreement grants ImmuPharma worldwide exclusive rights to
exploit certain key discoveries.
In addition to its three leading drug candidates, ImmuPharma has a drug
development pipeline using its rights to a virtual chemical library of hundreds
of thousands of molecules as well as an innovative technology for converting
peptides to drug candidates.
ImmuPharma has the option to commercialise its assets itself or to license them
to other pharmaceutical companies at an earlier stage.
The products
Treatment of Lupus (IPP-201101)
This is a long-term treatment for Lupus, a chronic, life-threatening autoimmune
disease where the immune system attacks healthy cells. There is currently no
cure and existing medications only treat the symptoms whereas ImmuPharma's drug
candidate has the potential to produce remission of the disease in a substantial
proportion of patients.
Based on independent forecasts, the value of ImmuPharma's Lupus drug is
estimated to be "substantial" with peak annual sales forecast to generate in
excess of $4 billion.
Severe pain relief (IPP-102199)
ImmuPharma is developing a potential non-addictive compound for relieving
moderate to severe pain, such as experienced by cancer sufferers and
post-surgical patients. Most existing treatments are derived from the opiate
morphine and tend to have serious side effects. ImmuPharma's new treatment is
based on met-enkephalin, the body's internal analgesic. IPP-102199 is being
developed to have major advantages over morphine such as longer pain relief
duration and reduced side effects. The market for chronic opioids in the US
currently exceeds $3.5 billion and is growing by more than 10 to 20 per cent a
year.
Antibiotic for MRSA and similar highly resistant infections (IPP-203101)
This is a novel antibiotic to combat MRSA and other severe hospital-acquired,
resistant infections which affect some two million people in the US, according
to the US Centers for Disease Control and Prevention. ImmuPharma's drug
candidate is targeted at disrupting the membrane potential of the bacterial
pathogens. It is hoped this novel approach will reduce their potential to become
resistant.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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