News

Company   ImmuPharma PLC
TIDM         IMM
Headline    Pivotal phase II/III trial
Released    07:01 10-Jul-07
Number     9448Z

FOR IMMEDIATE RELEASE

London, 10 July 2007

ImmuPharma submits file to the FDA for
pivotal phase II/III trial in Lupus patients

ImmuPharma plc (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, announced today that it has just submitted an IND (Investigational New Drug) file to the US Food and Drug Administration (FDA) for the initiation of a pivotal phase II/III trial for its drug IPP-201101 in patients suffering from Systemic Lupus Erythematosus.

Following a previous meeting with the FDA and subsequent feedback announced in October 2006 and the positive outcome of the phase II study showing statistically significant clinical efficacy in patients with Lupus, ImmuPharma has now filed with the FDA an IND for the pivotal phase II/III trial. This proposed phase II/III double blind, randomized, placebo controlled, multicentre study will include 240 patients treated during 12 months all in line with the FDA guidelines. It will take place in the US, Europe and Latin America and is expected to complete in early 2009.

If the phase II/III trial is positive, based on the feedback previously received from the FDA, the drug could be granted fast track approval (6 month review time) and receive US marketing authorisation at the end of 2009 / early 2010. Similar filings will also be made in key European and Latin American countries in the next few weeks.

For further information please contact:

ImmuPharma PLC

Dimitri Dimitriou, Chief Executive Officer                         +44 20 7152 4080
Dr Robert Zimmer, President & Chief                              + 33 389 32 76 50
Scientific Officer
Richard Warr, Chairman                                                +44 20 7152 4080

Buchanan Communications + 44 20 7466 5000

Lisa Baderoon
Rebecca Skye-Dietrich

Teather & Greenwood Limited +44 20 7426 7710

Thilo Hoffmann

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


Home About ImmuPharma Lead compounds Discovery pipeline Management team News For Investors Contact us	News Company ImmuPharma PLC TIDM IMM Headline Pivotal phase II/III trial Released 07:01 10-Jul-07 Number 9448Z FOR IMMEDIATE RELEASE London, 10 July 2007 ImmuPharma submits file to the FDA for pivotal phase II/III trial in Lupus patients ImmuPharma plc (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, announced today that it has just submitted an IND (Investigational New Drug) file to the US Food and Drug Administration (FDA) for the initiation of a pivotal phase II/III trial for its drug IPP-201101 in patients suffering from Systemic Lupus Erythematosus. Following a previous meeting with the FDA and subsequent feedback announced in October 2006 and the positive outcome of the phase II study showing statistically significant clinical efficacy in patients with Lupus, ImmuPharma has now filed with the FDA an IND for the pivotal phase II/III trial. This proposed phase II/III double blind, randomized, placebo controlled, multicentre study will include 240 patients treated during 12 months all in line with the FDA guidelines. It will take place in the US, Europe and Latin America and is expected to complete in early 2009. If the phase II/III trial is positive, based on the feedback previously received from the FDA, the drug could be granted fast track approval (6 month review time) and receive US marketing authorisation at the end of 2009 / early 2010. Similar filings will also be made in key European and Latin American countries in the next few weeks. For further information please contact: ImmuPharma PLC Dimitri Dimitriou, Chief Executive Officer +44 20 7152 4080 Dr Robert Zimmer, President & Chief + 33 389 32 76 50 Scientific Officer Richard Warr, Chairman +44 20 7152 4080 Buchanan Communications + 44 20 7466 5000 Lisa Baderoon Rebecca Skye-Dietrich Teather & Greenwood Limited +44 20 7426 7710 Thilo Hoffmann 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 ©2007 London Stock Exchange plc. All rights reserved