Immupharma Regulatory News (IMM)

The following replaces the announced release at 7am under RNS no 0764O

The contact details have been amended.

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."

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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.