Initiation of Phase IIb trial

Immupharma PLC 06 December 2007 For Immediate Release 6 December 2007 ImmuPharma PLC Initiation of Phase IIb trials for IPP - 201101 in patients with Lupus; Allows earlier release of efficacy data in mid 2008 ImmuPharma PLC (LSE:IMM), ('ImmuPharma' or the 'Company'), the specialist drug discovery and development company, announces today that following its discussions with the US Food and Drug Administration ('FDA'), it has obtained feedback that refines the phase II/III programme for IPP- 201101 in patients with Systemic Lupus Erythematosus. The outcome of this consultation with the regulator has been the segmenting of the development programme into separate phase IIb and phase III trials. The company had previously expected a single phase II/III trial in 240 patients over 12 months. The revised plans allow the company to have additional phase II data, which has the potential to enhance its commercial attractiveness, earlier than previously expected and continuing with a simpler phase III trial in Q3 2008, broadly in line with previous development timelines. ImmuPharma expects the first patients to be dosed into the phase IIb trials very shortly. As part of an Initial Investigational New Drug application, the company filed in July 2007 with the FDA a protocol for a phase II/III double blind, randomised, placebo controlled, multicentre study in 240 patients to be treated for 12 months. Following its meeting with the FDA, ImmuPharma is now planning to conduct a phase IIb study in 200 patients in Europe and Latin America. This phase IIb study, which has just started, is a robust, randomised, placebo-controlled, three-arm dose ranging study in patients treated for three months with an additional three month follow-up. It is expected that the patients from this phase IIb trial will be rolled into a one-year 'open label' safety and efficacy study which should report by Q3 2009. In addition, in Q3 2008 a similar but pivotal phase III study will be commenced in an additional 200 patients in the US, Europe and Latin America, to be treated for a period of six months. The phase III study is expected to report by Q3 2009. In parallel with the phase IIb trial, the company will also complete a long-term pre-clinical toxicology study as part of regulatory requirements. Dr Robert Zimmer, MD, PhD, ImmuPharma's Chief Scientific Officer commented: 'As IPP-201101 has already completed a successful phase II study last year, this second and larger study will yield valuable additional efficacy and safety data in the summer of 2008. A submission for approval is currently anticipated in late 2009. This phase IIb study will be funded from the Company's existing cash resources. Dimitri Dimitriou, ImmuPharma's CEO added: 'Essentially, we are dividing the phase II/III programme in two parts which reduces the risk for ImmuPharma and provides data much earlier than previously planned. This will provide patients with a much needed drug where there are no specific drugs available today. From a commercial perspective, the refined phase II/III programme has the potential to enhance the commercial attractiveness of our most advanced drug candidate earlier than anticipated once the data from our phase IIb are available.' 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 Panmure Gordon & Co Andrew Burnett +44 151 243 0963 For company information, visit www.immupharma.com 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. PLA2 inhibitor for inflammatory and allergic disorders (IPP-201007) Phospholipases A2 (PLA2s) are enzymes that catalyze the hydrolysis of phospholipids. This catalytic reaction is essential in the production of lipids during various processes in the body, involving prostaglandins, leukotrienes, thromboxanes, platelet activation factor and others. In certain cases, such lipids mediators cause allergic reactions and a number of inflammatory conditions such as asthma and other respiratory disorders, rheumatoid arthritis, septic shock and acute pancreatitis are characterized by a significant increase in PLA2 activity. Inhibiting PLA2 can therefore reduce some of these allergic reactions and inhibitors of PLA2 have already been shown to have positive effect in inflammatory conditions. ImmuPharma believes this new molecule has potential in becoming a drug for certain inflammatory conditions and intends to progress its development. The drug could be in clinical trials as early as 2009. This information is provided by RNS The company news service from the London Stock Exchange

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