FDA Meeting on Lupus

Immupharma PLC 02 October 2006 FOR IMMEDIATE RELEASE 2 October 2006 ImmuPharma Announces Summary of Meeting with FDA for design of development programme for IPP-201101 treatment for Lupus - Feedback reinforces model for potential fast track approval - ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, announced today that it held a meeting with the United States Food and Drug Administration ('FDA') on its IPP-201101 treatment for Lupus, a chronic, life-threatening autoimmune disease. The meeting was held following the successful completion of the phase I trial of IPP-201101 and the initiation of the phase II trial, results of which are due to be announced before year-end. The purpose of the meeting was to discuss technical and scientific information and the proposed clinical protocol design for IPP-201101. Highlights • The FDA stated their interest in IPP-201101 and believe the existing data would support the proposed clinical development programme. The FDA also provided useful advice on the construction of the remaining development activities. • IPP-201101 may be launched sooner than anticipated with a Phase 2/3 trial in 150 patients if a correlation is shown between the current phase II biomarker end-points and clinical benefit. • If development is completed successfully, marketing approval could be granted through the FDA 'fast track mechanisms'. This will require only a 6 month review period. Commenting on the announcement, Dr. Robert Zimmer, President and Chief Scientific Officer, said 'We are very pleased with the outcome of our meeting with the FDA and are grateful for their advice and input. It gives us further confidence that we are developing a drug candidate to help patients suffering from Lupus around the world.' For further information please contact: ImmuPharma PLC Dr Robert Zimmer, President & Chief Scientific +33 389 32 76 50 Officer Dimitri Dimitriou, Chief Executive Officer: +44 20 7152 4080 Richard Warr, Chairman: +44 20 7152 4080 Buchanan Communications + 44 20 7466 5000 Lisa Baderoon: Rebecca Skye-Dietrich 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: o blockbuster potential in niche markets o low promotional costs in few specialised physicians and centres and o 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) Lupus is 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. By selectively modulating the aberrant T-cells in Lupus, 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 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 have serious side effects associated with a morphine-like mechanism of action. ImmuPharma's new approach is based on met-enkephalin, one of the body's internal analgesics. 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 counter the effects of 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 MRSA and other bacterial strains. It is hoped this novel approach will reduce their potential to become resistant. Key management Richard Warr, MA, Chairman, has 20 years experience in investment banking and the capital markets. He was previously a director of ABN Amro; director and head of European sales and marketing at Credit Lyonnais; executive director at Dresdner Kleinwort Benson Securities Ltd; and head of European equity distribution at Swiss Bank Corporation. He has extensive experience in corporate and governmental equity capital market transactions. Dimitri F Dimitriou, MSc, Chief Executive Officer, has over 20 years experience in the pharmaceutical and biotech industry. He was senior director, worldwide business development, at GlaxoSmithKline, where his responsibilities included licensing deals, alliances and collaborations on a worldwide basis. Dr Robert Zimmer, MD, PhD, President and head of R&D, began his career with Roche in Basle, where he was responsible for numerous Phase I studies. In 1990 he joined Jago in Basle and, on its acquisition by SkyePharma, became director and head of research and development at SkyePharma. His expertise includes managerial experience in multifunctional research and development and the assessment of technologies with multi-national pharmaceutical companies. Paddy Walker-Taylor, FCA, MCT Chief Financial Officer, was previously finance director of Sir Robert McAlpine Ltd. He was involved in the AIM float of ISG Group, in which McAlpine had a minority shareholding. Previously he had held a number of key financial positions including finance director of Woolworths plc and treasurer of Marks & Spencer. Douglas Paterson, MA, FCA, senior Non-Executive Director, has been a chartered accountant for 37 years and was a senior audit partner at Coopers & Lybrand (now PricewaterhouseCoopers) for 22 years. He currently holds a number of non-executive directorships, including Close Brothers Group plc and Goldman Sachs International Bank. Anthony Johnson, B Pharm, MSc, Non-Executive Director, has over 30 years experience in the pharmaceutical industry, focused on the scientific aspects of deal making, support during competitive analysis, technical due diligence and input in development strategy. He was formerly senior director of scientific licensing at SmithKline Beecham (now GlaxoSmithKline). Collaboration with Centre National de la Recherche Scientifique (CNRS) ImmuPharma has important collaboration arrangements with Centre National de la Recherche Scientifique, France's scientific research institution, including a research collaboration agreement relating to the therapeutic use of peptides and peptide derivatives. ImmuPharma has been granted the worldwide exclusive rights to exploit all discoveries made under this agreement. ImmuPharma will co-own the relevant intellectual property with CNRS which will share in the revenue generated by ImmuPharma from exploiting CNRS' licensed and co-owned rights. This information is provided by RNS The company news service from the London Stock Exchange

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