Immupharma Regulatory News (IMM)

2 Oct 2006 07:01

Immupharma PLC02 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 DrugAdministration ("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 ofIPP-201101 and the initiation of the phase II trial, results of which are due tobe announced before year-end. The purpose of the meeting was to discusstechnical and scientific information and the proposed clinical protocol designfor 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 ChiefScientific Officer, said "We are very pleased with the outcome of our meetingwith the FDA and are grateful for their advice and input. It gives us furtherconfidence that we are developing a drug candidate to help patients sufferingfrom Lupus around the world." For further information please contact: ImmuPharma PLCDr Robert Zimmer, President & Chief Scientific +33 389 32 76 50OfficerDimitri Dimitriou, Chief Executive Officer: +44 20 7152 4080Richard Warr, Chairman: +44 20 7152 4080 Buchanan Communications + 44 20 7466 5000Lisa Baderoon:Rebecca Skye-Dietrich Notes to Editors: About ImmuPharma ImmuPharma PLC is a drug discovery and development company headquartered inLondon, UK and quoted on AIM of the London Stock Exchange (LSE:IMM). It hasresearch 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 suchas 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 medicalconditions, each of which would represent a significant breakthrough in itsfield. The furthest advanced drug candidate targets Lupus, a disease for whichthere is currently no cure or specific treatment. The other two address moderateto severe pain (such as that experienced by cancer sufferers and post-operativepatients), and MRSA and similar severe hospital-acquired resistant infections. All three have significant sales potential as well as low marketing costs and arelatively low risk of development failure. One or more have the potential to befast-tracked by the US Food and Drug Administration according to "Guidance forIndustry: Fast Track Drug Development Programs - Designation, Development andApplication Review" issued July 2004 and could therefore obtain their marketauthorization by 2010. Key to the potential success of ImmuPharma is its unique collaborative agreementwith Centre National de la Recherche Scientifique, France's scientific researchinstitution. This agreement grants ImmuPharma worldwide exclusive rights toexploit certain key discoveries. In addition to its three leading drug candidates, ImmuPharma has a drugdevelopment pipeline using its rights to a virtual chemical library of hundredsof thousands of molecules as well as an innovative technology for convertingpeptides to drug candidates. ImmuPharma has the option to commercialise its assets itself or to license themto 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 systemattacks healthy cells. There is currently no cure and existing medications onlytreat the symptoms. By selectively modulating the aberrant T-cells in Lupus,ImmuPharma's drug candidate has the potential to produce remission of thedisease in a substantial proportion of patients. Based on independent forecasts, the value of ImmuPharma's Lupus drug isestimated to be "substantial" with peak annual sales forecast to generate inexcess of $4 billion. Severe pain relief (IPP-102199) ImmuPharma is developing a compound for relieving moderate to severe pain, suchas experienced by cancer sufferers and post-surgical patients. Most existingtreatments are derived from the opiate morphine and have serious side effectsassociated with a morphine-like mechanism of action. ImmuPharma's new approachis based on met-enkephalin, one of the body's internal analgesics. IPP-102199 isbeing developed to have major advantages over morphine such as longer painrelief duration and reduced side effects. The market for chronic opioids in theUS currently exceeds $3.5 billion and is growing by more than 10 to 20 per centa year. Antibiotic for MRSA and similar highly resistant infections (IPP-203101) This is a novel antibiotic to counter the effects of MRSA and other severehospital-acquired, resistant infections which affect some two million people inthe US, according to the US Centers for Disease Control and Prevention.ImmuPharma's drug candidate is targeted at disrupting the membrane potential ofMRSA and other bacterial strains. It is hoped this novel approach will reducetheir potential to become resistant. Key management Richard Warr, MA, Chairman, has 20 years experience in investment banking andthe capital markets. He was previously a director of ABN Amro; director and headof European sales and marketing at Credit Lyonnais; executive director atDresdner Kleinwort Benson Securities Ltd; and head of European equitydistribution at Swiss Bank Corporation. He has extensive experience in corporateand governmental equity capital market transactions. Dimitri F Dimitriou, MSc, Chief Executive Officer, has over 20 years experiencein the pharmaceutical and biotech industry. He was senior director, worldwidebusiness development, at GlaxoSmithKline, where his responsibilities includedlicensing deals, alliances and collaborations on a worldwide basis. Dr Robert Zimmer, MD, PhD, President and head of R&D, began his career withRoche in Basle, where he was responsible for numerous Phase I studies. In 1990he joined Jago in Basle and, on its acquisition by SkyePharma, became directorand head of research and development at SkyePharma. His expertise includesmanagerial experience in multifunctional research and development and theassessment of technologies with multi-national pharmaceutical companies. Paddy Walker-Taylor, FCA, MCT Chief Financial Officer, was previously financedirector of Sir Robert McAlpine Ltd. He was involved in the AIM float of ISGGroup, in which McAlpine had a minority shareholding. Previously he had held anumber of key financial positions including finance director of Woolworths plcand treasurer of Marks & Spencer. Douglas Paterson, MA, FCA, senior Non-Executive Director, has been a charteredaccountant for 37 years and was a senior audit partner at Coopers & Lybrand (nowPricewaterhouseCoopers) for 22 years. He currently holds a number ofnon-executive directorships, including Close Brothers Group plc and GoldmanSachs International Bank. Anthony Johnson, B Pharm, MSc, Non-Executive Director, has over 30 yearsexperience in the pharmaceutical industry, focused on the scientific aspects ofdeal making, support during competitive analysis, technical due diligence andinput in development strategy. He was formerly senior director of scientificlicensing at SmithKline Beecham (now GlaxoSmithKline). Collaboration with Centre National de la Recherche Scientifique (CNRS) ImmuPharma has important collaboration arrangements with Centre National de laRecherche Scientifique, France's scientific research institution, including aresearch collaboration agreement relating to the therapeutic use of peptides andpeptide derivatives. ImmuPharma has been granted the worldwide exclusive rightsto exploit all discoveries made under this agreement. ImmuPharma will co-own therelevant intellectual property with CNRS which will share in the revenuegenerated 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