Business
FDA Meeting on Lupus
FDA Meeting on Lupus.
About this update from Immupharma Plc
[{"type":"text","content":"\n Immupharma PLC\n02 October 2006\n\n\nFOR IMMEDIATE RELEASE 2 October 2006\n\n ImmuPharma\n\n Announces Summary of Meeting with FDA for design of development programme for\n IPP-201101 treatment for Lupus\n\n - Feedback reinforces model for potential fast track approval -\n\n\nImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company,\nannounced today that it held a meeting with the United States Food and Drug\nAdministration ('FDA') on its IPP-201101 treatment for Lupus, a chronic,\nlife-threatening autoimmune disease.\n\nThe meeting was held following the successful completion of the phase I trial of\nIPP-201101 and the initiation of the phase II trial, results of which are due to\nbe announced before year-end. The purpose of the meeting was to discuss\ntechnical and scientific information and the proposed clinical protocol design\nfor IPP-201101.\n\nHighlights\n\n • The FDA stated their interest in IPP-201101 and believe the existing data\n would support the proposed clinical development programme. The FDA also\n provided useful advice on the construction of the remaining development\n activities.\n\n • IPP-201101 may be launched sooner than anticipated with a Phase 2/3 trial in\n 150 patients if a correlation is shown between the current phase II \n biomarker end-points and clinical benefit.\n\n • If development is completed successfully, marketing approval could be \n granted through the FDA 'fast track mechanisms'. This will require only a 6\n month review period.\n\nCommenting on the announcement, Dr. Robert Zimmer, President and Chief\nScientific Officer, said 'We are very pleased with the outcome of our meeting\nwith the FDA and are grateful for their advice and input. It gives us further\nconfidence that we are developing a drug candidate to help patients suffering\nfrom Lupus around the world.'\n\n\nFor further information please contact:\n\nImmuPharma PLC\nDr Robert Zimmer, President & Chief Scientific +33 389 32 76 50\nOfficer\nDimitri Dimitriou, Chief Executive Officer: +44 20 7152 4080\nRichard Warr, Chairman: +44 20 7152 4080\n\nBuchanan Communications + 44 20 7466 5000\nLisa Baderoon:\nRebecca Skye-Dietrich\n\n\n\nNotes to Editors:\n\nAbout ImmuPharma\n\nImmuPharma PLC is a drug discovery and development company headquartered in\nLondon, UK and quoted on AIM of the London Stock ...