Immupharma Regulatory News (IMM)

10 May 2006 07:00

Immupharma PLC10 May 2006 FOR IMMEDIATE RELEASE 10 MAY 2006 ImmuPharma announces successful results from its phase I clinical trial with IPP-201101 for Lupus - Phase II to start soon - ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company,announced today that it has successfully completed the placebo-controlled phaseI study involving 24 healthy volunteers of its lead compound IPP-201101 forLupus, a chronic, life-threatening autoimmune disease. This study, which took place in France, was the first administration in humansfor IPP-201101 and was designed to assess its safety and tolerability. Thepreliminary safety report confirmed that the drug was safe and well-tolerated. These encouraging results have allowed ImmuPharma to proceed with a phase IIproof-of-concept and efficacy study in Lupus patients in Europe. The phase IIstudy protocol was recently approved by the ethics committees and has been filedwith the appropriate regulatory authorities. The dosing of Lupus patients inthis study is expected to start soon and the trial will measure recognisedsurrogate markers of clinical efficacy, in preparation of the pivotal phase IIIstudies. To that effect, ImmuPharma has also scheduled a meeting with the FDA to designthe appropriate development programme to get market authorisation of the drug inthe US. Dr Robert Zimmer, President and Chief Scientific Officer of ImmuPharma, said:'IPP-201101, which has blockbuster potential, is a novel concept for thetreatment of Lupus. IPP-201101 modulates the signalling of CD4+ cells and mayalso interact with the T-reg pathway. The key element is that IPP-201101 hasbeen designed to interact only with the CD4+ cells linked to Lupus and leavesintact the remaining immune system, allowing Lupus patients to be protected by afully operational immune system unlike the currently used therapies such as highdose corticoids and immunosuppressants. When administered appropriately it hasthe potential to stop the progression of the disease and should therefore beprescribed as early as possible during the course of the Lupus disease. Thealready available preclinical package demonstrating efficacy and selectivity forLupus together with the good results of the phase I safety and tolerabilitystudy in man are critical in this respect and may offer clear benefit for thepatients when compared to the current therapies.' For further information please contact: ImmuPharma PLC:Richard Warr, Executive Chairman: tel: +44 20 7152 4080Dimitri Dimitriou, Chief Executive Officer: tel: +44 20 7152 4080Dr Robert Zimmer, President & Chief Scientific Officer: tel: + 33 389 32 76 50 Buchanan Communications:Lisa Baderoon, Director: tel: + 44 20 7466 5000Rebecca Skye-Dietrich : tel: + 44 20 7466 5000 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: • 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 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) This is a long-term treatment for Lupus, a chronic, life-threatening autoimmunedisease where the immune system attacks healthy cells. There is currently nocure and existing medications only treat the symptoms whereas ImmuPharma's drugcandidate has the potential to produce remission of the disease in a substantialproportion 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 non-addictive compound for relieving moderate tosevere pain, such as experienced by cancer sufferers and post-surgical patients.Most existing treatments are opioid-based (explain) and tend to have seriousside effects. ImmuPharma's new treatment is based on met-enkephalin, the body'sinternal analgesic. IPP-102199 is being developed to have major advantages overmorphine such as longer pain relief duration and reduced side effects. Themarket for chronic opioids in the US currently exceeds $3.5 billion and isgrowing 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 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 uniquely uses an electrical charge rather thanbiochemical methods against MRSA and other bacterial strains. It is hoped thisnovel approach will reduce their potential to become resistant. Key management Richard Warr, MA, executive chairman, (age 45) has 20 years experience ininvestment banking and the capital markets. He was previously a director of ABNAmro; director and head of European sales and marketing at Credit Lyonnais;executive director at Dresdner Kleinwort Benson Securities Ltd; and head ofEuropean equity distribution at Swiss Bank Corporation. He has extensiveexperience in corporate and governmental equity capital market transactions. Dimitri F Dimitriou, MSc, chief executive officer, (age 45) has 20 yearsexperience in the pharmaceutical and biotech industry. He was senior director,worldwide business development, at GlaxoSmithKline, where his responsibilitiesincluded licensing deals, alliances and collaborations on a worldwide basis. Dr Robert Zimmer, MD, PhD, chief science officer, (age 58) began his career in1985 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, becamedirector and head of research and development at SkyePharma. His expertiseincludes managerial experience in multifunctional research and development andthe assessment of technologies with multi-national pharmaceutical companies. Paddy Walker-Taylor, FCA, MCT chief financial officer, (age 59) was previouslyfinance director of Sir Robert McAlpine Ltd. He was involved in the AIM float ofISG Group, in which McAlpine had a minority shareholding. Previously he had helda number of key financial positions including finance director of Woolworths plcand treasurer of Marks & Spencer. Douglas Paterson, MA, FCA, senior non-executive director, (age 62) has been achartered accountant for 37 years and was a senior audit partner at Coopers &Lybrand (now PricewaterhouseCoopers) for 22 years. He currently holds a numberof non-executive directorships, including Close Brothers Group plc and GoldmanSachs International Bank. Anthony Johnson, B Pharm (Hons), MSc, MRPharmS, non-executive director, (age 62)has over 30 years experience in the pharmaceutical industry, focused on thescientific aspects of deal making, support during competitive analysis,technical due diligence and input in development strategy. He was formerlysenior director of scientific licensing at SmithKline Beecham (nowGlaxoSmithKline). 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's licensed and co-owned rights. This information is provided by RNS The company news service from the London Stock Exchange