Immupharma Regulatory News (IMM)

17 Oct 2006 07:00

Immupharma PLC17 October 2006 For Immediate Release 17 October 2006 ImmuPharma announces highly positive preliminary Phase II results for its potential blockbuster treatment for Lupus ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company,announced today that its potential blockbuster IPP-201101 for Lupus treatmenthas met its Phase II primary endpoints. IPP-201101 is a drug that specifically modulates the immune system of Lupuspatients by modifying the behaviour of some of the key cells (CD4+ T cells)involved in the pathogenesis of the disease. Lupus patients are often associatedwith high levels of antibodies against their own DNA (anti-dsDNA antibodies).The use of these antibodies as "surrogate markers", e.g. indicators of theoverall modulation of the immune system of Lupus patients are particularlyuseful with our drug due to its mechanism of action. Phase II clinical trial highlights • Study was a proof of concept, dose ranging and safety study • The drug met its primary endpoints (p< 0.0001) • The anti dsDNA antibodies decreased dose dependently and reductions of 47% were achieved • In one of the two dose groups, 80% of the patients were responders • The profile of other biomarkers supported the validation of the Proof of Concept • Excellent safety and tolerability profile • An US IND is expected to be filed in Q1 2007 for the Phase II/III program This study in Lupus patients was a proof of concept, dose ranging, safety,multi-centre European study. The proof of concept was assessed by measuring thedecrease of anti dsDNA antibodies as a surrogate marker for efficacy and IL10, acytokine, to ascertain its mechanism of action. The drug was administered 3times by subcutaneous injections 2 weeks apart at doses of 200(micro)g and 1000(micro)g and the patients were monitored one month after treatment stop.Clinical parameters were also assessed but have not been fully evaluated yet. Dr Robert Zimmer, President & Chief Scientific Officer said: "We are verypleased by these results. They are in line with our preclinical results andconfirm our view on the global mechanism of action of IPP-201101. Importantly itpaves the way for the Phase II/III study in Europe and the US as discussed withthe FDA". Dimitri Dimitriou, CEO added: "It is very exciting to deliver ahead of timepositive results, especially as we have been in discussions with a number of bigpharma companies on potential deals." For further information please contact: ImmuPharma PLC:Dimitri Dimitriou, Chief Executive Officer tel: +44 20 7152 4080Richard Warr, Chairman tel: +44 20 7152 4080Dr Robert Zimmer, President & Chief Scientific Officer tel: + 33 389 32 76 50 Buchanan Communications:Lisa Baderoon tel: + 44 20 7466 5000Rebecca Skye Dietrich tel: + 44 20 7466 5000 Dawnay Day Corporate Finance:Gerald Raingold tel: + 44 207 509 4570David Floyd tel:+ 44 207 509 4570 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) 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. This information is provided by RNS The company news service from the London Stock Exchange