Immupharma Regulatory News (IMM)

6 Dec 2007 07:01

Immupharma PLC06 December 2007 For Immediate Release 6 December 2007 ImmuPharma PLC Initiation of Phase IIb trials for IPP - 201101 in patients with Lupus; Allows earlier release of efficacy data in mid 2008 ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drugdiscovery and development company, announces today that following itsdiscussions with the US Food and Drug Administration ("FDA"), it has obtainedfeedback that refines the phase II/III programme for IPP- 201101 in patientswith Systemic Lupus Erythematosus. The outcome of this consultation with theregulator has been the segmenting of the development programme into separatephase IIb and phase III trials. The company had previously expected a singlephase II/III trial in 240 patients over 12 months. The revised plans allow thecompany to have additional phase II data, which has the potential to enhance itscommercial attractiveness, earlier than previously expected and continuing witha simpler phase III trial in Q3 2008, broadly in line with previous developmenttimelines. ImmuPharma expects the first patients to be dosed into the phase IIbtrials very shortly. As part of an Initial Investigational New Drug application, the company filed inJuly 2007 with the FDA a protocol for a phase II/III double blind, randomised,placebo controlled, multicentre study in 240 patients to be treated for 12months. Following its meeting with the FDA, ImmuPharma is now planning toconduct a phase IIb study in 200 patients in Europe and Latin America. Thisphase IIb study, which has just started, is a robust, randomised,placebo-controlled, three-arm dose ranging study in patients treated for threemonths with an additional three month follow-up. It is expected that thepatients from this phase IIb trial will be rolled into a one-year "open label"safety and efficacy study which should report by Q3 2009. In addition, in Q32008 a similar but pivotal phase III study will be commenced in an additional200 patients in the US, Europe and Latin America, to be treated for a period ofsix months. The phase III study is expected to report by Q3 2009. In parallelwith the phase IIb trial, the company will also complete a long-termpre-clinical toxicology study as part of regulatory requirements. Dr Robert Zimmer, MD, PhD, ImmuPharma's Chief Scientific Officer commented: "As IPP-201101 has already completed a successful phase II study last year, thissecond and larger study will yield valuable additional efficacy and safety datain the summer of 2008. A submission for approval is currently anticipated inlate 2009. This phase IIb study will be funded from the Company's existing cashresources. Dimitri Dimitriou, ImmuPharma's CEO added: "Essentially, we are dividing the phase II/III programme in two parts whichreduces the risk for ImmuPharma and provides data much earlier than previouslyplanned. This will provide patients with a much needed drug where there are nospecific drugs available today. From a commercial perspective, the refined phaseII/III programme has the potential to enhance the commercial attractiveness ofour most advanced drug candidate earlier than anticipated once the data from ourphase IIb are available." For further information please contact: ImmuPharma PLC:Dimitri Dimitriou, Chief Executive Officer +44 20 7152 4080Dr Robert Zimmer, President & Chief + 33 389 32 76 50Scientific OfficerRichard Warr, Chairman +44 20 7152 4080 Buchanan Communications + 44 20 7466 5000Lisa BaderoonRebecca Skye Dietrich Panmure Gordon & CoAndrew Burnett +44 151 243 0963 For company information, visit www.immupharma.com 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 potential non-addictive compound for relievingmoderate to severe pain, such as experienced by cancer sufferers andpost-surgical patients. Most existing treatments are derived from the opiatemorphine and tend to have serious side effects. ImmuPharma's new treatment isbased on met-enkephalin, the body's internal analgesic. IPP-102199 is beingdeveloped to have major advantages over morphine such as longer pain reliefduration and reduced side effects. The market for chronic opioids in the UScurrently exceeds $3.5 billion and is growing by more than 10 to 20 per cent ayear. Antibiotic for MRSA and similar highly resistant infections (IPP-203101) This is a novel antibiotic to combat MRSA and other severe hospital-acquired,resistant infections which affect some two million people in the US, accordingto the US Centers for Disease Control and Prevention. ImmuPharma's drugcandidate is targeted at disrupting the membrane potential of the bacterialpathogens. It is hoped this novel approach will reduce their potential to becomeresistant. PLA2 inhibitor for inflammatory and allergic disorders (IPP-201007) Phospholipases A2 (PLA2s) are enzymes that catalyze the hydrolysis ofphospholipids. This catalytic reaction is essential in the production of lipidsduring various processes in the body, involving prostaglandins, leukotrienes,thromboxanes, platelet activation factor and others. In certain cases, suchlipids mediators cause allergic reactions and a number of inflammatoryconditions such as asthma and other respiratory disorders, rheumatoid arthritis,septic shock and acute pancreatitis are characterized by a significant increasein PLA2 activity. Inhibiting PLA2 can therefore reduce some of these allergic reactions andinhibitors of PLA2 have already been shown to have positive effect ininflammatory conditions. ImmuPharma believes this new molecule has potential inbecoming a drug for certain inflammatory conditions and intends to progress itsdevelopment. The drug could be in clinical trials as early as 2009. This information is provided by RNS The company news service from the London Stock Exchange