News

Company   Immupharma PLC
TIDM         IMM
Headline    Phase 1 Lupus results
Released    07:00 10-May-06
Number     7006C

RNS Number:7006C
Immupharma PLC
10 May 2006

FOR IMMEDIATE RELEASE

London, 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 phase I study involving 24 healthy volunteers of its lead compound IPP-201101 for Lupus, a chronic, life-threatening autoimmune disease.

This study, which took place in France, was the first administration in humans for IPP-201101 and was designed to assess its safety and tolerability. The preliminary safety report confirmed that the drug was safe and well-tolerated.

These encouraging results have allowed ImmuPharma to proceed with a phase II proof-of-concept and efficacy study in Lupus patients in Europe. The phase II study protocol was recently approved by the ethics committees and has been filed with the appropriate regulatory authorities. The dosing of Lupus patients in this study is expected to start soon and the trial will measure recognised surrogate markers of clinical efficacy, in preparation of the pivotal phase III studies.

To that effect, ImmuPharma has also scheduled a meeting with the FDA to design the appropriate development programme to get market authorisation of the drug in the US.

Dr Robert Zimmer, President and Chief Scientific Officer of ImmuPharma, said: 'IPP-201101, which has blockbuster potential, is a novel concept for the treatment of Lupus. IPP-201101 modulates the signalling of CD4+ cells and may also interact with the T-reg pathway. The key element is that IPP-201101 has been designed to interact only with the CD4+ cells linked to Lupus and leaves intact the remaining immune system, allowing Lupus patients to be protected by a fully operational immune system unlike the currently used therapies such as high dose corticoids and immunosuppressants. When administered appropriately it has the potential to stop the progression of the disease and should therefore be prescribed as early as possible during the course of the Lupus disease. The already available preclinical package demonstrating efficacy and selectivity for
Lupus together with the good results of the phase I safety and tolerability
study in man are critical in this respect and may offer clear benefit for the
patients when compared to the current therapies.'

For further information please contact:

ImmuPharma PLC:
Richard Warr, Executive Chairman: tel: +44 20 7152 4080
Dimitri Dimitriou, Chief Executive Officer: tel: +44 20 7152 4080
Dr Robert Zimmer, President & Chief Scientific Officer: tel: + 33 389 32 76 50

Buchanan Communications:
Lisa Baderoon, Director: tel: + 44 20 7466 5000
Rebecca Skye-Dietrich : tel: + 44 20 7466 5000

Notes to Editors:

About ImmuPharma

ImmuPharma PLC is a drug discovery and development company headquartered in London, UK and quoted on AIM of the London Stock Exchange (LSE:IMM). It has research 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 such as 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 medical conditions, each of which would represent a significant breakthrough in its field. The furthest advanced drug candidate targets Lupus, a disease for which there is currently no cure or specific treatment. The other two address moderate to severe pain (such as that experienced by cancer sufferers and post-operative patients), and MRSA and similar severe hospital-acquired resistant infections.

All three have significant sales potential as well as low marketing costs and a relatively low risk of development failure. One or more have the potential to be fast-tracked by the US Food and Drug Administration according to "Guidance for Industry: Fast Track Drug Development Programs - Designation, Development and Application Review" issued July 2004 and could therefore obtain their market authorization by 2010.

Key to the potential success of ImmuPharma is its unique collaborative agreement with Centre National de la Recherche Scientifique, France's scientific research institution. This agreement grants ImmuPharma worldwide exclusive rights to exploit certain key discoveries.

In addition to its three leading drug candidates, ImmuPharma has a drug
development pipeline using its rights to a virtual chemical library of hundreds of thousands of molecules as well as an innovative technology for converting peptides to drug candidates.

ImmuPharma has the option to commercialise its assets itself or to license them to 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 autoimmune disease where the immune system attacks healthy cells. There is currently no cure and existing medications only treat the symptoms whereas ImmuPharma's drug candidate has the potential to produce remission of the disease in a substantial proportion of patients.

Based on independent forecasts, the value of ImmuPharma's Lupus drug is
estimated to be "substantial" with peak annual sales forecast to generate in
excess of $4 billion.

Severe pain relief (IPP-102199)

ImmuPharma is developing a non-addictive compound for relieving moderate to severe pain, such as experienced by cancer sufferers and post-surgical patients. Most existing treatments are opioid-based (explain) and tend to have serious side effects. ImmuPharma's new treatment is based on met-enkephalin, the body's internal analgesic. IPP-102199 is being developed to have major advantages over morphine such as longer pain relief duration and reduced side effects. The market for chronic opioids in the US currently exceeds $3.5 billion and is growing 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 severe
hospital-acquired, resistant infections which affect some two million people in the US, according to the US Centers for Disease Control and Prevention.
ImmuPharma's drug candidate uniquely uses an electrical charge rather than biochemical methods against MRSA and other bacterial strains. It is hoped this novel approach will reduce their potential to become resistant.

Key management

Richard Warr, MA, executive chairman, (age 45) has 20 years experience in
investment banking and the capital markets. He was previously a director of ABN Amro; director and head of European sales and marketing at Credit Lyonnais; executive director at Dresdner Kleinwort Benson Securities Ltd; and head of European equity distribution at Swiss Bank Corporation. He has extensive experience in corporate and governmental equity capital market transactions.

Dimitri F Dimitriou, MSc, chief executive officer, (age 45) has 20 years
experience in the pharmaceutical and biotech industry. He was senior director, worldwide business development, at GlaxoSmithKline, where his responsibilities included licensing deals, alliances and collaborations on a worldwide basis.

Dr Robert Zimmer, MD, PhD, chief science officer, (age 58) began his career in 1985 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, became director and head of research and development at SkyePharma. His expertise includes managerial experience in multifunctional research and development and the assessment of technologies with multi-national pharmaceutical companies.

Paddy Walker-Taylor, FCA, MCT chief financial officer, (age 59) was previously finance director of Sir Robert McAlpine Ltd. He was involved in the AIM float of ISG Group, in which McAlpine had a minority shareholding. Previously he had held a number of key financial positions including finance director of Woolworths plc and treasurer of Marks & Spencer.

Douglas Paterson, MA, FCA, senior non-executive director, (age 62) has been a chartered accountant for 37 years and was a senior audit partner at Coopers & Lybrand (now PricewaterhouseCoopers) for 22 years. He currently holds a number of non-executive directorships, including Close Brothers Group plc and Goldman Sachs 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 the scientific aspects of deal making, support during competitive analysis, technical due diligence and input in development strategy. He was formerly senior director of scientific licensing at SmithKline Beecham (now
GlaxoSmithKline).

Collaboration with Centre National de la Recherche Scientifique (CNRS)

ImmuPharma has important collaboration arrangements with Centre National de la Recherche Scientifique, France's scientific research institution, including a research collaboration agreement relating to the therapeutic use of peptides and peptide derivatives. ImmuPharma has been granted the worldwide exclusive rights to exploit all discoveries made under this agreement. ImmuPharma will co-own the relevant intellectual property with CNRS which will share in the revenue generated 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

END


Home About ImmuPharma Lead compounds Discovery pipeline Management team News For Investors Contact us	News Company Immupharma PLC TIDM IMM Headline Phase 1 Lupus results Released 07:00 10-May-06 Number 7006C RNS Number:7006C Immupharma PLC 10 May 2006 FOR IMMEDIATE RELEASE London, 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 phase I study involving 24 healthy volunteers of its lead compound IPP-201101 for Lupus, a chronic, life-threatening autoimmune disease. This study, which took place in France, was the first administration in humans for IPP-201101 and was designed to assess its safety and tolerability. The preliminary safety report confirmed that the drug was safe and well-tolerated. These encouraging results have allowed ImmuPharma to proceed with a phase II proof-of-concept and efficacy study in Lupus patients in Europe. The phase II study protocol was recently approved by the ethics committees and has been filed with the appropriate regulatory authorities. The dosing of Lupus patients in this study is expected to start soon and the trial will measure recognised surrogate markers of clinical efficacy, in preparation of the pivotal phase III studies. To that effect, ImmuPharma has also scheduled a meeting with the FDA to design the appropriate development programme to get market authorisation of the drug in the US. Dr Robert Zimmer, President and Chief Scientific Officer of ImmuPharma, said: 'IPP-201101, which has blockbuster potential, is a novel concept for the treatment of Lupus. IPP-201101 modulates the signalling of CD4+ cells and may also interact with the T-reg pathway. The key element is that IPP-201101 has been designed to interact only with the CD4+ cells linked to Lupus and leaves intact the remaining immune system, allowing Lupus patients to be protected by a fully operational immune system unlike the currently used therapies such as high dose corticoids and immunosuppressants. When administered appropriately it has the potential to stop the progression of the disease and should therefore be prescribed as early as possible during the course of the Lupus disease. The already available preclinical package demonstrating efficacy and selectivity for Lupus together with the good results of the phase I safety and tolerability study in man are critical in this respect and may offer clear benefit for the patients when compared to the current therapies.' For further information please contact: ImmuPharma PLC: Richard Warr, Executive Chairman: tel: +44 20 7152 4080 Dimitri Dimitriou, Chief Executive Officer: tel: +44 20 7152 4080 Dr Robert Zimmer, President & Chief Scientific Officer: tel: + 33 389 32 76 50 Buchanan Communications: Lisa Baderoon, Director: tel: + 44 20 7466 5000 Rebecca Skye-Dietrich : tel: + 44 20 7466 5000 Notes to Editors: About ImmuPharma ImmuPharma PLC is a drug discovery and development company headquartered in London, UK and quoted on AIM of the London Stock Exchange (LSE:IMM). It has research 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 such as 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 medical conditions, each of which would represent a significant breakthrough in its field. The furthest advanced drug candidate targets Lupus, a disease for which there is currently no cure or specific treatment. The other two address moderate to severe pain (such as that experienced by cancer sufferers and post-operative patients), and MRSA and similar severe hospital-acquired resistant infections. All three have significant sales potential as well as low marketing costs and a relatively low risk of development failure. One or more have the potential to be fast-tracked by the US Food and Drug Administration according to "Guidance for Industry: Fast Track Drug Development Programs - Designation, Development and Application Review" issued July 2004 and could therefore obtain their market authorization by 2010. Key to the potential success of ImmuPharma is its unique collaborative agreement with Centre National de la Recherche Scientifique, France's scientific research institution. This agreement grants ImmuPharma worldwide exclusive rights to exploit certain key discoveries. In addition to its three leading drug candidates, ImmuPharma has a drug development pipeline using its rights to a virtual chemical library of hundreds of thousands of molecules as well as an innovative technology for converting peptides to drug candidates. ImmuPharma has the option to commercialise its assets itself or to license them to 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 autoimmune disease where the immune system attacks healthy cells. There is currently no cure and existing medications only treat the symptoms whereas ImmuPharma's drug candidate has the potential to produce remission of the disease in a substantial proportion of patients. Based on independent forecasts, the value of ImmuPharma's Lupus drug is estimated to be "substantial" with peak annual sales forecast to generate in excess of $4 billion. Severe pain relief (IPP-102199) ImmuPharma is developing a non-addictive compound for relieving moderate to severe pain, such as experienced by cancer sufferers and post-surgical patients. Most existing treatments are opioid-based (explain) and tend to have serious side effects. ImmuPharma's new treatment is based on met-enkephalin, the body's internal analgesic. IPP-102199 is being developed to have major advantages over morphine such as longer pain relief duration and reduced side effects. The market for chronic opioids in the US currently exceeds $3.5 billion and is growing 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 severe hospital-acquired, resistant infections which affect some two million people in the US, according to the US Centers for Disease Control and Prevention. ImmuPharma's drug candidate uniquely uses an electrical charge rather than biochemical methods against MRSA and other bacterial strains. It is hoped this novel approach will reduce their potential to become resistant. Key management Richard Warr, MA, executive chairman, (age 45) has 20 years experience in investment banking and the capital markets. He was previously a director of ABN Amro; director and head of European sales and marketing at Credit Lyonnais; executive director at Dresdner Kleinwort Benson Securities Ltd; and head of European equity distribution at Swiss Bank Corporation. He has extensive experience in corporate and governmental equity capital market transactions. Dimitri F Dimitriou, MSc, chief executive officer, (age 45) has 20 years experience in the pharmaceutical and biotech industry. He was senior director, worldwide business development, at GlaxoSmithKline, where his responsibilities included licensing deals, alliances and collaborations on a worldwide basis. Dr Robert Zimmer, MD, PhD, chief science officer, (age 58) began his career in 1985 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, became director and head of research and development at SkyePharma. His expertise includes managerial experience in multifunctional research and development and the assessment of technologies with multi-national pharmaceutical companies. Paddy Walker-Taylor, FCA, MCT chief financial officer, (age 59) was previously finance director of Sir Robert McAlpine Ltd. He was involved in the AIM float of ISG Group, in which McAlpine had a minority shareholding. Previously he had held a number of key financial positions including finance director of Woolworths plc and treasurer of Marks & Spencer. Douglas Paterson, MA, FCA, senior non-executive director, (age 62) has been a chartered accountant for 37 years and was a senior audit partner at Coopers & Lybrand (now PricewaterhouseCoopers) for 22 years. He currently holds a number of non-executive directorships, including Close Brothers Group plc and Goldman Sachs 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 the scientific aspects of deal making, support during competitive analysis, technical due diligence and input in development strategy. He was formerly senior director of scientific licensing at SmithKline Beecham (now GlaxoSmithKline). Collaboration with Centre National de la Recherche Scientifique (CNRS) ImmuPharma has important collaboration arrangements with Centre National de la Recherche Scientifique, France's scientific research institution, including a research collaboration agreement relating to the therapeutic use of peptides and peptide derivatives. ImmuPharma has been granted the worldwide exclusive rights to exploit all discoveries made under this agreement. ImmuPharma will co-own the relevant intellectual property with CNRS which will share in the revenue generated 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 END ©2006 London Stock Exchange plc. All rights reserved