News

Company   ImmuPharma PLC
TIDM         IMM
Headline     Preliminary Results
Released    07:00 08-May-08
Number     9139T

FOR IMMEDIATE RELEASE

London, 08 May 2008

PRELIMINARY RESULTS ANNOUNCEMENT
for the year ended 31 December 2007

ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, is pleased to announce its preliminary results for the year ended 31 December 2007.

Key Highlights:
■ Recruitment of patients well underway with IPP-201101, drug candidate for the treatment of Systemic Lupus Erythematosus, in pivotal Phase IIb trial
■ Added a novel drug candidate to the pipeline, IPP-204106, for cancer; rights obtained from Centre National de la Recherche Scientifique (CNRS)
■ Discovery of a new lead candidate for inflammation, IPP-201007 from internal proprietary chemical library
■ Consolidated cash balance at 31 December 2007 of approx £2.9 million.

Dimitri Dimitriou, Chief Executive Officer, said: “2007 was an exciting year for ImmuPharma with good progress being made through our pipeline, particularly for our lead drug candidate IPP-201101 for Lupus and the addition of two new compounds to our portfolio. We look forward to reporting on further progress throughout 2008 principally the results of our Phase IIb trial for Lupus.”

For further information please contact:

ImmuPharma PLC

Dimitri Dimitriou, Chief Executive Officer                         +44 20 7152 4080
Dr Robert Zimmer, President & Chief Scientific Officer      + 33 389 32 7650
Richard Warr, Chairman                                                +44 20 7152 4080

Buchanan Communications + 44 20 7466 5000

Lisa Baderoon
Rebecca Skye-Dietrich

Panmure Gordon & Co +44 151 243 0963

Andrew Burnett

IMMUPHARMA PLC

The consolidated results for ImmuPharma and its subsidiaries (collectively the “Group”) cover the year ended 31 December 2007.

REPORT FROM THE CHAIRMAN AND THE CHIEF EXECUTIVE OFFICER

We are pleased to report our achievements and continued progress during 2007 and are enthusiastic about our plans for 2008. 2007 has been an important year in our corporate history. During our second year as a public company we have made a number of key achievements including the addition of two novel drug candidates to our portfolio and the continued progress of our most advanced asset in development, our lead candidate for the treatment of Lupus.

Following the successful completion of a phase II study in patients suffering from Lupus, where our lead drug candidate (IPP-201101) showed a statistically significant clinical improvement in patients’ overall symptoms, ImmuPharma has initiated a Phase IIb, double-blind, placebo-controlled trial in 200 patients in Europe and Latin America. The first patients have been dosed and the Company expects to report headline efficacy data in summer of 2008. Analysts estimate that IPP-201101 for the treatment of Lupus has blockbuster sales potential.

ImmuPharma was delighted to announce the addition of two novel drug candidates to our portfolio during 2007. IPP-204106 is a novel drug candidate for cancer, the rights to which have been obtained through the Company’s ongoing research collaboration with the Centre National de la Recherche Scientifique (CNRS), France’s leading scientific research institution. The molecule is a nucleolin antagonist and has a dual mechanism of action, acting both in preventing angiogenesis as well as proliferation. Preclinical data has shown that nucleolin antagonists inhibit the growth of tumours and metastasis in many cancer types.

Following investigation of our proprietary chemical library, ImmuPharma has discovered a new molecular series with potential application in inflammatory/allergic conditions such as asthma and rheumatoid arthritis. These molecules, programme code-named IPP-201007, have utility as selective phospholipase A2 subtype inhibitors and are already patented through ImmuPharma’s library broad patent.

Summary and Outlook

The ImmuPharma business model is to focus on innovative drugs for niche therapeutic areas with significant sales potential but without the need for a large commercial infrastructure. In contrast to other types of pharmaceutical development, this is characterised by relatively streamlined development costs and timelines. This is evident in our progress so far with IPP-201101 for the treatment of Lupus.

ImmuPharma is in discussions with a number of pharmaceutical companies regarding potential licensing deals. The Company intends to optimise the value of its asset portfolio and to maximise the return to its shareholders.

The focus for the year ahead will be on the current and next phase of trials for our Lupus compound, IPP-201101; to make progress advancing our other compounds, particularly our new cancer compound, IPP-204106, and to continue in dialogue with other pharmaceutical companies in respect of potential corporate deals.

With a strong team in place to execute these objectives, we believe we are well positioned to take the Group forward.

The Board of ImmuPharma should like to thank its shareholders for their support as well as its scientific advisors and the Centre Nationale de la Recherche Scientifique in France for their collaboration.

REPORT FROM THE CHIEF SCIENTIFIC OFFICER

2007 has been a year of exciting progress and new developments for ImmuPharma. Following the successful Phase II trial in 2006 and further to discussions with the US Food and Drug Administration (FDA), the first patients have been dosed with IPP-201101, our lead candidate for the treatment of Lupus, in a pivotal Phase IIb trial. Two new drug candidates have been discovered. The first one announced chronologically, IPP-201007, was discovered from our proprietary chemical library and has potential application in inflammatory/allergic conditions. The second, IPP-204106, represents an exciting approach to potentially treating cancer and is a further validation of the value of our ongoing collaboration with the Centre National de la Recherche Scientifique (CNRS), France’s leading scientific research institution. Furthermore, general progress on our other pipeline assets continues to be made.

IPP-201101 Lupus Drug Candidate

Following a Phase I study showing IPP-201101 to be generally safe and well-tolerated and the successful completion of a Phase II study in Lupus patients which met all of its primary endpoints (p<0.0001) during 2006, ImmuPharma submitted an IND (Investigational New Drug) application to the US FDA for the initiation of further pivotal studies for IPP-201101. The feedback obtained from the FDA enabled ImmuPharma to refine its late-stage development program for IPP-201101. Specifically, the outcome of this consultation has been the segmenting of the development program into separate Phase IIb and Phase III trials. The Company had previously expected a single Phase II/III trial in 240 patients over 12 months. The revised plans allow ImmuPharma to obtain additional Phase II data earlier than previously expected and continuing with a more simple Phase III trial in late 2008, broadly in line with previous development timelines.

Lupus patients are now being dosed with IPP-201101 in the Phase IIb trial for the treatment of Systemic Lupus Erythematosus and patient recruitment is well underway. The study is a robust, randomised, placebo-controlled, three-arm dose ranging study in 200 patients in Europe and Latin America with an additional three month follow-up. The first efficacy results are expected later this year. Following the completion of this study, it is expected that the patients will be rolled into a further study – a one-year “open label” safety and efficacy trial, which should report by late 2009, providing further clinical data. In addition, in late 2008 a similar but pivotal Phase III study is being planned to commence in an additional 200 patients in the US, Europe and Latin America, to be treated for a period of six months, subject to our FDA discussions and approval. In parallel with the Phase IIb trial, ImmuPharma is planning to complete a long-term pre-clinical toxicology study as part of regulatory requirements as well as the finalisation of a scale-up manufacturing process which will allow commercial production.

New Drug Candidate IPP-201007 : Inflammation

Following discovery activities on our proprietary chemical library, ImmuPharma discovered a new molecular series with potential application in inflammatory/allergic conditions such as asthma and rheumatoid arthritis. These molecules, code-named, IPP-201007, have utility as selective phospholipase A2 subtype inhibitors and are already patented through ImmuPharma’s library broad patent.

New Drug Candidate IPP-204106 : Cancer

As part of its successful ongoing research collaboration with the Centre National de la Recherche Scientifique (CNRS), France’s scientific research institution, ImmuPharma has taken the exclusive rights for the worldwide development and commercialisation of a novel drug candidate for cancer. The molecule code-named IPP-204106, has a dual mechanism of action, acting both in preventing angiogenesis as well as proliferation. IPP-204106 is a nucleolin antagonist, the lead molecule in a family of pseudopeptides designed to bind to the surface nucleolin and as a consequence to block the nucleolin activity on a nuclear basis; the stabilisation of various mRNAs is necessary to induce the proliferation of certain human cancer cell lines and is nucleolin dependent as demonstrated in many prestigious peer reviewed publications. By blocking nucleolin activity we expect to be able to control the cancer cell proliferation as evidenced in preclinical studies which have shown that nucleolin antagonists inhibit the growth of tumours and metastasis in many human cancer types as well as angiogenesis. Furthermore, preliminary data have also shown an absence of toxicity. Major manufacturing hurdles have also been solved and a large scale manufacturing is now possible and will be used for the up-coming preclinical and clinical trials. We now have established a new drug candidate family of proprietary molecules with a proven potential to treat cancer, with a known mechanism of action, with demonstrated preclinical activities and an advantageous safety profile. We expect to initiate a Phase I trial early in 2009.

Whilst our core strategy is to focus our current resources on the progression of our compounds for Lupus and cancer, we continue to progress our other two candidates for severe pain and for hospital-acquired infections. Both represent a breakthrough approach that fits perfectly with the Company’s model of niche diseases in areas where there are clear unmet medical needs.

On behalf of the Board we would like to extend our thanks to the team at the CNRS in Strasbourg with whom ImmuPharma has key collaborations, to our staff for their outstanding contribution during 2007 and our shareholders for their continued support

Please click below to view or download the full Interim Results


Home About ImmuPharma Lead compounds Discovery pipeline Management team News For Investors Contact us	News Company ImmuPharma PLC TIDM IMM Headline Preliminary Results Released 07:00 08-May-08 Number 9139T FOR IMMEDIATE RELEASE London, 08 May 2008 PRELIMINARY RESULTS ANNOUNCEMENT for the year ended 31 December 2007 ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, is pleased to announce its preliminary results for the year ended 31 December 2007. Key Highlights: ■ Recruitment of patients well underway with IPP-201101, drug candidate for the treatment of Systemic Lupus Erythematosus, in pivotal Phase IIb trial ■ Added a novel drug candidate to the pipeline, IPP-204106, for cancer; rights obtained from Centre National de la Recherche Scientifique (CNRS) ■ Discovery of a new lead candidate for inflammation, IPP-201007 from internal proprietary chemical library ■ Consolidated cash balance at 31 December 2007 of approx £2.9 million. Dimitri Dimitriou, Chief Executive Officer, said: “2007 was an exciting year for ImmuPharma with good progress being made through our pipeline, particularly for our lead drug candidate IPP-201101 for Lupus and the addition of two new compounds to our portfolio. We look forward to reporting on further progress throughout 2008 principally the results of our Phase IIb trial for Lupus.” For further information please contact: ImmuPharma PLC Dimitri Dimitriou, Chief Executive Officer +44 20 7152 4080 Dr Robert Zimmer, President & Chief Scientific Officer + 33 389 32 7650 Richard Warr, Chairman +44 20 7152 4080 Buchanan Communications + 44 20 7466 5000 Lisa Baderoon Rebecca Skye-Dietrich Panmure Gordon & Co +44 151 243 0963 Andrew Burnett IMMUPHARMA PLC The consolidated results for ImmuPharma and its subsidiaries (collectively the “Group”) cover the year ended 31 December 2007. REPORT FROM THE CHAIRMAN AND THE CHIEF EXECUTIVE OFFICER We are pleased to report our achievements and continued progress during 2007 and are enthusiastic about our plans for 2008. 2007 has been an important year in our corporate history. During our second year as a public company we have made a number of key achievements including the addition of two novel drug candidates to our portfolio and the continued progress of our most advanced asset in development, our lead candidate for the treatment of Lupus. Following the successful completion of a phase II study in patients suffering from Lupus, where our lead drug candidate (IPP-201101) showed a statistically significant clinical improvement in patients’ overall symptoms, ImmuPharma has initiated a Phase IIb, double-blind, placebo-controlled trial in 200 patients in Europe and Latin America. The first patients have been dosed and the Company expects to report headline efficacy data in summer of 2008. Analysts estimate that IPP-201101 for the treatment of Lupus has blockbuster sales potential. ImmuPharma was delighted to announce the addition of two novel drug candidates to our portfolio during 2007. IPP-204106 is a novel drug candidate for cancer, the rights to which have been obtained through the Company’s ongoing research collaboration with the Centre National de la Recherche Scientifique (CNRS), France’s leading scientific research institution. The molecule is a nucleolin antagonist and has a dual mechanism of action, acting both in preventing angiogenesis as well as proliferation. Preclinical data has shown that nucleolin antagonists inhibit the growth of tumours and metastasis in many cancer types. Following investigation of our proprietary chemical library, ImmuPharma has discovered a new molecular series with potential application in inflammatory/allergic conditions such as asthma and rheumatoid arthritis. These molecules, programme code-named IPP-201007, have utility as selective phospholipase A2 subtype inhibitors and are already patented through ImmuPharma’s library broad patent. Summary and Outlook The ImmuPharma business model is to focus on innovative drugs for niche therapeutic areas with significant sales potential but without the need for a large commercial infrastructure. In contrast to other types of pharmaceutical development, this is characterised by relatively streamlined development costs and timelines. This is evident in our progress so far with IPP-201101 for the treatment of Lupus. ImmuPharma is in discussions with a number of pharmaceutical companies regarding potential licensing deals. The Company intends to optimise the value of its asset portfolio and to maximise the return to its shareholders. The focus for the year ahead will be on the current and next phase of trials for our Lupus compound, IPP-201101; to make progress advancing our other compounds, particularly our new cancer compound, IPP-204106, and to continue in dialogue with other pharmaceutical companies in respect of potential corporate deals. With a strong team in place to execute these objectives, we believe we are well positioned to take the Group forward. The Board of ImmuPharma should like to thank its shareholders for their support as well as its scientific advisors and the Centre Nationale de la Recherche Scientifique in France for their collaboration. REPORT FROM THE CHIEF SCIENTIFIC OFFICER 2007 has been a year of exciting progress and new developments for ImmuPharma. Following the successful Phase II trial in 2006 and further to discussions with the US Food and Drug Administration (FDA), the first patients have been dosed with IPP-201101, our lead candidate for the treatment of Lupus, in a pivotal Phase IIb trial. Two new drug candidates have been discovered. The first one announced chronologically, IPP-201007, was discovered from our proprietary chemical library and has potential application in inflammatory/allergic conditions. The second, IPP-204106, represents an exciting approach to potentially treating cancer and is a further validation of the value of our ongoing collaboration with the Centre National de la Recherche Scientifique (CNRS), France’s leading scientific research institution. Furthermore, general progress on our other pipeline assets continues to be made. IPP-201101 Lupus Drug Candidate Following a Phase I study showing IPP-201101 to be generally safe and well-tolerated and the successful completion of a Phase II study in Lupus patients which met all of its primary endpoints (p<0.0001) during 2006, ImmuPharma submitted an IND (Investigational New Drug) application to the US FDA for the initiation of further pivotal studies for IPP-201101. The feedback obtained from the FDA enabled ImmuPharma to refine its late-stage development program for IPP-201101. Specifically, the outcome of this consultation has been the segmenting of the development program into separate Phase IIb and Phase III trials. The Company had previously expected a single Phase II/III trial in 240 patients over 12 months. The revised plans allow ImmuPharma to obtain additional Phase II data earlier than previously expected and continuing with a more simple Phase III trial in late 2008, broadly in line with previous development timelines. Lupus patients are now being dosed with IPP-201101 in the Phase IIb trial for the treatment of Systemic Lupus Erythematosus and patient recruitment is well underway. The study is a robust, randomised, placebo-controlled, three-arm dose ranging study in 200 patients in Europe and Latin America with an additional three month follow-up. The first efficacy results are expected later this year. Following the completion of this study, it is expected that the patients will be rolled into a further study – a one-year “open label” safety and efficacy trial, which should report by late 2009, providing further clinical data. In addition, in late 2008 a similar but pivotal Phase III study is being planned to commence in an additional 200 patients in the US, Europe and Latin America, to be treated for a period of six months, subject to our FDA discussions and approval. In parallel with the Phase IIb trial, ImmuPharma is planning to complete a long-term pre-clinical toxicology study as part of regulatory requirements as well as the finalisation of a scale-up manufacturing process which will allow commercial production. New Drug Candidate IPP-201007 : Inflammation Following discovery activities on our proprietary chemical library, ImmuPharma discovered a new molecular series with potential application in inflammatory/allergic conditions such as asthma and rheumatoid arthritis. These molecules, code-named, IPP-201007, have utility as selective phospholipase A2 subtype inhibitors and are already patented through ImmuPharma’s library broad patent. New Drug Candidate IPP-204106 : Cancer As part of its successful ongoing research collaboration with the Centre National de la Recherche Scientifique (CNRS), France’s scientific research institution, ImmuPharma has taken the exclusive rights for the worldwide development and commercialisation of a novel drug candidate for cancer. The molecule code-named IPP-204106, has a dual mechanism of action, acting both in preventing angiogenesis as well as proliferation. IPP-204106 is a nucleolin antagonist, the lead molecule in a family of pseudopeptides designed to bind to the surface nucleolin and as a consequence to block the nucleolin activity on a nuclear basis; the stabilisation of various mRNAs is necessary to induce the proliferation of certain human cancer cell lines and is nucleolin dependent as demonstrated in many prestigious peer reviewed publications. By blocking nucleolin activity we expect to be able to control the cancer cell proliferation as evidenced in preclinical studies which have shown that nucleolin antagonists inhibit the growth of tumours and metastasis in many human cancer types as well as angiogenesis. Furthermore, preliminary data have also shown an absence of toxicity. Major manufacturing hurdles have also been solved and a large scale manufacturing is now possible and will be used for the up-coming preclinical and clinical trials. We now have established a new drug candidate family of proprietary molecules with a proven potential to treat cancer, with a known mechanism of action, with demonstrated preclinical activities and an advantageous safety profile. We expect to initiate a Phase I trial early in 2009. Whilst our core strategy is to focus our current resources on the progression of our compounds for Lupus and cancer, we continue to progress our other two candidates for severe pain and for hospital-acquired infections. Both represent a breakthrough approach that fits perfectly with the Company’s model of niche diseases in areas where there are clear unmet medical needs. On behalf of the Board we would like to extend our thanks to the team at the CNRS in Strasbourg with whom ImmuPharma has key collaborations, to our staff for their outstanding contribution during 2007 and our shareholders for their continued support Please click below to view or download the full Interim Results ©2008 London Stock Exchange plc. All rights reserved