Immupharma Regulatory News (IMM)

RNS : FOR IMMEDIATE RELEASE 26 September 2017

ImmuPharma PLC

("ImmuPharma" or the "Company")

ImmuPharma initiates preparation of Lupuzor's™ regulatory submissions

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is pleased to confirm a further update on Lupuzor™ its lead programme for the potential breakthrough compound for Lupus, the life threatening auto-immune disease.

On 21 September 2017 ImmuPharma announced that that all patients in the Company's pivotal Phase III Lupuzor™ study had passed the six month stage, with 52 patients (26%) having now completed the full 12 months of the study. Importantly this announcement also confirmed the continuation of a robust safety record and that the trial remains on track to report the top line results by the end of Q1 2018.

With the trial progressing as planned, ImmuPharma is planning ahead in anticipation of the trial's successful outcome. In consultation with its regulatory advisors, the Company is now progressing the completion of the regulatory dossiers in preparation for submission to the Food and Drug Administration (FDA) and European Medicines Agency (EMA). This includes the finalisation of the Drug Master File ('DMF') and in particular the manufacture of commercial batches of the Lupuzor™ drug. These will be manufactured according to the described procedures in the DMF, to be ready for inclusion in these regulatory submissions.

Commenting on the announcement, Robert Zimmer MD, PhD President and Chief Scientific Officer said:  "We are delighted with the progress of the Lupuzor™ Phase III trial and are looking forward with confidence and planning for a successful outcome for the study. In consultation with our regulatory advisors, we are now completing the required regulatory dossiers to be submitted to the FDA and EMA as part of their approval process. We are keen to ensure that there are no delays in submission to enable us to fully exploit our 'fast track' status, previously granted by the FDA, so that the Company's package will be reviewed within 6 months of submission."

For more information on the trial please visit: www.ClinicalTrials.gov (Search term 'Lupuzor').

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

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Notes to Editors

ImmuPharma PLC 

ImmuPharma is a pharmaceutical development company listed since 2006 on AIM of the London Stock Exchange (LSE:IMM), focusing on developing novel medicines with high sales potential in specialist markets with serious unmet need. ImmuPharma is led by a commercially focused Board and management team with extensive experience.

Lupuzor™

Lupuzor™ (also referred to as Forigerimod, or P140) is ImmuPharma's lead compound and a potential treatment for lupus (or Systemic Lupus Erythematosus), a chronic, potentially life-threatening auto-immune disease. Lupuzor™ has a novel mechanism of action aimed at modulating the body's immune system so that it does not attack healthy cells, and avoids causing adverse side effects. It has the potential to halt the progression of the disease in a substantial proportion of patients.

Lupuzor™ has been granted Fast Track status by the US FDA and approval to start Phase III under Special Protocol Assessment (SPA). This SPA was subsequently amended due to its strong safety and efficacy profile to allow for a reduced number of patients in the pivotal Phase III trial thereby reducing the projected cost and time of development considerably.

The pivotal Phase III clinical study is entitled "A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus". It is a pivotal study designed to demonstrate the safety and efficacy of IPP-201101 and as a last step prior to the filing of the drug for approval with the US Food & Drug Administration ("FDA") and the European Medicines Agency ("EMA"). For more information please visit: www.ClinicalTrials.gov/lupuzor

Commercial Opportunity

There are an estimated five million people globally suffering from Lupus, with approximately 1.5 million patients in the US, Europe and Japan (Source: Lupus Foundation of America). Current 'standard of care' treatments, including steroids and immunosuppressants, can potentially have either serious side effects for patients or limited effectiveness, with over 60% of patients not adequately treated. GSK's Benlysta is the first Lupus drug approved in over 50 years and paves the path to market for Lupuzor™. Based on conservative estimates, and taking into account that Benlysta is priced currently at approximately $30,000 per patient per year, Lupuzor™ would be entering a market with the potential for multi-billion dollar sales. For more information on Lupuzor™ please visit: www.lupuzor.com