Immupharma Regulatory News (IMM)

ImmuPharma

Lupuzor™ Gears Up To Start Pivotal Phase III trials

ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, is delighted to announce that Phase III activities of its lead compound Lupuzor™ will soon commence.

Following advanced discussions and after completing detailed due diligence with a potential partner, ImmuPharma has started the preparatory steps for Lupuzor's ™ pivotal phase III clinical trials. Before these initial activities are completed, it is expected that a further agreement to develop Lupuzo™ will be finalised and signed which will see Immupharma and the potential partner fund the phase III trials. This agreement will also allow the partner to run the phase III pivotal programme based on the strengthened study protocol agreed between ImmuPharma and the FDA.

Commenting on the announcement, ImmuPharma's Chairman, Richard Warr, said: "Taking Lupuzor™ into pivotal Phase III trials represents a significant milestone in the history of ImmuPharma. Our strategy remains focused on maximising the full value of Lupuzor™ on behalf of our shareholders as we progress the compound through phase III and beyond."

Dr Robert Zimmer, ImmuPharma's President and Chief Scientific Officer, further commented: "The entry of Lupuzor™ into pivotal Phase III trials involves a potential partner with strong credentials and expertise in late stage clinical development. Furthermore they provide an independent validation of Lupuzor's™ potential to become a leading treatment for lupus patients world-wide. We are commencing Lupuzor's™ phase III activities immediately and look forward to providing further guidance on progress as soon as possible." 

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Notes to Editors

ImmuPharma PLC is a pharmaceutical 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 has five drug candidates in development, two platform technologies and a multitude of patents and IP. ImmuPharma is led by a commercially focused Board and management team with extensive experience. For more information please go to: www.immupharma.com

· LupuzorTM

LupuzorTM also referred to as rigerimod 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, LupuzorTM has a novel mechanism of action aimed at modulating the body's immune system so that it does not attack healthy cells, without causing adverse side effects. It has the potential to halt the progression of the disease in a substantial proportion of patients.

LupuzorTM has been granted Fast Track status by the US FDA and approved 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 of development considerably. ImmuPharma has been in discussions with a number of possible partner companies to progress LupuzorTM's development and commercialisation. The £50m equity finance facility from Darwin Strategic allows ImmuPharma further flexibility in structuring the further development of LupuzorTM

Commercial Opportunity

Current drugs either have serious side effects or have limited effectiveness

GSK's Benlysta's approval paves the way for Lupuzor™ (first Lupus drug approved in over 50 years)

There are an estimated 1.5 million patients in US, Europe and Japan

The target price per patient is estimated to be around $10,000 -$20,000 per year

For more information on Lupuzor™ please visit: (www.lupuzor.com)