Immupharma Regulatory News (IMM)

FOR IMMEDIATE RELEASE 22 JANUARY 2015

IMMUPHARMA

Landmark Collaboration Agreement & Commencement of Pivotal Phase III Lupuzor™ Study

with Simbec-Orion

Deal provides powerful validation for Lupuzor™

ImmuPharma PLC (AIM: IMM) ("ImmuPharma") and Simbec-Orion Group Limited ("Simbec-Orion") announce that they have today entered into a Collaboration Agreement for the execution of ImmuPharma's Pivotal Phase III clinical study of Lupuzor™.

Lupuzor™ (also known as Rigerimod, IPP-201101 and P140), is ImmuPharma's lead compound for the treatment of Lupus, (Systemic Lupus Erythematosus or "SLE"), a chronic, potentially life-threatening autoimmune disease. LupuzorTM has been granted Fast Track status by the US FDA and approved to start Phase III trials under a Special Protocol Assessment (SPA) due to its strong safety and efficacy profile. The multi-centre study will commence immediately and will recruit patients across Europe, the United States and other regions.

Simbec-Orion is a full service international Clinical Research Organisation ("CRO") specialising in Rare & Orphan conditions and has previous direct experience in Lupus trials.

Simbec-Orion was created in 2014 through the merger between Simbec Research Limited ("Simbec"), one of the most established and specialist CROs in Early Stage Clinical Development and ORION Clinical Services Limited ("ORION"), the specialist CRO in Late Stage Clinical Development. The merger was completed through the provision of funds raised from the Wales Life Sciences Fund LP, managed by Professor Sir Christopher Evans' Arthurian Life Sciences Limited. Sir Christopher, a highly successful scientist and entrepreneur, is also a Non-Executive Director of Simbec-Orion. The combined Group has revenues of approximately £25 million, employs approximately 250 staff and has operations across Europe, Australia and the United States, together with capabilities in multiple other territories. 

Simbec-Orion has agreed that it will reinvest a significant proportion of its fees in new ordinary shares at a fixed price of 150p per share, representing a premium of 206% to the closing mid-market price on 21 January 2015. It is expected that over the duration of the study Simbec-Orion will subscribe for approximately 900,000 new ordinary shares.

The clinical study is titled "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").

Commenting on the agreement, Dimitri Dimitriou, Chief Executive Officer said: "This deal is very attractive for ImmuPharma because it allows us to retain rights to LupuzorTM until commercialisation. This opens many options for the Company for further corporate deals including following in the path of all "big biotechs" by generating our own sales. We are delighted to have chosen to work with Simbec-Orion for a number of key clinical and commercial reasons. We are confident in their abilities and credentials and particularly appreciate their investment and commitment to Lupuzor'sTM success."

Richard Warr, Executive Chairman, commented: "This is a landmark deal for ImmuPharma. Lupuzor™ has been recognised as a significant asset by distinguished organisations. To enter phase III under the terms agreed for our partnership with Simbec-Orion demonstrates the commercial magnitude of our Lupuzor™ asset. Simbec-Orion are providing a powerful validation of Lupuzor™ by investing in our partnership. The transaction represents a groundbreaking structure which maximises shareholder value while Lupuzor™ is monetised. This vindicates our stated strategy of achieving the highest margins on behalf of our shareholders."

Dr Robert Zimmer, ImmuPharma's President and Chief Scientific Officer, further commented: "We are delighted to be working with such an established CRO as Simbec-Orion as we commence Lupuzor™ pivotal Phase III trials. Importantly they provide an independent validation of Lupuzor's™ potential in becoming a leading treatment for lupus patients world-wide. We look forward to providing further guidance on progress over the coming months." 

Ronald Openshaw, CEO, Simbec-Orion said: "We are delighted to be working with ImmuPharma. Lupuzor™ results to date are highly impressive and this has given us the confidence to invest in ImmuPharma. It is a key part of our strategy to use the deep know-how in our therapeutic areas of expertise and to make strategic investments in our clients thereby building long-term partnerships."

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NOTES TO EDITORS

ImmuPharma PLC 

ImmuPharma 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.

The pivotal Phase III clinical study is titled "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").

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)

Simbec-Orion

Simbec-Orion is a full service CRO operating from first in human Phase I clinical studies through to pivotal Phase III studies and Phase IV post marketing studies. The Company has expertise in all drug types, dosage forms and delivery mechanisms and in later stage development has particular expertise in oncology, rare and orphan diseases. Simbec-Orion supports its clients with its own in-house full service central laboratories, pharmacovigilance, data management and statistics, pharmacy, medical management. For more information please visit: www.simbec.com and www.orioncro.com