ImmuPharma share price: Company signs collaboration agreement with Simbec-Orion Group

on Jan 22, 2015
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ImmuPharma PLC (AIM: IMM) today issued a regulatory statement updating investors that the company and Simbec-Orion Group Limited have today entered into a Collaboration Agreement. Highlights from the company statement:

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The Collaboration Agreemen is for the execution of ImmuPharma’s Pivotal Phase III clinical study of Lupuzor, ImmuPharma’s lead compound for the treatment of Lupus, 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.

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.”

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