ImmuPharma And Simbec-Orion Collaborate And Start Pivotal Phase III Lupuzor™ Study
ImmuPharma PLC and Simbec-Orion Group Limited recently announced a collaboration agreement for the execution of a Pivotal Phase III clinical study of ImmuPharma’s Lupuzor™, the company’s lead compound to treat Systemic Lupus Erythematosus, a chronic and life-threatening autoimmune disease.
Lupuzor was granted Fast Track status by the Food and Drugs Administration (FDA); it was also approved under a Special Protocol Assessment (SPA) to start Phase III trials since it has a strong efficacy and safety profile. This multi-center evaluation will start immediately and patients across the United States, Europe and further regions will be recruited.
Simbec-Orion was created in 2014 and is a full service international Clinical Research Organisation (“CRO”) specializing in Rare & Orphan conditions and has previous direct experience in Lupus trials. The company is a result of a merger between Simbec Research Limited and ORION Clinical Services Limited and was managed by Christopher Evans, an entrepreneur and scientist. Now, Simbec-Orion employs 250 staff across the U.S., Europe and Australia.
According to a press release, 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 pivotal clinical study is designed to assess and demonstrate that IPP-201101 is both safe and effective, and it will be crucial as the last step in achieving approval for the drug with the European Medicines Agency (EMA) and the FDA.
Dimitri Dimitriou, ImmuPharma’s CEO, said: “This deal is very attractive for ImmuPharma because it allows us to retain rights to LupuzorTM until commercialization. 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.”
Ronald Openshaw, CEO of Simbec-Orion, stated: “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.”