ImmuPharma In Lupuzor Licensing Talks As FDA Says Trials Can Begin

U.K. drug discovery company ImmuPharma PLC (IMM.LN) Thursday said U.S. regulators have given it the green light to begin a Phase III trial for its flagship drug Lupuzor, and said it is in talks with pharmaceutical companies regarding a potential licensing deal for the Lupus treatment.

ImmuPharma said the U.S. Food and Drug Administration has granted Lupuzor fast-track status for the late stage clinical trial.

The company's previous licensing partner Cephalon Inc. (CEPH) last month handed back rights to the drug, following its acquisition by generic drugs giant Teva Pharmaceutical Industries Ltd. (TEVA), which has a competing lupus drug in development.

ImmuPharma then reviewed the information received from Cephalon and made a new submission to the FDA, which resulted in the fast-track designation. Japanese and European regulators have also approved the start of late stage trials for the drug.

Chief Executive Dimitri Dimitriou said: "We are excited about the prospects of Lupuzor, its progress in development and the approvals of the authorities in the U.S., Europe and Japan regarding its progression to the final stage of testing. The interest we are seeing already from pharma companies as potential partners gives us great confidence."

-By Tommy Stubbington, Dow Jones Newswires; 44-20-7842-9268; [e-mail]