Immupharma Partner Cephalon Starts Phase 2b Trials Recruitment

23rd Jun 2010 07:28

LONDON (Dow Jones)--Immupharma PLC (IMM.LN), a specialist drug discovery and development company, said Wednesday that Cephalon Inc. (CEPH), its license partner for IPP-201101 (Rigerimod; Lupuzor) has started the recruitment of lupus patients for a Phase IIb trial in the U.S. MAIN FACTS: -Study was designed to allow U.S.-based investigators and the FDA to evaluate Rigerimod (Lupuzor) as a treatment for lupus before commencing a Phase III clinical trial. -A large number of centers are involved and the study is expected to be extended to E.U. sites within a few months. -The data generated from this trial will be part of the package to be submitted to the FDA and other regulatory authorities for approval. -In addition to the U.S. trial and in order to prepare for the commercial development in Japan, Cephalon has entered into a separate sub-licence agreement with Symbio Pharmaceuticals. -Under the agreement, Cephalon retains all commercialization rights to Rigerimod (Lupuzor) in Japan, and Symbio is granted an exclusive right to conduct a Japanese-based Phase I clinical study which is mandatory for a future filing of Rigerimod (Lupuzor) with the Japanese regulatory bodies. -Immupharma shares closed Tuesday at 70.5 pence. -By Iain Packham, Dow Jones Newswires; 44-20-7842-9269; [email protected] (END) Dow Jones Newswires June 23, 2010 02:28 ET (06:28 GMT)