Eli Lilly Discontinues Phase 3 Rheumatoid Arthritis Program for Tabalumab

Eli Lilly and Company (NYSE: LLY)announced today that it will discontinue the Phase 3 rheumatoid arthritis (RA)program for tabalumab, an anti-BAFF (B cell activating factor) monoclonalantibody, due to lack of efficacy. The decision was not based on safetyconcerns. The tabalumab Phase 3 program for systemic lupus erythematosus,ILLUMINATE, is ongoing and will continue as planned.In December 2012, Lilly discontinued the Phase 3 RA registration study FLEX-Mfor lack of treatment effect. FLEX-M was investigating tabalumab in patientswith moderate-to-severe RA who had an inadequate response to methotrexatetherapy.Based on FLEX-M findings, an interim futility analysis was conducted of theFLEX-V study, which was investigating tabalumab for the treatment of patientswith moderate-to-severe RA who had an inadequate response to one or more tumornecrosis factor (TNF) inhibitors.Based on the outcomes of these two separate interim futility analyses, Lillyhas decided to discontinue development of tabalumab in the current RA program.All ongoing Phase 2 and Phase 3 RA studies will be stopped."While we are obviously disappointed by these results in rheumatoid arthritis,we continue to believe that tabalumab could have significant potential forpatients in other disease areas," said Eiry Roberts, M.D., vice president ofautoimmune product development at Lilly. "Autoimmune disorders are highlyindividualized. We believe that targeting BAFF with a molecule such astabalumab may still represent an important advance for patients, and thereforewe will continue the ongoing Phase 3 tabalumab lupus program."The decision to stop the current RA program for tabalumab is expected toresult in a first-quarter charge to research and development expense ofapproximately $50 million. The company's previously issued financial guidancefor 2013 remains unchanged.