Eli Lilly said today it will end its effort to develop the anti-BAFF (B-cell activating factor) monoclonal antibody tabalumab for rheumatoid arthritis (RA), ending three Phase III trials of the drug for that indication—but the pharma giant insisted it will continue the separate “ILLUMINATE” Phase III study of the drug for systemic lupus erythematosus.
Lilly said it will take a $50 million charge against its R&D costs in the first quarter of 2013 toward ending the RA program for tabalumab, one of the company’s 13 pipeline drugs in Phase III trials.
Lilly’s decision comes a month after the company ended the Phase III FLEX-M study, citing data showing that tabalumab failed to show sufficient efficacy. The company said at the time, and still maintains, that its decision did not reflect any problems with safety of tabalumab.
The FLEX-M results triggered an interim futility analysis of another Phase III trial of the drug, FLEX-V, which was studying tabalumab for patients with moderate-to-severe RA who had an inadequate response to one or more tumor necrosis factor inhibitors. Lilly said the two analyses prompted its decision to end not only FLEX-V, but all ongoing Phase II and Phase III RA studies.
"While we are obviously disappointed by these results in rheumatoid arthritis, we continue to believe that tabalumab could have significant potential for patients in other disease areas," said Eiry Roberts, M.D., vp of autoimmune product development at Lilly. "Autoimmune disorders are highly individualized. We believe that targeting BAFF with a molecule such as tabalumab may still represent an important advance for patients, and therefore we will continue the ongoing Phase III tabalumab lupus program."
Despite the failure, Lilly did not change its investor guidance for 2013, which calls for the company to earn $4.10 to $4.25 per share on a reported basis, or $3.82 to $3.97 on a non-GAAP basis excluding 28 cents per share from a one-time estimated $490 million of deferred exenatide-related income, hinging upon the company transferring commercial rights to the type 2 diabetes drug exenatide outside the U.S. to Amylin. Lilly said the transfer is expected to be largely complete by the end of the first quarter of 2013.
The failure of tabalumab for RA comes a month after Lilly said it would not file a marketing application for another Phase III drug following its failure in two clinical trials last summer in patients with mild-to-moderate forms of the disease. Instead, Lilly said it will launch another Phase III study of the Alzheimer’s disease treatment solanezumab, designed to provide more data on the drug candidate’s ability to restore cognitive function in patients with mild forms of Alzheimer’s.
Lilly said its Phase III pipeline includes four drug candidates that have indications for diabetes, three for cancer and autoimmunity, two for neuroscience, and one, cardiovascular.