Drugmaker Eli Lilly and Co. (LLY) said Thursday it will discontinue the Phase 3 program for its rheumatoid arthritis drug tabalumab, citing a lack of efficacy. The company added that the decision was not based on safety concerns.
The announcement comes less than two months after Lilly said it would stop one of three Phase 3 rheumatoid arthritis registration studies of tabalumab due to insufficient efficacy.
The Indianapolis, Indiana-based company said it expects the decision to result in a first-quarter charge to research and development expense of about $50 million. However, the company's previously issued financial guidance for 2013 remains unchanged.
Lilly said that the tabalumab Phase 3 program for systemic lupus erythematosus, ILLUMINATE, is ongoing and will continue as planned.
Eiry Roberts, vice president of autoimmune product development at Lilly said, "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. Autoimmune disorders are highly individualized."
Roberts added that targeting BAFF with a molecule such as tabalumab may be an important advance for patients, and hence it will continue the ongoing Phase 3 tabalumab lupus program.
Lilly decided to discontinue development of tabalumab in the current rheumatoid arthritis program, based on the outcomes of two separate interim futility analyses. The company said that all ongoing Phase 2 and Phase 3 rheumatoid arthritis studies will be stopped.
In December 2012, Lilly said it would stop one of three Phase 3 rheumatoid arthritis registration studies of tabalumab due to insufficient efficacy.
The decision followed a planned interim futility analysis of the FLEX-M study investigating tabalumab for the treatment of patients with moderate-to-severe rheumatoid arthritis who had an inadequate response to methotrexate therapy.
Based on FLEX-M findings, Lilly conducted an interim futility analysis of the FLEX-V study, which was investigating tabalumab for the treatment of patients with moderate-to-severe rheumatoid arthritis who had an inadequate response to one or more tumor necrosis factor inhibitors.
Tabalumab is one of three potential new medicines in late-stage clinical development by Lilly for a variety of autoimmune conditions. The other drugs are ixekizumab, an anti-IL-17 monoclonal antibody, for psoriasis and psoriatic arthritis; and baricitinib, a JAK1 and JAK2 inhibitor being developed in collaboration with Incyte Corp. (INCY), for rheumatoid arthritis, psoriasis and diabetic nephropathy.
In late January, Lilly reported a 4 percent decline in profit for the fourth quarter compared to the year-ago period, reflecting lower revenues amid the continued impact of schizophrenia drug Zyprexa's patent exclusivity loss. The company will lose patent protection for Humalog in May and the antidepressant Cymbalta in December 2013.
In Thursday's regular session, LLY is trading at $53.82, down $0.11 or 0.21 percent on a volume of 76,856 shares.
by RTT Staff Writer
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