Eli Lilly ($LLY) has added to a growing list of late-stage failures in recent years. The Indianapolis-based drug giant has slammed the brakes on development of enzastaurin, which failed to meet the main goal for boosting disease-free survival in a Phase III study of patients with diffuse large B-cell lymphoma.
Lilly's late-stage study tested the use of the experimental kinase inhibitor as a single-agent treatment for preventing relapse in patients with the immune system cancer who had previously been treated with chemotherapy and Roche's ($RHHBY) antibody drug Rituxan. Yet enzastaurin failed to provide enough of an improvement in disease-free survival compared with placebo. Now the company expects to take a $30 million charge in the second quarter related to the failure.
"We are disappointed in the results that we're announcing today," Dr. Richard Gaynor, Lilly's vice president, product development and medical affairs for oncology, stated. "However, our oncology pipeline is still one of the most robust across the industry, containing more than 20 molecules, including two Phase III molecules in 5 different tumor types."
Gaynor's late-stage oncology contenders include necitumumab, or LY3012211, for squamous non-small cell lung cancer and ramucirumab, which the company is investigating as a treatment for breast, colorectal and gastric cancers. Yet both those two programs have had troubles. In January, Bristol-Myers Squibb ($BMY) dumped its partnership with Lilly on necitumumab. And Lilly disappointed analysts in January with statistically significant gastric cancers survival data that fell below expectations.
Lilly's R&D shop has struggled to deliver new drugs. The group has suffered defeat in late-stage development of solanezumab in Alzheimer's, pomaglumetad for schizophrenia and tabalumab for rheumatoid arthritis. Along the way, Lilly has lagged behind its Big Pharma peers in measures of R&D productivity.
The list of clinical trial setbacks grows as the company adjusts to doing business without exclusivity for the schizophrenia med Zyprexa, which had been a key moneymaker for Lilly before generic versions arrived. And this week the company announced plans to cut 40% of its U.S. sales force as it faces the loss of patent exclusivity on its best-selling antidepressant Cymbalta in December.