Just weeks after throwing in the towel on one of three late-stage studies of the rheumatoid arthritis drug tabalumab, Eli Lilly ($LLY) has opted to dump the remaining two studies and scrap the whole RA program after concluding that the drug's efficacy failed to measure up to expectations. Lilly wrote off $50 million on the decision, yet another Phase III setback for a company that has suffered a string of late-stage setbacks over the past year.
Lilly, never quick to completely abandon any late-stage product, says it will go ahead with a Phase III trial of tabalumab for lupus, convinced that its BAFF-targeting approach continues to hold significant promise. But the Phase III failure marks another disappointing end for one of Lilly's 13 late-stage assets. Lilly's most spectacular failure in recent months was solanezumab, its Alzheimer's candidate which is being steered back into another Phase III after failing to demonstrate significant efficacy in mild to moderate patients. The company is staring down one of the biggest patent cliffs in the industry, with Cymbalta about to follow Zyprexa off the patent ledge.
"While we are obviously disappointed by these results in rheumatoid arthritis, we continue to believe that tabalumab could have significant potential for patients in other disease areas," said Eiry Roberts, M.D., vice president of autoimmune product development at Lilly. "Autoimmune disorders are highly individualized. We believe that targeting BAFF with a molecule such as tabalumab may still represent an important advance for patients, and therefore we will continue the ongoing Phase III tabalumab lupus program."
Lilly R&D, though, likes to insist that it's fundamentally right, despite maintaining one of the least effective development efforts in recent years among the Big Pharma group. It quietly put out the word recently that Bristol-Myers Squibb ($BMY) had backed out of a long-standing partnership for necitumumab. And Boehringer Ingelheim also recently bowed out of a pact for one of four diabetes drugs in the pipeline, signaling some additional trouble for a crucial late-stage effort on its part.
The clinical stage pratfall for tabalumab is good news for AbbVie ($ABBV), which leans heavily on its Humira franchise to sustain the company. And it's good news for Pfizer ($PFE), which is rolling out the newly approved Xeljanz.
Lilly executives have promised to produce two new approvals a year beginning in 2013. The clock is ticking.
- here's the press release
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