Eli Lilly's ($LLY) tabalumab has flopped in another Phase III program, failing to score well enough to survive as a potential new treatment for lupus--a follow-up setback to its earlier failure in rheumatoid arthritis. Lilly now plans to bury the program in its crowded graveyard of late-stage drugs.
The pharma giant says it will take a $75 million R&D charge in the third quarter to reflect the setback to its pipeline.
Lilly ran two late-stage trials for tabalumab--ILLUMINATE I and II. The first failed to clear the bar set on the primary endpoint while the high dose in the second trial succeeded, according to Lilly. Investigators, though, concluded that the sum total of the data for the drug didn't measure up compared to existing therapies.
The actual numbers from the study will be released at a future scientific conference.
Back in early 2013 Lilly took a $50 million charge when it scrapped its Phase III program for tabalumab in rheumatoid arthritis. That failure had closely followed a series of clinical setbacks, including the late-stage flop for solanezumab in Alzheimer's. But like the solanezumab program, which was put back into a new Phase III in an earlier-stage population, Lilly wasn't willing to give up on tabalumab. Up until this year, with recent approvals for the promising GLP-1 drug dulaglutide (Trulicity) in diabetes and the cancer drug ramucirumab (Cyramza), Lilly went for a long, barren stretch on the regulatory front as its leading drug franchises lost patent protection and were clobbered by cheaper generics.
The pharma giant now has 7 drugs in Phase III, including ixekizumab, which has performed well in Phase III for psoriasis but faces a crowded field of contenders. That drug is slated to go to the FDA next year. Another rheumatoid arthritis drug, baricitinib, is in late-stage studies along with its new Phase III for solanezumab. At ASCO last summer Lilly posted positive but weak results from a Phase III study of necitumumab for first-line squamous lung cancer, reminding many analysts why they discounted this drug to begin with. Then there's a high-risk, high-reward shot at the cardio market with evacetrapib. Lilly signed a $1.8 billion partnership with Pfizer on the pain drug tanezumab, which they're trying to get down from the shelf after it was sidelined by safety fears,
Lilly failed to deliver on a promised pair of approvals in 2013. But it followed up with a vow to deliver "several" new approvals each year for several years, starting in 2014.
Mark Schoenebaum at ISI noted quickly Thursday morning that analysts were not expecting a failure, but didn't have high regards for tabalumab's earning potential.
"Generally," he wrote, "investors expected this drug to work--but COMMERCIAL expectations were quite low with consensus modeling about $250-$300MM in out-year sales. As a benchmark, Benlysta (HGSI's Lupus drug, now GSK's) is doing under $200MM right now WW, with consensus modeling in about $550-$600MM in the out years."
Lilly's shares were left largely unmolested in morning trading, dropping 20 cents on the news.
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| Dr. J. Anthony Ware |
"Although we were pleased that tabalumab met the criteria for statistically significant improvement in the SRI-5 endpoint in one of our trials, we are nonetheless disappointed that the overall results did not meaningfully improve the condition of the patients in these studies," said Dr. J. Anthony Ware, SVP of product development at Lilly Bio-Medicines, in a release. "The ILLUMINATE trials are the largest Phase 3 clinical studies in lupus to date, and we are hopeful that our contribution of the extensive data from these studies will advance knowledge to enhance treatment in this devastating illness. Lilly remains committed to developing potential new medicines for the treatment of autoimmune conditions, including lupus."
- here's the release