Eli Lilly $LLY has just shuttered a Phase II trial for an experimental Bruton’s TKI inhibitor for rheumatoid arthritis after concluding that the nearly two-year-old study was going down in flames.
Lilly hasn’t put out any word on the trial failure, but the pharma giant reeled in the drug from South Korea’s Hanmi Pharmaceutical in 2015 with a $690 million deal. Hanmi filed a note on the Phase II failure with the country’s financial regulators, according to local press reports — including the Korea Biomedical Review. Hanmi’s shares took a beating Monday morning as investors reacted to the news.
The trial was halted, said Hanmi’s filing, “because interim results showed that the study could fail to demonstrate its target effectiveness.” According to clinical trials.gov the 276-patient study was due to wrap in May.
Lilly paid $50 million upfront to grab ex-Asian rights to the drug — code named LY3337641 — from Hanmi three years ago. Researchers for the pharma company said at the time that they were planning a wide range of studies for rheumatoid arthritis, lupus, lupus nephritis, Sjögren’s syndrome and other related conditions.
Hanmi has partnered with a variety of big pharma operations around the world. And this isn’t their first big setback. In the fall of 2016 Boehringer quietly handed back rights to a cancer drug olmutinib, ending a deal which subsequently exploded in a controversy over some dangerous side effects that were seen in clinical trials — side effects that weren’t disclosed by either of the two companies until after a scandal erupted over insider trading of Hanmi’s stock just before the danger was reported.
Lilly, meanwhile, is angling for a likely near-term approval of baricitinib after the FDA — under new commissioner Scott Gottlieb — decided to reverse its decision to reject the RA drug and require a new late-stage study to resolve safety concerns and permit a new pitch now under review. That decision was never fully explained either.
Hanmi and Lilly are reportedly now discussing what to do next.
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