Drug Development, Setbacks

Eli Lilly silently walks away from a troubled $690M alliance after BTK drug flounders in PhII

Eli Lilly has unceremoniously swept away a mid-stage immunology program for their BTK inhibitor LY3337641, shrugging off a $690 million pact for the immunology drug — in-licensed from Korea’s Hanmi 3 years ago.

Lilly noted the passing in a footnote on the roster of drugs pulled from the pipeline in Q4. 

Korean news organizations reported a few days ago that Hanmi disclosed the move in a regulatory filing, noting that Eli Lilly had returned the drug after concluding interim data underscored a lack of efficacy in a hotly competitive field. The move comes a year after researchers acknowledged that the drug had failed a Phase II for rheumatoid arthritis, but researchers had considered this drug had potential in a variety of diseases.

Lilly handed over $53 million in cash to get the deal in 2015.

Also purged in the quarterly cleanup: The Phase II diabetes drug DACRA-042 and a Phase I drug Urocortin-2 PEPT for heart failure.

Lilly has had a rough start to the year. Today the pharma giant was forced to cut its forecast on profits and revenue for 2019 after Lartruvo failed its confirmatory Phase III, forcing them to shave promotions. The focus now is on their $8 billion Loxo buyout, announced at JP Morgan in early January.

Hanmi has struck a wide-ranging series of collaborations in recent years, including one with Genentech, but this is by no means their only setback. Boehringer Ingelheim backed away from Olita (olmutinib) after that partnered drug — which they once heralded as a major advance — was linked with patient deaths in a clinical trial. Hanmi later dropped its development work on the drug, which had been approved in Korea.

Hanmi hasn’t given up on the BTK drug, though, saying it is exploring its potential.


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Sr. Manager, Regulatory Affairs, CMC
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