Drug Development

J&J is forced to suspend recruitment in PhI diabetes study, raising questions about another Hanmi drug

J&J has run into a problem with a Phase I diabetes drug — JNJ-64565111 — in-licensed from South Korea’s Hanmi. The investigators on the study reported on clinicaltrials.gov that the trial has suspended patient recruitment, and a spokesperson for J&J tells me that the delay was due to “a manufacturing-related delay.”

“Our partnership with Hanmi remains strong regarding this drug candidate and we look forward to restarting the study,” she added.

Hanmi has been bedeviled by issues surrounding olmutinib. The cancer drug was partnered with Boehringer Ingelheim, which abruptly canceled the deal following some toxic patient reactions and several reported deaths.

At the time Hanmi and J&J struck their deal last fall, the companies had outlined plans to start Phase II this year. This was one of a string of deals that Hanmi has struck over the past year as it focused more of its efforts on developing novel drugs. The Boehringer controversy erupted soon after Hanmi announced a deal with Genentech, and raucous accusations of insider trading on the company stock followed.


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RAPS Regulatory Convergence 2017