US pharmaceutical company Janssen is slated to begin carrying out new clinical trials in the US for a diabetes drug candidate developed by South Korea’s Hanmi Pharmaceutical by the end of this year, Hanmi said Friday.
Janssen, the drug developer of Johnson & Johnson, has submitted a new application for carrying out a new set of phase 1 clinical trials for the Hanmi-developed drug candidate, JNJ-64565111, to the US Food and Drug Administration, according to Hanmi.
The move comes after Janssen suddenly suspended in November recruitment for the first-stage trials of the drug that had been ongoing, raising investors’ concerns that there may be inherent problems with Hanmi’s drug candidate as well as Hanmi’s partnership with Janssen.
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(Janssen) |
At the time, the event led Hanmi Pharmaceutical shares to plunge by more than 10 percent, despite J&J’s assurance that the suspension was linked to “manufacturing-related issues” and that its partnership with Hanmi “remained strong.”
According to Hanmi, Janssen has posted on the US National Institutes of Health’s ClinicalTrials.gov that it has recently “terminated” last year’s phase 1 trials for JNJ-64565111, as it prepares to start the brand new trials.
Compared to the former trials, the new upcoming clinical study will adopt slightly different standards in terms of patient demographic, drug injection dosages and trial locations, according to Hanmi spokesperson Han Seung-woo.
“Based on the compiled research and data accumulated from initial phase 1 clinical data, Janssen is seeking to initiate its clinical trials to expand the drug’s usage across more indications (the use of the drug for treating a particular disease),” Han said.
Moreover, the production issues cited by Janssen have been resolved, and thus the new clinical trials are expected to begin without problems by the year’s end, according to Hanmi Pharmaceutical.
JNJ-64565111, also known as HM12525A, is a biologic drug for the treatment of diabetes, originally developed by Hanmi. It was licensed out by Hanmi to Janssen in November 2015 in a $915 million deal.
Janssen had begun phase 1 clinical trials in the US from July, testing the drug’s efficacy in treating patients with Type 2 diabetes mellitus. The firm suspended the trials in November, citing manufacturing issues.
By Sohn Ji-young (
jys@heraldcorp.com)
