Korean authorities say that Hanmi Pharmaceutical was too slow in revealing a side effect that later caused a fatality in the test of its lung cancer med olmutinib.
The South Korean company was found to have broken two medical laws, specifically regarding the monitoring and reporting of its clinical trials, by the Board of Audit and Inspection (BAI) of Korea.
This goes back to the summer of 2015, when a patient on EGFR inhibitor olmutinib (now Olita Tab and sold in South Korea) showed symptoms of the life-threatening skin condition Stevens-Johnson syndrome (SJS).
This happened in June, with the patient dying the next month. The person in charge of the test did not, however, immediately report the side effect to a monitoring agency, something it was mandated to do within 24 hours.
While the death was reported in July 2015, Hanmi and the agency didn't report the SJS symptoms to local health regulators until more than a year later, in September 2016. The story was reported this morning in the Korea Herald.
But while breaking two rules, the BAI said it did not find evidence that the company colluded in any way to try to cover up or delay reporting the side effect.
Hanmi Pharmaceutical said in a statement and quoted by the Herald that there were “shortcomings” in its reporting, but added that the patient with the SJS symptoms had also been taking bromhexine and tiocra, both of which have side effects including SJS.
It therefore believed the condition came from these meds and not its own. But Hanmi said it later “became aware” that the patient’s SJS had been linked to olmutinib, coming after it went through monitoring data for its trials a year after the event’s occurrence, and says it then “immediately reported its findings” to the Korean Ministry of Food and Drug Safety.
Last year, Boehringer said it would no longer be involved in the development of olmutinib (HM61713), on which it partnered in a $773 million deal in 2015, partially as a result of the trial problems.
It first emerged last year that there had been several cases of severe toxicity in trials of the drug, at least one of which proved fatal, with reports surfacing in October that three trial patients had died.