April 18, 2017
By Alex Keown, BioSpace.com Breaking News Staff
SEOUL – South Korea-based Hanmi Pharmaceuticals failed to report in a timely manner a patient death that occurred during clinical trials of tis lung cancer drug olmutinib—the same drug that Boehringer Ingelheim walked away from last year.
This morning The Korea Herald reported that Hanmi had violated two medical laws regarding the monitoring and reporting of its clinical trials. The Board of Audit and Inspection of Korea began its investigation following allegations aimed by Korea lawmakers against Hanmi that it failed to announce the clinical trial death in order to gain regulatory approval of the drug last year. It was that death, along with two other deaths that caused Boehringer Ingelheim to walk away from the $730 million developmental deal with Hanmi.
According to reports, one of the patients in the trial treated with Hanmi’s lung cancer drug displayed symptoms of Stevens-Johnson syndrome, a life-threatening skin-condition. The patient’s condition was not reported to the monitoring agency until his death more than a month later–a violation of Korea’s 24-hour reporting rule for severe incidents, the Herald said. But, to make matters worse, Hanmi and the monitoring agency did not report the death to health regulators for another 14 months.
Hanmi issued a statement in an attempt to explain the delayed reporting, saying the company had some shortcomings in reporting protocols. The company also said the patient had been taking two additional cancer medications, bromhexine and tiocr, which have side effects of Stevens-Johnson syndrome. Hanmi said medical staff believe those two drugs were the cause of the death and not olmutinib. Hanmi said the trial monitor classified the development of Stevens-Johnson as a “serious event” and not as a “serious unexpected serious adverse reaction,” which requires immediate reporting, the Herald said. In its statement, Hanmi said it became aware of the Stevens-Johnson-related death and its possible link to olmutinib during a data review one year later and then reported the death.
In October 2016, Boehringer Ingelheim walked away from its partnership with Hanmi. At the time, the company said it did not believe olmutinib would be a competitive drug in the lung cancer market. However, also at the time, Pharma Live reported that Boehringer terminated the licensing deal following the death of two patients who developed “serious skin reactions.” Dosage was cut back to reduce toxicity risks, but that also caused a drop in the efficacy of olmutinib, according to reports.
While Hanmi and Boehringer Ingelheim have severed their relationship, the South Korean company has a deal worth more than $900 million with Genentech to develop another cancer drug, a pan-RAF inhibitor. In addition to the deal with Genentech , Hanmi also has a deal with Johnson & Johnson ’s Janssen Pharmaceuticals to develop and commercialize oxyntomodulin-based drugs that improve metabolism, insulin secretion and suppress appetite.
Shares of Hanmi are trading at $28.60 this morning.
