Korean health officials have tied the deaths of three patients to a cancer drug launched by Hanmi Pharmaceuticals and partnered with Boehringer Ingelheim, according to a followup story in The Korea Herald.
Citing a report from the country’s Ministry of Food and Drug Safety, which was released by Rep. Kwon Mi-hyuk today, the three were a 75-year-old patient who died in late 2015, a 57-year-old who died in March and a 54-year-old who died in June.
Altogether eight patients died in the study, according to the Herald’s reporting of the ministry review, with 29 “serious adverse events and adverse drug reactions,” though health officials have not confirmed a link with the drug in every case.
Late Friday, Boehringer issued a tardy response to Endpoints News.
“Boehringer Ingelheim informed regulatory authorities, including the FDA, about relevant safety data related to olmutinib, including side effects such as severe skin reactions mentioned in the drug safety letter,” the company said in a statement. “At the same time Boehringer Ingelheim informed all investigators. We also made sure patients received timely communications and updated their consents regarding these findings. We are not aware of any additional official report or communication issued by the South Korean Authority.”
Boehringer Ingelheim abruptly washed its hand of the drug just days ago without initially raising any issues with deaths or adverse events. Queried by Endpoints News, a spokesperson for the company provided a statement saying that Korean officials had issued a letter referring to “two cases of toxic epidermal necrolysis, one of them fatal, and one case of Stevens-Johnson-Syndrome (non-fatal).”
The appropriate regulators, the company added, had been informed of “relevant safety data related to olmutinib, including side effects such as severe skin reactions.” Boehringer noted that the two cases of toxic epidermal necrolysis occurred in two studies: HM-EMSI-101 and HM-EMSI-202. The 101 study is listed on clinicaltrials.gov as sponsored by Hanmi with Boehringer cited as a collaborator.
Not long ago, though, Boehringer — which has paid Hanmi $65 million of a $730 million deal — had been eager to see if it could quickly put the drug through a mid-stage study and then seek a fast approval.
Back in May, two months after the second patient death reported by Korean officials, Boehringer put out a release touting the Korean approval of the drug, stating:
Olmutinib (BI 1482694 / HM61713) is a novel third-generation, oral, EGFR mutation-specific TKI. It is currently in accelerated development through the ambitious ELUXA clinical trial programme with the aim to submit data and evidence to the US FDA and EU EMA in 2016. The pivotal Phase II trial ELUXA 1 (HM-EMSI-202 (NCT02485652) is ongoing, enrolling EGFR T790M mutation-positive lung cancer patients who have become resistant to previous TKI treatment.
“This first approval of olmutinib is an exciting milestone for the compound and we are working diligently to make this novel treatment option globally available to patients and physicians as quickly as possible,” said Boehringer oncology chief Jörg Barth, in a statement.
Hanmi, meanwhile, is now under investigation to see if there was any insider trading of company stock around the report on adverse events, which came out just hours after the company completed a tie-up with Genentech. In the meantime, Korean officials have reportedly decided to keep the drug on the market under the conditional approval that was handed out earlier in the year. Even though there was one reported patient death at the time, they said, they had no direct link to the drug. Patients would have to be informed of the risks, they said, before they were given the drug.
Looking to make a big move into branded drugs, Hanmi has been racking up a series of partnerships with marquee drug developers. Just yesterday Genentech signed on to partner on an early-stage cancer drug. Last fall, Sanofi paid €400 million upfront to partner with Hanmi on a portfolio of diabetes drugs. Before that, there was a pact with Eli Lilly worth up to $690 million on an autoimmune drug for a variety of diseases. And J&J has also partnered with Hanmi, which has been beefing up its R&D arm in a concerted effort to build a portfolio of branded therapies.
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