Drug Development

Following lethal tox report, Boehringer scraps plans for high-speed development, kills $730M Hanmi deal

Boehringer-Ingelheim decided to abruptly wash its hands of a $730 million cancer drug collaboration with Hanmi after a South Korean ministry linked the therapy to several cases of severe toxicity — one of which left a patient dead. Boehringer confirmed the report in a reply to Endpoints News early Friday afternoon, saying Korean officials had tracked three cases of toxic epidermal necrolysis, which can spur hemorrhaging and respiratory failure.

Korean officials approved olmutinib (HM61713)  — an oral, EGFR mutation-specific TKI — in May after a rapid Phase I/II program. And Boehringer used the Korean approval to tout its own plans to hustle along an FDA and EMA application later this year after completing a Phase II trial. The FDA followed up with a breakthrough drug designation designed to speed development efforts.

“The South Korean Authority issued a drug safety letter today, available here (in Korean),” a Boehringer spokesperson said in an email. “The letter refers to two cases of toxic epidermal necrolysis, one of them fatal, and one case of Stevens-Johnson-Syndrome (non-fatal). Patient safety is our highest priority. We previously informed regulatory authorities, including the FDA, about relevant safety data related to olmutinib, including side effects such as severe skin reactions. For studies for which Boehringer Ingelheim is responsible all investigators received timely communications regarding these findings and were instructed to inform their patients accordingly. A comprehensive re-evaluation of all available clinical data and recent advances in the treatment of EGFR mutation-positive lung cancer contributed to the decision to return the commercial rights of olmutinib to Hanmi.”

In a followup, 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.

Boehringer enrolled treatment-resistant EGFR T790M mutation-positive lung cancer patients in its study. But it didn’t mention any of the safety issues in its statement today, saying only that it decided to exit the deal after a “re-evaluation of all available clinical data on olmutinib and recent treatment advances made in the treatment of EGFR mutation-positive lung cancer.”

Hanmi said it was keeping the $65 million in cash it had received so far.

Quoting the health ministry, The Korea Herald reported that two patients died (Boehringer says that the story is incorrect) after experiencing serious adverse skin events in the Boehringer study. Then they cited a local oncology professor who said that the trials were terminated after investigators tried reducing the dosage, but found that the efficacy had diminished substantially. While some of the details of their story are being disputed by a Boehringer representative, who insisted repeatedly on having them removed from this article, the Herald also posted their piece on the safety problems well before the company issued a statement to us clarifying what had happened with the drug, offering information that was clearly missing from Boehringer’s original release.

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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