The olmutinib development program is finally dead.
South Korea’s Hanmi has determined that the drug — once partnered with Boehringer Ingelheim and Zai Lab — is no longer commercially viable. The drug was seen as more or less equivalent to AstraZeneca’s Tagrisso, according to Hanmi. So they’ve opted to punt the late-stage trial and shelve it once and for all.
“We will thoroughly review the plan, putting patients’ safety first and foremost,” Korea’s health ministry said in a statement, according to Korea Biomedical Review. “We will also do our utmost to make sure that patients who are taking the medication will not face any difficulty in their treatment.”
This is likely the final chapter for a drug that has repeatedly stirred controversy in Korea.
The tale goes back to July, 2015, when a patient in one of its olmutinib studies died from Stevens-Johnson disease. According to subsequent media reports out of Korea — not an easy place to obtain info on cases like this — Hanmi was cited for not reporting the death until 14 months later. According to Hanmi, they only found out about it in September, 2016 — four months after it was approved in South Korea.
The controversy was stirred by reports of heavy insider trading on Hanmi shares just before the news hit, and the opposition party leveled a variety of accusations against Hanmi, accusing the company of hiding adverse events — which reportedly also claimed another life — so that it could get the drug approved first under an accelerated action program.
Boehringer Ingelheim, which had signed a $730 million deal to partner on the drug, exited just ahead of the incident, without breathing a word of any safety issues in its initial statement. At the time, the company said the decision was spurred by a “re-evaluation of all available clinical data on olmutinib and recent treatment advances made in the treatment of EGFR mutation-positive lung cancer.” Boehringer later told me that they knew of “two cases of toxic epidermal necrolysis, one of them fatal, and one case of Stevens-Johnson-Syndrome (non-fatal).” Company media reps told me that they had done everything required in alerting the proper regulatory officials.
Zai Lab did a deal for rights in China, but bowed out at the beginning of this month.
The story raises some uncomfortable questions for the biopharma industry. Developers have repeatedly hidden deaths and other serious adverse events in their clinical trials from the public, satisfied that they’ve met the letter of the law in alerting shareholders, regulators and the trial sites where they work. As the development effort goes global, with a surge of hundreds of studies in Asia, the lines around public adverse event reporting generally allow private companies to remain mum — even though the information could be relevant to other researchers, patients and companies studying similar drugs. Hanmi, and more pointedly a big developer like the private Boehringer, offers a case book example of how that can blow up.
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