Drug Development

Deaths, accusations of insider trading and an early warning from Boehringer stir Hanmi controversy

Controversy over a lethal cancer drug developed by Hanmi and Boehringer Ingelheim continues to bubble up in Korea.

In recent days a member of the opposition Minjoo party — Rep. Jung Choun-sook — circulated a letter from Boehringer Ingelheim dating back to August 23rd stating that they were halting enrollment and studies of olmutinib at the recommendation of the Data Monitoring Committee, according to a report in the Korea Herald. And he accused the country’s food and drug safety ministry of allowing trials to continue even after the dangers became apparent.

That was more than a month before Boehringer announced that it was washing its hands of their partnership with Hanmi — though the German company only later acknowledged that Korean officials had cited at least one death and two severe adverse events in studies of the drug. Another report cited by the opposition said three patients had died.

As Boehringer earlier acknowledged to me, there were “two cases of toxic epidermal necrolysis, one of them fatal, and one case of Stevens-Johnson-Syndrome in which the patient subsequently died due to disease progression and pneumonia.”

The drug was approved in Korea on May 17 — an occasion that Boehringer trumpeted with considerable fanfare as it promoted its own plans for a rapid development effort — and is still on the market.

Boehringer’s announcement that it was pulling out of the deal came on September 30. But Hanmi is under investigation for delaying the news to accommodate insider trading. The National Pension Service, which took a hit when Hanmi stock plunged after the news hit, is threatening to take action if the rumors of insider trading are confirmed. Some reports from Korea say that word of the setback was spread by a mobile messenger service ahead of the formal announcement.

Rep. Kim Myung-yeon of the Saenuri Party told the Korea Times that six funds sold Hanmi shares from 9 am to 9:13 am. The news broke at 9:28 am on September 30.

At that point, the ink had barely dried on a new pact that Genentech signed with Hanmi to partner on HM95573, a pan-RAF inhibitor now in Phase I. The big Roche subsidiary struck their deal on September 28, paying $80 million upfront to partner on the drug, the latest in a long lineup of marquee partners who have signed with Hanmi as the Korean company mounted a big effort to develop branded therapies. And a company spokesperson at Genentech said that they’re sticking with the deal.

“Our decision to collaborate with Hanmi was based on a rigorous review of the scientific data and our belief in the potential of the investigational medicine HM95573,” Genentech said in an email to me. “Genentech became aware of the recent news regarding the Hanmi/BI collaboration (olmutinib EGFR inhibitor), as well as allegations of insider trading when they were reported in the news in the past week. While the allegations against Hanmi are serious, they have nothing to do with our agreement.”

Boehringer didn’t answer queries about the document concerning the Data Monitoring Committee or when it first became aware of the adverse events reported in the studies. Neither did Pasi A. Jänne, a prominent researcher at Dana-Farber who’s listed on clinicaltrials.gov as one of the primary investigators on one of the studies for olmutinib.


Get Endpoints News in your inbox

Newsletters for those who discover, develop, and market drugs. Enjoy the news with the story intact — entire articles in your inbox, no clicks required. Join 12,000+ biopharma pros who read Endpoints News every day. Free subscription.

Subscribe

Subscribe to Endpoints

John Carroll, Editor and Co-Founder

We produce two daily newsletters designed to give you a complete picture of what's important in biopharma.

Early Edition is a skimmable digest of original sources you need to see by ~7:15a ET, and our Main Edition is the daily chronicle of biotech, with every story inside the email ~11:55a ET.
2x/weekdays. Privacy policy