Olmutinib

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.

October 10, 2016 By Alex Keown , BioSpace.com Breaking News Staff SEOUL, South Korea – Did employees from Hanmi Pharmaceuticals alert friends and family not to purchase stock in the company ahead of news of the company’s broken relationship with Boehringer Ingelheim becoming public information? Investigators at the Financial Service Commission in Korea have seized mobile phones and documents from an unknown number of employees on suspicion that the insider information was leaked through mobile messaging apps, Pulse News reported. According to the report, Kim Yong-beom , a senior official with the Korean government agency, said a team of investigators conducted an inspection of the Hanmi offices last week and “secured documents and mobile phones of related officials after interrogation.” According to the report, messages were sent out telling unnamed people not to buy Hanmi stocks because bad news was going to be made public on the next day. The report did not indicate how many employees could be involved with the sharing of undisclosed information, nor what level of employee was involved, such as a senior executive. Pulse reported there was a “sudden spike” in Hanmi shares sold right before Boehringer Ingelheim announced it was severing its development deal with Hanmi for olmutinib, a third-generation EGFR targeted therapy for lung cancer patients. Following the Sept. 30 announcement that Boehringer was breaking off its agreement, which included global commercialization rights, shares of Hanmi plunged more than 18 percent. Boehringer and Hanmi entered into an agreement in June 2015 that was worth about $730 million. However, in September the company said it did not believe olmutinib would be a competitive drug in the lung cancer market. However, Pharma Live reported that Boehringer terminated the licensing deal following the death of two patients who developed “serious skin reactions.” Following the deaths the company cut back on the dosage amount to reduce toxicity risks, but Pulse said that caused the drug’s efficacy to drop as well. Hanmi had already received about $65 million from Boehringer, which it will not have to repay. While Boehringer dropped olmutinib, the company said it has “has successfully launched two products for the treatment of non-small cell lung cancer (NSCLC), which have been widely adopted and established as important additions to current clinical practice.” Additionally, the company said it continues to increase its R&D investments, with about one-third of its experimental oncology treatments scheduled to enter the clinic within the next year. Boehringer returned the lung cancer drug one day after Hanmi licensed another cancer drug , a pan-RAF inhibitor, to Genentech in a deal worth up to $910 million. 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.