Hanmi Pharmaceutical is expected to discontinue developing lung cancer treatment Olita (ingredient: olmutinib) amid canceled licensing deals with drugmakers overseas, the government said Friday.
The Ministry of Food and Drug Safety said the Korean pharmaceutical firm submitted a plan to end the development of Olita 200mg and 400 mg.
Hanmi had to drop the drug due to cancellations of licensing deals with foreign drugmakers and difficulty in carrying out further clinical trials in competition with rival drug Tagrisso, which has the same efficacy.
To protect patients who are taking Olita, the ministry will review Hanmi’s plan to protect patients, appropriateness of procedures to implement safety measures, and cases of side effects after the drug sales by the end of April.
The government’s review will mainly focus on safety plans for patients participating in clinical trials, those in Olita treatment, and patients who will switch to other medication.
“We will thoroughly review the plan, putting patients’ safety first and foremost,” the ministry said in a statement. “We will also do our utmost to make sure that patients who are taking the medication will not face any difficulty in their treatment,”
Hanmi Pharm said Boehringer Ingelheim’s return of development rights caused a delay in global development of Olita. Also, China’s biotech firm Zai Lab also notified Hanmi recently that it would end the deal over olmutinib development, making a phase-3 clinical trial more uncertain.
Olita’s rival Tagrisso is already being sold (by AstraZeneca) in more than 40 countries around the world and Tagrisso’s winning of health insurance benefit late last year made it more challenging for Hanmi to go ahead with a phase-3 study, Hanmi added.
Even if Hanmi had finished developing Olita, it would have lost the value as an innovative drug, observers said.
Despite the termination of Olita development, Hanmi said it would still supply Olita for patients who have been taking it and people who were participating in clinical trials.
“We made such decision because it was certain that the value as a novel drug would decline significantly, relative to R&D costs in the future. It is very regretful,” an official at Hanmi Pharm said. “We decided to concentrate on more than 20 other new drug candidates currently under development.”
Olita had drawn much attention as the first targeted therapy developed by a domestic firm.
On May 13, 2016, Olita obtained an indication for patients who were resistant to EGFR (Epidermal Growth Factor Receptor)-TKI (Tyrosine kinase inhibitor), one of the conventional targeted therapies for lung cancer.
The treatment was able to win fast-track approval based on phase-2 clinical trials results, on the condition that Hanmi conducts a phase-3 study after the sales, as the authorities aimed to give broader treatment options to lung cancer patients who could not be treated with existing drugs.
The regulatory agency gives a conditional approval by reviewing phase-2 clinical trials data, on the condition that the drugmaker submits phase-3 trials materials, usage data, and safety use measures to the regulator later. The U.S., Europe, and Japan have a similar system.
The fast-track review and approval shortened Olita development by two years. In 2015, the U.S. Food and Drug Administration designated the medicine as innovative treatment, which was the first among local-developed novel drugs.
Anticipations for Olita’s global success peaked when Hanmi inked a series of licensing deals with Boehringer Ingelheim and Zai Lab.
However, the drug development hit a snag as three serious adverse reactions on skin occurred, and two patients died during trials.
Later, Hanmi was found to have belatedly reported fatal side effects during trials. The drugmaker also suffered a controversy after its employees engaged in illegal stock trading using insider information about the termination of the deal with Boehringer Ingelheim.
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