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Hanmi terminates lung cancer drug after being muscled out by AZ's Tagrisso

Published on 13/04/18 at 10:01am

South Korea’s Hanmi Pharmaceutical has announced its intention to terminate development of its lung cancer drug Olita (olmutinib) as it admits that circumstances within the space have meant that continued R&D costs would “eclipse its value”.

“We found it difficult to find participants for our clinical studies because there is a medication that has already completed global phase 3 trials and is covered by insurance,” a spokesperson for the company said.

The drug in question is AstraZeneca’s Tagrisso, which has beaten Hanmi’s candidate to market and is already sold in 40 countries around the world.

“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,” the company stated. “We decided to concentrate on more than 20 other new drug candidates currently under development.”

The Ministry of Food and Drug Safety confirmed that Hanmi had submitted a plan to cease development of Olita 200mg and 400mg, which the organisation said that it will review in order to protect patients.

“We will thoroughly review the plan, putting patients’ safety first and foremost,” the ministry said. “We will also do our utmost to make sure that patients who are taking the medication will not face any difficulty in their treatment.”

Development of the drug had been plagued with setbacks: in September 2016, Boehringer Ingelheim relinquished its rights to the drug after striking a $370 million deal for them, followed by Chinese firm ZAI Lab who also handed back their rights the following March. The company had secured an indication for the drug in lung cancer patients who were resistant to Epidermal Growth Factor Receptor (EGFR)-Tyrosine kinase inhibitor (TKI) back in May 2016, and had also been granted fast-track approval based on Phase 2 results, on the condition it could supply further robust Phase 3 data.

Matt Fellows


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