Hanmi Pharmaceutical will begin selling its next-generation targeted lung cancer therapy HM61713, in South Korea from next month under the name “Olita Tab.,” its vice president and chief medical officer said Friday.
The announcement comes a week after the Ministry of Food and Drug Safety approved the drug, also known as Olmutinib, for local sales, allowing it to debut on home turf. The drug’s pricing has yet to be determined.
“The approval of Olita Tab. is a great step forward for lung cancer patients around the world,” Hanmi Pharmaceutical vice president and CMO Son Ji-woong told reporters in Seoul at a press conference.
Hanmi Pharmaceutical vice president and chief medical officer Son Ji-woong speaks during a press conference held Friday in Seoul to mark the domestic sales approval of Olita Tab, a novel lung cancer treatment developed by Hanmi. (Hanmi Pharmaceutical)
“Given lung cancer is one of the most common types of cancers in the world, we expect our new drug to become a blockbuster treatment globally, set to bring in double-digit sales royalties from our partner Boehringer Ingelheim.”
Exclusively developed by Hanmi, HM61713 is a third-generation cancer-fighting drug for the treatment of lung cancer patients who have developed a tolerance to existing cancer-fighting drugs.
It was licensed out to German pharmaceutical giant Boehringer Ingelheim in a deal valued at $730 million in July 2015, setting a milestone for Hanmi and Korea’s pharmaceutical industry.
As of now, lung cancer is treated by inhibiting the growth of the epidermal growth factor receptor -- responsible for the growth of cancer cells. After prolonged use, many patients develop a tolerance to such drugs due to a mutation in a protein called T790M, leaving them with no other treatment options.
Hanmi’s new drug specifically targets this particular mutation of the T790 protein as well as EGFR, offering a new form of treatment to patients who have had to halt treatment as they no longer respond to existing EGFR-inhibitor drugs.
Due to its exclusive nature, HM61713 was designated as a “breakthrough therapy” by the U.S. Food and Drug Administration in December last year, which entails shortened clinical trials and fast-track approval procedures.
Son said he expects the U.S. FDA to approve the drug by next year, forecasting double-digit sales royalties upon the drug’s global commercialization.
Boehringer Ingelheim -- which exclusively holds the drug’s worldwide sales rights except in Korea, China and Hong Kong -- is currently carrying out phase-II clinical trials for Hanmi’s drug, with aims to submit the drug for approval to the U.S. FDA and the European Medicines Agency within this year.
Meanwhile, a similar lung cancer treatment developed by AstraZeneca, Tagrisso (AZD9291), was approved by the U.S. FDA in November 2015.
Tagrisso was also approved by the Korean Drug Ministry on Thursday, just days after the approval of Hanmi’s Olita Tab.
By Sohn Ji-young (jys@heraldcorp.com)