April 24, 2024

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[THE INVESTOR] Korean drug makers are looking to roll out generic versions of Pfizer’s smoking cessation medication Champix to heat up the competition.

Champix has been dominating the market on the government’s anti-smoking initiative. Sales of Champix in Korea soared to 4.2 billion won (US$37.25 million) last year from 5 billion won in 2014. 

Now joining the race is Kolmar Korea, which was granted approval from the Ministry of Food and Drug Safety on Aug. 3 for its phase 1 clinical trials of KKM-164 using varenicline fumarate. According to a company official, Kolmar plans to sign a supply contract with other drug makers once it completes its development.

Other companies that have entered early-stage clinical programs for similar drugs include Hanmi Pharmaceutical, Jeil Pharmaceutical and KyungDong Pharm. These firms will be able to launch their versions after November 2018 at the earliest because of patent issues.

To delay the entry of generic drugs, Pfizer has extended the patent for the substance used to develop Champix to July 2020 from November 2018. But pharmaceutical companies have requested a trial to confirm whether their anti-smoking medication would infringe the substance patent after 2018.

“We will decide whether to launch in 2018 or 2020, depending on the verdict,” a Kolmar official said,

About 22.6 percent of Korea’s population aged 19 years or higher are smokers, according to the Korea Center for Disease Control and Prevention.

By Park Han-na (hnpark@heraldcorp.com)