Korean Developed `Factive` Gets Approval from FDA

We are on the verge of having a new drug developed by Korea and approved worldwide for the first time. Accordingly to sources from the pharmaceutical and securities industries, the Food and Drug Administration (FDA) in the U.S. will issue sales approval of a new quinolone class antibiotic, “Factive” April 4 that LG Life and Sciences sought approval for.

This would be the first international approval of a Korean developed new drug in about 100 years since Korea`s modern pharmaceutical industry started in 1897 with the establishment of Donghwa Pharm. The first new drug approved by the Korean government was Sunpla injection developed by SK Chemicals in 1999. After that, Donghwa Pharm.`s Milican injection, Daewoong Pharmaceutical`s EasyF and three other drugs got approval for domestic use.

Factive is a quinolone class antibiotic which is more effective and stronger to resistance than the existing drugs. It is known to be especially effective for respiratory diseases. LG Life and Sciences is expected to generate revenues worth 400 million dollars a year with the sales of this drug.

Analyst Kim Hee-sung at Hanyang Securities said, “The drug will get approval easily since it was passed on the FDA advisory panel on March 4.” He expected that the FDA would issue approval for all the symptoms that LG had applied.

LG requested approval to the FDA in 2000 via U.S. SmithKline Beecham, but the FDA held the request. After that, SmithKline Beecham merged with British Glaxo Wellcome and dropped out of the Factive project. So LG had to solely push ahead with the project.

Factive got sales approval in Korea and New Zealand last year and is applied for approval in Britain, Canada, Hungary and South Africa. An Official from LG Life and Sciences said, “If we get approval in the U.S. which is the biggest pharmaceutical market as well as the worst country to get approval, it is easy to get approval in other countries.”

Apart from LG`s Factive, osteoporosis drug by Green Cross Corp. and antidepressant by SK got approval for clinical trials and the trials are now underway. So we will see more new Korean drugs approved by foreign countries.

Manager Yeo Jae-chun at Korea Drug Research Association said, “Korea is showing outstanding ability to develop new drugs even though its development history only went back 20 years. Currently scores of new materials are under clinical trials.” He also added, “Development of new drugs is the core of the biotech industry, thus needs more governmental support.”

Yeon-Su Shin ysshin@donga.com