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[Opinion] FACTIVE Gains FDA Approval

Posted April. 04, 2003 22:25,   


Three scientists established a venture firm called `Amgen` in California, U.S. in 1980. The company put its resources into serious research work for a decade. In 1989 it successfully introduced `Epogen,’ an anemia treatment, and `Neupogen,’ a supplement for cancer patients. With the two new drugs, the company became the world’s No. 1 biotech firm. It bought the third largest biotech firm eMunex for $11 billion won last year and now generates some $1 billion won in net profit every year. Amgen’s success underscores the economic potential of new drugs.

According to the U.S. pharmaceutical industry association, it takes about 10 years and $800 million to develop a new drug. It is so costly that leading multinationals form partnerships for co-development or buy out firms conducting research on a new drug. Even after development, they have to go through animal and clinical tests. After the lengthy process, only one out of 5,000 to 10,000 drugs is approved for sale. Once they make it, however, they reap staggering profits. It is said that a single new drug generates a $5 billion market, which is why new drugs are called flowers of high value-added businesses.

It has been a century since the pharmaceutical industry first took shape in Korea. But it was only in 1987 that efforts to develop new drugs began in earnest. The nation’s first new drug was `Sun Flaju,’ a cancer drug developed by SK Chemical in 1999.

Replacing imported drugs that cost 500,000 a pill, the company saved 8 billion won. Then the development efforts were accelerated and there have been 8 new drugs from the company. This poses a problem as they are only sold within the country. Domestic pharmaceutical companies, relatively small in size, cannot afford to bear the staggering cost of clinical testing and application procedures.

`Factive,’ a fourth-generation Quinolone antibiotic developed by LG Bioengineering, will soon be approved by the U.S. Food and Drug Administration. It is welcoming that this country now finally has a new world-class drug. So far only 9 countries have been able to list their drugs with the FDA and Korea will be the 10th. Once FDA approves sales, LG is expected to post some 500 billion won in sales and 80 billion won in net profit every year. Development of the drug began in 1990 and the head researcher died of cancer during the process. But, after 12 years of hard work, the team is now set to mark a turning point in the history of the domestic pharmaceutical industry.

Kim Sang-young, Editorial Writer, youngkim@donga.com