Phase 3 Clinical Trial of BTX
With its self-developed botulinum toxin (BTX) “Nabota,” Daewoong Pharmaceutical Co. is waking up from its long winter sleep. The company completed Phase 3 clinical trials of its BTX product in the U.S. at the end of last year for the first time in the domestic industry and recently filed the product for marketing approval by the U.S. Food and Drug Administration (FDA), accelerating the invasion of the world’s largest U.S. market.
According to investment banking industry sources on May 25, the stock price of Daewoong Pharmaceutical decreased to as low as 60,000 won (US$54) last year due to the overall stock price adjustment in the pharmaceutical industry and conflict over the originality of BTX strain, but it is rapidly rising this year. The company’s share price stood at 95,800 won (US$86) as of May 24, up 52.79 percent from 62,700 won (US$56) on December 8 last year. The figure is two times higher than 23.62 percent of the growth rate of the KOSPI Pharmaceutical Price Index over the same period.
As there have been visible signs of Nabota pushing into the U.S. market, the stock price of Daewoong Pharmaceutical is on the rise. Daewoong Pharmaceutical has less than 10 percent of share in the domestic BTX market, lagging behind its competitors such as Medytox and Hugel. However, the company is planning to jump up to be a global BTX supplier by putting Nobota on the world’s biggest BTX market.
The global BTX market was worth 4.5 trillion won (US$4.02 billion) as of the end of last year, and the U.S. accounted for half of the market. Considering the fact that the domestic market is worth 100 billion won (US$89.29 million), the domestic BTX industry landscape will change when Daewoong Pharmaceutical successfully pushes into the U.S. market. Daewoong Pharmaceutical became the first South Korean pharmaceutical company that completed Phase 3 clinical trials of Nabota in the U.S. at the end of last year and filed for approval by the U.S. FDA on May 16. The securities industry expects that Nabota will be able to receive a cGMP certification in the first half of next year and hit the U.S. market in the second half.
Jeon Sang-yong, an analyst at Taurus Investment & Securities, said, “There are only three companies in the U.S., France and Germany that have concluded Phase 3 clinical trials for BTX products and are licensed to sell the products around the world.”