Daewoong Pharma stocks fluctuate upon Nabota’s FDA approval

By Lim Jeong-yeo
  • Published : Feb 7, 2019 - 15:30
  • Updated : Feb 7, 2019 - 17:45

Daewoong Pharma stocks fluctuated Thursday upon market opening following reports during the Lunar New Year holiday that its botulinum toxin drug Nabota has gained approval from the US Food and Drug Administration.

When the market opened at 9 a.m. its shares jumped 10,000 won ($9) to 203,000 won from 193,000 won during the previous session. It quickly fell back to the 190,000 won range, and the price continued to fluctuate through the day before finishing at 204,000 won at market close, up 5.7 percent from the previous trading day.

Nabota, called Jeuveau outside Korea, will be commercialized by Evolus in the US. The drug will hit shelves in the US in the second quarter, the firm said in a statement.

(Daewoong Pharmaceutical Co. LTD)

Daewoong’s drug is now the fourth on the list of FDA-approved BTX drugs after Allergan’s Botox, Ipsen’s Dysport and Merz’ Xeomin. It is the only alternative drug that has the same molecular structure of 900Kda as Allergan’s Botox and the first Korea-made BTX to enter the US.

A breakthrough for Daewoong continues to be challenged by its local rival. On Jan. 31, Korean firm Medytox and partner Allergan once again filed a suit against the firm and Evolus for the alleged theft of a bacterial strain critical to Daewoong’s Nabota development.

The firm claims that the suit is without merit.

“This is a typical strategy to stifle competition. It will neither affect the FDA approval nor our business in the US,” it said.

Daewoong has inked commercialization deals for Nabota in 80 countries. It expects to get approval from the European Medicines Agency in the first half of this year.

By Lim Jeong-yeo (