Daewoong cleared to sell Nuceiva in Europe

Daewoong Pharmaceutical has won approval to sell its botulism toxin in Europe, a major win for the company that has been trying to increase its presence in the global drug market.

The Korean pharmaceutical company announced in a statement Wednesday that its partner company Evolus won approval from the European Commission on Tuesday to start selling Nuceiva in 28 European Union member countries and three European Economic Areas.

Evolus, which has the authority to distribute and sell Nuceiva in North America and Europe, is expected to start supplying the botulism toxin in Europe next year. Nuceiva is also known as Nabota in Korea and Jeuveau in the United States.

Nabota was first introduced in Korea in 2014 as a treatment for wrinkles and arm paralysis by weakening or paralyzing muscles or blocking nerves.

The drug has already hit the U.S. market after Daewoong Pharmaceutical won sales approval for a Korean botulism toxin from the U.S. Food and Drug Administration for Nabota in February. Nabota is also awaiting an official launch in Canada after the manufacturer received sales approval from the country’s health authority in August 2018.

The latest approval is expected to help Daewoong Pharmaceutical gain a competitive edge in the European botulism toxin market, which combined with the United States, accounts for around 70 percent of the global market.

“Gaining approval from Europe after winning it in the United States shows the outstanding quality, safety and efficacy of Nabota across the world,” said Park Sung-soo, head of Daewoong’s Nabota business division, in a statement.

“By launching the product in the United States and Europe, the two largest botulism toxin markets in the world, we will actively advertise Nabota’s efficacy and help raise the value of Korean pharmaceutical companies.”

At the moment, Daewoong Pharmaceutical is engaged in a dispute with Medytox at the U.S. International Trade Commission (ITC) after the latter company accused Daewoong of stealing its strain in making Nabota. Daewoong claimed earlier this month that the ITC confirmed through tests that its botulism toxin strain is different from that of Medytox.

BY KO JUN-TAE [ko.juntae@joongang.co.kr]