Adimmune, the nation’s only human vaccine manufacturer, said yesterday it would start clinical tests on its seasonal flu vaccines in the EU next month in a bid to obtain EU certification.
“The tests will kick off in mid-October. If all goes smoothly, the company should obtain the license approval from the EU in June 2011,” Adimmune vice president Simon Kao (高聖凱) said.
“After approval is granted, the company’s seasonal flu vaccines will be allowed to go on sale in all EU member countries. We look forward to being in the huge EU market,” Kao said.
Last month, Adimmune’s production facilities were certified by the European Medicines Agency, the EU’s pharmaceutical regulatory body. The certification means that the company’s production equipment meets EU requirements.
“This is part of our effort to develop sales overseas as demand for H1N1 vaccines in Taiwan is on the decline,” Kao said.
The government’s purchases of A(H1N1) vaccines from Adimmune accounted for about 80 percent of the company’s total revenue last year. The company is the sole A(H1N1) vaccine provider in Taiwan.
Apart from the EU market, Kao said his company is also targeting Malaysia, the Philippines and Hong Kong as potential markets for seasonal flu vaccine sales.
Kao added that his company is planning to unveil vaccines against avian flu in July next year and against the enterovirus in 2015.
Adimmune was listed on the GreTai Securities Market as an emerging stock yesterday. The company sees the move as a stepping stone to a future listing on Taiwan’s main stock exchange, which it hopes to achieve by the fourth quarter of next year.