EMA: Intercell can market Ixiaro in EU
The road hasn't been smooth as of late for Australian vaccine maker Intercell. In December, the company OK'd a plan to be acquired by France's Vivalis in a deal that values the biotech at $174 million. And Intercell's only approved product, Japanese encephalitis vaccine Ixiaro, has disappointed investors with weak sales.
Still, the European Medicines Agency and the European Commission gave the company renewed hope by granting it marketing authorization of Ixiaro in 27 EU member countries and Norway, Liechtenstein and Iceland. The shot has been licensed in 30 countries, including India, where it hit the market as Jeev in September in partnership with Biological E.
"We are delighted that our JE vaccine has been granted pediatric licensure in Europe, which will now enable travelers of all ages to obtain protection against this disease with a licensed vaccine," said Intercell CEO Thomas Lingelbach. "The approval of Ixiaro for children is based on additional clinical studies that have once more confirmed the favorable safety and immunogenicity."
Japanese encephalitis is most prevalent in Southeast Asia and the Far East, where tens of thousands of cases are reported annually. The disease can cause inflammation of the brain, headache, high fever, disorientation, coma, tremors and convulsions. About 1 in 4 cases are fatal.
Intercell and Vivalis will form Valneva when they merge, and plan to appear on the NYSE Euronext Paris and the Vienna Stock Exchange. The merger is expected to close in May.
- read the Intercell release
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