Bavarian Nordic to file Imvamune NDS in Canada

Published: 30-Nov-2009
Regulatory

Bavarian Nordic will file a New Drug Submission (NDS) for its third-generation smallpox vaccine, Imvamune, with Health Canada in 2010. If successful, this would be the first marketing approval of the drug.


Bavarian Nordic will file a New Drug Submission (NDS) for its third-generation smallpox vaccine, Imvamune, with Health Canada in 2010. If successful, this would be the first marketing approval of the drug.

In 2008, Bavarian Nordic was awarded a contract by the Canadian Government for the acquisition of 20,000 doses of Imvamune, which were recently delivered and accepted under a Canadian Special Access Programme.

Under the contract, the Canadian Authorities will provide Bavarian Nordic with milestone-based funding for the filing of the NDS for Imvamune in Canada.

The drug has so far been shown to be safe and well tolerated in more than 2,700 people in 12 ongoing or completed clinical trials. This includes approximately 1,000 people currently contraindicated for licensed smallpox vaccines, namely HIV-infected or people diagnosed with Atopic Dermatitis.

The Biomedical Advanced Research and Development Authority (BARDA) in the US recently awarded Bavarian Nordic a US$40m contract to develop a freeze-dried version of Imvamune.

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