Bavarian Nordic will file for market approval for Imvamune in Canada

KVISTGARD, Denmark — Bavarian Nordic A/S announced Nov. 30 that it expects to file a new drug submission for its third-generation smallpox vaccine, Imvamune with Health Canada in the second half of 2010.

If successful, this would be the first marketing approval of Imvamune. That could happen in 2011.

Following the completion of the Phase II development for Imvamune, Bavarian Nordic met with Health Canada officials in October. Upon review of the manufacturing, clinical and animal data, Health Canada recommended that Bavarian Nordic submit an NDS application for consideration to license Imvamune as a smallpox vaccine for the general population.

"We are well on the way to achieve a significant milestone in the development of Imvamune, as we are about to get the first regulatory approval of the vaccine,” said Anders Hedegaard, president and CEO of Bavarian Nordic.

Bavarian Nordic says that so far, Imvamune has 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 contraindicated for licensed smallpox vaccines, namely HIV-infected or people diagnosed with atopic dermatitis.

Bavarian Nordic’s pipeline is focused on biodefense, cancer and infectious diseases, and includes seven development programs. In addition to Imvamune, Prostvac is ready for Phase III study. It is a therapeutic vaccine for advanced prostate cancer being developed under a collaboration agreement with the National Cancer Institute.