Bavarian Nordic will file for market approval for IMVAMUNE® in Canada

Kvistgård, Denmark, November 30, 2009 - Bavarian Nordic A/S (OMX: BAVA) announced today that the company expects to file a New Drug Submission (NDS) for its third-generation smallpox vaccine, IMVAMUNE® with the Canadian Authorities, Health Canada in 2010. If successful, this would be the first marketing approval of IMVAMUNE®.

Following the completion of the Phase II development for IMVAMUNE®, Bavarian Nordic held a meeting with Health Canada in October, 2009. Upon review of the current data package, which included the manufacturing, clinical and animal data, Health Canada recommended that Bavarian Nordic submit a NDS application for consideration to license IMVAMUNE® as a smallpox vaccine for the general population. 

The NDS is expected to be filed in the second half of 2010, possibly leading to the first license of IMVAMUNE® during 2011.

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, and this forms part of Bavarian Nordic's global licensure plans for IMVAMUNE®.

Anders Hedegaard, President & CEO of Bavarian Nordic said: "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. This is indeed recognition that IMVAMUNE® is superior to the current approved smallpox vaccines that are stockpiled in many countries. Our strategy to develop and obtain regulatory approval for IMVAMUNE® as a vaccine for the general population, including those who are contraindicated to the traditional vaccines, and without causing the same serious adverse events, is now finally about to succeed. Furthermore this is a recognition of our technology since it will represent the first approval of an MVA-BN® based product, leading to new opportunities for commercialising our technology."

IMVAMUNE® represents a safer smallpox vaccine Currently, 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 currently contraindicated for licensed smallpox vaccines, namely HIV-infected or people diagnosed with Atopic Dermatitis.  IMVAMUNE® has shown to be highly immunogenic in both healthy subjects and people with weakened immune systems and these immune responses have been shown to be comparable to those induced by traditional smallpox vaccines. IMVAMUNE® has also been shown to induce a post-exposure protection in immune suppressed animals, which succumbed to the vaccination with traditional smallpox vaccines.  Moreover, IMVAMUNE® was shown to induce a comparable efficacy as ACAM2000™, the licensed second-generation smallpox vaccine in the US, in non-human primates.