Bavarian Nordic will file for market approval for IMVAMUNE® in Canada
(Thomson Reuters ONE) - Kvistgård, Denmark, November 30, 2009 - Bavarian Nordic A/S (OMX:BAVA) announced today that the company expects to file a New DrugSubmission (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 themanufacturing, clinical and animal data, Health Canada recommendedthat Bavarian Nordic submit a NDS application for consideration tolicense IMVAMUNE® as a smallpox vaccine for the general population.The NDS is expected to be filed in the second half of 2010, possiblyleading to the first license of IMVAMUNE® during 2011.In 2008, Bavarian Nordic was awarded a contract by the CanadianGovernment for the acquisition of 20,000 doses of IMVAMUNE® whichwere recently delivered and accepted under a Canadian Special AccessProgramme. Under the contract, the Canadian Authorities will provideBavarian Nordic with milestone-based funding for the filing of theNDS for IMVAMUNE® in Canada, and this forms part of Bavarian Nordic'sglobal licensure plans for IMVAMUNE®.Anders Hedegaard, President & CEO of Bavarian Nordic said: "We arewell on the way to achieve a significant milestone in the developmentof IMVAMUNE®, as we are about to get the first regulatory approval ofthe vaccine. This is indeed recognition that IMVAMUNE® is superior tothe current approved smallpox vaccines that are stockpiled in manycountries. Our strategy to develop and obtain regulatory approval forIMVAMUNE® as a vaccine for the general population, including thosewho are contraindicated to the traditional vaccines, and withoutcausing the same serious adverse events, is now finally about tosucceed. Furthermore this is a recognition of our technology since itwill represent the first approval of an MVA-BN® based product,leading to new opportunities for commercialising our technology."IMVAMUNE® represents a safer smallpox vaccineCurrently, IMVAMUNE® has been shown to be safe and well tolerated inmore than 2,700 people in 12 ongoing or completed clinical trials.This includes approximately 1,000 people currently contraindicatedfor licensed smallpox vaccines, namely HIV-infected or peoplediagnosed with Atopic Dermatitis. IMVAMUNE® has shown to be highlyimmunogenic in both healthy subjects and people with weakened immunesystems and these immune responses have been shown to be comparableto those induced by traditional smallpox vaccines. IMVAMUNE® has alsobeen shown to induce a post-exposure protection in immune suppressedanimals, which succumbed to the vaccination with traditional smallpoxvaccines. Moreover, IMVAMUNE® was shown to induce a comparableefficacy as ACAM2000(TM), the licensed second-generation smallpoxvaccine in the US, in non-human primates.Asger AamundChairman of the BoardContactAnders Hedegaard, President & CEO. Phone +45 23 20 30 64http://hugin.info/100065/R/1357828/330432.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 30.11.2009 - 08:01 Uhr
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