Bavarian Nordic submit authorization application to EU for smallpox vaccine

Bavarian Nordic A/S, a vaccine-focused biotechnology company, announced on Thursday that it has submitted a marketing authorization application to the European Medicines Agency for IMVAMUNER, its third-generation smallpox vaccine.

The smallpox vaccine, which will be marketed under the trade name IMVANEXR in Europe, could potentially be authorized for European countries during 2013. The MAA was filed under the centralized procedure after a successful review.

If the vaccine is accepted by the EMA, it will be indicated for the active immunization against smallpox infection and disease in people 18 years of age and above. The vaccine will be indicated for individuals with skin disorders and immune deficiencies such as atopic dermatitis and human immunodeficiency virus.

Bavarian Nordic also filed a new drug submission during 2011 with Health Canada. While the review process is ongoing, the company expects that the IMVAMUNER vaccine will be approved for the market in Canada during 2012.

"The submission of the application for marketing authorization for IMVANEXR in Europe marks yet an important milestone for the company, and from a regulatory point of view, things are currently progressing well," Anders Hedegaard, the president and CEO of Bavarian Nordic, said. "We have entered into the registration phase in both Canada and Europe and if both applications successfully lead to market approval for IMVAMUNER/IMVANEXR , this will greatly expand the market opportunities worldwide beyond the current sales to the US government."