Bavarian Nordic Submits a Marketing Application for its Smallpox Vaccine to the European Medicines Agency
KVISTGAARD, Denmark, March 1, 2012 - Bavarian Nordic A/S (OMX: BAVA) announced today that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its smallpox vaccine (IMVAMUNE®) that will be marketed under the trade name IMVANEX® in Europe. The MAA has been filed for consideration under the centralized procedure and following a successful review could potentially lead to the market authorization of IMVANEX® in Europe (EAA countries) during 2013.
If found acceptable by EMA, IMVANEX® will be indicated for active immunization against smallpox infection and disease in persons 18 years of age and older. The indication will include individuals with immune deficiencies and skin disorders such as those who are Human Immunodeficiency Virus (HIV) infected and those diagnosed with Atopic Dermatitis (AD).
This submission to EMA follows the New Drug Submission (NDS) filed with Health Canada during 2011, which is currently undergoing the review process and still expected to result in a market approval for IMVAMUNE® in Canada during 2012.
"The submission of the application for Marketing Authorization for IMVANEX® in Europe marks yet an important milestone for the company, and from a regulatory point of view, things are currently progressing well. We have entered into the registration phase in both Canada and Europe and if both applications successfully lead to market approval for IMVAMUNE®/ IMVANEX®, this will greatly expand the market opportunities worldwide beyond the current sales to the US government.," stated Anders Hedegaard, President & CEO of Bavarian Nordic.