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
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
Anders Hedegaard, President & CEO.
Phone: +45 23 20 30 64