Bavarian Nordic submits market application to Health Canada for IMVAMUNE®
Kvistgård, Denmark, March 30, 2011 - Bavarian Nordic A/S (OMX: BAVA) announced today that it has submitted a marketing authorization application (MAA) in Canada for its smallpox vaccine candidate IMVAMUNE®. The MAA has been filed as a standard New Drug Substance (NDS) submission to Health Canada based on clinical indicators of efficacy.
Background of the NDS submission in Canada
Bavarian Nordic was awarded a Request for Proposal (RFP) in December 2008 by the Canadian Government to supply IMVAMUNE® to the Canadian armed forces. As part of this contract, Bavarian Nordic was requested to evaluate the potential for licensing IMVAMUNE® in Canada. In October 2009, Bavarian Nordic consulted with the agency during a pre-NDS advice meeting. Based on the data presented, Health Canada encouraged Bavarian Nordic to submit a standard NDS application, outlining the clinical indicators of efficacy for IMVAMUNE®.
If found acceptable by Health Canada following a standard NDS review time of approximately one year, IMVAMUNE® 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 who have Atopic Dermatitis (AD). The vaccine may be used for both primary vaccination and re-vaccination, both in an emergency and non-emergency setting.
Anders Hedegaard, President & CEO of Bavarian Nordic said: "We are extremely excited about this licensing application in Canada which represents the first marketing authorization application for the company. It emphasizes the potential of IMVAMUNE® as a third generation smallpox vaccine and we are looking forward to collaborating with the Canadian authorities to complete a successful review cycle, which may turn into the first vaccine license for the company."