GlaxoSmithKline‘s (NYSE:GSK) activity on the vaccine front continues as the pharma giant seeks regulatory approval on two new influenza vaccines.
Britain-based GSK filed a biologics license application with the U.S. Food and Drug Administration seeking approval for a vaccine targeting H5N1 pandemic influenza. The vaccine, called Pumarix, is already approved in Europe. GSK’s H5N1 vaccine program was supported by a contract with the Biomedical Advanced Development and Research Authority (BARDA) of the U.S. Department of Health and Human Services.
GSK has also filed for U.S. and European regulatory approval on a new influenza vaccine that targets four strains of the virus. The GSK filing for its quadrivalent vaccine comes on the heels of AstraZeneca (NYSE:AZN) subsidiary MedImmune’s FDA approval last week on a quadrivalent vaccine for its immunization product FluMist. A quadrivalent vaccines provides immunity against two strains each of influenza virus types A and B.
GSK, which has its U.S headquarters in Research Triangle Park, has become more active in vaccine development following its $1.4 billion acquisition of Canada-based vaccines company ID Biomedical in 2005. That deal brought to GSK ID Biomedical facilities in Canada, the United States and Germany. GSK last week announced a joint venture with Japanese pharma company Daiichi-Sankyo to form what could become the largest vaccines company in Japan.
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