CHMP backs GSK's malaria vaccine

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) received a positive opinion from EMA's CHMP for its Mosquirix malaria vaccine in children aged 6 weeks to 17 months -- moving the product a step closer to becoming the first vaccine ever approved to prevent malaria. GSK expects the World Health Organization (WHO) to formulate a policy recommendation on use of the vaccine by YE15, after which GSK will submit an application to WHO for pre-qualification of the vaccine. Once pre-qualification is granted, GSK will apply for marketing authorization in countries in sub-Saharan Africa.

Mosquirix (RTS, S) targets the circumsporozoite protein (CSP) sequence of Plasmodium falciparum and uses the AS01 adjuvant. AS01 contains the QS-21 Stimulon adjuvant from Agenus Inc. (NASDAQ:AGEN). Agenus, which said this would be the first approval of a product containing QS-21, will receive a milestone payment on approval and low single-digit royalties for 10 years. GSK developed the vaccine in partnership with the PATH Malaria Vaccine Initiative (MVI). ...