Astellas Pharma Inc. and UMN Pharma Inc. have completed administration of the recombinant seasonal influenza HA vaccine ASP7374 successfully in new two currently ongoing phase III clinical trials. Astellas Pharma also pursues drug development of this vaccine in cooperation with UMN Pharma.
One of these clinical studies aims to enroll 900 healthy volunteers aged from 20 to 64 years, and to evaluate the immunogenicity and safety of subcutaneously-administered ASP7374 compared with approved egg-derived trivalent inactivated vaccine to prove non-inferiority of ASP7374 to the egg- derived vaccine. Astellas Pharma is conducting this clinical study following the successfully-conducted clinical study among 1,060 elderly volunteers.
Another clinical study aims to enroll 55 healthy volunteers aged 61 and over, and to evaluate the immunogenicity and safety of intramuscularly-administered ASP7374.
The recombinant seasonal influenza HA vaccine ASP7374 containing three different strains of antigens, has been produced by a cell-culture manufacturing method employing the Baculovirus Expression Vector System, a next-generation technology platform for manufacturing biopharmaceutical products. In the US, Protein Sciences Corporation obtained approval of this vaccine from the Food and Drug Administration in January 2013.
UMN Pharma Inc. is a venture company dedicated to developing innovative pharmaceutical products that address unmet medical needs.
Astellas Pharma Inc., is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals.