Astellas/UMN's cell cultured flu vaccine edges nearer possible '15 nod
This article was originally published in Scrip
The Japanese venture UMN Pharma and partner Astellas have completed dosing in two ongoing Phase III trials with a cell cultured candidate flu vaccine, taking the product a step closer to a possible launch in Japan in 2015.
Administration of a subcutaneous formulation of the trivalent inactivated vaccine ASP7374 (formerly UMN-0502) in 900 healthy volunteers aged 20-64 has ended in a study designed to show non-inferiority to an approved, egg-derived trivalent inactivated vaccine.
Dosing has also been completed in a second study in 55 healthy volunteers aged 61 and over that is assessing an intramuscular formulation, adding to an already completed program in 1,060 elderly volunteers with the subcutaneous version. Summary results from this trial released in March showed non-inferiority to the egg-derived vaccine.
Astellas in Japan told Scrip that a Japanese approval submission is currently being planned for ASP7374 within the fiscal year ending March 2015.
UMN, which listed in Japan last December raising around $52m, has licensed baculovirus expression vector technology from Protein Sciences of the US, which allows manufacturing production lead times to be reduced and efficiency of hemagglutinin antigen production to be improved compared with egg-derived vaccines.
Protein Sciences' product was approved in the US in January as Flublok, which sent shares in UMN soaring (scripintelligence.com, 17 January 2013). The venture closed up 1.1% in Tokyo at JPY4,070 ($41.53) on 21 October before the latest Phase III announcement, still well over three times its IPO price of JPY1,300 per share.
Astellas is also co-developing with UMN in Japan ASP7373, a H5N1 prophylactic vaccine currently in Phase II trials.
Japan's government is subsidizing the development of various cell-cultured and conventional flu vaccines for pandemic flu as part of outbreak preparedness plans, with UMN among the beneficiaries of the scheme (scripintelligence.com, 2 September 2010).