VIENNA (Reuters) - Beleaguered biotech group Intercell said on Wednesday it would start an efficacy study on its pseudomonas aeruginosa vaccine with Swiss peer Novartis after some good feedback.
The confirmatory efficacy study will start in the first quarter of next year with the first interim data expected in mid-2013, Intercell said in a statement.
“The trial will be executed by Intercell and cost will be shared between both parties,” it said, referring to Novartis, which holds a 15 percent stake in Intercell.
Pseudomonas aeruginosa is a type of bacteria that can be fatal if it infects internal organs.
Intercell, Europe’s last independent vaccine maker, has had a tough year after a string of product setbacks, and has said it is open to being bought.
Earlier this year, Merck & Co decided to discontinue a major trial of a vaccine designed to protect against serious hospital infections, adding to worries about Intercell’s pipeline prospects.
The Austrian group said on Wednesday that the European Medicines Agency had given the green light for the key elements of the pseudomonas trial such as the size, population, and primary endpoint.
The vaccine’s Phase II study recorded a lower mortality rate in the vaccine groups than in the control group, Intercell said.
Reporting by Sylvia Westall; Editing by Will Waterman