Acambis gains as its smallpox vaccine gets the nod from key FDA Advisory Committee
Acambis plc (ACM.L) said the Vaccines and Related Biological Products Advisory Committee of the US Food and Drug Administration voted unanimously on Thursday that Acambis' ACAM2000 is safe and effective.
The Advisory Committee was asked to review the clinical data and voted 11-0 in favour on both the safety and efficacy of the smallpox vaccine ACAM2000.
The FDA has the final decision on licensure of ACAM2000. It has identified 31 August as the target date for its response to Acambis' ACAM2000 licence application under the Prescription Drug User Fee Act.
CEO Ian Garland (pictured) said: "This positive vote further reinforces our confidence in the potential for ACAM2000 to be licensed, which is a necessary prerequisite to finalising a warm-base manufacturing contract with the CDC and securing a long-term revenue stream that will underpin Acambis' continued growth."
The Cambridge headquartered company’s share rice gained 7%, or 9p, to 137p after the news was released. The group is now valued at almost £150m.
Acambis developed ACAM2000 under contracts with the US Centers for Disease Control and Prevention (CDC) in response to the US Government's need for a stockpile of smallpox vaccine to counter the threat of smallpox being used as a biological weapon. To date, Acambis has supplied 192.5 million doses of ACAM2000 to the US's Strategic National Stockpile under an FDA Investigational New Drug
(IND) application.
ACAM2000 is intended to be used for protection of persons determined by the US Government to be at high risk for smallpox infection, which currently includes vaccination of military personnel being deployed to certain regions. The CDC and Acambis are discussing provision by Acambis of a long-term production capability and licence maintenance activities under a 'warm-base manufacturing' contract, which would provide smallpox vaccine production entirely in the US.
17 May 2007
