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FDA approves Acambisí smallpox vaccine

UK-headquartered vaccine company Acambis wins FDA approval for its ACAM2000 smallpox vaccine

UK-headquartered vaccine company Acambis has won FDA approval for its ACAM2000 smallpox vaccine.

ACAM2000 is intended for active bio-defence immunisation against smallpox disease in high-risk patients, such as soldiers. The vaccine is the first to win approval as part of the US bioterrorism strategy.

Acambis developed ACAM2000 as part of a US Centers for Disease Control and Prevention (CDC) contract and was derived from Dryvax, a first-generation vaccine used during the global smallpox eradication programme.

The company has since supplied 192.5m doses of the vaccine to the CDC for the US Strategic National Stockpile (SNS), an agency established to provide medicines to the US public in the event of a public health emergency, such as a terrorist attack.

ACAM2000 is a single-dose vaccine and is the first choice smallpox vaccine for use in an emergency. It is the mainstay of the US government's smallpox vaccine stockpile and will also be used by the US Department of Defense for protection of military personnel.

The clinical trials data generated on ACAM2000 were reviewed by the FDA Vaccines and Related Biological Products Advisory Committee in May 2007. The committee voted in favour of the vaccine's safety and efficacy.

Acambis and the CDC are now discussing a "warm-base manufacturing" contract for the British company to provide ACAM2000 production and licence maintenance activities in the long term.

Following the FDA approval, Landsbanki analysts reiterated their 'Buy' recommendation on Acambis' stock, based on their positive outlook for both ACAM2000 and the Japanese Encephalitis vaccine ChimeriVax-JE.

3rd September 2007

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