Acambis awarded second smallpox contract

UK/US biotech company Acambis has been awarded a contract potentially worth up to $131m by the National Institute of Allergy and Infectious Disease (NIAID), part of the US National Institutes of Health, for the manufacture and development of a modified vaccinia ankara (MVA) vaccine. Acambis is co-developing its MVA vaccine candidate with Baxter Healthcare.

MVA is a weakened form of smallpox vaccine that is being developed for use in people for whom the traditional smallpox vaccine is contraindicated, such as patients with disorders of the immune system or skin conditions such as eczema.

The NIAID funding is split between core contract requirements and an optional manufacturing section. The core component of the contract, worth approximately $76m, requires Acambis to manufacture, fill, finish and release half a million single-dose vials of MVA and to carry out development work. The clinical testing programme, which is expected to continue into 2007, includes:

• safety and immunogenicity studies in healthy adults and target-population subjects;

• a dose-response study; and trials involving both vaccinia-naïve and previously vaccinated subjects.

The optional element of the contract, worth an additional $55m, would require manufacture, fill, finish and release of up to a further 2.5m single-dose vials of MVA.

This is the second contract the Acambis-Baxter partnership has been awarded by the US

Government for MVA. It received an initial $9.2m contract in February 2003 for development of its MVA vaccine candidate, manufacture of several thousand doses and clinical testing in a Phase I trial, which is ongoing. Incorporated into the new, second contract is work that was originally proposed to take place under an optional 'Part B' of the first contract, including clinical testing in healthy adults and at risk subjects.

In its second request for proposals, the NIAID indicated it was targeting MVA vaccine candidates that can be produced at commercial scale and have demonstrated safety and immunogenicity in extensive pre-clinical studies.

The US Government has indicated its intention to procure a stockpile of an attenuated smallpox vaccine, such as MVA, as part of its defence against the threat of smallpox virus being used as a bioterrorist weapon, for which Acambis and Baxter plan to tender in due course. Acambis' MVA vaccine was recently granted fast-track designation by the FDA.

Gordon Cameron, chief executive officer, said: 'Being awarded this contract means that we continue to be well positioned to compete for US government supply contracts for an MVA stockpile. We are confident that the Acambis-Baxter partnership represents a very strong proposition, combining our expertise in government contracting and product development with Baxter's considerable manufacturing track record.'