UK vaccine maker Acambis has filed the first portion of a rolling Biologics License Application for its smallpox vaccine, ACAM2000, with the US Food and Drug Administration.
The BLA will include safety, tolerability and immunogenicity data from clinical trials of the vaccine carried out in more than 3,800 subjects, and the firm hopes to complete the submission during the first quarter of this year, Lyndsay Wright, Vice President of Communications and Investor Relations at Acambis, told PharmaTimes News Online. As the ACAM2000 programme was assigned fast-track status by the FDA in late last year, the company is hoping for a decision by the end of 2006.
A license for ACAM2000 will mark the final stage of a big contract signed with the US government in November 2001, in the wake of the 09/11 terrorist attacks. According to Lyndsay, this was the first step taken by the government in its program to protect soldiers and citizens against bioterrorism, as smallpox was considered the number one threat.
Under the contract, Acambis has already shipped 180 million doses of the vaccine to the USA. And the group is looking to extend its partnership US government even further. Lynsday told PharmaTimes News Online that talks are currently underway regarding a “warm-based manufacturing” deal. Under this concept, Acambis would manufacture a batch of ACAM2000 once a year for the US government, in order to test its processes, maintain knowledge and ensure that, if an outbreak of smallpox should occur, production can be ramped up to meet increased demand for the vaccine.