Acambis’ smallpox vaccine, ACAM2000, has been granted US Food and Drug Administration fast track designation. Investors sent the company’s share price up by more than 2% during trading on the London Stock Exchange yesterday on the news, which will speed up the product’s approval process.
Although not yet approved, 182.5 million doses of ACAM2000 have already been delivered to the US government for inclusion in its emergency stockpile, for use in the event of a bioterrorist attack. The company says it has received vaccine orders from several other governments around the world.
Acambis says that it is currently proceeding toward an ACAM2000 submission, which will include data from more than 2,900 subject vaccinated in the Phase III clinical trials as well as all other study data.
The news is a definite boost for Acambis, which was hit last year when the US government said it would not be completing a smallpox vaccine order [[20/09/04b]]. However, the latter has since placed an order for Acambis’ so-called MVA (modified vaccinia ankara) vaccine – a weakened form of smallpox vaccine that is being developed together with Baxter for use in people unable to take the traditional smallpox vaccine [[30/09/04c]]. The governmental contracts have been key to turning Acambis into a profit-making company – 2003 revenues more than doubled versus the previous year, and the firm saw a three-fold boost in pre-tax profits for the period [[02/03/04b]].