Acambis plc (Acambis) has reached agreement with the US Government that it will order a further 10 million doses of ACAM2000. The order is worth approximately $30m.
Under this new order, the US Centers for Disease Control and Prevention (CDC) has agreed to procure an additional 10 million doses under the existing ACAM2000 supply contract, under which Acambis produced and delivered 182.5 million doses of ACAM2000 for the US's Strategic National Stockpile. Acambis expects to supply the new 10 million-dose order from its existing vaccine inventory in 2006.
In addition, advanced negotiations are continuing to finalise the long-term warm-base manufacturing contract, which is expected to be awarded following licensure of ACAM2000. A Biologics License Application (BLA) for ACAM2000 is currently being reviewed by the US Food and Drug Administration (FDA). A "First Action Due Date" of 14 February 2007 has been set by the FDA.
The aim of the warm-base manufacturing programme is to provide the US with access to ACAM2000 smallpox vaccine production capability entirely in the US. To achieve this, all stages of the bulk production process are being transferred to Acambis' Canton, MA facility, and lyophilisation and fill/finish activities will take place at Acambis' Rockville, MD facility. Following the CDC's agreement to place the new $30m order, Acambis is initiating warm-base manufacturing activities.
Gordon Cameron, chief executive officer of Acambis, commented: "This agreement from the CDC clearly demonstrates the US Government's commitment to ACAM2000 warm-base manufacturing for the long term. Through this order, we can immediately start activities to bring ACAM2000 production entirely in the US. We look forward to securing a long-term warm-base manufacturing contract shortly after the expected licensure of ACAM2000 in early 2007."
Acambis is a leading developer of vaccines to prevent and treat infectious diseases. Recognised internationally as the leading producer of smallpox vaccines, Acambis is developing an investigational smallpox vaccine, ACAM2000, and is manufacturing emergency-use stockpiles of this investigational vaccine for the US Government and other governments around the world. It is also developing an attenuated smallpox vaccine, MVA3000, under contracts with the US National.