Acambis brings smallpox vaccine production in-house
its soon to be approved smallpox vaccine in-house while its
agreement with contract manufacturer Baxter comes to an end.
"Our contract with Baxter is fulfilled and while they did a fantastic job for us, we are now looking at bringing all the manufacturing processes to our US facilities," Acambis spokersperson Lindsay Wright told Outsourcing-Pharma.com.
The reason behind the move has indeed little to do with Baxter at all.
Acambis is currently in discussions with the US Centers for Disease Control and Prevention (CDC) to secure a new contract to provide the American government with long-term manufacturing capability of the vaccine, ACAM2000. One of the terms of the potential deal is that the vaccine production must be executed on US soil, said Wright.
And since Baxter was manufacturing the vaccine in Austria, Acambis plans to transfer all manufacturing processes to its US based facilities - the firm currently has a plant in Canton, Massachusetts and another one in Rockville, Maryland.
Wright said that her company teamed with Baxter in 2000 to manufacture the vaccine as Acambis did not have the capacity to bring the production in-house at the time.
But now both its US plants are up and running and able to supply commercial quantities of the product.
The company's objective is to meet the US government's need to maintain a constant state of production through annual manufacturing runs, known as 'warm-base manufacturing', said Wright.
Warm-base manufacturing would produce doses of the vaccine each year for the Strategic National Stockpile and in future, could be used to maintain the stockpile.
Acambis developed ACAM2000 under a contract with the CDC in response to the US government's decision to stockpile smallpox vaccine in anticipation of the potential threat of smallpox being used as a biological weapon.
The firm contracted Baxter seven years ago to conduct the bulk manufacturing of the vaccine, while Acambis was in charge of the downstream processing in a $500m (€372m) deal with the CDC to provide 155m doses of the vaccine.
A US Food and Drug Administration (FDA) advisory committee recently voted unanimously that ACAM2000 is both safe and efficacious - a positive step for Acambis in the approval process.
But the agency's official green light is essential for Acambis to secure the contract with the CDC.
A final ruling will be made before the end of August - the target date the FDA has given for the license application response for the vaccine.
Acambis failed to win a further government contract last November for its other smallpox vaccine.
Wright could not disclose any financial details related to the contract with the CDC as it is currently being finalised.
