Emergent Gets FDA OK For Smallpox Vaccine Mfg plantBy
The US Food and Drug Administration has approved the supplemental biologics license application for manufacturing ACAM2000, a small-pox vaccine, from Emergent BioSolutions, a specialty pharmaceutical company and contract manufacturer. The vaccine will be manufactured in the company’s newly-acquired cGMP live viral manufacturing facility in Canton, Massachusetts.
In October 2017, Emergent acquired the ACAM2000 business from Sanofi for $117 million, which included the vaccine business, two US manufacturing facilities, and office/warehouse space.This included a live viral fill/finish facility in Rockville, Maryland that will be responsible for the processing of bulk ACAM2000 into final packaged vaccine vials as well as the viral product manufactring facility in Canton. Emergent also assumed responsibility for a 10-year contract with the US Centers for Disease Control and Prevention (CDC), originally valued at $425 million, to maintain readiness against smallpox. The contract has a remaining value of $160 million for the delivery of ACAM2000 to the Strategic National Stockpile, a US government supply of pharmaceuticals and medical supplies. With the approval of the Canton facility, Emergent expects to complete all remaining product deliveries under the existing CDC contract in early 2019.
Source: Emergent Biosolutions