Emergent BioSolutions, a specialty biopharmaceutical company, has agreed to acquire ACAM2000, a small-pox vaccine, from Sanofi for up to $125 million, consisting of $97.5 million upfront and up to $27.5 million in near-term contingent regulatory and manufacturing-related milestones. 

Upon the closing of the transaction, Emergent will acquire ACAM2000, a vaccine licensed by the US Food and Drug Administration, for active immunization against smallpox disease for persons determined to be at high risk for small-pox infection. The company will also acquire an existing 10-year contract, originally valued at up to $425 million, with the US Centers for Disease Control and Prevention (CDC) with a remaining value of up to approximately $160 million for deliveries of ACAM2000 to the Strategic National Stockpile (SNS), which is a US government supply of potentially life-saving pharmaceuticals and medical supplies. The contract will expire or by up for renewal in 2018.

Emergent will also acquire a cGMP bulk manufacturing facility and a lease to a cGMP fill/finish facility, both US-based, along with the existing staff of approximately 100 employees. The original CDC contract called for establishing US-based manufacturing of ACAM2000. This required the technology transfer of the upstream portion of the production process from Austria to a US-based manufacturing facility. Sanofi is in the process of completing this technology transfer to the cGMP bulk manufacturing facility to be acquired in this transaction. Emergent anticipates that a supplemental biologics license application for licensure of this facility will be filed in the second half of 2017. Upon closing, Emergent will assume all responsibilities under the CDC contract, including completing the FDA licensure process and the fulfillment of all remaining product deliveries to the SNS, valued at up to approximately $160 million, subject to the availability of government funding and the exercise of contract options.

Emergent anticipates that product deliveries will resume in 2018, following expected FDA licensure of the US-based manufacturing facility. The company intends to negotiate a follow-on, multi-year contract with the US government to ensure the continued supply of ACAM2000 to the SNS.

Emergent expects that this transaction will enhance its contract manufacturing operations through the addition of live viral manufacturing and fill/finish capabilities and the execution of a contract manufacturing agreement to supply bulk drug substance for one of Sanofi’s commercial vaccines.

This transaction, which is subject to customary closing conditions, including antitrust regulatory approval, is expected to close in 2017.

Source: Emergent BioSolutions