Emergent BioSolutions reports Imojev manufacturing pact with Substipharm

Emergent BioSolutions (EBS) announced it has entered into an agreement with Substipharm Biologics valued at approximately $34.5M to support drug substance manufacturing for its Japanese Encephalitis vaccine, licensed internationally under the brand name Imojev at Emergent’s Canton, Massachusetts facility, and for Emergent to serve as the exclusive distributor of the vaccine to the U.S. government, following potential FDA regulatory endeavors. Emergent Canton is a BSL-2, multi-product commercial facility that provides viral drug substance manufacturing. Following an inspection in February, the FDA listed “No Action Indicated” status classification for the Canton manufacturing facility, reflecting Emergent’s commitment to ensuring continued compliance with current good manufacturing practices. Emergent has begun scale-up efforts at the Canton facility and intends to hire additional employees later this year. Under a master manufacturing services agreement, Emergent will conduct operational and regulatory inspection readiness activities and manufacture drug substance to support Substipharm’s U.S. regulatory submission for the vaccine with the FDA. The parties have entered into a distribution agreement under which Emergent will be the exclusive distributor of the vaccine to the U.S. government upon FDA approval. Emergent has previously manufactured Imojev drug substance for international markets and continues to actively manage and maintain product inventory at the Canton facility for Substipharm.