EBS News & Events

Emergent BioSolutions announced that Singapore's Health Sciences Authority has approved an expanded indication for ACAM2000 to include prevention of mpox disease in adults determined to be at high risk for mpox infection. "The Singapore HSA approval of ACAM2000 for immunization against mpox in high-risk individuals demonstrates the strength and breadth of Emergent's medical countermeasures portfolio," said Simon Lowry, chief medical officer of Emergent. "We are committed to working with international regulatory authorities as part of our broader vision to become the leader in delivering protective and life-saving solutions to communities around the world."

Emergent BioSolutions (EBS) announced a multi-year agreement with SAB Biotherapeutics (SABS) to support the process development and manufacturing of SAB-142, SAB BIO's lead program in clinical development for autoimmune type 1 diabetes. The executed agreement is valued at approximately $50M, of which $36M is contingent on future regulatory approval and downstream milestones. Under the terms of the agreement, Emergent will provide end-to-end development and manufacturing services to SAB BIO that are compliant with current good manufacturing practices. These services will include process development and scale-up, technology and analytical method transfer, manufacturing for SAB-142's ongoing clinical program and commercial manufacturing services upon regulatory approval.

Emergent BioSolutions 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.

Emergent BioSolutions announced that it has partnered with the B.C. Provincial Health Services Authority to supply Narcan Nasal Spray for the province's Take-Home Naloxone Program. This order follows an additional investment of C$18M by the B.C. government to expand the BC THN Program to include nasal naloxone. This is an expansion of B.C.'s nasal naloxone pilot program, which launched in 2024, and provided 60,000 nasal naloxone kits to community sites, pharmacies, post-secondary institutions, First-Nations-mandated institutions, fire departments, municipalities and libraries.