Benzinga | Apr 5, 2021 05:27AM EDT

Emergent BioSolutions Announced it's On Track with Respect to COVID-19 Contractual Commitments; Said it Received Modified Task Order from the U.S. Department of Health & Human Services to Support the Opportunity for Further Expansion of Manufacturing Capacity for Johnson & Johnson's COVID-19 Vaccine

Emergent BioSolutions Inc. (NYSE:EBS) announced that the Company continues to be on track with its manufacturing agreements related to COVID-19 vaccines and confirmed that there are no changes to its financial guidance for 2021. In addition, the Company received a contract modification to increase the original task order by $23 million from Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services (HHS).

The $23 million will be used for the purchase of biologics manufacturing equipment specific to Johnson & Johnson's COVID-19 vaccine for the potential expansion of manufacturing of that bulk drug substance into a third suite of Emergent's Baltimore Bayview facility. In addition, Emergent expects to align with the U.S. government and AstraZeneca on a mutually agreed ramp down of manufacturing for AstraZeneca's COVID-19 vaccine bulk drug substance.

"Emergent is actively working with the U.S. government to fulfill its policy objectives consistent with the Center for Innovation in Advanced Development and Manufacturing (CIADM) that was put in place under the Obama-Biden Administration in 2012," said Robert G. Kramer, president and chief executive officer of Emergent. "This unique public-private partnership has been a key element in our ability to quickly scale up to produce COVID-19 vaccines at a current rate of more than one billion dose-equivalents annually."

Emergent continues to own and operate the facility consistent with its obligations to all of its customers and in compliance with the regulatory standards promulgated by the U.S. Food and Drug Administration and all other applicable regulatory authorities.

"Emergent's top priority continues to be the strengthening of the supply chain for Johnson & Johnson's vitally needed COVID-19 vaccine," added Kramer. "We have been working closely with Johnson & Johnson (NYSE:JNJ) and welcome the additional oversight and support at our Bayview facility. We value their partnership and that of the U.S. government to help deliver critically needed COVID-19 vaccines to the American public and globally."

Emergent entered into the landmark COVID-19 arrangement with BARDA, under the CIADM agreement first established as a public-private partnership for pandemic preparedness in 2012. This landmark arrangement was designed to expand manufacturing capacity and has provided the government with the flexibility to use reserved capacity for production for COVID-19 vaccines and therapeutics consistent with the U.S. government's policy objectives.

Today, Emergent has nine COVID-19 CDMO partnerships with pharmaceutical and biotech innovators, the U.S. government, non-government organizations for vaccines and therapeutics across a multitude of sites and drug substance, drug product, and development service offerings.