Emergent BioSolutions said today it has won a 10-year, approximately $535 million contract from the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) to continue supplying VIGIV (vaccinia immune globulin intravenous, human) into the U.S. Strategic National Stockpile (SNS) toward the nation’s smallpox preparedness.
VIGIV, also known as CNJ-016®, is an immune globulin, 5% liquid that was developed on Emergent’s hyperimmune specialty plasma product manufacturing platform, which uses purified gamma globulin (IgG) containing polyclonal antibodies to specific antigen(s) obtained from human plasma.
VIGIV is an immune globulin (human), 5% liquid, that is indicated for the treatment of complications due to vaccinia vaccination, including: eczema vaccinatum, progressive vaccinia, severe generalized vaccinia, vaccinia infections in individuals who have skin conditions, and aberrant infections induced by vaccinia virus (except in cases of isolated keratitis).
VIGIV is one of two Emergent products against smallpox that are part of the SNS. The other is ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) smallpox vaccine, which Emergent acquired in 2017 from Sanofi Pasteur for up to $125 million.
Emergent was awarded Contract 75A50119C00037 for the advancement of the VIGIV program, funded by ASPR. The contract consists of a one-year base period of performance valued at $23 million, and nine option years that, if they are all exercised, would increase the total contract value to approximately $535 million.
Under the contract, the scope of work includes the collection of plasma, manufacturing, and delivery of finished drug product. During the first year of the contract, Emergent will use plasma provided by the U.S. government to manufacture VIGIV doses. All subsequent years will involve Emergent-led plasma collection and production efforts resulting in higher annual revenue potential.
$26M contract completed
The 10-year contract follows the conclusion of a one-year, $26 million procurement contract awarded by the U.S. Centers for Disease Control and Prevention in February 2018. Under that contract (200-2018-96321), Emergent agreed to conduct manufacturing runs, collect plasma for future manufacturing, and undertake additional activities in support of maintaining FDA licensure of VIGIV.
“Emergent is pleased to continue its successful track record of being a solutions provider to governments to help address serious public health threats such as smallpox,” Emergent president and CEO Robert G. Kramer, Sr., said in a statement.
VIGIV is the only product licensed by the FDA for the treatment of complications due to smallpox vaccination, and has been stockpiled at a ratio of one dose of VIGIV per 10,000 doses of first or second generation smallpox vaccine. VIGIV was first procured for inclusion in the SNS in 2002, and three years later won FDA licensing, followed in 2007 by licensing from Health Canada.
“Emergent is honored to continue its long-term partnership with the U.S. government, whose support of the VIGIV program reflects its commitment to protect the population against serious public health threats,” Laura Saward, PhD, senior vice president and antibody therapeutics business unit head at Emergent, said in a statement.