Pfenex signed a five-year contract valued at up to $143.5m with HHS’ Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of Px563L, a mutant recombinant protective antigen anthrax vaccine.
Under the contract, the base period will fund activities related to current Good Manufacturing Practice (cGMP) manufacturing of drug product and a Phase 1a clinical study. Milestone-based option periods include completion of a Phase 1b clinical study, a Phase 2 clinical study and non-clinical efficacy studies as well as manufacturing technology transfer and optimization, process and analytical method validation and consistency lot manufacture.
Pfenex said it believes the successful completion of the trials under the contract could lead to a procurement contract for supply of the vaccine to the Strategic National Stockpile.
In Emergent’s case, the Centers for Disease Control and Prevention (CDC) has selected the company for a two-year, $44m contract for the supply of the FDA-approved smallpox vaccination complications treatment Vaccinia Immune Globulin (VIGIV) into the US Strategic National Stockpile.
The contract will require Emergent to collect plasma for future manufacturing in addition to current collection requirements, conduct manufacturing runs, and conduct additional activities in support of maintaining the FDA licensure of VIGIV.
"Emergent is proud to support the U.S. government's implementation of its long-term stockpiling strategy. Thirteen years after VIGIV was first delivered to the SNS, VIGIV still remains a critical medical countermeasure in the government's preparedness efforts," said Adam Havey, executive vice president and president biodefense division of Emergent BioSolutions.
This contract modification increases the total contract value to approximately $80 million. The scope of the contract, originally awarded to Cangene Corporation, which Emergent acquired in February 2014, was to maintain the ability to manufacture licensed VIGIV, with annual options to conduct additional services to support licensure maintenance activities for the product and to allow for additional manufacturing and plasma collections.
VIGIV was licensed in the US by FDA in 2005 and in Canada by Health Canada in 2007.