Status: U.S. biodefense stockpiling contract in 2007

Organizations involved:

Emergent BioSolutions, Inc. –Manuf.; R&D; Tech.

Centers for Disease Control and Prevention (CDC) – USA mark. [stockpiling]

National Institute of Allergy and Infectious Diseases (NIAID) – R&D

National Institutes of Health (NIH) – Parent

Cross ref.: See the entry (no. 103) regarding other recombinant anthrax vaccine, and the generic Anthrax Vaccines entry (#404).

Description: Emergent BioSolutions is developing a recombinant Bacillus anthracis (anthrax) protective antigen (rPA 102) for addition to the U.S. biodefense stockpile (and that of other countries). The rPA is Escherichia coli (E. coli) expressed and otherwise the same or very similar to rPA 102 previously manufactured (or attempted) by VaxGen (see entry above). Emergent's rPA vaccine candidate is a reformulated and more stable form of this rPA 102 vaccine originally developed at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and manufactured by VaxGen.

Nomenclature: Anthrax Vaccine, rDNA/Emergent [BIO]; rPA vaccine [SY]; rPA102 [SY]; Bacillus anthracis protective antigen vaccine, recombinant [SY].

Companies.: Emergent BioSolutions, the parent company of the manufacturer of BioThrax (AVA), the original U.S. anthrax vaccine, is developing and will manufacture this product.

In late July 2008, Emergent BioSolutions submitted a proposal in response to a request for proposal (RFP) issued by the U.S. Department of Health and Human Services (HHS) for a recombinant protective antigen anthrax vaccine (rPA). HHS's RFP was designed to procure 25 million doses of an rPA anthrax vaccine for the Strategic National Stockpile (SNS). This was in addition to the 18.75 million doses of the company's FDA-licensed product, BioThrax, that HHS was procuring under an existing $448M contract with Emergent (see the BioThrax entry).

Ongoing: In Sept. 2009, Emergent was awarded a cooperative agreement from the National Institute of Allergy and Infectious Diseases (NIAID), NIH, to further the development of one of its advanced anthrax vaccine candidates known as dmPA7909. The anthrax vaccine candidate is composed of the double-mutant recombinant protective antigen (dmPA), which has been genetically engineered for improved stability. dmPA is adsorbed to Alhydrogel (see the Aluminum-based Adjuvants entry), combined with the immunostimulatory compound CPG 7909 (VaxImmune; licensed from Pfizer) and formulated as a dry powder. Emergent is employing proven stabilizing technologies for each of the components in the vaccine formulation to seek to m aximize vaccine stability even at elevated temperatures and to extend shelf life. Funding in the amount of $4.9 million over a two-year period provides for manufacturing of clinical lots, non-clinical safety and efficacy studies, and stability studies to demonstrate whether the vaccine candidate can withstand high temperatures up to 37˚C.

In Sept. 2010, Emergent BioSolutions received a 5-year contract valued at up to $186.6 million from the Biomedical Advanced Research and Development Authority (BARDA) for the development of its rPA vaccine. This was a cost plus fixed fee development contract with a two-year base period of performance valued at approximately $51 million, three successive one-year option periods valued at approximately $126 million and funding for optional non-clinical studies valued at approximately $9 million. Under the contract, the base value will fund activities related to process characterization and assay validation, as well as formulation and stability studies. Milestone-based options include completion of a Phase II clinical study and non-clinical efficacy studies, process validation, as well as consistency lot manufacture. Emergent anticipated recognizing revenues from this award in the fourth quarter of 2010 of ~$2 millions.