Two pharma get US anthrax biodefense contracts

Biopharmaceutical company Emergent BioSolutions has signed a three-year contract with the Department of Health and Human Services (HHS) worth $448m for the development and supply of 18.75 million doses of the company's BioThrax (anthrax vaccine adsorbed) for the strategic national stockpile. BioThrax is the only FDA-approved vaccine for the prevention of anthrax infection. The company anticipated being able to supply approximately six-million doses by the end of this year. Under the terms of the contract, if Emergent BioSolutions receives US Food and Drug Administration (FDA) approval for its supplement to its biologics license application to extend the shelf life of the vaccine from three to four years, the company would receive a lump sum payment of the value of approximately $34m. If not approved for a four-year expiry dating, the company is not entitled to receive any of the $34m. The contract also includes up to $11.5m towards milestone payments for the advancement of a post-exposure prophylaxis indication for BioThrax, which would expand the vaccines current pre-exposure prophylaxis indication. In addition, under the contract the company has agreed to provide all shipping services related to the delivery of doses. "We are honored to continue our long-standing relationship with HHS to provide BioThrax as a critical component of our nation's biodefense stockpile,"​ Emergent BioSolutions chairman and chief executive Fuad El-Hibri said in a statement. Previously, Emergent BioSolutions has provided 10 million doses of BioThrax to the national stockpile under a 2005 and a 2006 supply agreements valued together at $243m. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Baccillus anthracis and contains no dead or live bacteria. It is administered by subcutaneous injection. Meanwhile, Elusys Therapeutics has been awarded a $12m contract for the advanced development of Anthim, the company's late stage anthrax therapeutic. Anthim is seen as a 'just in time anthrax therapeutic' which has been shown to demonstrate complete protection against an anthrax spore challenge with a single prophylactic dose and "significant protection"​ when administered two days after exposure. Anthim is a high affinity monoclonal antibody that targets the protective antigen component of anthrax infection, blocking the bacteria's ability to form deadly toxins. The drug has been granted Fast Track status and Orphan Drug Designation by the FDA. "Elusys is encouraged by the continued support from the US Government and we look forward to extending our collaboration with the National Institute of Allergy and Infectious Disease and Biomedical Advanced Research and Development Authority. We are confident that Elusys has developed a highly effective and valuable anthrax therapeutic for procurement under Project BioShield for addition to the US Government's Strategic National Stockpile,"​ Elusys president and chief executive Elizabeth Posillico said in a statement.