It is expected that approval will facilitate clearance in other countries that recognize products registered by Singapore government.
The Singapore government’s Health Sciences Authority (HSA) has approved Emergent BioSolutions’ BioThrax anthrax vaccine. The biodefense vaccine was recently approved by FDA. Emergent says sanction in Singapore will facilitate the regulatory process in other countries that recognize HSA-registered products.
BioThrax is currently the only FDA-licensed vaccine for the prevention of anthrax infection and is indicated for the active immunization of adults who are at high risk of exposure to anthrax. To date, Emergent has delivered over 42 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts.
Earlier this month Emergent announced that its investigational anthrax vaccine NuThrax™ (AV7909; anthrax vaccine adsorbed with CPG 7909 adjuvant), has been granted Fast Track Designation by FDA. The vaccine candidate combines BioThrax with an immunostimulatory oligodeoxynucleotide compound, CPG 7909. NuThrax is currently being evaluated in a Phase Ib trial. The study, initiated in December 2010, is supported by the NIAID and BARDA.
Emergent’s anthrax pipeline also includes other clinical-stage candidates. Anthrivig™ (human anthrax immunoglobulin) is being developed as a single-dose intravenous therapeutic for the treatment of patients with manifest symptoms of anthrax disease resulting from the release of anthrax toxins into the body. Phase I/II studies with the polyclonal antibody candidate were started in 2009.
The firm’s Phase II-stage PreviThrax™ (recombinant protective antigen anthrax vaccine, purified), acquired from VaxGen in 2008, is designed to induce antibodies that neutralize anthrax toxins. Emergent says the vaccine is a reformulated and potentially more stable form of the rPA 102 vaccine originally developed at the U.S. Army Medical Research Institute of Infectious Diseases.
PreviThrax has been the subject of two R&D grants totaling approximately $100 million from the NIAID and one R&D grant valued at up to $186.6 million from the HHS.
Thravixa™ (fully human anthrax mAb) is a monoclonal anthrax therapeutic, acquired from Avanir Pharmaceuticals in 2008, in development against symptomatic anthrax infection. The Phase I-stage product candidate is being developed with over $24.3 million in funding support from NIAID.