Emergent BioSolutions and the Health Protection Agency (HPA) are both leaders in biodefense vaccines, with long-established capabilities in the prevention of botulism dating back to the 1950s.
In a series of agreements, Emergent and HPA have committed to the sharing of technology and expertise to develop both toxoid and recombinant botulinum vaccines. There is currently no licensed vaccine in the world to prevent botulism.
“This collaboration represents a significant move forward in the development of a vaccine to prevent the deadly disease botulism,” said Emergent BioSolutions CEO, Fuad El-Hibri. “Botulism is ranked just behind anthrax and smallpox in terms of the threat it poses as a potential weapon of bioterror.”
Under the series of agreements between Emergent and HPA, Emergent holds worldwide, exclusive (except in the UK), royalty-bearing rights to manufacture, market and sell botulinum vaccines that incorporate HPA’s patented technologies and know-how. In addition, both parties will hold rights under any future patents or proprietary technologies developed under the development program.
Emergent has committed to minimum expenditures of $2 million for the development of these products over a two-year period. In the UK, HPA retains a non-exclusive right to manufacture and sell botulinum vaccines for UK public health needs including its National Health Service (NHS).
The initial objectives for these programs will be the development of both multivalent botulinum toxoid vaccines and multivalent recombinant botulinum vaccines. The toxoid vaccine under development is derived from a pentavalent botulinum toxoid vaccine previously produced by Emergent.
That vaccine has been used in more than 11,000 people for more than 30 years under investigational new drug applications (INDs) held by the Centers for Disease Control and Prevention (CDC) and the US Department of Defense.
The recombinant vaccine development program, which is at an earlier stage, targets specific serotypes. Initial data has demonstrated efficacy in a variety of animal models and has shown advantages in stability, immunogenicity, and the potential for multivalent formulations.