Hilleman Laboratories announced on Wednesday that it will collaborate with Hyderabad-based vaccine maker Bharat Biotech International Limited (BBIL) for further development, manufacture and commercialisation of its next generation oral cholera vaccine, Hillchol.
Hillchol was designed at the University of Gothenburg in Sweden and subsequently developed by Hilleman Labs. The development process included demonstration of safety and imnmunogenicity in an age de-escalating phase I/II clinical trial conducted in Bangladesh.
For further development of the vaccine candidate, Hilleman Labs has entered into a licensing and manufacturing agreement with BBIL, which will scale the manufacturing process to commercial stage and establish product specifications required for WHO pre-qualification.
Hillchol contains a single recombinant Hikojima strain which expresses both Inaba and Ogawa antigens, resulting in a shorter and simpler manufacturing process as compared to licensed OCVs. Hillchol, will therefore prove to be of great importance and value to cholera afflicted countries, according to Jan Holmgren, University of Gothenburg, who invented the vaccine along with his team.
"We are delighted to lead the scale-up, development, manufacturing and commercialisation efforts for Hillchol with our collaboration marking an important step. Our capacity to deliver 50 million doses per year and the addition of a WHO pre-qualification of Hillchol in the future, will not only solve the demand uncertainty but aid in affordability thereby resulting in the wider use of such a vital oral cholera vaccine worldwide,"Bharat Biotech chairman and managing director Krishna Ella said.