Reportedly, the ability to produce VaxInnate’s recombinant vaccine in a bacterial expression system will enable BE to manufacture vaccine at the company’s existing biotechnology facilities with microbial production capacity.
The agreement also permits BE to sell excess vaccine to other South Asian countries, including Bangladesh, Bhutan, the Maldives, Nepal, Pakistan and Sri Lanka.
As per the agreement, the vaccine is expected to enter clinical development in India early this year and could become available for emergency use in India after completion of clinical trials. As with all new vaccines, the Indian Government must approve the vaccine based upon clinical evaluation before it can be used. Financial terms of the agreement include initial fees, milestone payments and royalties on sales.
Furthermore, VaxInnate plans to pursue clinical development and licensure of pandemic and seasonal flu vaccines in the US. In 2009, VaxInnate has conducted successful clinical trials evaluating the potency, efficacy and safety of the vaccine using the Solomon Islands’ seasonal influenza strain of the H1N1 flu. VaxInnate’s pandemic H1N1 flu vaccine is expected to enter clinical development in the US this year.
Vijay Kumar Datla, chairman and managing director of BE, said: “BE looks forward to working closely with VaxInnate to rapidly develop and manufacture this innovative vaccine in India.”
Alan Shaw, president and CEO of VaxInnate, said: “VaxInnate is pleased to partner with BE to meet the H1N1 vaccine needs of India and to demonstrate the speed and volume capabilities of our proprietary vaccine technology. We will continue to pursue domestic and other international partnerships for development of this and other vaccines to meet global needs.”