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Hilleman licenses oral cholera vaccine Hillchol to Bharat Biotech

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The collaboration seeks to accelerate the development, licensure, manufacture and supply of an affordable, next-generation cholera vaccine to support access in low and middle-income countries

Hilleman Laboratories announced that it has entered into a collaboration with Bharat Biotech International (BBIL) for further development, manufacturing and commercialization of its next-generation oral cholera vaccine, Hillchol. This collaboration will strengthen the ability of both organizations towards prevention of Cholera through rapid and cost-effective deployment of vaccine doses in low and middle-income countries.

Cholera is an acute diarrheal infection caused by vibrio cholerae and has been responsible for seven pandemics to date. Cholera is a poverty-related disease, endemic in South Asia and Africa, and is on the WHO priority list. Globally, Cholera accounts for roughly 2.8 million cases and an estimated 95,000 deaths annually. In India, about 30 per cent of the population – 375 million people – remains at risk. Deployment of oral cholera vaccines (OCVs) is an essential public health component of comprehensive cholera prevention and control, recommended by the WHO and an element of its “EndCholera” initiative.

Hillchol was designed at the University of Gothenburg in Sweden and subsequently developed by Hilleman Labs including demonstration of safety and immunogenicity in an age de-escalating Phase I/II clinical trial conducted in Bangladesh with the assistance of icddr,b and Incepta Vaccines.

For further development of Hillchol, Hilleman Labs has entered into a licensing and manufacturing agreement with BBIL, who will scale the manufacturing process to the commercial stage and establish product specifications required for WHO pre-qualification.

Prof. Jan Holmgren, University of Gothenburg who along with his colleague Dr Michael Lebens and their team invented the vaccine commented, “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, be of great importance and value to help to meet the urgent demands from Cholera afflicted countries for much expanded oral Cholera vaccines manufacturing and supplies for the control of Cholera globally.”

Speaking about the partnership, Dr Davinder Gill, Chief Executive Officer, Hilleman Laboratories said, “Vaccines play a critical role in improving healthcare outcomes globally, and Hilleman Laboratories is honoured to work with Bharat Biotech, a leading vaccine manufacturer in India for development, and if licensed, eventual manufacturing and commercialization of our innovative oral Cholera vaccine Hillchol. Availability of an affordable Cholera vaccine is particularly significant considering that more than 50 GAVI eligible countries have been categorized as cholera-endemic. We hope this collaboration will provide an innovative vaccine solution which is both affordable and accessible.”

Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech International Limited, said, “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.”

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