Bharat Biotech, Hilleman Labs collaborate to develop oral cholera vaccine HILLCHOL

New Delhi: Hyderabad-based vaccine maker, Bharat Biotech and Hilleman Laboratories today entered into a collaboration for further development, manufacturing and commercialization of its next-generation Oral Cholera Vaccine, Hillchol.

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.

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 Ltd.

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.

Speaking to Medical Dialogues Dr Davinder Gill, Chief Executive Officer, Hilleman Laboratories said, " The vaccine can be given to children above one year of age up to adults of 55 years. The clinical trial has shown the safety and effectiveness of this vaccine in this age group."

"When we license this vaccine we will license this vaccine for that age vacant now in terms of efficacy our goal is that with the two-dose regimen we would like to see the protection for up to 3 years and that is what the phase 3 clinical trial will test, " he added.

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Commenting on the partnership, Dr Gill 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."

Prof. Jan Holmgren, the 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"

Dr Krishna Ella, Chairman & Managing Director of Bharat Biotech International Limited, said, "We are delighted to lead the scale-up, development, manufacturing and commercialization 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."

Speaking to Medical Dialogues Dr Ella added that it will take almost 4-5 years for the said vaccine to enter the Indian market.

Dr Gerd Zettlmeissl, Chairman, Hilleman Laboratories congratulated both partners on entering into a collaboration agreement to align efforts and said "By working together, we can move even closer to meeting the critical public health goal of reducing Cholera burden by 90% by 2030, a key objective of WHO End Cholera initiative"

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 ~2.8 million cases and an estimated 95,000 deaths annually. In India, about 30% of the population - 375 million people - remain 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.

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