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Hilleman Laboratories is in discussions with vaccine makers to produce and market its products targeting respiratory and gastro-intestinal infections, two of the biggest health challenges in young children, said Chief Executive Davinder Gill.
Gill was speaking to Business Line on Hilleman’s collaboration to develop a next-generation oral cholera vaccine, along with Sweden’s Gotovax AB, a University of Gothenburg spin-off biopharmaceutical company.
Pre-clinical tests
A lead vaccine candidate is available and pre-clinical tests are currently underway, Gill said, adding that clinical trials on the product were expected to start next year. A viable product is expected only by 2018, but discussions are underway with vaccine makers in India and the region to help scale-up production and distribution once a final product is available, he said.
Hilleman is an equally-partnered joint-venture between drug major Merck and global charitable foundation Wellcome Trust, started with a seed funding of £ 90 million in 2009. Its 40-scientist strong research centre has been operational in India since late 2011.
Low - priced and heat-stable
Hilleman expects to price its oral cholera vaccine lower than similar products available in the market place, Gill said. Competitors include Shantha Biotech’s (now owned by Sanofi) Shanchol vaccine priced at $ 1.85 per doze and Dukoral at $ 10.5 per dose, he added.
Outlining the benefits in Hilleman’s oral cholera vaccine, he said it was more heat-stable, provided expanded protection against ETEC diarrhea, and it was easier to give to patients.
Heat-stability in vaccines allows for them to be transported and used in remote regions without requiring cold storages to stock-pile them. Traditionally, the absence of cold storage chains has been a key concern in keeping vaccines stable in hot regions like India and Africa
Hilleman is also working on a rotavirus vaccine that shows greater thermo-stability than those in the market, Gill said. Rotavirus cause gastroenteritis with symptoms, including severe watery diarrhea, says the Centers for Disease Control and Prevention.
Clinical trials to test the safety and efficacy of Hilleman’s rotavirus vaccine are also expected to start next year. The company would like to partner with a single manufacturer across multiple products, he said, on the scale-up plan, once the rotavirus product was ready to be commercialised.
Usually structured as profit-sharing agreements, Gill expects to seal a partnership with the companies, for the manufacture and sale of these products, within this year.
Cholera is endemic in over 50 countries, estimated mortality of 100,000-120,000 deaths annually.
Low-cost vaccine needed for use in epidemic outbreaks and mass vaccinations in such settings. Demand also exists for travellers to these regions.
Cholera vaccines demand estimated at 30 million doses by 2016 rising to 200 million doses by 2025, assuming vaccination of all 1-14 year old patients in high risk populations.
Rotavirus infected cases pegged at upto 5,00,000 annually.
Source: Hilleman Laboratories
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