The Hyderabad-based Shanta Biotechnics will develop a multivalent vaccine against rotavirus for childhood diarrhoea. The technology for the development of vaccine has been licensed from the US National Institute of Health (NIH). The company has signed an agreement with PATH to develop the vaccine.
"We are excited about working on the multivalent rotavirus vaccine, which has the potential to save many lives," said K Varaprasad Reddy, managing director of the company.
The vaccine has already been developed at NIH, USA and the technology has been transferred to Shantha. At present the company is making the lots of the vaccine that will go into Pre-clinical studies. With the completion of preclinical toxicology studies the company plans to conduct clinical trials of in 2008. It is estimated that 50 million doses of vaccines will be produced, the company said.
According to Shantha, PATH would be the facilitator and will oversee the development of the vaccine. It would provide funds for the development including the early stage clinical trials. The organisation would also proved the necessary expertise in production, formulation, packaging and clinical development.
The overall development of the vaccine till commercialisation is expected to cost over seven million dollars over a five year period. The company is looking at a WHO prequalification for the vaccine to be supplied through UNICEF. The estimated demand for the vaccine is for over 170 million doses per annum.
According to Shantha, rotavirus is the common most cause of the severe dehydrating diarrhoea responsible for more than 5, 27,000 deaths occurring annually in children under the age of five years with majority of the cases in developing nations. It is estimated that rotavirus accounts for 26 per cent of the total diarrhoea cases in the country with prevalence in first two years of life.
"Bringing new vaccine to the market is a key component in improving affordability; PATH is pleased to be partnering with Shantha to develop the vaccine to meet the requirements in India and other countries," said Rajat Goyal, director of PATH.
Currently, the two vaccines that are available in the market are Merck's RotaTeq and GDK's Rotatrix. These are not available in India; PATH is working with Shantha and other emerging manufacturers to develop promising candidates into safe effective and affordable vaccine, the company said.
PATH is an international nonprofit organisation, which works for the development of high priority new health technologies, immunisation, HIV and sexual reproductive health, and maternal and new born healthcare. It operates in India from New Delhi, Chennai, Hyderabad, Imphal, Lucknow, Mumbai, as well as with partnership operations in Assam and Bihar.