In order to meet the needs of Japanese Encephalitis (JE) vaccine in Asian countries, Nasdaq listed Acambis Plc has signed a manufacturing and marketing agreement with Bharat Biotech International Ltd for its ChimeriVax, an investigational vaccine against Japanese Encephalitis. Currently, there are no anti-viral drugs to fight against JE except for only one preventive vaccine derived out of animal origin (from mouse-brain).

“The phase III clinical trials are expected to be completed by February 2006 and we are hoping to launch the product by June 2006,” Krishna Mohan President Bharat Biotech told the media here on Wednesday.

Dr Mohan further expressed that the existing vaccine has production limitations, as it is been manufactured by a government-owned laboratory at Kasauli. Moreover, it is a multi-dose vaccine and priced at about Rs.150 per dose. The new vaccine, ChimeriVax which is recombinant in nature is a live, single-shot attenuated second-generation vaccine having better clinical efficiency and durable protection, he said.

On the demand front he said, there is a need for more than 10 million doses and the company will start with one million doses initially and scale it further. The company is hoping that the government will consider this as a fast track project and bring it under mass immunization programmes.

JE, a virus transmitted to humans by mosquitoes, is an epidemic affecting areas of north India where more than 1,000 people have died since July 2005. As per the estimates, there are 30,000-50,000 cases of JE and a high proportion of survivors left with neurological impairment.

Following the increasing demand, the World Health Organisation and the Gates Foundation have identified the need for a second-generation. In this relation, Acambis is preparing to commence the phase III trials of a single dose of its ChimeriVax-JE vaccine.

Under this agreement, Bharat Biotech will be responsible fill/finish processing of ChimeriVax at Hyderabad besides marketing and distributing the vaccine in India and neighbouring countries. However, bulk vaccine will continue to be manufactured at Acambis’ Cantor facility where the material for phase III testing has already been produced following technology transfer and scale-up manufacturing.