Acambis joins forces with Bharat Biotech to address unmet need for JE vaccine in India
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Acambis plc announced that it has established a manufacturing and marketing agreement with Bharat Biotech International Limited ("Bharat Biotech") of India relating to Acambis' ChimeriVax(TM)-JE investigational vaccine against Japanese encephalitis ("JE").
Despite the availability of first-generation JE vaccines for 60 years, the virus continues to cause death and disease. As a result of this significant unmet public health need and in the absence of a safe, single-dose vaccine, both the World Health Organization's Initiative for Vaccine Research and the Gates Foundation have identified a need for development of a second-generation, affordable JE vaccine that has an acceptable safety profile and requires fewer doses than currently available vaccines.
The introduction of a single-dose vaccine could potentially transform the use of vaccines against JE by making it simpler, faster, easier and cheaper for healthcare providers to administer, particularly in regions where achieving compliance to multi-dose regimens can be difficult. Acambis is preparing to commence pivotal Phase lll trials of a single-dose regimen of its ChimeriVax-JE vaccine candidate before the end of 2005, having completed Phase ll clinical testing. Current JE vaccines are administered in multiple doses.
Under the agreement Bharat Biotech will be responsible for end-stage fill/finish processing of ChimeriVax-JE at its facilities in India and, once ChimeriVax-JE is approved, will market and distribute the vaccine in India and neighbouring countries. Bulk vaccine will continue to be manufactured at Acambis' Canton, Massachusetts facility, where material for Phase lll testing has already been produced following technology transfer and scale-up to commercial scale manufacture.
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