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Bharat Biotech inks pact with Acambis for JE vaccine
Y V Phani Raj, Hyderabad | Thursday, November 24, 2005, 08:00 Hrs  [IST]

Acambis has established a manufacturing and marketing agreement with Bharat Biotech International Limited (BBIL) for ChimeriVax-JE investigational vaccine against Japanese Encephalitis (JE). Under the agreement, Bharat Biotech will be responsible for

end-stage fill / finish processing of ChimerVax-JE at its Hyderabad facility. Once the vaccine is approved, BBIL will market and distribute the vaccine in India and neighbouring countries. The agreement is initially for five-years which is subjected to further extension.

Bulk vaccine will continue to be manufactured at Acambis' Canton, Massachusetts facility, where material for phase-III testing has already been produced following technology transfer and scale-up to commercial scale manufacture.

Acambis is preparing to commence pivotal phase III trials of a single-dose regimen of its ChimeriVax-JE vaccine candidate by the end of 2005, having completed phase II clinical testing. The vaccine is likely to be introduced in India in 2006.

According to Gordon Cameron, chief executive officer of Acambis, the scale of the current epidemic in India has highlighted the current need for a safe, efficacious and cost-effective vaccine against JE. This collaboration is part of the company's strategy to establish the vaccine as the optimum vaccine in endemic countries.

Mick Garstang, director-Marketing, Acambis told Pharmabiz that the vaccine will be targeted to markets such as the non-endemic regions like the US, Australia, Europe, and endemic regions like China, Japan, Taiwan, Philippines, Malaysia, India, Bangladesh and Sri Lanka. The JE vaccine will be launched in Asian markets first and gradually be launched in the US.

Dr Krishna M Ella, chairman and managing director of BBIL stated, " It is Bharat Biotech's endeavour to provide vaccines based on the most up-to-date technology platforms and of the highest quality to people living in developing countries. This partnership with Acambis will enable us to bring a much-needed and improved JE vaccine to children in the Indian subcontinent."

JE, a virus transmitted to humans by mosquitoes is the leading cause of childhood encephalitis and viral encephalitis in Asia. There are estimated 30,000 to 50,000 cases of JE reported every year, of which about 30 per cent are fatal, and a high proportion of survivors are left with serious neurological impairment. JE is prevalent in Andhra Pradesh, Assam, Bihar, Goa, Karnataka, Manipur, Tamil Nadu, Uttar Pradesh and West Bengal.

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