Hyderabad|India|September'2011: Biological E. Limited (BE) has successfully completed the phase 2/3 study in healthy infants between 1 to 3 years old in India across eight study sites. This is an important milestone in the clinical development of this vero cell based inactivated JE vaccine manufactured in India based on the technology transfer agreement with Intercell.

Japanese encephalitis (JE) is the leading cause of viral encephalitis in Asia, with 30,000–50,000 cases reported annually. Case-fatality rates range from 0.3% to 60% and depends on the population and on age. There is no specific treatment for Japanese encephalitis and therapeutic management is only supportive. This year, large numbers of cases and deaths have been reported in Eastern Uttar Pradesh, Assam & Bihar. Also the southern states have reported large number of cases as per government reports.

The results of the study would be submitted to the Indian regulatory authority for licensure. With this vaccine coming into the Indian market there would be an efficacious and safe vaccine for use in children in India and other parts of Asia.

BE’s inactivated JE vaccine (JEEV®)is not produced in mouse brains, but in vitro using cell culture hence there is reduced risk of rare autoimmune neurological complications. Unlike mouse brain derived vaccines which require three doses given at 0, 7–14 and 28–30 days, BE’s inactivated JE vaccine, like IXIARO™, has an unique advantage of offering a convenient two dose schedule (day 0 & 28), better safety profile and efficacy. The route of administration is intramuscular unlike the mouse brain derived vaccines which are administered subcutaneously.

Dr. Vijay Kumar Datla, Chairman and Managing Director of Biological E. Limited added: “We are excited about the successful completion of our phase-II/III clinical study which enables us to offer this novel and safe vaccine to combat Japanese Encephalitis not only in India but also across Asia. There is also an urgent need to respond to the JE epidemic throughout India and Asia where large-scale immunization is critical. Our strategic partnership with Intercell furthers the aim of ensuring a sustainable supply of our vaccine at the earliest.”