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Intercell Successfully Completes Vaccine Study in India

Published: September 16, 2011; 11:36 · (Vindobona)

The Austrian biotech company achieved an important step in the licensure process of a vaccine for children.

Intercell Successfully Completes Vaccine Study in India / Picture: © Intercell

Intercell AG and its partner Biological E. Ltd. today announced the successful completion of a pediatric Phase II/III study for the vaccine to protect children from Japanese Encephalitis (JE). Analysis of the pivotal Phase III safety and immunogenicity data showed positive results and that the study met its primary endpoint.

The study, conducted across eight study sites in India and including 456 randomized subjects, was designed to lead to licensure in India. The vaccine is manufactured in India by Biological E and is based on Intercell's technology, which was successfully used to gain product licensure of the adult vaccine in Europe, the United States, Canada, Hong Kong and Australia.

"We are very pleased to have reached this important milestone in our collaboration with Biological E. which moves us one step closer towards being able to provide a vaccine to protect children living in endemic areas threatened by this terrible disease. The successful completion of this Phase II/III study is a major step towards making our modern cell culture-derived product available in Asia, and supports our global territory expansion", states Thomas Lingelbach, Chief Executive Officer of Intercell AG.

In 2005, Intercell and Biological E. signed a contract for the development, manufacturing, marketing and distribution in India and the Indian subcontinent of Intercell's Japanese Encephalitis vaccine. The vaccine's further regulatory approval route for other Asian territories is expected through the World Health Organization – Novartis will be responsible for the marketing and distribution in these regions. Following the approval and launch of Intercell's vaccine against Japanese Encephalitis for adult travelers and military personnel in Europe, the USA and Australia, the development of a vaccine to protect children in endemic areas from Japanese Encephalitis has been a major goal of the Company.