INTERCELL AG 
By - Indian authorities granted approval for Japanese Encephalitis (JE) vaccine in endemic region
- Important milestone towards introduction of Intercell's modern, cell culture-derived technology based vaccine in endemic countries
Vienna (Austria)/Hyderabad (India), November 10, 2011 - Intercell AG and its partner Biological E. Ltd. today announced the approval of their vaccine to protect children and adults from Japanese Encephalitis (JE) by the Drugs Controller General of India (DCGI).
As previously announced, the analysis of the pivotal Phase III safety and immunogenicity data showed positive results and the study met its primary endpoint. Through a rolling submission process initiated in 2010 and an external "Expert Committee" review in October 2011 as well as recognized disease burden in endemic regions in India, the Indian authorities were able to facilitate the review and grant approval. The launch of the product, which will be known as JEEV®, is on track and expected for H1 2012, following the manufacturing and release of commercial launch batches at Biological E.'s facility in Hyderabad.
"The approval by the Indian authorities represents an important milestone in our strategy to roll out our Japanese Encephalitis vaccine in endemic countries with high medical need and to protect children and adults against this terrible disease. Without a local strategic partner like Biological E. however, this success wouldn't have been possible", states Thomas Lingelbach, Chief Executive Officer of Intercell AG.
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 (IXIARO®) and Australia (JESPECT®).
Dr. Vijay Kumar Datla, Chairman & Managing Director of Biological E. said, "This is a significant milestone and has tremendous relevance for India. We are pleased that we are able to now manufacture this important vaccine, (JEEV®) locally and will begin discussion with key stakeholders to see how this vaccine can play in role in supporting India's on-going fight against the dreadful disease."
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.
To download the full release please follow the link:
