Intercell's partner Biological E. Ltd. launches Japanese Encephalitis vaccine JEEV® in India
Novel vaccine to protect children and adults from Japanese Encephalitis (JE), manufactured by partner Biological E. Ltd. is now available in India
Important milestone towards introduction of vaccine based on Intercell's modern, cell culture-derived technology in endemic countries
Vienna (Austria)/ Hyderabad (India), September 13, 2012 – Intercell AG (VSE: ICLL) today announced that its partner Biological E. Ltd. launched the product JEEV® – a vaccine to protect children and adults from Japanese Encephalitis (JE) – in India. The vaccine, manufactured by Biological E. Ltd. at its facility in Hyderabad and based on Intercell's technology was approved by the Drugs Controller General of India (DCGI).
"With the market launch in India we have taken a major step forward in achieving our goal of rolling-out this Japanese Encephalitis vaccine in endemic countries with a high medical need in order to protect children and adults against this terrible disease. Our strategic partnership with Biological E. has made this possible. Now, we will continue to fight against this disease and collaborate on increasing market penetration in the endemic region", states Thomas Lingelbach, Chief Executive Officer of Intercell AG.
Japanese Encephalitis is endemic in Asia and Southeast Asia, a region with more than 3 billion inhabitants. In 2005, an epidemic outbreak of Japanese Encephalitis in Uttar Pradesh, India, and Nepal killed more than 1,200 children.
Biological E. plans to focus its sales efforts of JEEV® initially on private market customers including pediatricians and general practitioners. To ensure a successful product launch, Biological E. has recruited and trained its own sales force, which will initially be fully dedicated to the product.
According to the product label, the initial approval age groups of the vaccine are children (≥1 - <3 years of age) and adults (≥18 – ≤49 years of age). First deliveries of JEEV® are planned between mid-September and beginning of October, with full scale commercial manufacturing commencing shortly thereafter.
Dr. Vijay Kumar Datla, Chairman & Managing Director of Biological E. said: "With the launch of JEEV®, the indigenous vaccine with excellent safety profile and proven efficacy in Indian subjects is now available to doctors for prevention of Japanese Encephalitis in children and adults."
Biological E. has submitted the Product Summary File under the WHO Prequalification process and the same is under review.
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 countries. Following the approval and launch of Intercell's vaccine against Japanese Encephalitis for adult travelers and military personnel in Europe, the United States, Canada, Hong Kong, Singapore, Israel (IXIARO®) and Australia (JESPECT®) the development of a vaccine to protect children and adults in endemic areas from Japanese Encephalitis has been a major goal of the Company.
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.