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 vaccineʹs 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 Intercellʹs 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 Intercellʹs Japanese Encephalitis vaccine.
About Japanese Encephalitis
Japanese Encephalitis (JE) is a deadly infectious disease found mainly in Asia. Approximately 30,000 to 50,000 cases of JE are reported in Asia each year, and the actual number of cases are likely much higher due to underreporting in rural areas. JE is fatal in approximately 30 percent of those who show symptoms and leaves half of survivors with permanent brain damage. The disease is endemic in Asia and Southeast Asia, a region with more than 3 billion inhabitants. In the year 2005, Japanese Encephalitis killed more than 1,200 children during an epidemic outbreak in Uttar Pradesh, India, and Nepal.
About Biological E. Ltd.
Established in 1953, Biological E. Ltd. (BE) has been a leading vaccine and pharmaceutical company based out of Hyderabad, India. The company produces a range of critical vaccines and has been an active partner with the National Immunization Programs of various countries. The company continues to invest in large scale cGMP facilities in order to increase its capacities and product range to offer vaccines/biologics on a global basis including US FDA and EMA markets. Three vaccines manufactured by Biological E. – BE TT, Combefive (Reconstituted) & Combefive (Liquid) – have WHO Prequalification approval. In addition to its pipeline of vaccines and biologics, the company has entered into a number of strategic collaborations with leading biotech companies and research institutes for joint R&D projects. Biological E. is a privately held company and run by professionals with significant experience in global biopharmaceutical business. For more information please visit:
About Intercell AG
Intercell AG is a vaccine‐biotechnology company with the clear vision to develop and
commercialize novel immunomodulatory biologicals to prevent disease and reduce suffering across the world.
Intercellʹs vaccine to prevent Japanese Encephalitis (JE) is the Companyʹs first product on the market. This is a next generation vaccine against the most common vaccine‐preventable cause of encephalitis in Asia licensed in more than thirty countries.
The Companyʹs technology base includes novel platforms, such as the patch‐based delivery
system and the proprietary human monoclonal antibody discovery system eMAB®, in addition to well‐established technologies upon which Intercell has entered into strategic partnerships with a number of leading pharmaceutical companies, including GSK, Novartis, Merck & Co., Inc., and Sanofi.
The Companyʹs pipeline of investigational products includes a development program for the pediatric use of Intercellʹs JE‐Vaccine IXIARO®/JESPECT® in non‐endemic markets and the development for endemic markets in collaboration with Biological E. of a comparable vaccine based on Intercell’s technology. Furthermore, the portfolio comprises different product candidates in clinical trials: a Pseudomonas aeruginosa vaccine candidate (Phase II/III) partnered with Novartis, a vaccine to prevent Pandemic Influenza by combining the Companyʹs Vaccine Enhancement Patch with an injected vaccine (Phase I), a vaccine candidate against infections with C. difficile (Phase I) as well as numerous investigative vaccine programs using the Companyʹs IC31® adjuvant, e.g. in a Tuberculosis vaccine candidate (Phase II).
Intercell has in‐house cGMP capability to manufacture both clinical and commercial biologicals at its fully owned site in Livingston, Scotland. The manufacturing site is currently dedicated to the production of the Company‘s novel Japanese Encephalitis vaccine. It is licensed and operates under a Manufacturing Authorisation granted by the Medicines and Healthcare products Regulatory Agency (MHRA) and it is also registered by the FDA. As such, the facility is subject to routine inspection by the MHRA, FDA and other Competent Authorities in connection with the manufacture, sale and supply of Japanese Encephalitis vaccine (trade name IXIARO®/JESPECT®).
Intercell is listed on the Vienna Stock Exchange under the symbol ʺICLLʺ (U.S. level one ADR symbol ʺINRLYʺ).
For more information, please visit: www.intercell.com