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Intercell AG. (11/10/11). "Press Release: Intercell and Biological E. Ltd. Announce Approval for Japanese Encephalitis Vaccine in India". Vienna & Hyderabad.

Region Region India
Organisation Organisation Intercell AG (VSE: ICLL)
  Today Valneva Austria GmbH
  Group Valneva (Group)
Products Product Ixiaro®
  Product 2 vaccine technology
Persons Person Lingelbach, Thomas (Intercell 201106– CEO before COO before 2001– Chiron Behring)
  Person 2 Datla, Vijay Kumar (Biological E 201109 Managing Director)
     


– 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


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.


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 Southeast Asia, a region with more than 3 billion inhabitants. Only within 1 month 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 EMEA markets. 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: www.biologicale.com


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. Intercell's vaccine to prevent Japanese Encephalitis (JE) is the Company's first product on the market. The Company's technology base includes novel platforms, such as the patch-based delivery system and the proprietary human monoclonal antibody discovery system eMabs®, 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-aventis.

The Company's pipeline of investigational products includes a development program for the pediatric use of Intercell's JE-Vaccine IXIARO® in endemic markets (in collaboration with Biological E.) and non-endemic markets. 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 Company's Vaccine Enhancement Patch with an injected vaccine (Phase I), a combination
treatment approach for Hepatitis C (Phase II) partnered with Romark, a vaccine candidate against infections with C. difficile (Phase I) as well as partnered vaccine programs using the Company's IC31® adjuvant, e.g. in a Tuberculosis vaccine candidate.

Intercell is listed on the Vienna Stock Exchange under the symbol "ICLL" (U.S. level one ADR
symbol "INRLY").

For more information, please visit: www.intercell.com

Contact

Intercell AG
Corporate Communications
Campus Vienna Biocenter 3, A-1030 Vienna
P: +43-1-20620-1222/-1116
Mail to: communications@intercell.com

Biological E. Ltd
Corporate Communications
18/3 Azamabad, Hyderabad 20
AP India
Mail to: info@biologicale.co.in

This communication expressly or implicitly contains certain forward-looking statements concerning Intercell AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Intercell AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Intercell AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

   
Record changed: 2019-06-09

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