Intercell’s first product on the market is a Japanese Encephalitis (JE) vaccine. The product is approved in the U.S. (FDA), Europe (European Commission), Canada (Health Canada), Switzerland (Swissmedic), Hong Kong and Australia (TGA). 

The vaccine contains a purified, inactivated Japanese Encephalitis virus strain. The virus is propagated in Vero cells, purified and formulated. It is a liquid formulation in a ready-to use prefilled syringe. The vaccine neither does nor contains gelatin or any other stabilizer, nor thimerosal or any other preservative.

In clinical trials Intercell's Japanese Encephalitis vaccine demonstrated an overall clinical safety profile similiar to the control arm; it was less reactogenic, it showed a higher potency, a higher persistency and patient convenience (two instead of three doses) than current available vaccines. Results of the non-inferiority randomized controlled Phase III study was published in the renowned international journal "The Lancet" in December 2007. (Link publication, opens in a new window)

Furthermore, the vaccine shows on a successful ability to prevent childhood Encephalitis. Analysis of Phase II data suggests that a half-dose given to young children (1 to 3 years of age) has the excellent immunogenicity and the safety profile comparable to that of adults taking the full adult dosage. The start of Phase III clinical trials in India are planned for 2010.

Manufacturing and supplies

Intercell received Manufacturing Licenses for future commercial manufacturing of the JE vaccine after successfully passing the inspection by the British Medicines and Healthcare products Regulatory Agency (MHRA) in the beginning of 2008. The vaccine is manufactured in-house at Intercell Biomedical Ltd, Scotland, according to GMP guidelines.

Important Information on Expiry Dating of IXIARO^®, Japanese Encephalitis Vaccine, Inactivated, Adsorbed, delivered in the U.S.

Please note that the expiry date for the following lots are incorrect on the syringe labels. There is no evidence of any safety concern with these lots.

• Lot JEV10F53F: The correct expiry date is End of March 2012.
• Lot JEV10G56F: The correct expiry date is End of July 2012.
• Lot JEV10H61F: The correct expiry date is End of July 2012.

Please click here to read the Dear Healthcare Professional Letter.

Regulatory filing

In December 2007 Intercell submitted a Marketing Authorization Application (MAA) and Biologics License Application (BLA) to the European Medicines Agency (EMEA) and U.S. Food and Drug Administration (FDA). 

Intercell’s Japanese Encephalitis vaccine, IXIARO®, was approved by the U.S. Food and Drug Administration (FDA) on March 30, 2009.

Intercell's Japanese Encephalitis vaccine was granted product approval by the Australian Therapeutic Goods Administration (TGA) in January 2009. This followed the positive recommendation issued by the Australian Drug Evaluation Committee (ADEC) on December 12, 2008. 

The new vaccine to prevent Japanese Encephalitis, IXIARO®, was approved by the European Commission on April 2, 2009. The approval by the European Union, the first for a vaccine to prevent the disease, provides formal market authorization in all 27 member states as well as Norway and Iceland. The approval followed the positive opinion from European Committee for Human Medicinal Products (CHMP) in December 2008. Please click on the link to read CHMP Summaries of Opinion:

• CHMP - Summary of positive opinion for IXIARO® (opens in new window)

The product approval in Canada by Health Canada was obtained on October 30, 2009.

Intercell is also applying in other countries like Switzerland and others. 

Distribution

By entering into distribution partnerships with various partners for selected markets, Intercell has followed a structured approach in order to maximize vaccine sales. So far, Intercell has signed three commercial agreements;

• Novartis will serve the U.S., EU and Canadian travelers’ markets, Japan and South Korea as well as certain other markets in Latin America and Asia
• Biological E. Ltd. (India) will manufacture and market the vaccine in India, Bhutan, Nepal and Bangladesh
• CSL Biotherapies (Australia) will market and distribute the vaccine in Australia, New Zeeland, Papua New Guinea and Pacific Islands

Vaccine sales to the U.S. military will be handled in-house.

A disease with substantial unmet medical need

Japanese Encephalitis is a mosquito-borne flaviviral infection. The endemic disease is a major health problem throughout Asia, predominantly affecting children in rural areas. JE virus has recently spread to new areas due to agricultural development and an intense increase in rice cultivation (Source WHO). A mild infection may cause symptoms such as low fewer and headache, while a more severe infection could result in high fever, disorientation, coma, tremor, occasional convulsions, and spastic paralysis. 

Every year, approximately 30,000 to 50,000 humans are infected and about 30 percent die, though those estimates are believed to be low as the disease is underreported. Moreover, about half of all cases result in permanent neuropsychiatric disabilities significantly (Source WHO). JE is not only a threat to people living in endemic areas but also to travelers and military personnel who work or travel in such areas.

Current treatment and prevention

At present, there is no therapy available. However, JE can be prevented by vaccination. Routine immunization with live-attenuated or inactivated vaccines is performed in some countries in Asia where JE is endemic. But available products are suboptimal due to the way they are produced and most are only registered for selected Asian markets. The inactivated vaccines that have been available in the U.S. and Europe are effective, but have been hampered by reports on neurological reactions and other side effects.

In autumn 2007, it was announced that the company BIKEN would discontinue the production of their vaccine against Japanese Encephalitis, JE-VAX®. JE-VAX® is produced in mouse brain and was for many years the only licensed prophylactic vaccine available in the United States. Though never licensed in Europe, JE-VAX® has been available also for European travelers, but then used at one’s own risk on a patient name basis.

• Novartis
• CSL Biotherapies
• Biological E. Ltd.