Intercell AG (VSE: ICLL) today announced that the Australian Therapeutic Goods Administration (TGA) granted product approval for the company's vaccine to prevent Japanese Encephalitis. This decision of the Australian authorities represents the first regulatory approval for the vaccine in any country.
Intercell AG (VSE: ICLL) today announced that the Australian Therapeutic Goods Administration (TGA) granted product approval for the company's vaccine to prevent Japanese Encephalitis. This final decision step for the new vaccine follows the positive recommendation provided by Australian Drug Evaluation Committee (ADEC) in December 2008.
This decision of the Australian authorities represents the first regulatory approval for the vaccine in any country. Intercell has been successfully advancing parallel regulatory processes in all key markets for travelers and military personnel with an imminent product approval in the U.S. Following the CHMP positive opinion of the European Medicines Agency (EMEA) obtained in December 2008, the approval by the European Union providing formal market authorization for all 27 member states as well as for Norway and Iceland will follow within the next weeks according to the defined EMEA process.
"We are very pleased that all approval processes for our novel Japanese Encephalitis vaccine have proceeded in line with our planned time-lines. We are now moving forward to bring this important product to both travelers and military personnel in early 2009," states Thomas Lingelbach, Chief Operating Officer of Intercell.
Japanese Encephalitis is a deadly disease that kills as many as 30% of those who manifest the disease. Japanese Encephalitis is only becoming a larger risk for travelers. There is increasing travel to rural areas where the disease is more common, and climate change is extending the range of disease-carrying mosquitoes.
Intercell's vaccine will be the only registered JE-vaccine available in the Australian market and will be distributed and marketed by CSL Biotherapies Pty Ltd., which has the exclusive right for marketing and distribution of the novel cell culture-based vaccine in Australia, New Zealand, Papua New Guinea and Pacific Islands (trade name JESPECT). Intercell is committed to make JESPECT available to the Australian market as soon as possible.
Intercell's vaccine is a purified, inactivated product for active immunization against viral infections of Japanese Encephalitis. The vaccine is manufactured in Intercell's proprietary manufacturing facility in Scotland and is prepared using tissue culture rather than live organisms.
About Japanese Encephalitis
Japanese Encephalitis is a mosquito-borne infection that strikes 30,000 to 50,000 individuals a year, causing 10,000 to 15,000 deaths. Up to 50% of survivors have persistent neurological sequelae. Japanese Encephalitis is the leading cause of viral neurological disease and disability in Asia and the most important viral encephalitis in Asia. The disease is most common in several developing countries in Asia. No treatment is currently available; only vaccination effectively prevents the disease. Though other vaccines have been available in the past, use of those products was limited due to reports of neurological reactions.
About Intercell's JE vaccine
Intercell's novel JE vaccine is a purified, inactivated vaccine for active immunization against the Japanese Encephalitis virus. The vaccine was developed for over 10 years under a Collaborative Research and Development Agreement (CRADA) with the Walter Reed Army Institute of Research (WRAIR).
Intercell's Phase III trials for the vaccine found that the vaccine demonstrated excellent immunogenicity against Japanese Encephalitis and an overall clinical safety profile similar to placebo combined with an excellent local tolerability profile. These data were published in The Lancet in December 2007:
The immunogenicity was comparable to that of the U.S. licensed product, JE-VAX
Intercell's vaccine demonstrated an overall clinical safety profile similar to placebo
Further, Intercell's JE vaccine had an excellent local tolerability profile in the head-to-head study with JE-VAX
In December 2008 Intercell AG received the CHMP (European Committee for Human Medicinal Products) positive opinion for the approval of its vaccine in Europe. Furthermore, the Australian Drug Evaluation Committee (ADEC) has issued a positive approval recommendation for the company's new vaccine against Japanese Encephalitis.
Reference: Intercell AG is a growing biotechnology company that designs and develops novel vaccines for the prevention and treatment of infectious diseases with substantial unmet medical needs. Intercell's vaccine to prevent Japanese Encephalitis is the company's first product on the market.
The Company's technology platforms include an antigen-discovery system, adjuvants and a novel patch-based delivery system. Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including Novartis, Merck & Co., Inc., Wyeth, Sanofi Pasteur, Kyowa Hakko Kirin and the Statens Serum Institut.
The Company's development pipeline includes Phase II vaccine programs for Pseudomonas (in-house development) and S. aureus, which is being developed with Merck & Co. Inc. The Company's novel Travelers' Diarrhea vaccine patch will enter Phase III testing in 2009. Intercell is also in clinical trials of a vaccine enhancement patch with injected Pandemic Influenza vaccines (one shot plus patch). In addition, four other products focused on infectious diseases are in pre-clinical development.
Intercell is listed on the Vienna stock exchange under the symbol "ICLL".
For more information, please visit: www.intercell.com CONTACT: Lucia Malfent, Head of Corporate Communications of Intercell AG, +43-1-20620-1303, LMalfent@intercell.com
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