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This decision of the Australian authorities represents the firstregulatory approval for the vaccine in any country. Intercell has beensuccessfully advancing parallel regulatory processes in all key markets fortravelers 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 formalmarket authorization for all 27 member states as well as for Norway andIceland will follow within the next weeks according to the defined EMEAprocess.
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"We are very pleased that all approval processes for our novel JapaneseEncephalitis vaccine have proceeded in line with our planned timelines. We arenow moving forward to bring this important product to both travelers andmilitary personnel in early 2009," states Thomas Lingelbach, Chief OperatingOfficer of Intercell.
Japanese Encephalitis is a deadly disease that kills as many as 30% ofthose who manifest the disease. Japanese Encephalitis is only becoming alarger risk for travelers. There is increasing travel to rural areas where thedisease is more common, and climate change is extending the range ofdisease-carrying mosquitoes.
Intercell's vaccine will be the only registered JE-vaccine available inthe Australian market and will be distributed and marketed by CSL BiotherapiesPty Ltd., which has the exclusive right for marketing and distribution of thenovel cell culture-based vaccine in Australia, New Zealand, Papua New Guineaand Pacific Islands (trade name JESPECT(R)). Intercell is committed to makeJESPECT(R) available to the Australian market as soon as possible.
Intercell's vaccine is a purified, inactivated product for activeimmunization against viral infections of Japanese Encephalitis. The vaccine ismanufactured in Intercell's proprietary manufacturing facility in Scotland andis prepared using tissue culture rather than live organisms.
About Japanese Encephalitis
Japanese Encephalitis is a mosquito-borne infection that strikes 30,000 to50,000 individuals a year, causing 10,000 to 15,000 deaths. Up to 50% ofsurvivors have persistent neurological sequelae. Japanese Encephalitis is theleading cause of viral neurological disease and disability in Asia and themost important viral encephalitis in Asia. The disease is most common inseveral developing countries in Asia. No treatment is currently available;only vaccination effectively prevents the disease. Though other vaccines havebeen available in the past, use of those products was limited due to reportsof neurological reactions.
About Intercell's JE vaccine
Intercell's novel JE vaccine is a purified, inactivated vaccine for activeimmunization against the Japanese Encephalitis virus. The vaccine wasdeveloped for over 10 years under a Collaborative Research and DevelopmentAgreement (CRADA) with the Walter Reed Army Institute of Research (WRAIR).
Intercell's Phase III trials for the vaccine found that the vaccinedemonstrated excellent immunogenicity against Japanese Encephalitis and anoverall clinical safety profile similar to placebo combined with an excellentlocal tolerability profile. These data were published in The Lancet inDecember 2007:
-- The immunogenicity was comparable to that of the U.S. licensed product,JE-VAX(R)
-- Intercell's vaccine demonstrated an overall clinical safety profilesimilar to placebo
-- Further, Intercell's JE vaccine had an excellent local tolerabilityprofile in the head-to-head study with JE-VAX(R)
In December 2008 Intercell AG received the CHMP (European Committee forHuman Medicinal Products) positive opinion for the approval of its vaccine inEurope. Furthermore, the Australian Drug Evaluation Committee (ADEC) hasissued a positive approval recommendation for the company's new vaccineagainst Japanese Encephalitis.
About Intercell AG
Intercell AG is a growing biotechnology company that designs and developsnovel vaccines for the prevention and treatment of infectious diseases withsubstantial unmet medical needs. Intercell's vaccine to prevent JapaneseEncephalitis 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 thesetechnologies, Intercell has strategic partnerships with a number of globalpharmaceutical companies, including Novartis, Merck & Co., Inc., Wyeth, SanofiPasteur, Kyowa Hakko Kirin and the Statens Serum Institut.
The Company's development pipeline includes Phase II vaccine programs forPseudomonas (in-house development) and S. aureus, which is being developedwith Merck & Co. Inc. The Company's novel Travelers' Diarrhea vaccine patchwill enter Phase III testing in 2009. Intercell is also in clinical trials ofa vaccine enhancement patch with injected Pandemic Influenza vaccines (oneshot plus patch). In addition, four other products focused on infectiousdiseases are in pre-clinical development.
Intercell is listed on the Vienna stock exchange under the symbol "ICLL".
For more information, please visit: http://www.intercell.com
This communication expressly or implicitly contains certainforward-looking statements concerning Intercell AG and its business. Suchstatements involve certain known and unknown risks, uncertainties and otherfactors which could cause the actual results, financial condition, performanceor achievements of Intercell AG to be materially different from any futureresults, performance or achievements expressed or implied by suchforward-looking statements. Intercell AG is providing this communication as ofthis date and does not undertake to update any forward-looking statementscontained herein as a result of new information, future events or otherwise.
SOURCE Intercell AG
