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Intercell is developing a Pandemic Influenza Vaccine Patch System thatincludes an immunostimulant patch administered in conjunction with an injectedPandemic Influenza vaccine (manufactured by Solvay Biologicals, B.V., TheNetherlands); the system is designed to enhance the immune response and enabledose sparing of the Pandemic Influenza vaccine.
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The actual funding forms part of an HHS contract with potential funding ofup to USD 128 m over five years. If successful, Intercell's Pandemic InfluenzaVaccine Patch System would have the effect of expanding limited vaccinesupplies by allowing fewer or lower doses of the vaccine.
The next Phase II study is expected to start in early 2009 and will be arandomized, blinded study to determine the optimal combination and dose of aninjected H5N1 influenza vaccine and the vaccine patch from Intercell. Thestudy will be conducted in the U.S. and is expected to enroll 500 subjects atsix study sites.
The initial Phase I/II clinical trial funded under this HHS contractdemonstrated that a single 45-microgram dose of an injected H5N1 influenzavaccine, coupled with a single 50-microgram Intercell patch was sufficient toprovide an immune response considered protective in 73 percent of thosetested: a statistically significant improvement over those who received theH5N1 influenza vaccine alone. The trial was one of the first to demonstratethat a single dose of Pandemic Influenza vaccine may meet the level ofprotection suggested in U.S. Food and Drug Administration (FDA) guidance.
Thomas Lingelbach, COO of Intercell AG and CEO of Intercell USA commented:"The financial support from HHS enables us to continue our Pandemic Fluprogram with full speed in 2009. The progress of this program is also animportant endorsement of the ability of our patch technology to enhance theimmune response, when combining it with an injected vaccine."
About Pandemic Influenza
Three influenza pandemics have occurred in the 20th century leading to thedeath of more than 50 million people globally. By U.S. government estimates,pandemic influenza has a greater potential to cause deaths and illnesses thanvirtually any other natural health threat. Signs of a pandemic influenza haveemerged in Southeast Asia, as lethal infections of poultry and humans withavian influenza virus continue. The current virus is now endemic in birdpopulations, having spread to more than 40 countries and causing the deaths ofhundreds of millions of birds. Furthermore, the World Health Organizationreports that the number of avian flu cases in humans has reached more than370 cases in 14 countries.
Development of Pandemic Influenza Vaccines
Intercell believes that its vaccine patch (immunostimulant patch) has thepotential for the development of improved influenza vaccines, especially inthe field of pandemic influenza. Preclinical studies and the Phase I/IIclinical study results using the patch with H5N1 vaccine suggest that thisstrategy may be used for other applications where improved immunogenicity,decreased antigen doses, or fewer immunization visits are desired.
About Intercell AG
Intercell AG is a growing biotechnology company which focuses on thedesign and development of novel vaccines for the prevention and treatment ofinfectious diseases with substantial unmet medical need. The Company developsantigens and adjuvants which are derived from its proprietary technologyplatforms and has in-house GMP manufacturing capabilities. 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 leading product, a prophylactic vaccine against JapaneseEncephalitis, is currently in the process of marketing approval in the U.S.,Europe, Australia and Canada. Marketing approval in the U.S., Europe andAustralia is expected for 2008.
The company's broad development pipeline includes a Travelers' Diarrheavaccine (patch) in Phase II (start of Phase III expected in 2009), aPseudomonas vaccine in Phase II, as well as a pandemic Influenza VaccineEnhancement patch, a partnered S. aureus vaccine in Phase II and four productsfocused on infectious diseases in preclinical 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 asof this 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
