Novartis MF59® adjuvanted cell culture-based vaccine shows strong
immune response in A(H1N1) clinica
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * First pilot trial of investigational A(H1N1) vaccine with 100 subjects indicates strong, potentially protective, immune response in 80% of subjects after one dose, more than 90% after two doses. * MF59® adjuvanted cell culture-based A(H1N1) vaccine was well tolerated, pain at the injection site the most frequent adverse event. * Larger pivotal trials with both cell culture and traditional egg based vaccines under way to include more than 6000 adults and children.Basel, September 3 2009 - A pilot trial of Novartis adjuvanted cellculture-based A(H1N1) vaccine[1] indicates that the "swine flu"vaccine elicited a strong immune response and was well tolerated. Thetrial was run by the UK's University of Leicester and UniversityHospitals of Leicester. The vaccine, to be called Celtura®, wastested with 100 healthy volunteers, aged between 18 and 50.The trial evaluated the tolerability and immunogenicity of thevaccine. Different schedules and timing between vaccinations weretested. The vaccine schedule comprised one or two doses of 7.5µgMF-59® adjuvanted surface-antigen A/California/2009 vaccine derivedfrom cell-culture. Results showed that the serum antibody responseswere highest among subjects who received two doses of vaccine,however a single vaccine dose also induced responses associated withprotection against influenza. Hemagglutination-inhibition titresreached 1:40 or greater in 80 percent and more than 90 percent ofthose receiving one dose and two doses respectively. These wouldsatisfy the immunogenicity criteria as set out by European and USregulators. The findings showed that it is possible to induceprotective antibodies against A(H1N1) infection within two weeks ofadministration of a single low-dose adjuvanted vaccine.Non-adjuvanted formulations were not evaluated in the study.Additional pivotal clinical trials, with larger numbers of subjectsand sponsored by Novartis, are already under way around the world.They will include more than 6000 adults and children."The pilot trial results are encouraging," said Dr. Andrin Oswald,CEO of Novartis Vaccines and Diagnostics. "The study suggests thatwhile two doses seem to provide better protection, one dose of ouradjuvanted Celtura vaccine may be sufficient to protect adultsagainst the swine flu. This is important information for publichealth authorities who prepare for vaccination in the coming monthswith limited vaccine supply."The pilot trial was led by Dr. Stephenson of the Department ofInfection, Immunity and Inflammation at the University of Leicester.He is a clinical senior lecturer at the University, and a consultantin infectious diseases at the University Hospitals of Leicester NHSTrust. Dr. Stephenson said "the aim of the trial was to find out howmany doses and what type of vaccine is needed to give protection.These initial results should help to plan vaccination campaigns inthe autumn, including doses and timings. We concluded that theMF59-adjuvanted A(H1N1) vaccine of low antigen content was welltolerated and generated antibody responses associated with protectionagainst influenza, even after a single dose."DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "potentially," "to include,""will," "encouraging," "suggests," "may," "should," "plan", "orsimilar expressions, or by express or implied discussions regardingpotential marketing approvals for an influenza A(H1N1) vaccine,potential production timing and volumes for such a vaccine orregarding potential future revenues from such a vaccine. You shouldnot place undue reliance on these statements. Such forward-lookingstatements reflect the current views of management regarding futureevents, and involve known and unknown risks, uncertainties and otherfactors that may cause actual results to be materially different fromany future results, performance or achievements expressed or impliedby such statements. There can be no guarantee that influenza A(H1N1)vaccines will be approved for sale in any market. Nor can there beany guarantee that influenza A(H1N1) vaccines will be produced by anyparticular date, or in any particular volumes. Neither can there beany guarantee that influenza A(H1N1) vaccines will achieve anyparticular levels of revenue in the future. In particular,management's expectations could be affected by, among other things,unexpected clinical trial results, including unexpected new clinicaldata from the ongoing trials of the A(H1N1) vaccine, and unexpectedadditional analysis of existing clinical data regarding the vaccine;unexpected regulatory actions or delays or government regulationgenerally; unexpected manufacturing difficulties or delays, includingunexpected difficulties with our flu cell culture manufacturingfacility and processes, and unexpected difficulties with theestablished egg-based manufacturing process; competition in general;government, industry and general public pricing pressures; thecompany's ability to obtain or maintain patent or other proprietaryintellectual property protection; the impact that the foregoingfactors could have on the values attributed to the Novartis Group'sassets and liabilities as recorded in the Group's consolidatedbalance sheet, and other risks and factors referred to in NovartisAG's current Form 20-F on file with the US Securities and ExchangeCommission. Should one or more of these risks or uncertaintiesmaterialize, or should underlying assumptions prove incorrect, actualresults may vary materially from those anticipated, believed,estimated or expected. Novartis is providing the information in thispress release as of this date and does not undertake any obligationto update any forward-looking statements contained in this pressrelease as a result of new information, future events or otherwise.About NovartisNovartis Vaccines and Diagnostics is a Novartis division focused onthe development of preventive treatments. The division has twobusinesses: Novartis Vaccines and Chiron. Novartis Vaccines is theworld's fifth-largest vaccines manufacturer and second-largestsupplier of flu vaccines in the US. The division's products alsoinclude meningococcal, pediatric and travel vaccines. Chiron, theblood testing and molecular diagnostics business, is dedicated topreventing the spread of infectious diseases through the developmentof novel blood-screening tools that protect the world's blood supply.Novartis provides healthcare solutions that address the evolvingneeds of patients and societies. Focused solely on healthcare,Novartis offers a diversified portfolio to best meet these needs:innovative medicines, cost-saving generic pharmaceuticals, preventivevaccines, diagnostic tools and consumer health products. Novartis isthe only company with leading positions in each of these areas. In2008, the Group's continuing operations achieved net sales of USD41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2billion was invested in R&D activities throughout the Group.Headquartered in Basel, Switzerland, Novartis Group companies employapproximately 99,000 full-time-equivalent associates and operate inmore than 140 countries around the world. For more information,please visit http://www.novartis.com ###Novartis Media RelationsCentral media line : +41 61 3242200Eric Althoff Paul NewmanNovartis Global Media Relations Novartis Vaccines and Diagnostics+41 61 324 7999 (direct) +1 (617) 871 7931 (direct)+41 79 593 4202 (mobile) +1 (617) 710 8953 (mobile)eric.althoff(at)novartis.com paulc.newman(at)novartis.come-mail: media.relations(at)novartis.comNovartis Investor RelationsCentral phone: +41 61 324 7944Ruth Metzler-Arnold +41 61 324 North America: 9980Pierre-Michel +41 61 324 Richard Jarvis +1 212 830Bringer 1065 2433John Gilardi +41 61 324 Jill Pozarek +1 212 830 3018 2445Thomas +41 61 324 Edwin Valeriano +1 212 830Hungerbuehler 8425 2456Isabella Zinck +41 61 324 7188e-mail: e-mail:investor.relations(at)novartis.com investor.relations(at)novartis.comFootnote[1] Development of Novartis' cell-based influenza vaccine,construction of the cell-based influenza manufacturing facility atHolly Springs, NC and purchase of H1N1 antigen and adjuvant are beingfunded in whole or in part with Federal funds from the Office ofPublic Health Emergency Preparedness, Office of Research andDevelopment Coordination, under Contract Numbers HHSO100200600012C,HHSO100200900101C and HHSO100200800072I, respectively.http://hugin.info/134323/R/1339223/319731.pdf --- End of Message ---Novartis International AGPosfach Basel WKN: 904278; ISIN: CH0012005267; Index: SLCI, SMI, SPI, SLIFE;Listed: Main Market in SIX Swiss Exchange, ZLS in BX Berne eXchange;
Datum: 03.09.2009 - 07:15 Uhr
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