Novartis Influenza A(H1N1) 2009 vaccine US interim data show lower
doses of antigen may suffice to g
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Interim clinical data from approximately 4,000 individuals suggest that half a dose of the currently US-approved Novartis unadjuvanted Influenza A(H1N1) 2009 vaccine met immunogenicity criteria in adults and the elderly * Data also show that Novartis MF59® adjuvant was well tolerated and could potentially quadruple the Novartis A(H1N1) 2009 influenza vaccine supply * MF59® adjuvant has an established safety profile supported by clinical data from more than 33,000 study participants and 12 years of real life safety data with more than 45 million doses of influenza vaccine administered since 1997 in EuropeBasel, November 17, 2009 - Novartis announced today new interim datafrom ongoing clinical trials demonstrating that a single 7.5µg doseof the company's influenza A(H1N1) 2009 unadjuvanted vaccine, half ofthe currently-approved US dose, fulfilled immune response criteriaassociated with protection in adults and the elderly (>=65 years ofage).The data also showed a single 3.75µg dose of MF59-adjuvanted A(H1N1)2009 vaccine met serologic protection criteria against influenzaA(H1N1) in children ages 3 to 8, adults ages 18 to 64, and theelderly. All A(H1N1) 2009 influenza study vaccines were manufacturedusing the Novartis established seasonal Fluvirin® manufacturingplatform. Novartis has discussed these new data with the US Food andDrug Administration (FDA) and is performing additional statisticalanalysis suggested by the agency. It is still under evaluationwhether the antigen content per dose can be reduced in the US.Current US guidelines for A(H1N1) 2009 vaccine use state thatadolescents, adults and the elderly are required to receive one 15µgdose to achieve adequate protective antibody levels against theA(H1N1) virus, and children 9 years of age and under are required toreceive two 15µg doses four weeks apart."These promising data suggest that many more people could potentiallybe vaccinated with our current vaccines supply, protecting morepeople earlier against the current pandemic," said Andrin Oswald, CEOof Novartis Vaccines and Diagnostics. "The data also confirms theantigen sparing potential of our proprietary adjuvant, MF59®. Thevaccines output of our Liverpool, U.K., based flu manufacturingfacility, fully dedicated to the US since the emergence of thepandemic, could be quadrupled if vaccines are adjuvanted."These interim data were generated from pivotal clinical studiesdesigned to evaluate the immunogenicity, safety and reactogenicity ofboth MF59-adjuvanted and unadjuvanted, inactivated novel swine originA(H1N1) 2009 monovalent subunit influenza virus vaccine in 4,080 USsubjects. In the pediatric trial, the findings are based on 80% offirst dose data from 1,360 subjects ages 3 to 8 at day 22. In theadult trial, the findings are based on 95% of first dose data at day1 and day 8 and approximately 40% of first dose data at day 22 from1,360 adult subjects and 1,360 elderly subjects. Second dose data anddata in ages 6-36 months of age are expected in December 2009.About MF59Novartis proprietary MF59 adjuvant has an established safety profile,supported by more than 12 years of clinical safety data and more than45 million doses of commercial use in Europe. The adjuvant has beenstudied in clinical trials involving more than 33,000 people,including children, and has been licensed for use in people 65 yearsof age and over in the seasonal influenza vaccine Fluad® since 1997in the European Union. Novartis also produces two A(H1N1) vaccines,Focetria® and Celtura®, which contain MF59 and are available outsidethe US. Currently, there are no approved vaccines in the UnitedStates that contain MF59.Novartis has been contracted by the US Department of Health and HumanServices (HHS) to produce 90 million doses of MF59 by the end ofNovember.[1]About A(H1N1) 2009 VaccineNovartis influenza A(H1N1) 2009 monovalent vaccine, manufacturedusing the established seasonal Fluvirin platform, is an inactivatedinfluenza virus egg-derived vaccine indicated for active immunizationof persons 4 years of age and older against influenza disease causedby pandemic A(H1N1) 2009 virus. The vaccine was approved by the FDAon September 15, 2009 as an unadjuvanted 15µg dose.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "may," "suggest," "could,""potentially," "promising," "potential," "expected," or similarexpressions, or by express or implied discussions regarding regardingpotential additional marketing approvals for Novartis' A(H1N1)vaccines and adjuvants, potential new indications or labeling forNovartis' A(H1N1) vaccines and adjuvants, potential future deliveriesof influenza vaccines and adjuvants, or regarding potential futurerevenues from Novartis' A(H1N1) vaccines and adjuvants. 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 with Novartis' A(H1N1) vaccinesand adjuvants to be materially different from any future results,performance or achievements expressed or implied by such statements.Novartis' A(H1N1) vaccines will achieve any additional marketingapprovals. Nor can there be any guarantee that Novartis' A(H1N1)vaccines and adjuvants will be approved for any additionalindications or labeling in any market. Nor can there be any guaranteethat Novartis will successfully meet its delivery obligations for itsA(H1N1) vaccines and adjuvants. Neither can there be any guaranteethat Novartis' A(H1N1) vaccines and adjuvants will achieve anyparticular levels of revenue in the future. In particular,management's expectations regarding Novartis' A(H1N1) vaccines andadjuvants could be affected by, among other things, unexpectedregulatory actions or delays or government regulation generally;unexpected manufacturing difficulties or delays, including continuedunexpected difficulties with seed virus yields, and unexpecteddifficulties with our flu cell culture manufacturing facility andprocesses; unexpected clinical trial results, including unexpectednew clinical data and unexpected additional analysis of existingclinical data; the company's ability to obtain or maintain patent orother proprietary intellectual property protection; competition ingeneral; government, industry and general public pricing pressures;the impact that the foregoing factors could have on the valuesattributed to the Novartis Group's assets and liabilities as recordedin the Group's consolidated balance sheet, and other risks andfactors referred to in Novartis AG's current Form 20-F on file withthe US Securities and Exchange Commission. Should one or more ofthese risks or uncertainties materialize, or should underlyingassumptions prove incorrect, actual results may vary materially fromthose anticipated, believed, estimated or expected. Novartis isproviding the information in this press release as of this date anddoes not undertake any obligation to update any forward-lookingstatements contained in this press release as a result of newinformation, future events or otherwise.About NovartisNovartis 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.References[1] This project has been funded in whole or in part with Federalfunds from the Office of the Assistant Secretary for Preparedness andResponse, Biomedical Advanced Research and Development Authority,under Contract No. HHS100200800072I. # # #Novartis Media RelationsCentral media line : +41 61 324 2200Eric AlthoffNovartis Global Media Relations+41 61 324 7999 (direct)+41 79 593 4202 (mobile)eric.althoff(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 Bringer +41 61 324 Richard Jarvis +1 212 830 1065 2433John Gilardi +41 61 324 Jill Pozarek +1 212 830 3018 2445Thomas Hungerbuehler +41 61 324 Edwin Valeriano +1 212 830 8425 2456Isabella Zinck +41 61 324 7188e-mail: e-mail:investor.relations(at)novartis.com investor.relations(at)novartis.comhttp://hugin.info/134323/R/1355458/329016.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: 17.11.2009 - 07:16 Uhr
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