Novartis receives regulatory approval in Germany for Celtura®, a cell
culture-based Influenza A(H1N1
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Approval marks an important milestone in the process of replacing 50 year-old egg-based flu vaccine production with modern biotechnology * Clinical trials in more than 1,850 individuals across all age groups show strong efficacy, that can induce immune responses associated with protection against influenza in individuals from 3 to 50 years of age * Novartis continues to pursue registration of Celtura in other major countriesBasel, November 5, 2009 - Novartis announced today that it receivedapproval from the German regulatory authorities for its adjuvantedcell culture-based Influenza A(H1N1) 2009 monovalent vaccine,Celtura®. Novartis continues to pursue registration in other majorcountries, including Japan and Switzerland.Celtura is manufactured in Marburg, Germany and is an MF59®adjuvanted inactivated influenza virus vaccine indicated for activeimmunization of persons six months of age and older against influenzadisease caused by the novel pandemic A(H1N1) influenza virus. Thevaccine contains 3.75 micrograms (ug) of antigen and 0.125 ml ofMF59®. It will be offered in multi-dose vials and in single-dosepre-filled syringes.Clinical studies conducted with more than 1,850 subjects evaluatedCeltura's tolerability and immunogenicity. The studies showed thateven with the lowest antigen content (3.75 ug) a single Celtura dosecan induce immune responses associated with protection againstinfluenza in individuals from 3 to 50 years of age. Safety andtolerability profiles were as expected. Local injection site(redness, swelling and pain) and systemic complaints of mild fever,headache and fatigue were the most frequent side effects reported.Celtura uses a validated cell culture line for production of viralantigen components rather than traditional chicken eggs. Thetechnology has previously been licensed in Europe for the productionof the seasonal flu vaccine, Optaflu®."Our modern cell culture technology can enable a faster start-up ofvaccine manufacturing, offering the ability to respond more quicklyto future pandemic threats", said Andrin Oswald, CEO of NovartisVaccines and Diagnostics. "We quickly ramped up capacity at ourlicensed cell culture facility in Marburg, Germany to respond to theneed for a pandemic vaccine. Also we are close to completion of asecond cell culture-based influenza vaccine manufacturing site in theUS[1], which is being built in partnership with the US Department ofHealth and Human Services (HHS)."MF59 is an adjuvant with an established safety profile supported bymore than 12 years of clinical safety data in Europe and more than 45million doses of commercial use in the influenza vaccine Fluad®(licensed in Europe but not the US).Novartis has already begun delivery of the company's egg-basedpandemic vaccines, Fluvirin® A(H1N1) monovalent vaccine to the US,and Focetria® A(H1N1) monovalent vaccine to countries around theworld. The US Food and Drug Administration approved the FluvirinA(H1N1) vaccine on September 15, 2009, and the EMEA approved theFocetria A(H1N1) vaccine on September 29, 2009.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "continues to pursue," "can,""potentially," "offering the ability," or similar expressions, or byexpress or implied discussions regarding potential additionalmarketing approvals for Novartis' A(H1N1) vaccines, potential futuredeliveries of influenza vaccines, or regarding potential futurerevenues from influenza vaccines. You should not place undue relianceon these statements. Such forward-looking statements reflect thecurrent views of management regarding future events, and involveknown and unknown risks, uncertainties and other factors that maycause actual results to be materially different from any futureresults, performance or achievements expressed or implied by suchstatements. There can be no guarantee that Novartis' A(H1N1) vaccineswill be approved for sale in any additional countries. Nor can therebe any guarantee that Novartis will successfully meet its deliveryobligations for its influenza vaccines. Neither can there be anyguarantee that Novartis' influenza vaccines will achieve anyparticular levels of revenue in the future. In particular,management's expectations regarding Novartis' influenza vaccinescould be affected by, among other things, unexpected regulatoryactions or delays or government regulation generally; unexpectedmanufacturing difficulties or delays, including continued unexpecteddifficulties with seed virus yields, and unexpected difficulties withour flu cell culture manufacturing facility and processes; unexpectedclinical trial results, including unexpected new clinical data andunexpected additional analysis of existing clinical data; thecompany's ability to obtain or maintain patent or other proprietaryintellectual property protection; competition in general; government,industry and general public pricing pressures; the impact that theforegoing factors could have on the values attributed to the NovartisGroup's assets and liabilities as recorded in the Group'sconsolidated balance sheet, and other risks and factors referred toin Novartis AG's current Form 20-F on file with the US Securities andExchange Commission. Should one or more of these risks oruncertainties materialize, or should underlying assumptions proveincorrect, actual results may vary materially from those anticipated,believed, estimated or expected. Novartis is providing theinformation in this press release as of this date and does notundertake any obligation to update any forward-looking statementscontained in this press release as a result of new information,future events or otherwise.About NovartisNovartis Vaccines and Diagnostics is a division of Novartis focusedon the development of preventive treatments. The division has twobusinesses: Novartis Vaccines and Novartis Diagnostics. NovartisVaccines is the world's fifth-largest vaccines manufacturer andsecond-largest supplier of flu vaccines in the US. The division'sproducts also include meningococcal, pediatric and travel vaccines.Novartis Diagnostics prevents the spread of infections through thedevelopment and marketing of innovative technologies that enableearly detection of pathogens to protect the world's blood supply andprevent the spread of infectious diseases.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.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. HHSO100200900101C. # # #Novartis Media RelationsCentral media line : +41 61 3242200Eric Althoff Paul NewmanNovartis Global Media Novartis Vaccines and DiagnosticsRelations +1 (617) 871 7931 (direct)+41 61 324 7999 (direct) +1 (617) 710 8953 (mobile)+41 79 593 4202 (mobile) paulc.newman(at)novartis.comeric.althoff(at)novartis.com nvd.communications(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/1352736/327467.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: 05.11.2009 - 07:15 Uhr
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