Novartis on track to deliver Influenza A (H1N1) vaccine for the US
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Novartis on track to produce 90 million units of bulk antigen in line with commitment to US Department of Health and Human Services, despite very low yields of initial seed virus * 90 million units of bulk antigen expected to result in 60 million vaccine doses due to required overage and overfills in the filling process of multi-dose vials and pre-filled syringes * To date, Novartis has shipped more than 7.5 million doses of Influenza A (H1N1) vaccines in multi-dose vials and pre-filled syringes ready to use, and expects to reach 25 to 30 million doses by the end of November * Novartis also initiated deliveries against the 90 million doses of proprietary adjuvant, which could be used to double the amount of vaccine doses producedBasel, October 29, 2009 - Novartis confirmed today that it hasshipped over 7.5 million doses of Influenza A(H1N1)[1] vaccine readyto use and expects 25 to 30 million doses of unadjuvanted vaccine tobecome available in pre-filled syringes and multi-dose vials by theend of November. Smaller changes in delivery timelines and volumescan result out of the variability of the underlying biologicalproduction process. The deliveries are in line with commitments madeto the US Department of Health and Human Services (HHS).In addition, the company is progressing with the production of itsproprietary adjuvant MF59(TM) for the US. Adjuvants have shown to beantigen sparing and can double the number of vaccine doses produced."Overall, we are pleased with the progress achieved to date, giventhe many challenges and uncertainties of the current pandemic. Notonly did we complete our commitment to provide seasonal vaccine aheadof schedule, we are making every effort to make as much H1N1 vaccineavailable as quickly as possible," said Andrin Oswald, CEO ofNovartis Vaccines and Diagnostics. "However, we acknowledge thelimitations of the old manufacturing sites and technologies forinfluenza vaccines to rapidly respond to the needs of a pandemic.Over the last three years, Novartis has made major R&D investments todevelop new technologies. And in partnership with HHS, we arebuilding the first cell based flu manufacturing facility in the US.The opening of the site is planned later this year."Production of the H1N1 vaccine is progressing, despite the unexpectedvery low yields observed with the initial seed virus at 23 percent ascompared to average yield seen with seasonal vaccines. Novartisstarted production with a new seed virus in the middle of Septemberwhich provides an improved yield of 63 percent. To date, 42 millionbulk units of vaccine have been produced. The company expects tocomplete production of 90 million doses of bulk antigen by Decemberand will continue to rapidly fill-finish the bulk antigen as it isproduced and ordered by HHS.Novartis is fully utilizing its manufacturing capacity and hasentirely dedicated one of its two major flu manufacturing sites,based in Liverpool, U.K., to supplying H1N1 vaccine antigen for theUS. Production capacity at the Liverpool site has been maximized byhiring and training 300 additional staff, as well as the accelerationof the opening of a new facility and egg incubation unit at the site.Following a more than USD 200 million investment over three years,the additional facility was recently approved by the US Food and DrugAdministration (FDA) as suitable to manufacture vaccines for the USA.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "on track," "commitment,""expected," "expects," "could," "planned," "will," or similarexpressions, or by express or implied discussions regarding potentialfuture deliveries of A (H1N1) vaccines, or regarding potential futurerevenues from A (H1N1) 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 with A (H1N1) vaccines to be materiallydifferent from any future results, performance or achievementsexpressed or implied by such statements. There can be no guaranteethat that Novartis will successfully meet its delivery obligationsfor its A (H1N1) vaccines. Nor can there be any guarantee that the A(H1N1) vaccines will achieve any particular levels of revenue in thefuture. In particular, management's expectations regarding the A(H1N1) vaccines could be affected by, among other things, unexpectedmanufacturing difficulties or delays, including continued unexpecteddifficulties with seed virus yields, and unexpected difficulties withour flu cell culture manufacturing facility and processes; unexpectedregulatory actions or delays or government regulation generally;unexpected clinical trial results, including unexpected new clinicaldata and unexpected additional analysis of existing clinical data;the company's ability to obtain or maintain patent or otherproprietary intellectual property protection; competition in general;government, industry and general public pricing pressures; the impactthat the foregoing factors could have on the values attributed to theNovartis Group'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 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 part with Federal funds from theOffice of the Assistant Secretary for Preparedness and Response,Biomedical Advanced Research and Development Authority, underContract Number HHSO100200800072I. # # #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 1065 Richard Jarvis +1 212 830 2433John Gilardi +41 61 324 3018 Jill Pozarek +1 212 830 2445Thomas +41 61 324 8425 Edwin +1 212 830Hungerbuehler Valeriano 2456Isabella Zinck +41 61 324 7188e-mail: e-mail:investor.relations(at)novartis.com investor.relations(at)novartis.comhttp://hugin.info/134323/R/1351038/326339.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: 29.10.2009 - 07:16 Uhr
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