Novartis inaugurates large-scale US based cell-culture influenza
vaccine manufacturing facility
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Total investment of nearly USD 1 billion through a partnership between Novartis and the US Department of Health and Human Services * Inauguration marks important milestone in using modern biotechnologies for flu vaccine production to replace the 50 year-old egg-based process * Facility designed to supply 150 million doses of pandemic vaccine within 6 months of influenza pandemic declaration; facility ready to respond to a pandemic as early as 2011 if licensed in an emergencyBasel, November 24, 2009 - Today, Novartis officially inaugurated theUS's first ever large-scale flu cell culture vaccine and adjuvantmanufacturing facility in Holly Springs, North Carolina. The facilityis a result of a partnership between Novartis and the US Departmentof Health and Human Services (HHS). It is the first of its kind inthe United States and highlights an important milestone in efforts toimprove influenza vaccine manufacturing technology in the US andenhance domestic pandemic preparedness."We are proud to be one of the first companies to bring influenzacell culture as well as adjuvant technology to the United States,"said Daniel Vasella, CEO and Chairman of Novartis. "We have seen agreat need to invest into new technologies for flu vaccines that willallow for quicker and more reliable production capacity. We arepleased to be working closely with the US government to build aworld-class, state of the art manufacturing facility in the US thatwill change the way we manufacture influenza vaccines in the future."The total investment in the facility is nearly USD 1 billion, througha partnership between Novartis and HHS to support the design,construction, validation and licensing of the manufacturing facilityin Holly Springs.The operations at this facility will use modern, cell culture-basedmanufacturing technology. Cell culture-based production operationsare cleaner, can be scaled up more quickly to respond to a pandemicand do not rely on eggs for rapid response to a pandemic. Cellculture technology for influenza vaccines is not yet approved in theUS, however part of the HHS contract support for Holly Springsincludes funding for the development of a flu cell culture vaccine.If licensed in an emergency, the facility will be ready to respond toa pandemic as early as 2011. The plant is planned to be running atfull scale commercial production in 2013.Novartis already operates a cell culture-based manufacturing plant inMarburg, Germany. It is licensed to produce a seasonal cellculture-based influenza vaccine, Optaflu®, which is approved in all27 member states of the European Union as well as in Iceland andNorway. It currently produces Celtura®, a H1N1 pandemic vaccinelicensed in Germany and Switzerland.The Novartis Holly Springs facility can also start producing MF59®,the Novartis proprietary adjuvant, as early as December 2009.Although not yet approved in the US, studies with adjuvants arecurrently underway in the US. Results of the most recent clinicaltrials conducted with the Novartis MF59 adjuvanted cell culture-basedvaccine have shown that it is possible to induce protective antibodylevels against A(H1N1) infection within two weeks of administrationof a single low-dose adjuvanted vaccine. MF59 has also been shown toprovide cross-protection across similar strains of a H5N1 virus,which is an additional important element for a pre-pandemic vaccinegiven that mutations are a common feature of emerging influenzastrains.As part of its partnership with HHS, Novartis is responsible for,among other things, pre-construction document development, land useand zoning, construction, commissioning, validation and licensing ofthe facilities with the goals of regulatory licensure, manufactureand release of seasonal and pre-pandemic vaccine, as well asprovision for pandemic vaccine supply in the event of a pandemic orother vaccines or biologicals in the event of an emergency for anemerging infectious disease. The partnership also requires Novartisto provide two commercial-scale annual lots of pre-pandemic vaccinefor a minimum of three years. In addition, HHS has the right toexercise options to purchase additional influenza vaccine over 17years.About MF59®Novartis 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.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "as early as," "will," "future,""planned," "can," or similar expressions, or by express or implieddiscussions regarding the potential completion of the productionfacility at Holly Springs, the timing of potential commencement ofand continued successful production of vaccines and adjuvants atHolly Springs, regarding the potential marketing approvalcell-culture influenza vaccines, regarding the amounts to be paid bythe government under the agreement described in this release, orregarding potential future revenues from vaccines produced at HollySprings. You should not place undue reliance on these statements.Such forward-looking statements reflect the current views of theCompany regarding future events, and involve known and unknown risks,uncertainties and other factors that may cause actual results at theHolly Springs facility to be materially different from any futureresults, performance or achievements expressed or implied by suchstatements. There can be no guarantee that we will complete the HollySprings facility, commence production there, or successfully continueproduction of vaccines there. Nor can there be any guarantee that anyof the products expected to be produced at the Holly Springs facilitywill be approved for sale in any market. Neither can there be anyguarantee that we will be paid the full amount referred to in thisrelease. Neither can there be any guarantee that vaccines andadjuvants to be produced at Holly Springs will achieve any particularlevels of revenue in the future. In particular, management'sexpectations regarding the Holly Springs production facility andvaccines produced there could be affected by, among other things,unexpected regulatory actions or delays or government regulationgenerally; unexpected construction difficulties or delays; unexpectedproduction difficulties or delays, including difficulties or delaysrelating to the novel cell-culture production technique to beemployed there; unexpected clinical trial results, includingunexpected new clinical data and unexpected additional analysis ofexisting clinical data; the company's ability to obtain or maintainpatent or other proprietary intellectual property protection;competition in general; government, industry and general publicpricing pressures; the impact that the foregoing factors could haveon the values attributed to the Novartis Group's assets andliabilities as recorded in the Group's consolidated balance sheet,and other risks and factors referred to in Novartis AG's current Form20-F on file with the US Securities and Exchange Commission. Shouldone or more of these risks or uncertainties materialize, or shouldunderlying assumptions prove incorrect, actual results may varymaterially from those anticipated, believed, estimated or expected.Novartis is providing the information in this press release as ofthis date and does not undertake any obligation to update anyforward-looking statements contained in this press release as aresult of new information, future events or otherwise.This project has been funded in whole or in part with Federal fundsfrom the Office of the Assistant Secretary for Preparedness andResponse, Biomedical Advanced Research and Development Authority,under Contract No's. HHSO100200600012C, HHSO100200700030C,HHSO100200900101C.About NovartisNovartis Vaccines and Diagnostics is a division of Novartis focusedon the 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 61 324 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 +41 61 324 Richard Jarvis +1 212 830Bringer 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/1356789/329854.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: 24.11.2009 - 07:16 Uhr
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