Novartis completes shipment of US supply of Fluvirin® seasonal
influenza vaccine
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * 27 million doses shipped to US market by Novartis - providing more seasonal flu vaccine earlier than in any previous year * Shipments completed ahead of normal seasonal vaccine delivery schedules to allow for earlier vaccination * First shipments of A(H1N1) vaccine delivered to US government less than four months after the pandemic declaration by the WHOBasel, October 6, 2009 - Novartis announced today that the companyhas completed its entire shipment of seasonal influenza vaccine tothe United States for the 2009/2010 season. As previouslyanticipated, the company delivered 27 million doses of Fluvirin®influenza virus vaccine, which has been approved by the U.S. Food andDrug Administration (FDA). Novartis completed this season's shipmentearlier than in previous years, in anticipation of demand for earliervaccination with seasonal influenza vaccine created by the currentglobal A(H1N1) influenza pandemic."Novartis is pleased to have delivered more seasonal influenzavaccine to the US market by the end of September than we have in anyprevious year allowing more people to get their vaccine early in theseason," said Andrin Oswald, CEO of Novartis Vaccines andDiagnostics. "We are relieved to have been able to complete ourdeliveries ahead of schedule despite the challenging task to producelarge quantities of A(H1N1) pandemic vaccines at the same time. Wehope that the early delivery of our Fluvirin vaccine will helpphysicians and public health officials better prepare for theupcoming flu season and balance the needs for pandemic and seasonalvaccination."On September 27, Novartis also began shipments of the first doses ofits influenza A(H1N1) 2009 monovalent vaccine[1] to the UnitedStates. The early shipment is the first of an accelerated effort toprovide as much A(H1N1) vaccine as soon as possible, despite the lowyield seen with the initial production seed strain provided by theWorld Health Organization. Production has switched to a new higheryielding seed strain which will allow deliveries of higher volumeslater in the year.Novartis Influenza A(H1N1) 2009 monovalent vaccine was approved bythe FDA on September 15, 2009. The A(H1N1) vaccine is an inactivatedsubunit vaccine approved for active immunization of persons 4 yearsof age and older, including patients with underlying chronic medicalconditions. The US Department of Health and Human Services (HHS)awarded Novartis two contracts totaling USD 979 million for purchaseof H1N1 bulk vaccine and the Novartis proprietary MF59 adjuvant.The Novartis seasonal influenza vaccine, Fluvirin is indicated forpatients 4 years and older. Fluvirin vaccine contains antigens to thethree influenza virus strains for this year's vaccine recommended bythe World Health Organization (WHO) in January 2009: * A/Brisbane/59/2007, IVR-148 (H1N1) * A/Uruguay/716/2007, NYMC X-175C (H3N2) (an A/Brisbane/10/2007-like virus) * B/Brisbane/60/2008[2]About seasonal influenzaSeasonal influenza is a highly communicable, acute viral infectionthat predominantly attacks the respiratory tract and sometimes thelungs. It can cause mild to severe illness and can lead to death[3].The number of people in the U.S. who die every year from the flu issimilar to the more than 40,000 people in the U.S. estimated to diefrom breast cancer every year[4] and about half of the estimated70,000 people who die annually of diabetes and its complications[5].During the 2007-2008 influenza season, 83 children were reported tohave died of influenza-related causes[6]. Of the 63 whose vaccinationstatus was known, 58 (92 percent) were not vaccinated according torecommendations[7]. Final numbers for the 2008-2009 flu season arenot yet available.Influenza vaccination is one of the most effective public healthinterventions ever implemented, sparing millions of people fromcomplications of the infectious disease. Use of currently availableseasonal flu vaccines has been calculated to save more than 8 millionlives annually; translating to one person saved every fiveseconds[8].ACIP recommends seasonal influenza vaccinations as the principalmethod of preventing seasonal influenza. The vaccine is recommendedfor those at greatest risk for serious complications, including: * Children between 6 months and 18 years of age * Pregnant women * People 50 years of age and older * People of any age with certain chronic health conditions, such as asthma, diabetes or heart disease * People in nursing homes and other long-term care facilities, * Household contacts of person at high risk for complications from influenza, * Household contacts and out-of-home caregivers of children less than 6 months of age * Healthcare workers[9]Important safety informationAs is the case with most drugs and vaccines, there is a chance that aserious allergic reaction, serious illness or even death could occuras a result of vaccination with Fluvirin vaccine. The most commonside effect of vaccination with Fluvirin influenza virus vaccine issoreness at the injection site. Less common side effects includefever, malaise, myalgia and allergic reactions. Fluvirin vaccineshould not be administered to anyone with a history ofhypersensitivity to any component of the vaccine, including eggs, eggproducts or thimerosal. Generally, persons should not be vaccinatedduring an acute febrile illness. Vaccination should be delayed inpersons with an active, unstable neurological disorder, but should beconsidered when the disorder has been stabilized. The occurrence ofany neurological symptoms or signs following administration of anyvaccine is a contraindication to further use. Fluvirin vaccine is notindicated for use in children under four years of age. Persons shouldconsult with their healthcare providers if they are pregnant and/orare taking other medications. Fluvirin vaccine may not protect 100%of individuals who are susceptible to influenza. Before administeringFluvirin vaccine, please see full prescribing information.Important Safety Information for US MarketAdverse reaction information is based on studies conducted withseasonal trivalent Influenza Virus Vaccine manufactured by Novartis(Fluvirin). The most frequently reported adverse reactions are mildhypersensitivity reactions (such as rash), local reactions at theinjection site, and influenza-like symptoms. For patients who haveexperienced Guillain-Barré syndrome within 6 weeks of receipt ofprior influenza vaccine, the decision to administer Influenza A(H1N1) 2009 Monovalent Vaccine should be based on carefulconsideration of the potential benefits and risks. Immunocompromisedpersons may have a reduced immune response to Influenza A (H1N1) 2009monovalent vaccine.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "hope," "will," or similarexpressions, or by express or implied discussions 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 will successfullymeet its delivery obligations for its influenza vaccines. Neithercan there be any guarantee that Novartis' influenza vaccines willachieve any particular levels of revenue in the future. Inparticular, management's expectations regarding Novartis' influenzavaccines could be affected by, among other things, unexpectedregulatory actions or delays or government regulation generally;unexpected manufacturing difficulties or delays, including 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 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. # # #Footnotes[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.[2] World Health Organization, "Recommended composition of influenzavirus vaccines for use in the 2009-2010 northern hemisphere influenzaseason," available athttp://www.who.int/csr/disease/influenza/recommendations2009_10north/en/index.html,accessed on July 20, 2009[3] Novartis Vaccines & Diagnostics, Inc., "Seasonal Influenza FactSheet," available athttp://www.novartis.com/downloads/newsroom/seasonal-flu-fact-sheet.pdf accessedon July 20, 2009[4] The Centers for Disease Control and Prevention, "Breast CancerStatistics," available at www.cdc.gov/cancer/breast/statistics,accessed on July 20, 2009[5] The Centers for Disease Control and Prevention, "NationalDiabetes Fact Sheet, United States 2005," available athttp://www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf accessed on July20, 2009[6] The Centers for Disease Control and Prevention, "Questions andAnswers: 2007-2008 Influenza (Flu) Season," available athttp://www.cdc.gov/flu/about/qa/season.htm, accessed on July 20, 2009[7] The Centers for Disease Control and Prevention, "InfluenzaActivity-United States and Worldwide, 2007-08 Season," Morbidity andMortality Weekly Report, June 27, 2008[8] Novartis Vaccines & Diagnostics, Inc., "Agrippal ProductMonograph"[9] The Centers for Disease Control and Prevention, "2008-09Influenza Prevention & Control Recommendations: Persons for WhomAnnual Vaccination is Recommended," available athttp://www.cdc.gov/flu/professionals/acip/persons.htm, accessed onJuly 20, 2009Novartis 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.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 1065 Richard Jarvis +1 212 830 2433John Gilardi +41 61 324 3018 Jill Pozarek +1 212 830 2445Thomas Hungerbuehler +41 61 324 8425 Edwin Valeriano +1 212 830 2456Isabella Zinck +41 61 324 7188e-mail: e-mail:investor.relations(at)novartis.com investor.relations(at)novartis.comhttp://hugin.info/134323/R/1345850/323140.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: 06.10.2009 - 07:15 Uhr
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