Novartis begins shipment of Fluvirin® seasonal influenza vaccine for
the U.S. market ahead of schedu
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Novartis Vaccines ships doses of seasonal influenza vaccine to the U.S. market aided by an expedited FDA review * Providing 30 million doses of Fluvirin vaccine in the U.S., to support the annual seasonal influenza vaccination campaign * Early delivery of vaccine will allow public health officials to begin the vaccination campaign weeks ahead of the normal scheduleBasel, August 5, 2009 - Novartis Vaccines has started shippingseasonal influenza vaccine to U.S. healthcare facilities for the2009-2010 season. The company delivered Fluvirin® influenza virusvaccine, which has been approved by the U.S. Food and DrugAdministration (FDA), to the U.S. weeks ahead of schedule inanticipation of the increased demand for seasonal influenza vaccinecreated by the current global (A) H1N1 influenza pandemic."With the (A) H1N1 influenza pandemic underway, it is important thatwe take every possible precaution to help protect U.S. citizens fromall circulating strains of influenza," said Andrin Oswald, CEO ofNovartis Vaccines and Diagnostics. "By receiving the seasonalinfluenza vaccine early, physicians and public health officials canbetter prepare for the upcoming flu season."An estimated 36,000 people in the United States die each year fromthe flu and another 200,000 are hospitalized[1]. Early arrival of theseasonal influenza vaccine will also allow public health officials tobegin administering vaccinations weeks ahead of their normalschedule, which is in accordance with guidelines from the AdvisoryCommittee on Immunization Practices (ACIP) of the U.S. Centers forDisease Control and Prevention (CDC)[2]. Federal health officialsadvise that the single best way to protect against the flu is to getvaccinated each year, and that in general anyone who wants to reducetheir chances of getting the flu can get vaccinated[3].Novartis Vaccines will provide the U.S. market with approximately 30million doses of Fluvirin vaccine, indicated for patients 4 years andolder. Fluvirin vaccine contains antigens to the three influenzavirus strains for this year's vaccine recommended by the World HealthOrganization (WHO): * 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[4]"Novartis Vaccines committed early on that we would not letproduction of a pandemic vaccine get in the way of our ongoingcommitment to provide seasonal influenza vaccine for the U.S.market," Oswald said. "We have been able to meet that promise withthe early delivery of Fluvirin to the U.S. Our next goal will be tobring an (A) H1N1 influenza vaccine for public health use as soon aspossible."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[5].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[6] and about half of the estimated70,000 people who die annually of diabetes and its complications[7].During the 2007-2008 seasonal influenza season, 83 children werereported to have died of influenza-related causes[8]. Of the 63 whosevaccination status was known, 58 (92 percent) were not vaccinatedaccording to recommendations[9]. Final numbers for the 2008-2009 fluseason are not 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[10].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[11]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.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "will," "can," "committed,""would," "commitment," "goal," "recommends," "recommended," orsimilar expressions, or by express or implied discussions regardingNovartis' potential production output for Fluvirin and A(H1N1)vaccines, and regarding potential future revenues from Fluvirinvaccine. You should not place undue reliance on these statements.Such forward-looking statements reflect the current views ofmanagement regarding future events, and involve known and unknownrisks, uncertainties and other factors that may cause actual resultsto be materially different from any future results, performance orachievements expressed or implied by such statements. There can be noguarantee that Novartis will achieve any particular production outputfor its Fluvirin or A(H1N1) vaccines, or indeed that the A(H1N1)vaccine will be approved for sale in any market. Nor can there be anyguarantee that Fluvirin vaccine will achieve any particular levels ofrevenue in the future. In particular, management's expectations couldbe affected by, among other things, unexpected regulatory actions ordelays or government regulation generally; unexpected clinical trialresults, including unexpected new clinical data and unexpectedadditional analysis of existing clinical data; unexpectedmanufacturing difficulties or delays; the company's ability to obtainor maintain patent or other proprietary intellectual propertyprotection; competition in general; government, industry and generalpublic pricing pressures; the impact that the foregoing factors couldhave on 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.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.References1. The Centers for Disease Control and Prevention, "Key Facts aboutInfluenza and the Influenza Vaccine," available atwww.cdc.gov/flu/keyfacts.htm, accessed on July 20, 20092. The Centers for Disease Control and Prevention, "Key Facts AboutSeasonal Flu Vaccine," available athttp://www.cdc.gov/FLU/protect/keyfacts.htm, accessed on July 28,20093. The Centers for Disease Control and Prevention, "2008-09 InfluenzaPrevention & Control Recommendations: Timing of Vaccination,"available at http://www.cdc.gov/FLU/PROFESSIONALS/acip/timing.htm,accessed on July 20, 20094. 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, 20095. Novartis Vaccines & Diagnostics, Inc., "Seasonal Influenza FactSheet," available athttp://www.novartis.com/downloads/newsroom/seasonal-flu-fact-sheet.pdf,accessed on July 20, 20096. The Centers for Disease Control and Prevention, "Breast CancerStatistics," available at www.cdc.gov/cancer/breast/statistics,accessed on July 20, 20097. The Centers for Disease Control and Prevention, "National DiabetesFact Sheet, United States 2005," available athttp://www.cdc.gov/diabetes/pubs/pdf/ndfs_2005.pdf, accessed on July20, 20098. 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, 20099. The Centers for Disease Control and Prevention, "InfluenzaActivity-United States and Worldwide, 2007-08 Season," Morbidity andMortality Weekly Report, June 27, 200810. Novartis Vaccines & Diagnostics, Inc., "Agrippal ProductMonograph"11. 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, 2009 # # #Novartis Media RelationsCentral media line : +41 61 324 2200Eric Althoff Beth BirkeNovartis Global Media Relations Novartis Vaccines and+41 61 324 7999 (direct) Diagnostics+41 79 593 4202 (mobile) +1 617 871 4281 (direct)eric.althoff(at)novartis.com beth.birke(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/1332676/315659.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: 05.08.2009 - 07:15 Uhr
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