Novartis receives Complete Response letter from the US Food and Drug
Administration for its investig
Novartis receives Complete Response letter from the US Food and Drug Administration for its investigational vaccine Menveo®
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Cambridge, MA, June 30, 2009 - Novartis Vaccines and Diagnosticsreceived feedback from the US Food and Drug Administration (FDA) inthe form of an initial regulatory determination on the BiologicsLicense Application (BLA) for the investigational vaccine Menveo®.The FDA has requested additional information on the clinical and theCMC (Chemistry Manufacturing and Control) sections of the BLA. No newclinical trials are required, and it is expected that Novartis willbe able to respond to all questions fully in 2009. The BLA wassubmitted on August 28, 2008 for use of Menveo in subjects age 11 -55.In clinical trials, Menveo has been shown to elicit a protectiveimmune response against four of the most common serogroups - A, C,W-135 and Y - of Neisseria meningitides, also known as meningococcus.These serogroups can cause potentially deadly bacterial infectionsand account for most cases of meningococcal disease worldwide."Meningococcal disease is a devastating illness that can result inrapid death or have long-lasting repercussions for survivors andtheir families," said Andrin Oswald, CEO of Novartis Vaccines andDiagnostics. "We are dedicated to applying our industry-leadingtechnology and expertise to further the development of Menveo andother vaccines that elicit robust, long-lasting, protective immuneresponses for all age groups at risk."About the Novartis Vaccines global meningococcal franchiseMenveo is based on the same proprietary technology Novartis Vaccinespioneered to produce Menjugate®, a meningococcal serogroup Cconjugate vaccine approved outside the US since 2000 for use inindividuals from age 2 months through adulthood.Studies have reported that Menveo generates a robust immune responseagainst the four vaccine-preventable serogroups, A, C, W-135 and Y inpeople across age groups from infancy to adulthood. A Phase II studyin infants published in the January 9, 2008, issue of the Journal ofthe American Medical Association reported that Menveo is the firstmeningococcal vaccine candidate to elicit a robust immune response ininfants[1]. There is no vaccine currently licensed in the US for usein infants.Novartis Vaccines is a global leader in providing vaccines to protectagainst deadly meningococcal disease. Through industry-leadingscientific expertise, the company is focused on extending criticalmeningococcal vaccines research. In addition to Menveo, NovartisVaccines is developing a recombinant vaccine for its potential toprovide broad coverage against multiple strains of serogroup B, forwhich no vaccine is currently available. The company has alreadydistributed more than 26 million doses of Menjugate around the worldand produced MenZB®, a vaccine against a strain of meningococcus Bspecific to a recent outbreak in New Zealand.About meningococcal disease, a leading cause of bacterial meningitisMeningococcal disease can manifest as bacterial meningitis - aninfection of the protective coverings of the brain and spinal cord -or meningococcemia - a bloodstream infection[2]. It is caused by thebacterium Neisseria meningitidis (N. meningitidis). The symptoms,which can include sudden onset of fever, rash, headache and stiffneck, can progress rapidly. Even with early and appropriatetreatment, between 10% and 14% of meningitis cases are fatal,typically within 24 to 48 hours[4],[5]. For those who survive, asmany as 19% suffer serious long-term consequences such as deafness,neurological damage or limb loss.Because invasive meningococcal disease can progress so rapidly, highlevels of circulating antibodies are critical for protection. Immunememory typically takes up to five days to develop, so there often isnot enough time for immune memory to mount a protective response[3].Five serogroups cause the majority of meningococcal diseaseworldwide: A, B, C, W-135 and Y[1]. Distribution of serogroupsvaries widely from geographic region to region and changes overtime. In the US, the prevalence of serogroup Y has increased overthe last few years (from 9% of reported cases in 1990-92 to 39% in2006)[3]. Serogroups B and C are predominant in Europe. While Asiahas primarily seen serogroup A, recent outbreaks of serogroup C havebeen noted. The dynamic and unpredictable nature of meningococcaldisease epidemiology warrants a vaccine that offers broad serogroupprotection[6].For more information, please visit www.meningitis.com.The foregoing release contains forward-looking statements that can beidentified by terminology such as "expected," "will," "can,""dedicated," "potential," or similar expressions, or by express orimplied discussions regarding potential marketing approvals forMenveo or regarding potential future revenues from Menveo. You shouldnot place undue reliance on these statements. Such forward-lookingstatements reflect the current views of management regarding futureevents, and involve known and unknown risks, uncertainties and otherfactors that may cause actual results with Menveo to be materiallydifferent from any future results, performance or achievementsexpressed or implied by such statements. There can be no guaranteethat Menveo will be approved for sale in any market. Nor can there beany guarantee that Menveo will achieve any particular levels ofrevenue in the future. In particular, management's expectationsregarding Menveo could be affected by, among other things, unexpectedregulatory actions or delays or government regulation generally,including an unexpected inability to meet the requirements of theFDA: unexpected clinical trial results, including unexpected newclinical data and unexpected additional analysis of existing clinicaldata; 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 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 business, is dedicated to preventing the spread ofinfectious diseases through the development of novel blood-screeningtools that protect the world's blood supply.Novartis AG 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 these areas. In 2008, theGroup's continuing operations achieved net sales of USD 41.5 billionand net income of USD 8.2 billion. Approximately USD 7.2 billion wasinvested in R&D activities throughout the Group. Headquartered inBasel, Switzerland, Novartis Group companies employ approximately98,000 full-time-equivalent associates and operate in more than 140countries around the world. For more information, please visithttp://www.novartis.com.References[1.] Snape, MD et al. Immunogenicity of a Tetravalent MeningococcalGlycoconjugate Vaccine in Infants: A Randomized Controlled Trial.Journal of the American Medical Association. 2008;299(2): 173-184[2.] Centers for Disease Control and Prevention. Epidemiology andPrevention of Vaccine-Preventable Diseases (The Pink Book: CourseTextbook). 10th Edition, 2nd printing. February 2008 update.Available at: http://www.cdc.gov/vaccines/pubs/pinkbook/default.htm[3.] Novartis Vaccines and Diagnostics, Scientific Platform:Meningococcal Diseases, Revised December 11, 2008[4.] Centers for Disease Control and Prevention. Prevention andControl of Meningococcal Disease - Recommendations of the AdvisoryCommittee on Immunization Practices. MMWR 2005; 54 (RR07): 1-21.[5.] World Health Organization. Meningococcal meningitis Fact sheet.May 2003. Available at:http://www.who.int/mediacentre/factsheets/fs141/en/[6.] Harrison, Lee H. Prospects for Vaccine Prevention ofMeningococcal Infection, Clinical Microbiology Reviews: January 2006: 142-16 # # #Novartis Media RelationsCentral media line : +41 61 3242200Eric Althoff Paul NewmanNovartis Global Media Relations Novartis Vaccines Global+41 61 324 7999 (direct) Communications+41 79 593 4202 (mobile) +1-617-871-7931 (direct)eric.althoff(at)novartis.com +1-617-710-8953 (mobile) paulc.newman(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/1326284/312112.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;
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