(ONE) Novartis International AG : FDA Expands Age Indication for Menveo®, First and Only Quadrivalent Meningococcal Vaccine

Novartis (NYSE: NVS) announced today that the US Food and DrugAdministration (FDA) approved Menveo^® (Meningococcal Group A, C, W-135 and Yconjugate vaccine) for the prevention of meningococcal disease caused by fourstrains of the bacterium Neisseria meningitidis (N. meningitidis) in infantsand toddlers from 2 months of age[1]. With this expanded indication,pediatricians in the US can now offer a single vaccine for the protection ofinfants, children and adolescents against four of the five most commonserogroups that cause meningococcal disease[1],[5]."Each year, more children in the US die or are left with permanent disabilityfrom meningococcal disease than from two other diseases combined that weroutinely vaccinate infants against - rotavirus and varicella," said Dr. SteveBlack, Center for Global Health, University of Cincinnati Children's Hospital."With the expanded indication for this MCV4 vaccine, we now have theopportunity to help protect our infants against four strains of meningococcaldisease earlier, when they are most vulnerable."Infants younger than 7 months old are the most vulnerable age group tomeningococcal disease in the US. In their first year of life, infants are morethan seven times more likely to contract the disease than 14 to 24 yearolds[4]. Of the infants who contract the disease, more than 10 percent willdie from it and of those who do survive, approximately one in every five willsuffer permanent, devastating side effects, including amputations, hearingloss, paralysis and brain damage[3],[6]."Despite recommendations for routine immunization of adolescents, collegestudents living in dormitories and certain infants in the US, meningococcaldisease continues to kill and maim," said Andrin Oswald, Head of NovartisVaccines and Diagnostics. "With this approval for the expanded use of Menveo,we hope that health authorities will deploy this vaccine to further reduce theburden of this devastating disease in the US."This FDA approval was based on data from three randomized multicenter studiesinvolving more than 8,700 infants, conducted in Australia, Canada, LatinAmerica, Taiwan and the US. The studies demonstrated that Menveo generated arobust protective immune response and was generally well tolerated whenadministered with other routine pediatric vaccines[1].About MenveoMenveo is a quadrivalent conjugate vaccine for use to protect against invasivedisease caused by four groups of the bacterium Neisseria meningitidis (A, C, Yand W-135)[1]. As of July 2013, Menveo is registered in more than 50 countriesfor active immunization to prevent invasive meningococcal disease caused byNeisseria meningitidis serogroups A, C, W-135 and Y[1]. Studies are ongoing ininfants, toddlers, adolescents and adults.Menveo has been available for use in adolescents and adults (11 to 55 years ofage) since February 2010 and in children (2 to 10 years of age) since January2011[1],[7].For more information about Menveo, visit www.menveo.com.Important Safety InformationSevere allergic reaction (e.g., anaphylaxis) after a previous dose of Menveo,any component of this vaccine, or any other CRM[197], diphtheria toxoid ormeningococcal-containing vaccine is a contraindication to administration ofMenveo. Appropriate medical treatment must be available should an acuteallergic reaction, including an anaphylactic reaction, occur followingadministration of Menveo.Syncope, sometimes resulting in falling injury associated with seizure-likemovements has been reported following vaccination with Menveo. Vaccineesshould be observed for at least 15 minutes after vaccine administration toprevent and manage syncopal reactions.Safety and effectiveness of Menveo have not been evaluated inimmunocompromised persons. If Menveo is administered to immunocompromisedpersons, including those receiving immunosuppressive therapy, the expectedimmune response may not be obtained.Guillain-Barré Syndrome (GBS) has been reported in temporal relationshipfollowing administration of another US-licensed meningococcal quadrivalentpolysaccharide conjugate vaccine. The decision to administer Menveo tosubjects with a known history of GBS should take into account the potentialbenefits and risks. Apnea following intramuscular vaccination has been observed in some infantsborn prematurely. The decision about when to administer an intramuscularvaccine, including Menveo, to an infant born prematurely should be based onconsideration of the individual infant's medical status, and the potentialbenefits and possible risks of vaccination.In clinical trials, common solicited adverse reactions with Menveo amongchildren initiating vaccination at 2 months of age and receiving the four-doseseries were tenderness and erythema at injection site, irritability,sleepiness, persistent crying, change in eating habits, vomiting and diarrhea.Common solicited adverse reactions among children initiating vaccination at 7months through 23 months of age and receiving the two-dose series weretenderness and erythema at injection site, irritability, sleepiness,persistent crying, change in eating habits and diarrhea. Common solicitedadverse reactions among children 2 years through 10 years of age wereinjection site pain, erythema, irritability, induration, sleepiness, malaise,and headache. Common solicited adverse reactions among adolescents and adultswere pain at the injection site, headache, myalgia, malaise and nausea. Someevents were severe. Safety has not been established in pregnant women.Vaccination with Menveo may not protect all individuals.Before administering Menveo, please see full Prescribing Information.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "can," "opportunity," "hope," "will,""potential," "may," or similar expressions, or by express or implieddiscussions regarding potential new indications or labeling for Menveo orregarding potential future revenues from Menveo. You should not place unduereliance on these statements. Such forward-looking statements reflect thecurrent views of management regarding future events, and involve known andunknown risks, uncertainties and other factors that may cause actual resultswith Menveo to be materially different from any future results, performance orachievements expressed or implied by such statements. There can be noguarantee that Menveo will be approved for any additional indications orlabeling in any market, or at any particular time. Nor can there be anyguarantee that Menveo will achieve any particular levels of revenue in thefuture. In particular, management's expectations regarding Menveo could beaffected by, among other things, unexpected regulatory actions or delays orgovernment regulation generally; unexpected clinical trial results, includingunexpected new clinical data and unexpected additional analysis of existingclinical data; competition in general; government, industry and general publicpricing pressures; unexpected manufacturing issues; the company's ability toobtain or maintain patent or other proprietary intellectual propertyprotection; the impact that the foregoing factors could have on the valuesattributed to the Novartis Group's assets and liabilities as recorded in theGroup's consolidated balance sheet, and other risks and factors referred to inNovartis AG's current Form 20-F on file with the US Securities and ExchangeCommission. Should one or more of these risks or uncertainties materialize, orshould underlying assumptions prove incorrect, actual results may varymaterially from those anticipated, believed, estimated or expected. Novartisis providing the information in this press release as of this date and doesnot undertake any obligation to update any forward-looking statementscontained in this press release as a result of new information, future eventsor otherwise.About NovartisNovartis provides innovative healthcare solutions that address the evolvingneeds of patients and societies. Headquartered in Basel, Switzerland, Novartisoffers a diversified portfolio to best meet these needs: innovative medicines,eye care, cost-saving generic pharmaceuticals, preventive vaccines anddiagnostic tools, over-the-counter and animal health products. Novartis is theonly global company with leading positions in these areas. In 2012, the Groupachieved net sales of USD 56.7 billion, while R&D throughout the Groupamounted to approximately USD 9.3 billion (USD 9.1 billion excludingimpairment and amortization charges). Novartis Group companies employapproximately 131,000 full-time-equivalent associates and operate in more than140 countries around the world. For more information, please visithttp://www.novartis.com.