Novartis International AG /Novartis drug Tasigna® approved in Japan for treatment of patients with newly diagnosed Ph+ chronic myeloid leukemia Processed and transmitted by Thomson Reuters.the issuer is solely responsible for the content of this announcement.

* Approval based on Phase III trial showing superiority of Tasigna to standard of care Glivec® in key measures of efficacy, including delay of cancer progression * Newly diagnosed patients now have a new medical option; Tasigna also available in the US and Switzerland with other submissions under review

Basel, December 21, 2010 – Novartis has received approval from Japan´s Ministryof Health, Labour and Welfare to offer Tasigna(®) (nilotinib) as a treatment foradult patients with newly diagnosed Philadelphia chromosome-positive chronicmyeloid leukemia (Ph+ CML) in chronic phase.

The approval is based on positive findings from a pivotal Phase III trialdemonstrating superiority to the standard of care Glivec(® )(imatinib)* inachieving molecular and cytogenetic response and delaying cancer progression.These data were first published in the June 17 issue of the new England Journalof Medicine[1] and were confirmed by 18-month median follow-up data presented atthe 46(th) American Society of Clinical Oncology (ASCO) annual meeting held inJune[2].

The US Food and Drug Administration (FDA) and Swissmedic have also approvedTasigna in this first-line indication. Regulatory submissions are under reviewin other countries worldwide.

“The approval of Tasigna for newly diagnosed Ph+ CML patients in chronic phaseillustrates the Novartis commitment to continue challenging and advancing thescience for treating cancer, ” said Hervé Hoppenot, President, Novartis Oncology.”Tasigna was developed because we believed we could improve upon the standard ofcare to meet patients´ unmet needs, and as a result, patients now have a new andeffective option for the treatment of CML.”

In laboratory studies, Tasigna has been shown to be a potent and selectiveinhibitor of the Bcr-Abl protein that causes production of cancer cells in Ph+CML[3], [4]. it is also active against a broad spectrum of Bcr-Abl mutationsassociated with resistance to Glivec[5].

In its pivotal head-to-head trial, Tasigna surpassed Glivec in key measures oftreatment efficacy, as has been previously reported. Tasigna eliminated Bcr-Ablfaster and more deeply than Glivec and resulted in lower rates of cancerprogression after 12 months of therapy[1]ajor molecular response (MMR), ameasure of deep reduction in Bcr-Abl, is considered to be a critical therapeuticmilestone associated with good long-term outcomes for patients with Ph+ CML inchronic phase[6-8]. Treatment with Tasigna led to higher rates of both MMR andcomplete cytogenetic response (CCyR) (undectable Philadelphia chromosome that isthe hallmark of this cancer) compared with Glivec[1].after a median of 18 months of follow-up treatment, two patients on the Tasigna300 mg twice daily arm progressed to either accelerated phase or blast crisiswhile 17 patients on the Glivec arm progressed to either accelerated phase orblast crisis. in the study, Tasigna and Glivec were well tolerated. Fewerpatients discontinued due to adverse events from the Tasigna 300 mg twice dailyarm of the study compared to the Glivec 400 mg once daily arm.

The randomized, open-label, multicenter trial called ENESTnd (EvaluatingNilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CMLPatients), compared the efficacy and safety of Tasigna versus Glivec in adultpatients with newly diagnosed Ph+ CML in chronic phase[1]. it is the largestglobal randomized comparison of two oral therapies ever conducted in newlydiagnosed Ph+ CML patients in chronic phase.

This year, Novartis also began a collaboration with molecular diagnosticscompany Cepheid to develop a new FDA cleared/approved Bcr-Abl test, whichadheres to the International Scale. the goal of the collaboration is to helpdoctors more reliably monitor Ph+ CML patients. Cepheid and Novartis also willdevelop a next generation test, which is expected to enable even more sensitivetesting, indicating the depth of a patient´s response to tyrosine kinaseinhibitors, including Tasigna and Glivec. Currently, there are no FDAcleared/approved tests to monitor for Bcr-Abl.

About Tasigna[3]Tasigna is indicated for the treatment of adult patients with newly diagnosedPhiladelphia chromosome-positive chronic myelogenous leukemia (CML) in thechronic phase.

Tasigna has also been approved in over 90 countries for the treatment of chronicphase (CP) and accelerated phase Ph+ CML in adult patients resistant orintolerant to at least one prior therapy, including Glivec. the effectiveness ofTasigna for this indication is based on confirmed hematologic and unconfirmedcytogenetic response rates. There are no controlled trials demonstrating aclinical benefit, such as improvement in disease-related symptoms or increasedsurvival.

Tasigna is not approved in the EU for the treatment of newly diagnosed Ph+ CML-CP.

Tasigna important safety informationTasigna should be taken twice daily at an interval of approximately 12 hoursapart and must not be taken with food. No food should be consumed for two hoursbefore the dose and for at least one hour after the dose. Avoid grapefruit juiceand other foods that are known to inhibit CYP3A4.

Tasigna should not be used in patients who are hypersensitive to nilotinib orany of the excipients.

Treatment with Tasigna has been associated with hematological side effects suchas thrombocytopenia, neutropenia and anemia, which was generally reversible andusually managed by withholding Tasigna temporarily or dose reduction. Completeblood counts should be performed every two weeks for the first two months andthen monthly thereafter as clinically indicated.

Tasigna should be used with caution in patients with uncontrolled or significantcardiac disease (e.g., recent heart attack, congestive heart failure, unstableangina or clinically significant bradycardia), as well as in patients who haveor may develop prolongation of QTc. These include patients with abnormally lowpotassium or magnesium levels, patients with congenital long QT syndrome, patients taking anti-arrhythmic medicines or other drugs that may lead to QTprolongation. low levels of potassium or magnesium must be corrected prior toTasigna administration. Close monitoring for an effect on the QTc interval isadvisable and a baseline electrocardiography is recommended prior to initiatingtherapy with Tasigna and as clinically indicated. Uncommon cases (0.1 to 1%) ofsudden death have been reported in clinical studies in patients with significantrisk factors.

Tasigna should be used with caution in patients with liver impairment, inpatients with a history of pancreatitis and in patients with total gastrectomy.Patients with rare hereditary problems of galactose intolerance, severe lactasedeficiency or glucose-galactose malabsorption should not use Tasigna. Tasignashould not be used during pregnancy unless clearly necessary and breast feedingis not recommended during treatment.

The most frequent Grade 3 or 4 adverse events for Tasigna were primarilyhematological in nature and included neutropenia and thrombocytopenia.Elevations seen in bilirubin, liver function tests, lipase enzymes and bloodsugar were mostly transient and resolved over time. These cases were easilymanaged and rarely led to discontinuation of treatment. Pancreatitis wasreported in less than 1% of cases. the most frequent non-hematologic drug-related adverse events were rash, pruritus, nausea, fatigue, headache, alopecia, myalgia, constipation and diarrhea. most of these adverse events were mild tomoderate in severity.

About Glivec[9]Glivec is approved in more than 110 countries, including the US, EU and Japan, for the treatment of all phases of Ph+ CML. Glivec is also approved in the US, EU and other countries for the treatment of patients with Kit (CD117)-positivegastrointestinal tumors (GIST), which cannot be surgically removed and/or havealready spread to other parts of the body (metastasized). in the US and EU, Glivec is now approved for the post-surgery treatment of adult patientsfollowing complete surgical removal of Kit (CD117)-positive gastrointestinalstromal tumors. in the EU, Glivec is also approved for the treatment of adultpatients with newly diagnosed Ph+ acute lymphoblastic leukemia (Ph+ ALL) incombination with chemotherapy and as a single agent for patients with relapsedor refractory Ph+ ALL. Glivec is also approved for the treatment of adultpatients with unresectable, recurrent and/or metastatic dermatofibrosarcomaprotuberans (DFSP) who are not eligible for surgery. Glivec is also approved forthe treatment of patients with myelodysplastic/myeloproliferative diseases(MDS/MPD). Glivec is also approved for hypereosinophilic syndrome and/or chroniceosinophilic leukemia (HES/CEL).

The effectiveness of Glivec is based on overall hematological and cytogeneticresponse rates and progression-free survival in CML, on hematological andcytogenetic response rates in Ph+ ALL, MDS/MPD, on hematological response ratesin systemic mastocytosis (SM), HES/CEL, on objective response rates andprogression-free survival in unresectable and/or metastatic GIST, on recurrencefree survival in adjuvant GIST and on objective response rates in DFSP.Increased survival in controlled trials has been demonstrated only in newlydiagnosed chronic phase CML and GIST.

Not all indications are available in every country.

Glivec important safety informationThe majority of patients treated with Glivec in clinical trials experiencedadverse events at some time. most events were of mild to moderate grade andtreatment discontinuation was not necessary in the majority of cases.

The safety profile of Glivec was similar in all indications. the most commonside effects included nausea, superficial edema, muscle cramps, skin rash, vomiting, diarrhea, abdominal pain, myalgia, arthralgia, hemorrhage, fatigue, headache, joint pain, cough, dizziness, dyspepsia and dyspnea, dermatitis, eczema and fluid retention, as well as neutropenia, thrombocytopenia and anemia.Glivec was generally well tolerated in all of the studies that were performed, either as monotherapy or in combination with chemotherapy, with the exception ofa transient liver toxicity in the form of transaminase elevation andhyperbilirubinemia observed when Glivec was combined with high dosechemotherapy.

Rare/serious adverse reactions include: sepsis, pneumonia, depression, convulsions, cardiac failure, thrombosis/embolism, ileus, pancreatitis, hepaticfailure, exfoliative dermatitis, angioedema, Stevens-Johnson syndrome, renalfailure, fluid retention, edema (including brain, eye, pericardium, abdomen andlung), hemorrhage (including brain, eye, kidney and gastrointestinal tract), diverticulitis, gastrointestinal perforation, tumor hemorrhage/necrosis and hiposteonecrosis/avascular necrosis.

Patients with cardiac disease or risk factors for cardiac failure should bemonitored carefully and any patient with signs or symptoms consistent withcardiac failure should be evaluated and treated. Cardiac screening should beconsidered in patients with HES/CEL, and patients with MDS/MPD with high levelof eosinophils (echocardiogram, serum troponin level).

Glivec is contraindicated in patients with known hypersensitivity to imatinib orany of its excipients. Women of childbearing potential should be advised toavoid becoming pregnant while taking Glivec.

DisclaimerThe foregoing release contains forward-looking statements that can be identifiedby terminology such “under review, ” “commitment, ” “to develop, ” “goal, ” orsimilar expressions, or by express or implied discussions regarding potentialnew indications or labeling for Tasigna or regarding potential future revenuesfrom Tasigna or Glivec. You should not place undue reliance on these statements.Such forward-looking statements reflect the current views of managementregarding future events, and involve known and unknown risks, uncertainties andother factors that may cause actual results with Tasigna and Glivec to bematerially different from any future results, performance or achievementsexpressed or implied by such statements. There can be no guarantee that Tasignawill be submitted or approved for any additional indications or labeling in anymarket. nor can there be any guarantee that Tasigna or Glivec will achieve anyparticular levels of revenue in the future. in particular, management´sexpectations regarding Tasigna and Glivec could be affected by, among otherthings, unexpected clinical trial results, including unexpected new clinicaldata and unexpected additional analysis of existing clinical data; unexpectedregulatory actions or delays or government regulation generally; competition ingeneral; government, industry and general public pricing pressures; thecompany´s ability to obtain or maintain patent or other proprietary intellectualproperty protection; the impact that the foregoing factors could have on thevalues attributed to the Novartis Group´s assets and liabilities as recorded inthe Group´s consolidated balance sheet, and other risks and factors referred toin Novartis 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. Novartis isproviding the information in this press release as of this date and does notundertake any obligation to update any forward-looking statements contained inthis press release as a result of new information, future events or otherwise.

About NovartisNovartis provides healthcare solutions that address the evolving needs ofpatients and societies. Focused solely on healthcare, Novartis offers adiversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools andconsumer health products. Novartis is the only company with leading positions inthese areas. in 2009, the Group´s continuing operations achieved net sales ofUSD 44.3 billion, while approximately USD 7.5 billion was invested in R&Dactivities throughout the Group. Headquartered in Basel, Switzerland, NovartisGroup companies employ approximately 100,000 full-time-equivalent associates andoperate in more than 140 countries around the world. for more information, please visitnovartis.com.

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*Known as Gleevec(®) (imatinib mesylate) tablets in the US, Canada and Israel.

References[1] Saglio G, Kim D-W, Surapol Issaragrisil S, et al. Nilotinib versus imatinibfor newly diagnosed chronic myeloid leukemia. N Engl J Med. 2010 Jun17;362(24):2251-9.[2] Larson R, Philipp le Coutre, Reiffers J, Hughes T. et al. Nilotinib isSuperior to Imatinib in Patients (pts) with Newly Diagnosed Chronic MyeloidLeukemia in Chronic Phase (CML-CP): ENESTnd Beyond one Year. Abstract # CRA6501. American Society of Clinical Oncology 2010 Annual Meeting.[3] Novartis data on file.[4] le Coutre P, Ottmann OG, Giles F, et al. Nilotinib (formerly AMN107), ahighly selective BCR-ABL tyrosine kinase inhibitor, is active in patients withimatinib-resistant or-intolerant accelerated-phase chronic myelogenous leukemia.Blood. 2008 Feb15;111(4):1834-9.[5] Swords R, Mahalingam D, Padmanabhan S, et al. Nilotinib: optimal therapy forpatients with chronic myeloid leukemia and resistance or intolerance toimatinib. Drug Des Devel Ther. 2009 Sep 21;3:89-101.[6] Hochhaus A, O´Brien SG, Guilhot F, et al. IRIS Investigators. Six-yearfollow-up of patients receiving imatinib for the first-line treatment of chronicmyeloid leukemia. Leukemia. 2009 Jun;23(6):1054-61.[7] Müller MC, Hanfstein B, Erben P, et al. Molecular response to first lineimatinib therapy is predictive for long term event free survival in patientswith chronic phase chronic myelogenous leukemia – an interim analysis of therandomized German CML Study IV. Blood (ASH Annual Meeting Abstracts)2008., 112: Abstract 333.[8] Baccarani M, Cortes J, Pane F, et al. Chronic myeloid leukemia: an update ofconcepts and management recommendations of European LeukemiaNet. J Clin Oncol.2009 Dec 10;27(35):6041-51.[9] Glivec® (imatinib) prescribing information. Basel, Switzerland: NovartisInternational AG; March 2009.

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