This past Friday, the U.S. Food and Drug Administration (FDA) approved the first of a new generation of chronic hepatitis C drugs, known as protease inhibitors. The drug, VICTRELIS? (boceprevir), from Merck & Co., has been shown to increase the rate of sustained viral response and shorten treatment times when used in combination with the current standard of care, ribavirin and pegylated alpha interferon, in the treatment of chronic hepatitis C. Vertex Pharmaceuticals is seeking approval to market a similar drug, INCIVEK? (telaprevir).

The addition of protease inhibitors to the current standard of care puts a new and significantly greater treatment burden on the patient. under most treatment regimens, pegylated alpha-interferon is injected once a week, and ribavirin is taken twice a day, for a total of five or six pills when prescribed in generic form. VICTRELIS is taken three times a day, for a total of 12 pills. INCIVEK is also taken three times a day, for a total of 6 pills. A treatment cycle lasting 48 weeks could mean that the patient is responsible for taking over 5,700 pills on schedule for the entire regimen. If the patient does not adhere to the prescribed regimen, the risk of treatment failure or relapse is increased (Reddy KR, Shiffman ML, Morgan TR, et al. Clin Gastroenterol Hepatol. 2007;5:124-129). Furthermore, because of the direct antiviral mechanism of protease inhibitors, missed doses of a protease inhibitor could lead to viral resistance (Weiss, et al. Aliment Pharmacol Ther 2009; 30:14-27).

Kadmon Pharmaceuticals’ proprietary RIBASPHERE? RIBAPAK? (ribavirin, USP) is the only ribavirin available in a daily, two-pill compliance package designed to enhance therapy adherence. with RIBASPHERE RIBAPAK, the patient takes only two pills each day — one in the morning and one at night — reducing the total ribavirin pill burden by up to 66 percent over a 48 week course of treatment. RIBASPHERE RIBAPAK packaging is clearly marked for seven days of AM and PM dosing, and the completion of a compliance pack reminds the patient to administer their accompanying weekly interferon therapy. Kadmon is also offering patients a daily therapy diary to help keep track of their treatment schedule.

“Maintaining treatment adherence under the burden of a triple therapy combination will require significantly greater vigilance from the patient,” said Bruce R. Bacon, M.D., professor of internal medicine at the Saint Louis University School of Medicine, and a clinical investigator for VICTRELIS. “With only one chance at success with this therapeutic approach, RIBASPHERE RIBAPAK represents an invaluable insurance policy for a treatment combination which could transform the enormous public health risks of hepatitis C.”

About Hepatitis C

Hepatitis C is a liver disease that results from infection with the hepatitis C virus. it can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Hepatitis C virus can be either “acute” or “chronic.” Acute hepatitis C virus infection is a short-term illness that occurs within the first 6 months after someone is exposed to the hepatitis C virus. Seventy-five – 85% of acute HCV infections become chronic HCV infections. Chronic hepatitis C virus is a serious disease than can result in long-term health problems, such as serious liver disease, including cirrhosis and liver cancer, or even death. An estimated 3.2 million Americans have a chronic infection of the hepatitis C virus.

About RIBASPHERE? RIBAPAK? (ribavirin, USP)

INDICATION

RIBASPHERE? (ribavirin, USP) in combination with peginterferon alfa-2a is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha.

IMPORTANT SAFETY INFORMATION

RIBASPHERE (ribavirin, USP) monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication (see WARNINGS). The primary clinical toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple dose half-life of 12 days, and it may persist in non-plasma compartments for as long as 6 months. Ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of therapy in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6 month post treatment follow-up period.

CONTRAINDICATIONS

RIBASPHERE (ribavirin, USP) is contraindicated in:

• Patients with known hypersensitivity to RIBASPHERE (ribavirin, USP) or to any component of the tablet.
• Women who are pregnant.
• Men whose female partners are pregnant, plan to become pregnant, or are not using contraception.
• Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia).
• In combination with didanosine. Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials.

RIBASPHERE (ribavirin, USP) and peginterferon alfa-2a combination therapy is contraindicated in patients with:

• Autoimmune hepatitis.
• Hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment.
• Hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment.

WARNINGS AND PRECAUTIONS

Treatment with RIBASPHERE (ribavirin, USP) and peginterferon alfa-2a should be administered under the guidance of a qualified physician and may lead to moderate to severe adverse experiences requiring dose reduction, temporary dose cessation or discontinuation of therapy.

RIBASPHERE (ribavirin, USP) must not be used alone because ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection.

RIBASPHERE (ribavirin, USP) and peginterferon alfa-2a should be discontinued in patients who develop evidence of hepatic decompensation during treatment.

There are significant adverse events caused by ribavirin/peginterferon alfa-2a therapy, including severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, ophthalmologic disorders, cerebrovascular disorders, pulmonary dysfunction, colitis, pancreatitis, and diabetes. The peginterferon alfa-2a package insert and medication guide should be reviewed in their entirety prior to initiation of combination treatment for additional safety information.

Pregnancy: Ribavirin may cause birth defects and/or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.

Anemia: The primary toxicity of ribavirin is hemolytic anemia (hemoglobin < 10 g/dL), which was observed in approximately 13% of all ribavirin and peginterferon alfa-2a treated patients in clinical trials.

Hepatic Failure: Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including peginterferon alfa-2a. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART.

Hypersensitivity: Severe acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, and anaphylaxis) have been observed during alpha interferon and ribavirin therapy.

Renal Impairment: RIBASPHERE (ribavirin, USP) should not be used in patients with creatinine clearance < 50 mL/min.

Pulmonary: Pulmonary symptoms, including dyspnea, pulmonary infiltrates, pneumonitis, pulmonary hypertension, pneumonia, and occasional cases of fatal pneumonia, have been reported during therapy with ribavirin and interferon. In addition, sarcoidosis or the exacerbation of sarcoidosis has been reported.

Bone Marrow Suppression: Pancytopenia (marked decreases in RBCs, neutrophils and platelets) and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the concomitant administration of pegylated interferon/ribavirin and azathioprine.

Pancreatitis: RIBASPHERE (ribavirin, USP) and peginterferon alfa-2a therapy should be suspended in patients with signs and symptoms of pancreatitis, and discontinued in patients with confirmed pancreatitis.

Laboratory Tests: Before beginning peginterferon alfa-2a/RIBASPHERE (ribavirin, USP) combination therapy, standard hematological and biochemical laboratory tests are recommended for all patients.

Drug Interactions: Nucleoside Analogues: NRTIs: In clinical trials, cases of hepatic decompensation (some fatal) were observed among the CHC/HIV coinfected cirrhotic patients receiving NRTIs. Patients receiving peginterferon alfa-2a/ribavirin and NRTIs should be closely monitored for treatment associated toxicities.

ADVERSE REACTIONS

Peginterferon alfa-2a in combination with ribavirin causes a broad variety of serious adverse reactions. The most common serious or life-threatening adverse reactions induced or aggravated by peginterferon alfa-2a and ribavirin include depression, suicide, relapse of drug abuse/overdose, and bacterial infections, each occurring at a frequency of < 1%. Hepatic decompensation occurred in 2% of CHC/HIV patients. nearly all patients in clinical trials experienced one or more adverse events.

For more information please see the accompanying RIBASPHERE RIBAPAK (ribavirin, USP) Tablets Full Prescribing Information. The peginterferon alfa-2a Package Insert should be reviewed in its entirety for additional safety information prior to initiation of combination treatment.

About Kadmon Pharmaceuticals

Kadmon Pharmaceuticals LLC is a privately held, new York City-based biopharmaceutical company founded on its expertise in novel science. The company explores new understandings in molecular biology to develop therapies that target the metabolomic or signaling pathways associated with disease, including novel anti hepatitis C therapies. Collaborating with academic centers and private enterprise at the forefront of innovation, Kadmon is focused on pioneering medicines in the areas of oncology, infectious diseases and immunology. for more information, visit kadmon.com.

U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C -Six-month review date of May 23, 2011 set by FDA-

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has accepted the new Drug Application (NDA) for telaprevir and granted the company’s request for six-month Priority Review. Telaprevir is Vertex’s lead medicine in development for people with genotype 1 chronic hepatitis C. the FDA grants Priority Review to medicines that offer major advances in treatment or provide a treatment where no adequate therapy exists. a target review date of May 23, 2011 is set under the Prescription Drug User Fee Act (PDUFA) for the FDA’s approval decision, which is four months earlier than the standard review time of 10 months.

Additionally, Vertex today announced the completion of a new Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada. Telaprevir was also granted Priority Review in Canada, which allows for faster review for promising medicines that address life-threatening or severely debilitating conditions and for which there are few effective therapies already available. Standard review in Canada takes 18 months or more and Priority Review typically shortens the review time to approximately six to nine months.

In December 2010, Janssen-Cilag International NV announced that the European Medicines Agency (EMA) accepted telaprevir for accelerated assessment in Europe, which is granted to new medicines of major public health interest.

“Data from Phase 3 studies showed that when compared to currently available medicines, telaprevir-based combination therapy nearly doubled viral cure rates and cut treatment time in half for the majority of patients new to treatment,” said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. “We look forward to working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C.”

Data to Support the Telaprevir Submissions

The regulatory submissions in the United States, Canada and Europe are supported by data from three Phase 3 studies, known as ADVANCE, ILLUMINATE and REALIZE, which evaluated up to 12 weeks of telaprevir in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) in people chronically infected with genotype 1 hepatitis C virus (HCV) who were new to treatment as well as those who were treated before with currently available medicines but did not achieve a sustained viral response (SVR, or viral cure). in these studies, treatment with telaprevir-based combination therapy resulted in significantly higher viral cure rates compared to approved medicines, regardless of prior treatment experience, race or stage of liver disease. up to 75 percent of people new to treatment achieved a viral cure with telaprevir-based therapy. the majority of these people were able to complete their course of treatment at six months – half the time needed with currently available medicines. Among those who did not achieve a viral cure with a prior treatment course of currently available medicines, Phase 3 data showed that telaprevir-based combination therapy resulted in viral cure rates three to five times higher compared to re-treatment with currently available medicines. the safety and tolerability results of telaprevir-based combination therapy were consistent across the Phase 3 studies. the most common adverse events regardless of treatment regimen were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia, with the majority being mild or moderate in severity.

Vertex provided a summary of Phase 3 results, including SVR and safety data for telaprevir, in its November 23, 2010 press release announcing the NDA submission.

Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication. To date, more than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies.

Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain far East countries.

Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1 Approximately 60 percent of genotype 1 patients who undergo an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved medicines, do not achieve SVR,2,3,4 or viral cure.5 if treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.6,7,8.9,10

Hepatitis C in the United States

Up to 3.9 million people in the United States have chronic hepatitis C and 75 percent of them are unaware of their infection.11 the majority of people with hepatitis C in the U.S. were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.10 Hepatitis C is the leading cause of liver transplantations in the U.S. and is reported to contribute to 4,600 to 12,000 deaths annually.7 by 2029, total annual medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.10

Hepatitis C in Canada

Approximately 250,000 people in Canada have chronic hepatitis C and more than a third of them do not know they are infected.12 three provinces account for 80 percent of hepatitis C infections in Canada: Ontario (42 percent), British Columbia (22 percent) and Quebec (16 percent).13 each year up to 5,000 people are newly infected with hepatitis C and in 2007 alone, nearly 8,000 people were infected.12, 13 in 2010, the annual cost of hepatitis C due to medical treatment and lost productivity in Canada was estimated to reach $1 billion.14 by 2022, the number of hepatitis C-related deaths is expected to increase by one-third.15

Additional resources for media are available at: investors.vrtx.com/press.cfm.

PEGASYS® and COPEGUS® are registered trademarks of Hoffman-LA Roche.

Special Note regarding Forward-looking Statements

This press release contains forward-looking statements, including statements regarding (i) the FDA’s target review date for the telaprevir NDA, (ii) Priority Review in Canada allowing for faster review of new Drug Submissions, typically shortening the review time to approximately six to nine months and (iii) Vertex working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C. while the company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that Vertex could experience unforeseen delays in obtaining approval to market telaprevir; that there may be varying interpretations of the data from the telaprevir clinical trials; that future outcomes from clinical trials of telaprevir may not be favorable; that future scientific, clinical, competitive or other market factors may adversely affect the potential for telaprevir-based therapy and the other risks listed under Risk Factors in Vertex’s annual report and quarterly reports filed with the Securities and Exchange Commission and available through Vertex’s website at vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

Vertex creates new possibilities in medicine. Our team aims to discover, develop and commercialize innovative therapies so people with serious diseases can lead better lives.

Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.

Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.

About Vertex in Canada

In 2009, Vertex established a research and development site in Laval, Quebec through the acquisition of Virochem Pharma, Inc. Vertex is expanding its existing research and development infrastructure with the addition of commercial and medical teams to support the potential launch of telaprevir in Canada.

For more information and to view Vertex’s press releases, please visit vrtx.com.

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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