Significant potential of late- and mid-stage Novartis hematology
portfolio to be showcased at upcomi
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Late-breaking abstract to report data from pivotal trial of Tasigna® versus Glivec® in newly diagnosed patients with a form of chronic myeloid leukemia * Data from Phase II studies to show the potential of everolimus in a rare form of non-Hodgkin lymphoma and of panobinostat in Hodgkin lymphoma[1],[2] * Oral presentation featuring early data on midostaurin to show promise in FLT3-mutated acute myeloid leukemia[3] * New data to be presented on a Janus kinase (JAK) inhibitor, recently added to the Novartis Oncology pipeline[4],[5] * Two-year data from EPIC trial to demonstrate Exjade® continues to significantly reduce toxic iron that can damage the heart of chronically transfused patients[6]Basel, December 2, 2009 - Novartis announced today that new data,including a late-breaking presentation on Tasigna® (nilotinib) in aform of chronic myeloid leukemia, demonstrate the strength of thecompany's hematology portfolio in advancing the care of patients.The new data, at the 51st American Society of Hematology (ASH) AnnualMeeting and Exposition, highlight the company's current therapies andinvestigational agents in 195 studies including 39 oralpresentations. Data will be presented on Tasigna, Afinitor®(everolimus) tablets, Exjade® (deferasirox) and pipeline agentsincluding PKC412 (midostaurin), LBH589 (panobinostat), BHQ880 andINCB18424, an oral, selective Janus kinase (JAK) inhibitor that wasrecently added to the oncology pipeline through a licensingagreement."Data presented at ASH will demonstrate the vigorous researchunderway to explore the best treatment approaches for patients withrare blood cancers and conditions," said David Epstein, President andCEO, Novartis Oncology and Novartis Molecular Diagnostics. "We expectthese data to lay the groundwork for regulatory submissions andprovide a roadmap for the initiation of late-stage and pivotaltrials."The ASH Annual Meeting will feature results from a pivotalhead-to-head study comparing the efficacy and safety of Tasignaversus Glivec® (imatinib)* in adult patients with newly diagnosedPhiladelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)in chronic phase (Abstract #LBA-1; Tuesday, December 8, 2009 at 7:30AM CST).Data from this Phase III clinical trial, ENESTnd (EvaluatingNilotinib Efficacy and Safety in Clinical Trials of Newly DiagnosedPh+ CML Patients), will show that Tasigna produced faster and deeperresponses than Glivec when used as first-line therapy.Other key presentations at ASH include: * Everolimus Phase II data to show efficacy and safety in patients with Waldenström's macroglobulinemia (WM) who had relapsed or become resistant to prior treatment (Abstract #587; Monday, December 7, 2009 at 3:45 PM CST)[1] * LBH589 (panobinostat) data from two early phase studies to show efficacy in heavily pre-treated patients with multiple myeloma and Hodgkin lymphoma (Abstract #3852; Monday, December 7, 2009 at 6:00 PM CST; Abstract #923; Tuesday, December 8, 2009 at 8:30 AM CST)[2],[7] * PKC412 (midostaurin) early stage data will demonstrate benefit in patients with FLT3-mutated acute myeloid leukemia when used in combination with chemotherapy (Abstract #634; Monday, December 7, 2009 at 5:15 PM CST)[3] * INCB18424 data from a Phase II study in advanced polycythemia vera (PV) and essential thrombocythemia (ET) refractory to hydroxyurea (Abstract #311; Monday, December 7, 2009, 8:00 AM CST)[5] * INCB18424 long-term follow-up data to demonstrate durable clinical, functional and symptomatic responses with excellent hematological safety in patients with myelofibrosis (Abstract #756; Monday, December 7, 2009 at 5:45 PM CST)[4] * Exjade two-year data from EPIC (Evaluation of Patients Iron Chelation with Exjade) trial to show benefit of Exjade for chronically transfused beta-thalassemia patients by continuing to significantly reduce toxic iron that can damage the heart (Abstract #4062; Monday, December 7, 2009 at 6:00 PM CST)[6] * BHQ880 preliminary Phase I study data in combination with Zometa® (zoledronic acid) and an approved anti-myeloma therapy in patients with relapsed or refractory multiple myeloma who experienced a prior skeletal-related event (Abstract #750; Monday, December 7, 2009 at 5:45 PM CST)[8].[9]The Novartis Oncology pipeline features compounds in all phases ofdevelopment, including six in late-stage development, and encompassesa broad array of therapeutic strategies for fighting cancer.About Tasigna[10]Tasigna is approved in more than 80 countries for the treatment ofchronic phase and accelerated phase Ph+ CML in adult patientsresistant or intolerant to at least one prior therapy, includingGlivec. The effectiveness of Tasigna for this indication is based onconfirmed hematologic and unconfirmed cytogenetic response rates.There are no controlled trials demonstrating a clinical benefit, suchas improvement in disease-related symptoms or increased survival.Tasigna important safety informationBecause taking Tasigna with food may increase the amount of drug inthe blood, Tasigna should not be taken with food and patients shouldwait at least two hours after a meal before taking Tasigna. Inaddition, no food should be consumed for at least one hour after thedose is taken.The most frequent Grade 3 or 4 adverse events for Tasigna wereprimarily hematological in nature and included neutropenia andthrombocytopenia. Elevations seen in bilirubin, liver function tests,lipase enzymes and blood sugar, were mostly transient and resolvedover time. These cases were easily managed and rarely led todiscontinuation of treatment. Pancreatitis was reported in less than1% of cases. The most frequent non-hematologic drug-related adverseevents were rash, pruritus, nausea, fatigue, headache, constipationand diarrhea. Most of these adverse events were mild to moderate inseverity.Tasigna should be used with caution in patients with uncontrolled orsignificant cardiac disease (e.g., recent heart attack, congestiveheart failure, unstable angina or clinically significantbradycardia), as well as in patients who have or may developprolongation of QTc. These include patients with abnormally lowpotassium or magnesium levels, patients with congenital long QTsyndrome, patients taking anti-arrhythmic medicines or other drugsthat may lead to QT prolongation. Low levels of potassium ormagnesium must be corrected prior to Tasigna administration. Closemonitoring for an effect on the QTc interval is advisable and abaseline echocardiogram is recommended prior to initiating therapywith Tasigna and as clinically indicated.About Glivec[11]Glivec is approved in more than 90 countries, including the US, EUand Japan, for the treatment of all phases of Ph+ CML. Glivec is alsoapproved in the US, EU and other countries for the treatment ofpatients with Kit (CD117)-positive gastrointestinal tumors (GIST),which cannot be surgically removed and/or have already spread toother parts of the body (metastasized). In the US and EU, Glivec isnow approved for the post-surgery treatment of adult patientsfollowing complete surgical removal of Kit (CD117)-positivegastrointestinal stromal tumors. In the EU, Glivec is also approvedfor the treatment of adult patients with newly diagnosed Ph+ acutelymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy andas a single agent for patients with relapsed or refractory Ph+ ALL.Glivec is also approved for the treatment of adult patients withunresectable, recurrent and/or metastatic dermatofibrosarcomaprotuberans (DFSP) who are not eligible for surgery. Glivec is alsoapproved for the treatment of patients withmyelodysplastic/myeloproliferative diseases (MDS/MPD). Glivec is alsoapproved for hypereosinophilic syndrome and/or chronic eosinophilicleukemia (HES/CEL).The effectiveness of Glivec is based on overall hematological andcytogenetic response rates and progression-free survival in CML, onhematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, onhematological response rates in systemic mastocytosis (SM), HES/CEL,on objective response rates and progression-free survival inunresectable and/or metastatic GIST, on recurrence-free survival inadjuvant GIST and on objective response rates in DFSP. Increasedsurvival 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 trialsexperienced adverse events at some time. Most events were of mild tomoderate grade and treatment discontinuation was not necessary in themajority of cases.The safety profile of Glivec was similar in all indications. The mostcommon side effects included nausea, superficial edema, musclecramps, skin rash, vomiting, diarrhea, abdominal pain, myalgia,arthralgia, hemorrhage, fatigue, headache, joint pain, cough,dizziness, dyspepsia and dyspnea, dermatitis, eczema and fluidretention, as well as neutropenia, thrombocytopenia and anemia.Glivec was generally well tolerated in all of the studies that wereperformed, either as monotherapy or in combination with chemotherapy,with the exception of a transient liver toxicity in the form oftransaminase elevation and hyperbilirubinemia observed when Glivecwas combined with high dose chemotherapy.Rare/serious adverse reactions include: sepsis, pneumonia,depression, convulsions, cardiac failure, thrombosis/embolism, ileus,pancreatitis, hepatic failure, exfoliative dermatitis, angioedema,Stevens-Johnson syndrome, renal failure, fluid retention, edema(including brain, eye, pericardium, abdomen and lung), hemorrhage(including brain, eye, kidney and gastrointestinal tract),diverticulitis, gastrointestinal perforation, tumorhemorrhage/necrosis and hip osteonecrosis/avascular necrosis.Patients with cardiac disease or risk factors for cardiac failureshould be monitored carefully and any patient with signs or symptomsconsistent with cardiac failure should be evaluated and treated.Cardiac screening should be considered in patients with HES/CEL, andpatients with MDS/MPD with high level of eosinophils (echocardiogram,serum troponin level).Glivec is contraindicated in patients with known hypersensitivity toimatinib or any of its excipients. Women of childbearing potentialshould be advised to avoid becoming pregnant while taking Glivec.About everolimusIn the US, everolimus is approved under the trade name Afinitor forthe treatment of patients with advanced renal cell carcinoma (RCC)after failure of treatment with sunitinib or sorafenib. In theEuropean Union (EU), Afinitor is approved for the treatment ofpatients with advanced RCC whose disease has progressed on or aftertreatment with vascular endothelial growth factor (VEGF)-targetedtherapy. Further, in the EU, everolimus is available in differentdosage strengths under the trade name Certican® for the prevention oforgan rejection in heart and kidney transplant recipients.With once-daily dosing, everolimus continuously targets mammaliantarget of rapamycin (mTOR) in cancer cells, a protein that acts as acentral regulator of tumor cell division, blood vessel growth andcell metabolism. Everolimus is being studied in multiple tumor types,including breast cancer, neuroendocrine tumors, gastric cancer,hepatocellular carcinoma (HCC) and non-Hodgkin lymphoma (NHL), aswell as tuberous sclerosis complex (TSC).As an investigational compound, the safety and efficacy profile ofeverolimus has not yet been established in these cancer and tumortypes. Access to everolimus for these cancer and tumor types isavailable through carefully controlled and monitored clinical trials.These trials are designed to better understand the potential benefitsand risks of the compound. For more information about everolimusclinical trials, healthcare professionals can visitwww.theWIDEprogram.com. Because of the uncertainty of clinicaltrials, there is no guarantee that everolimus will ever becomecommercially available for these cancer and tumor types anywhere inthe world.Afinitor (everolimus) tablets important safety informationAfinitor is contraindicated in patients with hypersensitivity toeverolimus, to other rapamycin derivatives or to any of theexcipients.Cases of non-infectious pneumonitis have been described; some ofthese have been severe and occasionally fatal. Management ofpneumonitis may require dose adjustment and/or interruption, ordiscontinuation of treatment and/or addition of corticosteroidtherapy.Afinitor is immunosuppressive. Localized and systemic bacterial,fungal, viral or protozoal infections (e.g., pneumonia,aspergillosis, candidiasis, hepatitis B reactivation) have beendescribed; some of these have been severe and occasionally fatal.Pre-existing infections should be treated prior to startingtreatment. Be vigilant for symptoms and signs of infection; in caseof emergent infections, institute appropriate treatment promptly andconsider interruption or discontinuation of Afinitor. Patients withsystemic invasive fungal infections should not receive Afinitor.Mouth ulcers, stomatitis and oral mucositis have been seen inpatients treated with Afinitor. Monitoring of renal function, bloodglucose and complete blood counts is recommended prior to initiationand periodically during treatment.Afinitor is not recommended in patients with severe hepaticimpairment. Use of live vaccines should be avoided. Afinitor is notrecommended during pregnancy or for women of childbearing potentialnot using contraception. Afinitor may cause fetal harm in pregnantwomen. Women should not breast feed.Avoid concurrent treatment with strong CYP3A4 and PgP inhibitors anduse caution with moderate inhibitors. Avoid concurrent treatment withstrong CYP3A4 or PgP inducers.The most common adverse reactions (>=10%) include stomatitis, rash,fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,vomiting, cough, infections, peripheral edema, dry skin, epistaxis,pneumonitis, pruritus, dyspnea and dysgeusia. Common adversereactions (>=1 to <10%) include headache, dry mouth, pyrexia, weightdecreased, hand-foot syndrome, abdominal pain, erythema, insomnia,dyspepsia, dysphagia, hypertension, increased daytime urination,dehydration, chest pain, hemoptysis and exacerbation of diabetesmellitus. Uncommon adverse reactions (<1%) include ageusia,congestive cardiac failure, new-onset diabetes mellitus, impairedwound healing, grade 1 hemorrhage and hepatitis B reactivation.About ExjadeExjade is approved in more than 90 countries, including the US,Switzerland, Japan and the countries comprising the European Union.Exjade is indicated for chronic iron overload due to bloodtransfusions. The approved indication may vary depending upon theindividual country. Exjade is approved for use at doses up to 40mg/kg in many countries, including the US, Canada, Australia, andSwitzerland. Exjade may be available in additional countries atsimilar dosing pending approval. The European Medicines Agency (EMEA)is currently considering an application for similar dosing (up to 40mg/kg) in the European Union.Disclaimer: The results seen in the EPIC study were achieved with astarting dose of 30 mg/kg, which is not approved in all countries anda dose range up to 45 mg/kg which is not approved in any country.Exjade important safety informationExjade is contraindicated in patients with hypersensitivity to theactive substance or to any of the excipients. Exjade has not beenstudied in patients with renal impairment and is contraindicated inpatients with moderate/severe renal impairment.Caution should be utilized in high-risk MDS patients and patientswith other hematological and non-hematological malignancies who arenot expected to benefit from chelation therapy due to the rapidprogression of their disease. Caution should be used in elderlypatients due to a higher frequency of adverse reactions.There have been postmarketing reports of acute renal failure, hepaticfailure and cytopenias in patients treated with Exjade, some with afatal outcome. Monthly monitoring of serum creatinine, creatinineclearance, proteinuria, serum transaminases is recommended, and thedose of Exjade should be modified or interrupted if necessary. Morefrequent creatinine monitoring is recommended in patients with anincreased risk of renal complications. Liver function tests should beconducted every 2 weeks during the first month of treatment andmonthly thereafter. Upper gastrointestinal ulceration and hemorrhagehave been reported and caution should be exercised when combined withdrugs with ulcerogenic potential. There have been rare reports offatal GI hemorrhages, especially in elderly patients who had advancedhematologic malignancies and/or low platelet counts. Caution shouldbe used in patients with platelet counts <50 x 1.000.000.000/L. Skinrashes, including hypersensitivity reactions, have been reported.Exjade should be interrupted if severe rash develops and discontinuedif severe hypersensitivity reaction occurs. Auditory and ophthalmictesting should be conducted annually.Exjade should not be taken with aluminium-containing antacids.Caution should be exercised when Exjade is combined with drugsmetabolized through CYP3A4, CYP2C8 substrates, potent UGT inducers,drugs with ulcerogenic potential and anticoagulants.The most common adverse reactions in clinical trials are nausea,vomiting, diarrhea, abdominal pain, rash, non-progressive increase inserum creatinine, increased transaminases, abdominal distension,constipation, dyspepsia, proteinuria and headache.About midostaurin (PKC412)Midostaurin is a multi-targeted kinase inhibitor that suppresses theFLT3 receptor tyrosine kinase, resulting in increased cell death andreduced cell division in tumors. The FLT3 gene is one of severalcancer genes associated with the development of AML and approximately30% of AML patients will have a mutation in their FLT3 gene. Patientswho have this mutation have poor prognosis with reduced overallsurvival, and show higher relapse rates when compared to patients whodo not have the mutation, often referred to as FLT3-wild-type.There is an ongoing global randomized, placebo-controlled Phase IIIclinical trial called CALGB 10603-RATIFY (Randomized AML Trial InFLT3 in <60 Year Olds) to study midostaurin in combination withstandard chemotherapy in newly diagnosed patients with FLT3-mutatedAML. This is a multi-cooperative group global trial, sponsored by theCancer and Leukemia Group B (CALGB) in North America and Novartisoutside North America.About panobinostat (LBH589)Panobinostat is a potent pan-deacetylase (DAC) inhibitor. Byinterfering in the nucleus with gene expression and transcription,panobinostat decreases tumor cell division, causes tumor cell deathand inhibits the formation of new blood vessels that feed tumors.Furthermore, in diseases that involve plasma cells such as multiplemyeloma, panobinostat inhibits HDAC6 (a key enzyme in the eliminationof pathologically hypersecreted monoclonal immunoglobulins) leadingto cell death.About BHQ880BHQ880 is a first-in-class, fully human, anti-dickkopf-1 (DKK-1)neutralizing antibody. By inhibiting the DDK-1 antibody, BHQ880promotes activity of osteoblasts, cells that form bones.About INCB18424INCB18424 (also known as INCB018424) is a Janus kinase (JAK)inhibitor. This oral targeted therapy is now in Phase III clinicaltrials for the treatment of myelofibrosis, a life-threateningneoplastic condition with no effective medical treatment that ischaracterized by varying degrees of bone marrow failure, splenomegaly(enlarged spleen) and debilitating symptoms. INCB18424 has thepotential of becoming a first-in-class therapeutic agent for thetreatment of this and other hematologic diseases.About ZometaZometa is indicated for the treatment or prevention of skeletalrelated events (pathological fractures, spinal compression, radiationor surgery to bone, or tumor-induced hypercalcemia) in patients withadvanced malignancies involving bone. An intravenous bisphosphonate,Zometa is the only therapy to demonstrate efficacy in reducing ordelaying bone complications across a broad range of tumor types suchas breast, prostate, lung and renal cell cancers, in patients withmetastatic disease when administered monthly. Zometa offers patients,nurses and clinicians a 4 mg, 15-minute infusion.Zometa is the world's leading treatment for the prevention or delayof skeletal-related events (SREs) in patients with advancedmalignancies involving bone across a broad range of tumors.Laboratory research has suggested that Zometa may also help protectpatients from the spread of cancer to other parts of the body(distant metastatic sites) and help keep patients recurrence-free.Zometa important safety informationZometa has been associated with reports of renal insufficiency.Patients should be adequately rehydrated and have their serumcreatinine assessed prior to receiving each dose of Zometa. Due tothe risk of clinically significant deterioration in renal function,single doses of Zometa should not exceed 4 mg and the duration ofinfusion should be no less than 15 minutes in 100 ml of dilutent.Severe and occasionally incapacitating bone, joint, and/or musclepain has been reported in patients taking bisphosphonates includingZometa. Caution is advised when Zometa is used in aspirin-sensitivepatients, or with aminoglycosides, loop diuretics and otherpotentially nephrotoxic drugs. Zometa contains the same activeingredient (zoledronic acid) as found in Aclasta®. Patients beingtreated with Zometa should not be treated with Aclasta concomitantly.In clinical trials, the most commonly reported adverse eventsincluded flu-like syndrome (fever, arthralgias, myalgias, skeletalpain), fatigue, gastrointestinal reactions, anemia, weakness, cough,dyspnea and edema. Zometa should not be used during pregnancy. Zometais contraindicated in patients with clinically significanthypersensitivity to zoledronic acid or other bisphosphonates, or anyof the excipients in the formulation of Zometa.Osteonecrosis of the Jaw (ONJ): ONJ has been reported in patientswith cancer receiving treatment including bisphosphonates,chemotherapy, and/or corticosteroids. The majority of reported caseshave been associated with dental procedures such as tooth extraction.A dental examination with appropriate preventive dentistry should beconsidered prior to treatment with bisphosphonates in patients withconcomitant risk factors. While on treatment, these patients shouldavoid invasive dental procedures if possible. No data are availableto suggest whether discontinuation of bisphosphonate therapy reducesthe risk of ONJ in patients requiring dental procedures. A causalrelationship between bisphosphonate use and ONJ has not beenestablished.Not all indications are approved in every country. Please see fullPrescribing Information.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "potential," "to present," "toshow," "to demonstrate," "can," "will," "to explore," "pipeline," orsimilar expressions, or by express or implied discussions regardingpotential new indications or labeling, or potential marketingapprovals for the products described in this release, or regardingpotential future revenues from such products. You should not placeundue reliance on these statements. Such forward-looking statementsreflect the current views of management regarding future events, andinvolve known and unknown risks, uncertainties and other factors thatmay cause actual results to be materially different from any futureresults, performance or achievements expressed or implied by suchstatements. There can be no guarantee that any of the products oradditional indications or labeling described in this release will besubmitted for approval or approved for sale in any market. Nor canthere be any guarantee that any of these products will achieve anyparticular levels of revenue in the future. In particular,management's expectations regarding these products could be affectedby, among other things, unexpected clinical trial results, includingunexpected new clinical data and unexpected additional analysis ofexisting clinical data; unexpected regulatory actions or delays orgovernment regulation generally; the company's ability to obtain ormaintain 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 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 approximately99,000 full-time-equivalent associates and operate in more than 140countries around the world. For more information, please visithttp://www.novartis.com.*Known as Gleevec® (imatinib mesylate) tablets in the US, Canada andIsrael.References[1] Ghobrial, et al. A Phase II Trial of the Oral mTOR InhibitorEverolimus (RAD001) in Relapsed or Refractory Waldenstrom'sMacroglobulinemia. 51st American Society of Hematology Annual Meetingand Exposition, New Orleans, LA. December 5-8, 2009.[2] Younes, et al. Efficacy of Panobinostat in Phase II Study inPatients with Relapsed/Refractory Hodgkin Lymphoma (HL) AfterHigh-Dose Chemotherapy with Autologous Stem Cell Transplant. 51stAmerican Society of Hematology Annual Meeting and Exposition, NewOrleans, LA. December 5-8, 2009.[3] Stone, et al. A Phase 1b Study of Midostaurin (PKC412) inCombination with Daunorubicin and Cytarabine Induction and High-DoseCytarabine Consolidation in Patients Under Age 61 with NewlyDiagnosed De Novo Acute Myeloid Leukemia: Overall Survival ofPatients Whose Blasts Have FLT3 Mutations is Similar to Those withWild-Type FLT3. 51st American Society of Hematology Annual Meetingand Exposition, New Orleans, LA. December 5-8, 2009.[4] Verstovsek, et al. Long-Term Follow Up and Optimized DosingRegimen of INCB018424 in Patients with Myelofibrosis: DurableClinical, Functional and Symptomatic Responses with ImprovedHematological Safety. 51st American Society of Hematology AnnualMeeting and Exposition, New Orleans, LA. December 5-8, 2009.[5] Verstovsek, et al. A Phase 2 Study of INCB018424, An Oral,Selective JAK1/JAK2 Inhibitor, in Patients with Advanced PolycythemiaVera (PV) and Essential Thrombocythemia (ET) Refractory toHydroxyurea. 51st American Society of Hematology Annual Meeting andExposition, New Orleans, LA. December 5-8, 2009.[6] Pennell, et al. Efficacy and Safety of Deferasirox (Exjade®) in ÿ-Thalassemia Patients with Myocardial Siderosis: 2-Year Results Fromthe EPIC Cardiac Sub-Study. 51st American Society of HematologyAnnual Meeting and Exposition, New Orleans, LA. December 5-8, 2009.[7] San-Miguel, et al. A Phase IB, Multi-Center, Open-LabelDose-Escalation Study of Oral Panobinostat (LBH589) and I.V.Bortezomib in Patients with Relapsed Multiple Myeloma. 51st AmericanSociety of Hematology Annual Meeting and Exposition, New Orleans, LA.December 5-8, 2009.[8] Padmanabhan, et al. A Phase I/II Study of BHQ880, a NovelOsteoblat Activating, Anti-DKK1 Human Monoclonal Antibody, inRelapsed and Refractory Multiple Myeloma (MM) Patients Treated withZoledronic Acid (Zol) and Anti-Myeloma Therapy (MM Tx). 51st AmericanSociety of Hematology Annual Meeting and Exposition, New Orleans, LA.December 5-8, 2009.[9] Zometa Prescribing Information. March 2008.[10] Tasigna (nilotinib) European Summary of Characteristics.Novartis AG.http://www.tasigna.com/en/tasigna-product-information.jsp# .[11] Glivec (imatinib) prescribing information. Basel, Switzerland:Novartis International AG; March 2009. # # #Novartis Media RelationsCentral media line : +41 61 324 2200Eric Althoff Megan HumphreyNovartis Global Media Relations Novartis Oncology+41 61 324 7999 (direct) +1 862 778 6724 (direct)+41 79 593 4202 (mobile) megan.humphrey(at)novartis.comeric.althoff(at)novartis.come-mail: media.relations(at)novartis.comNovartis Investor RelationsCentral phone: +41 61 324 7944Ruth +41 61 324 9980 North America:Metzler-ArnoldPierre-Michel +41 61 324 1065 Richard Jarvis +1 212 830Bringer 2433John Gilardi +41 61 324 3018 Jill Pozarek +1 212 830 2445Thomas +41 61 324 Edwin Valeriano +1 212 830Hungerbuehler 8425 2456Isabella Zinck +41 61 324 7188e-mail: e-mail:investor.relations(at)novartis.com investor.relations(at)novartis.comhttp://hugin.info/134323/R/1358558/330830.pdf --- End of Message ---Novartis International AGPostfach Basel WKN: 904278; ISIN: CH0012005267; Index: SLCI, SMI, SPI, SLIFE;Listed: Main Market in SIX Swiss Exchange, ZLS in BX Berne eXchange;
Datum: 02.12.2009 - 07:15 Uhr
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