cancer market year book 2005 - fdanews...no part of this publication may be reproduced or used in...

CanCer Market Year Book 2005

©Espicom Business Intelligence December 2005ii

Cancer Market Year Book 2005

ISBN: 1 85822 251 6

© Copyright 2005 Espicom Business Intelligence

All rights reserved. No part of this publication may be reproduced or used in any form or by any means graphic, electronic or mechanical, including photocopying, recording, taping or storage in information retrieval systems without the express permission of the publisher.

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©Espicom Business Intelligence iiiDecember 2005


FOREWORD........................................................ 1Key............................................................................2

GLOBAL.OVERVIEW............................................ 3Cancer.Drugs.Market...............................................3Cancer.Drug.R&D.....................................................3Growth.Drivers.in.the.Cancer.Drug.Sector............3Global.Cancer.Incidence.........................................4

Incidence of Cancer Worldwide by Cancer Site – 2002 ...................5Cancer Mortality Worldwide by Cancer Site – 2002 .......................5

Developed.versus.Developing.Countries..............6Regional Cancer Deaths as a Percentage of Total Deaths ................6Leading Causes of Death in the United States, 2002 (%) ................6Causes of Death in Brazil, 2001 (%) ................................................7Causes of Death in Pakistan, 2001 (%) ...........................................7Global Cases of Selected Cancers, 2002 ...........................................8Global Deaths from Selected Cancers, 2002 ....................................8Global Incidence of Selected Cancers per 100,000 Population, 2002 ................................................................................................9Global Death Rate per 100,000 Population from Selected Cancers, 2002 ................................................................................................9Estimated New Cases of Cancer in the USA, 2003-2005..................102004 Revenues for Selected Leading Cancer Drugs, by Company ..11Selected Leading Cancer Drugs Ranked by 2003-2004 Revenue Growth ............................................................................................12

BLADDER.CANCER............................................. 13OVERVIEW.................................................................... 13PREVALENCE................................................................ 14

Cancer of the Bladder in Selected Countries, 2002 ..........................14Deaths from Cancer of the Bladder in Selected Countries, 2002 .....15Incidence of Cancer of the Bladder per 100,000 population, in Selected Countries in 2002 ..............................................................16Death Rate from Cancer of the Bladder per 100,000 population, in Selected Countries in 2002 ..........................................................17

BLADDER.CANCER.DRUGS.IN.USE............................ 18Companies.&.Products.............................................. 19

Akzo.Nobel...............................................................19OncoTICE/TiceBCG................................................... 19

Eli.Lilly.......................................................................19Gemzar....................................................................... 19

Pfizer.........................................................................20Farmorubicin/Pharmorubicin/Ellence................. 20

Sumitomo.Chemical................................................21Calsed......................................................................... 21

Wyeth.......................................................................21Thioplex..................................................................... 21

R&D.PHASE.III.............................................................. 22Bristol-Myers.Squibb..............................................22

Javlor.......................................................................... 22GlaxoSmithKline......................................................22

Tykerb......................................................................... 22Intracel.Resources...................................................23

BCI-ImmuneActivator............................................. 23R&D.PHASE.II................................................................ 24

Bioenvision..............................................................24Gossypol.................................................................... 24

Gloucester.Pharmaceuticals...................................24FK228.(depsipeptide).............................................. 24

PharmaMar..............................................................25Aplidin........................................................................ 25

PhotoCure................................................................25Hexvix......................................................................... 25

Spectrum.Pharmaceuticals....................................27EOquin........................................................................ 27

INDUSTRY.DEVELOPMENTS.2003/2004.................. 28Strategic.Alliances.in.Bladder.Cancer.-.June.2004.to.December.2005..........................................28

Significant.Events.in.Bladder.Cancer.Drugs-June.2004.to.December.2005................................... 29

September.2004......................................................29PhotoCure.gains.approval.for.Hexvix.in.Sweden....................................................................... 29Stellar.receives.Canadian.approval.to.market.NMP22.BladderChek............................................... 29

January.2005............................................................29FDA.approves.UroVysion.for.diagnosis.of.BC..... 29

March.2005..............................................................30PhotoCure’s.Hexvix.approved.in.26.European.countries.................................................................... 30

June.2005.................................................................30Hexvix.NDA.submitted.to.FDA............................... 30

July.2005..................................................................30Sanochemia.acquires.rights.to.innovative.cancer.diagnostic.and.treatments..................................... 30NMP22.BladderChek.receives.marketing.approval.in.Japan..................................................... 31

BREAST.CANCER................................................. 33OVERVIEW.................................................................... 33PREVALENCE................................................................ 34

United.States...........................................................34Cancer of the Breast in Selected Countries, 2002 ............................35Deaths from Cancer of the Breast in Selected Countries, 2002........36Incidence of Cancer of the Breast per 100,000 population, in Selected Countries in 2002 ..............................................................37Death Rate from Cancer of the Breast per 100,000 female population, in Selected Countries in 2002.......................................38

BREAST.CANCER.DRUGS.IN.USE............................... 39SERMs.(selective.oestrogen-receptor.modulators).............................................................39Aromatase.inhibitors..............................................39Biologic.response.modifiers...................................39Other.hormonal.therapies......................................40Chemotherapy.........................................................40

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©Espicom Business Intelligence December 2005iv


Adjuvant.chemotherapy.........................................40Leading Branded Drugs Used in Breast Cancer – Sales 2002-2004 41

Companies.&.Products.............................................. 42AEterna.Zentaris......................................................42

Lobaplatin................................................................. 42AstraZeneca.............................................................42

Arimidex..................................................................... 42Nolvadex.................................................................... 43Faslodex..................................................................... 44Zoladex....................................................................... 44

Aventis......................................................................45Taxotere..................................................................... 45

Bioenvision..............................................................46Modrenal................................................................... 46

Bristol-Myers.Squibb..............................................47Taxol............................................................................ 47Megace....................................................................... 47

BTG............................................................................48Zinecard..................................................................... 48

Daiichi.......................................................................48Topotecin................................................................... 48

Eli.Lilly.......................................................................48Gemzar....................................................................... 48

GlaxoSmithKline......................................................49Navelbine................................................................... 49

Generic competition ................................................................49Merck........................................................................49

UFT.............................................................................. 49Novartis....................................................................50

Femara....................................................................... 50Lentaron..................................................................... 50

Orion.Pharma...........................................................50Fareston..................................................................... 50

Pfizer.........................................................................51Farmorubicin/Pharmorubicin/Ellence................. 51Zavedos/Idamycin.................................................... 51Zinecard..................................................................... 52Aromasin.................................................................... 52

Roche........................................................................53Herceptin................................................................... 53Xeloda......................................................................... 54Nolvadex.................................................................... 54

Schering-Plough......................................................55Caelyx......................................................................... 55Fareston..................................................................... 55

Takeda......................................................................56Leuplin/Lupron/Enantone..................................... 56

R&D.-.Phase.III.............................................................. 57Alfacell......................................................................57

Onconase................................................................... 57Aphton......................................................................57

IGN101........................................................................ 57AstraZeneca.............................................................58

Faslodex..................................................................... 58Biomira.....................................................................58

Theratope.................................................................. 58Bristol-Myers.Squibb..............................................60

Ixabepilone/BMS-310705....................................... 60Eli.Lilly.......................................................................60

Evista.......................................................................... 60Arzoxifene................................................................. 60

GlaxoSmithKline......................................................61Lapatinib.(572016)................................................... 61

Intarcia.Therapeutics..............................................61Atamestane............................................................... 61

NeoPharm................................................................62Liposome.Encapsulated.Doxorubicin.(LED)........ 62

Novartis....................................................................62Zometa....................................................................... 62Femara....................................................................... 63

Pfizer.........................................................................65Lasofoxifene.............................................................. 65

Roche........................................................................66Herceptin................................................................... 66Xeloda......................................................................... 66Avastin........................................................................ 67

sanofi-aventis..........................................................68XRP9881/XRP6258................................................... 68

Schering...................................................................68MS-209....................................................................... 68

Wyeth.......................................................................68Temsirolimus.(CCI-779)............................................ 68

YM.BioSciences........................................................69Tesmilifene................................................................ 69

R&D.Phase.II................................................................. 70AEterna.Zentaris......................................................70


Iressa........................................................................... 70Attenuon..................................................................71

ATN-224...................................................................... 71AVI.BioPharma.........................................................71

Oncomyc-NG............................................................. 71Bayer.........................................................................72

BAY.59-8862.(IDN.5109).......................................... 72Biomira.....................................................................72

Theratope.................................................................. 72Bristol-Myers.Squibb..............................................73

Javlor.......................................................................... 73Cyclacel.....................................................................73

CYC202....................................................................... 73Cytokinetics.............................................................74

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©Espicom Business Intelligence vDecember 2005


SB-715992.................................................................. 74SB-743921.................................................................. 75

Eli.Lilly.......................................................................75Alimta......................................................................... 75

Genta........................................................................75Genasense................................................................. 75

Genzyme.Oncology.................................................76Dendritic.cell/cancer.cell.fusion.vaccine.............. 76

GlaxoSmithKline......................................................77SB-715992.................................................................. 77

Introgen.Therapeutics............................................77INGN.225.................................................................... 77

Keryx.Biopharmaceuticals.....................................77KRX-0403................................................................... 77

Kosan.Biosciences...................................................78KOS-862/R1492......................................................... 78

Ligand.Pharmaceuticals.........................................79Targretin..................................................................... 79Pipendoxifene.......................................................... 80

Lorus.Therapeutics..................................................80GTI-2040..................................................................... 80

Medarex...................................................................80MDX-010..................................................................... 80

Micromet..................................................................81MT201......................................................................... 81

Millenium.Pharmaceuticals....................................82Velcade....................................................................... 82

NeoPharm................................................................82LE-SN38...................................................................... 82Liposome.Encapsulated.Doxorubicin.(LED)........ 83

Novartis....................................................................83Sandostatin............................................................... 83PTK787....................................................................... 84

OSI.Pharmaceuticals...............................................84Tarceva....................................................................... 84

Oxford.BioMedica...................................................85MetXia........................................................................ 85

OXiGENE...................................................................86Combretastatin.A4P................................................ 86

PharmaMar..............................................................87Yondelis...................................................................... 87

Roche........................................................................87Tarceva....................................................................... 87Omnitarg................................................................... 87R1492.......................................................................... 88Herceptin................................................................... 88Avastin........................................................................ 90

sanofi-aventis..........................................................90XRP6258/XRP9881................................................... 90

Telik...........................................................................91Telcyta........................................................................ 91

Vion.Pharmaceuticals.............................................91Triapine...................................................................... 91

Xenova......................................................................92Tariquidar.(XR9576)................................................. 92

Phase.II.–.Others......................................................... 93INDUSTRY.DEVELOPMENTS.2003/2004.................. 94

Strategic.Alliances.in.Breast.Cancer.-.June.2004.to.December.2005...................................................94

Significant.Events.in.Breast.Cancer.Drugs-.June.2004.to.December.2005................................... 104

June.2004.................................................................104EC.approves.Herceptin+Taxotere.as.first-line.therapy.in.HER2-positive.MBC............................... 104FDA.grants.priority.review.for.new.indication.of.Femara....................................................................... 104

July.2004..................................................................104Health.Canada.approves.Arimidex.for.EBC......... 104

August.2004.............................................................104Femara.gains.Swiss.approval.as.only.post-tamoxifen.treatment.for.EBC................................. 104FDA.approves.Aventis’.Taxotere.for.the.treatment.of.early.BC............................................... 105

September.2004......................................................105FDA.accepts.Bonefos.for.filing.and.grants.priority.review.in.treatment.of.bone.metastases.of.BC.. 105

October.2004...........................................................106Femara.gains.FDA.approval.as.post-tamoxifen.treatment.for.EBC..................................................... 106

November.2004.......................................................106New.ASCO.recommendation.for.postmenopausal.women.with.EBC...................................................... 106New.tamoxifen.pathway.may.lead.to.improved.BC.treatments........................................................... 107

December.2004........................................................107Gemzar+Taxol.combination.receives.UK.approval.for.MBC...................................................... 107

January.2005............................................................107Savient.submits.NDA.for.Soltamox.to.FDA.......... 107FDA.issues.approvable.letter.for.Bonefos........... 107FDA.approves.Abraxane.for.MBC.......................... 108Taxotere.receives.two.new.European.approvals.for.BC.treatment....................................................... 108

February.2005..........................................................108FDA.approves.BioGenex’.InSite.HER2/neu.kit.... 108UK.Court.of.Appeal.finds.Pfizer’s.epirubicin.patent.infringed.by.Mayne..................................... 108

March.2005..............................................................109Femara.approved.in.Germany.in.extended.adjuvant.setting....................................................... 109Taxol.receives.approval.in.Europe.for.adjuvant.treatment................................................................... 109

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April.2005.................................................................110Health.Canada.approves.Novartis’.Femara.for.extended.adjuvant.treatment.of.BC..................... 110

May.2005..................................................................110TriPath.receives.FDA.clearance.for.OR.and.PR.applications.for.VIAS................................................ 110Applied.Imaging.gains.FDA.clearance.for.BC.patient.selection.application................................. 110Further.trial.data.required.for.Bonefos.NDA....... 110

June.2005.................................................................110Kyowa.obtains.additional.approval.for.Navelbine................................................................... 110NDS.for.Abraxane.filed.in.Canada.for.MBC......... 110Arimidex.approved.in.UK.for.early.adjuvant.treatment................................................................... 111

July.2005..................................................................111Novartis.submits.US.and.European.applications.for.Femara................................................................. 111

August.2005.............................................................112TriPath.receives.FDA.510(k).clearance.for.HER2/neu.application.for.VIAS........................................ 112Takeda.obtains.approval.of.additional.indication.for.Leuplin.SR.for.injection.kit.11.25..................... 112Femara.granted.FDA.priority.review.for.new.indication................................................................... 112Genentech.provides.updated.cardiotoxicity.data.related.to.Herceptin................................................. 112

September.2005......................................................113Agendia.acquires.ISO.accreditation.for.MammaPrint.test..................................................... 113Pfizer.receives.European.approval.to.market.Aromasin.for.adjuvant.treatment.of.early.BC.in.postmenopausal.women....................................... 113Arimidex.gains.full.FDA.approval.for.adjuvant.treatment.of.hormone.receptor-positive.EBC.in.postmenopausal.women....................................... 113

October.2005...........................................................114FDA.approves.BioGenex.InSite.HER2/neu.(CB11).MAb............................................................................. 114Pfizer.receives.FDA.approval.of.Aromasin.for.the.adjuvant.treatment.of.early.BC.in.postmenopausal.women....................................... 114Allos.withdraws.European.MAA.for.Revaproxyn............................................................... 114St.Gallen.BC.panel.recommends.sequential.treatment.for.postmenopausal.women.with.hormone-sensitive.early.BC................................... 115Veridex.receives.additional.510(k).clearance.for.the.CellSearch.circulating.tumour.cell.kit................... 115Savient.receives.FDA.approval.to.market.Soltamox.................................................................... 115

November.2005.......................................................116Agendia’s.MammaPrint.receives.CE.registration................................................................ 116US.Court.of.Appeals.affirms.dismissal.of.tamoxifen.antitrust.lawsuits.................................. 116

December.2005........................................................116Femara.approved.by.MHRA.for.post-surgery.use.in.early.invasive.BC....................................................... 116

COLORECTAL.CANCER........................................ 117OVERVIEW.................................................................... 117PREVALENCE................................................................ 118

Cancer of the Colon and Rectum in Selected Countries, 2002 .........118Deaths from Cancer of the Colon and Rectum in Selected Countries, 2002 ...............................................................................119Incidence of Cancer of the Colon and Rectum per 100,000 population, in Selected Countries in 2002.......................................120Death Rate from Cancer of the Colon and Rectum per 100,000 population, in Selected Countries in 2002.......................................121

COLORECTAL.CANCER.DRUGS.IN.USE..................... 122Antimetabolites.......................................................122Platinum.analogs....................................................122Topoisomerase.Inhibitors.......................................123Monoclonal.antibodies...........................................123

Companies.&.Products.............................................. 125AstraZeneca.............................................................125

Tomudex.................................................................... 125sanofi-aventis..........................................................125

Campto....................................................................... 125Bristol-Myers.Squibb./.ImClone./.Merck.KGaA......126

Erbitux........................................................................ 126Colorectal cancer .............................................................................128

BTG............................................................................129Tomudex.................................................................... 129


Merck.KGaA..............................................................130Erbitux........................................................................ 130UFT.............................................................................. 130

Pfizer.........................................................................130Camptosar................................................................. 130Celebrex/Celebra/Onsenal..................................... 131

Roche........................................................................132Xeloda......................................................................... 132Avastin........................................................................ 132

sanofi-aventis..........................................................133Eloxatin...................................................................... 133

R&D.–.PHASE.III........................................................... 135Abgenix....................................................................135

Panitumumab........................................................... 135Colorectal.cancer...................................................... 135

ADVENTRX.Pharmaceuticals..................................136

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CoFactor..................................................................... 136Aphton......................................................................138

IGN101........................................................................ 138ImClone.Systems./.Bristol-Myers.Squibb./.Merck.KGaA.........................................................................138


Novartis....................................................................140PTK787....................................................................... 140

Pfizer.........................................................................141Camptosar................................................................. 141

Roche........................................................................142Avastin........................................................................ 142Xeloda......................................................................... 143

Schering...................................................................144ZK.222584.................................................................. 144Leukine....................................................................... 145

R&D.–.PHASE.II............................................................ 146Abgenix....................................................................146

Panitumumab........................................................... 146Colorectal.cancer...................................................... 146

Antigenics................................................................147Oncophage.(HSPPC-96)........................................... 147Aroplatin.................................................................... 147

AVI.BioPharma.........................................................148Avicine........................................................................ 148Oncomyc-NG............................................................. 149

Bayer.........................................................................149BAY.43-9006.............................................................. 149

Biomira.....................................................................150Theratope.................................................................. 150

Can-Fite.BioPharma................................................151CF101.......................................................................... 151

Cell.Therapeutics.....................................................152Xyotax......................................................................... 152PG-CPT....................................................................... 153

Cephalon..................................................................154Trisenox...................................................................... 154

Cytokinetics.............................................................154Ispinesib..................................................................... 154

Eli.Lilly.......................................................................155Alimta......................................................................... 155Vitaxin........................................................................ 155

Genta........................................................................156Genasense................................................................. 156

GenVec......................................................................156TNFerade.................................................................... 156

GlaxoSmithKline......................................................157Ispinesib..................................................................... 157

ImClone.Systems./.Bristol-Myers.Squibb./.Merck.KGaA.........................................................................158


IDM.Pharma.............................................................160EP-2101.....................................................................160

Collidem..................................................................... 160Immunomedics........................................................161

IMMU-100,.IMMU-111.............................................. 161Keryx.Biopharmaceuticals.....................................162

KRX-0402................................................................... 162Kosan.Biosciences...................................................162

KOS-862/R1492......................................................... 162KuDOS.Pharmaceuticals.........................................163

Patrin.......................................................................... 163Lorus.Therapeutics..................................................164

GTI-2040..................................................................... 164MedImmune............................................................165

Vitaxin........................................................................ 165Meditech.Research..................................................165

HyCAMP..................................................................... 165Merck.KGaA..............................................................167

Erbitux........................................................................ 167Colorectal cancer .............................................................................168EMD.273066/EMD.273063...................................... 169

NeoPharm................................................................170LE-SN38...................................................................... 170

Oxford.BioMedica...................................................170TroVax......................................................................... 170

OXIGENE...................................................................172Combretastatin.A4P................................................ 172

PharmaMar..............................................................173Aplidin........................................................................ 173

sanofi-aventis..........................................................174Cancer.vaccines/ALVAC-CEA/B7.1.......................... 174

Schering...................................................................174MS-275........................................................................ 174

Telik...........................................................................175Telcyta........................................................................ 175

Therion.....................................................................176ALVAC-CEA/B7.1........................................................ 176

Wilex.........................................................................177WX-UK1...................................................................... 177


Strategic.Alliances.in.Colorectal.Cancer.-.June.2004.to.December.2005..........................................179

Significant.Events.in.Colorectal.Cancer.Drugs-.June.2004.to.December.2005............................................ 184

June.2004.................................................................184Pfizer.to.acquire.Campto.following.merger.of.Sanofi-Synthélabo.and.Aventis............................. 184

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Erbitux.approved.for.launch.in.Europe.to.treat.MCRC.......................................................................... 184

AUGUST.2004...........................................................184Roche.files.Xeloda.in.Europe.and.the.US.for.the.treatment.of.CC.after.surgery................................ 184

September.2004......................................................185Eloxatin.to.gain.expanded.indication.for.treatment.of.early-stage.MCRC.in.Europe.............................. 185

October.2004...........................................................185Pfizer.acquires.Campto.in.the.UK.......................... 185

November.2004.......................................................185Eloxatin.receives.FDA.approval.for.adjuvant.treatment.of.CC......................................................... 185

January.2005............................................................186Avastin.approved.in.the.EU.................................... 186

February.2005..........................................................186sanofi-aventis.receives.FDA.approval.for.new.Eloxatin.formulation................................................ 186

March.2005..............................................................187Inverness/Wampole.launch.new.tool.for.CRC.screening................................................................... 187

April.2005.................................................................187Xeloda.wins.EU.approval.for.adjuvant.therapy.in.the.treatment.of.colon.cancer........................... 187

June.2005.................................................................187FDA.approves.oral.Xeloda.for.the.adjuvant.treatment.of.CC......................................................... 187

July.2005..................................................................188NICE.issues.final.determination.on.CRC.drugs... 188

August.2005.............................................................188Xeloda.approved.by.the.SMC.for.use.in.the.adjuvant.treatment.of.CC....................................... 188Beckman.introduces.Hemoccult.ICT.for.colorectal.cancer.screening...................................................... 188

August.2005.............................................................189NICE.extends.its.recommendations.for.the.use.of.drugs.for.the.treatment.of.advanced.CRC........... 189

September.2005......................................................189Health.Canada.approves.Avastin.for.CRC............ 189Health.Canada.approves.Erbitux.for.the.treatment.of.MCRC.................................................. 189

October.2005...........................................................189Preliminary.NICE.recommendations.favour.Eloxatin.and.Xeloda.for.Stage.III.CC.patients...... 189

November.2005.......................................................190SMC.approves.Eloxatin.for.CC................................ 190

December.2005........................................................190Genzyme.launches.CRC.test.to.determine.appropriate.Camptosar.dosage............................ 190

KIDNEY.CANCER................................................. 191OVERVIEW.................................................................... 191

PREVALENCE................................................................ 192Cancer of the Kidney in Selected Countries, 2002 ............................192Deaths from Cancer of the Kidney in Selected Countries, 2002 .......193Incidence of Cancer of the Kidney per 100,000 population, in Selected Countries in 2002 ..............................................................194Death Rate from Cancer of the Kidney per 100,000 population, in Selected Countries in 2002 ..........................................................195

KIDNEY.CANCER.DRUGS.IN.USE............................... 196Chiron.......................................................................196

Proleukin.................................................................... 196Roche........................................................................197

Roferon-A.................................................................. 197New.formulations.................................................... 198

Sumitomo.Chemical................................................198Sumiferon.................................................................. 198

Shionogi...................................................................198Imunace.(S-6820)..................................................... 198

R&D.PHASE.III.............................................................. 199Antigenics................................................................199

Oncophage.(HSPPC-96)........................................... 199Bayer.........................................................................200

Nexavar...................................................................... 200Celgene.....................................................................200

Thalomid.................................................................... 200GlaxoSmithKline......................................................201

Tykerb......................................................................... 201Pfizer.........................................................................201

Sutent......................................................................... 201Roche........................................................................202

Avastin........................................................................ 202Wyeth.......................................................................204

Temsirolimus.(CCI-779)............................................ 204R&D.PHASE.II................................................................ 205

Abgenix....................................................................205ABX-EGF..................................................................... 205

Biomira.....................................................................205L-IL-2............................................................................ 205

Coley.Pharmaceutical.............................................206PF-3512676................................................................ 206

Genta........................................................................206Genasense................................................................. 206

Idera.Pharmaceuticals............................................207IMOxine...................................................................... 207

OSI.Pharmaceuticals...............................................209OSI-461....................................................................... 209

Renal Cell Carcinoma (RCC) ......................................................209Pharmacyclics..........................................................210

Xcytrin........................................................................ 210PharmaMar..............................................................211

Aplidin........................................................................ 211Phase.II.–.Others......................................................... 212

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INDUSTRY.DEVELOPMENTS.2003/2004.................. 213Strategic.Alliances.in.Kidney.Cancer.-.June.2004.to.December.2005..........................................213

Significant.Events.in.Kidney.Cancer.Drugs-.June.2004.to.December.2005................................... 214

July.2005..................................................................214Bayer.and.Onyx.complete.filing.of.NDA.for.sorafenib.for.treatment.of.advanced.RCC........... 214

August.2005.............................................................214Pfizer.submits.NDA.for.Sutent............................... 214

September.2005......................................................215Bayer/Onyx.submit.sorafenib.MAA.for.treatment.of.RCC...................................................... 215FDA.accepts.NDA.submission.for.sorafenib.in.RCC.............................................................................. 215

LIVER.CANCER.................................................... 217OVERVIEW.................................................................... 217PREVALENCE................................................................ 218

Cancer of the Liver in Selected Countries, 2002 ...............................218Deaths from Cancer of the Liver in Selected Countries, 2002 ..........219Incidence of Cancer of the Liver per 100,000 population, in Selected Countries in 2002 ..............................................................220Death Rate from Cancer of the Liver per 100,000 population, in Selected Countries in 2002 ..............................................................221

LIVER.CANCER.DRUGS.IN.USE................................... 222Chemotherapy.........................................................222Chemoembolisation...............................................222

R&D.–.PHASE.III........................................................... 223Bayer.........................................................................223

Nexavar...................................................................... 223EXIMIAS.Pharmaceutical........................................223

Thymitaq.................................................................... 223Tularik.......................................................................224

T67.(batabulin).......................................................... 224R&D.–.PHASE.II............................................................ 226

Attenuon..................................................................226ATN-224...................................................................... 226

Bristol-Myers.Squibb..............................................226Ixabepilone/BMS-310705.......................................226Genzyme..................................................................227

DENSPM..................................................................... 227Immunomedics........................................................227

IMMU-105.................................................................. 227MGI.Pharma.............................................................227

Irofulven..................................................................... 227Novartis....................................................................229

Sandostatin............................................................... 229PharmaMar..............................................................230

Kahalalide.F............................................................... 230Progen.Industries....................................................230

PI-88............................................................................ 230

Protherics.................................................................231Prolarix....................................................................... 231

sanofi-aventis..........................................................232Alvocidib.(flavopiridol)............................................ 232

SciClone.Pharmaceuticals.......................................232Zadaxin...................................................................... 232

Transgene.................................................................233Ad-IFNg.(TG1042)..................................................... 233


Strategic.Alliances.in.Liver.Cancer.-.June.2004.to.December.2005........................................................235

Significant.Events.in.Liver.Cancer.Drugs-.June.2004.to.December.2005................................... 236

October.2004...........................................................236Primovist.MRI.liver.contrast.agent.approved.in.the.EU......................................................................... 236

LUNG.CANCER.................................................... 237OVERVIEW.................................................................... 237

Small.Cell.Lung.Cancer............................................237Non-small.Cell.Lung.Cancer....................................237Other.Types.of.Lung.Cancer....................................237

Prevalence.................................................................... 238Cancer of the Lung in Selected Countries, 2002...............................238Deaths from Cancer of the Lung in Selected Countries, 2002 ..........239Incidence of Cancer of the Lung per 100,000 population, in Selected Countries in 2002 ..............................................................240Death Rate from Cancer of the Lung per 100,000 population, in Selected Countries in 2002 ..............................................................241

LUNG.CANCER.DRUGS.IN.USE................................... 242Chemotherapy.........................................................242EGFR.anatgonists.....................................................242Photodynamic.therapy...........................................242

Companies.and.Products.......................................... 243AEterna.Zentaris......................................................243


Iressa........................................................................... 243Aventis......................................................................245

Taxotere..................................................................... 245Bristol-Myers.Squibb..............................................245

Taxol............................................................................ 245Generic competition ................................................................246

Paraplatin.................................................................. 247Etopophos................................................................. 247


Eli.Lilly.......................................................................248Gemzar....................................................................... 248

GlaxoSmithKline......................................................249Hycamtin.................................................................... 249

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Navelbine................................................................... 249Generic.competition................................................ 250

Kyowa.Hakko...........................................................250Navelbine................................................................... 250

Sumitomo.Chemical................................................250Calsed......................................................................... 250

R&D.–.PHASE.III........................................................... 251AEterna.Zentaris......................................................251

Neovastat................................................................... 251Alfacell......................................................................252

Onconase................................................................... 252Ranpirnase Conjugates and Fusion Proteins ...........................254Evaluation of Onconase as A Radiation Enhancer ...................254Onconase As a Resistance-Overcoming and Apoptosis-Enhancing Agent ......................................................................255

Allos.Therapeutics...................................................255Efaproxyn.................................................................. 255

RSR13 in the treatment of NSCLC ............................................255Bristol-Myers.Squibb..............................................256

Javlor.......................................................................... 256Cell.Therapeutics.....................................................257

Xyotax......................................................................... 257Coley.Pharmaceutical.............................................260

PF-3512676................................................................ 260Genta........................................................................261

Genasense................................................................. 261GlaxoSmithKline......................................................262

Hycamtin.................................................................... 262Tykerb......................................................................... 262

Igeneon....................................................................263IGN101........................................................................ 263

ImClone.Systems.....................................................263Erbitux........................................................................ 263Erbitux in Non-Small Cell Lung Cancer (NSCLC) Phase II & III Trials, March 2005 .....................................................................................264

Ligand.Pharmaceuticals.........................................264Targretin..................................................................... 264

Capsule formulation ................................................................265OSI.Pharmaceuticals...............................................266

Tarceva....................................................................... 266OXIGENE...................................................................270

Combretastatin.A4P................................................ 270Pharmacyclics..........................................................271

Xcytrin........................................................................ 271Roche........................................................................273

Tarceva....................................................................... 273Avastin........................................................................ 274

Schering...................................................................275MS-209....................................................................... 275

Telik...........................................................................275Telcyta........................................................................ 275

R&D.PHASE.II................................................................ 277Abgenix....................................................................277

Panitumumab........................................................... 277Non-small cell lung cancer ......................................................277

AEterna.Zentaris......................................................277Lobaplatin................................................................. 277RC-3095...................................................................... 278

AnorMED..................................................................278NX473......................................................................... 278

Antigenics................................................................279Oncophage.(HSPPC-96)........................................... 279QS-21........................................................................... 279

Attenuon..................................................................280ATN-224...................................................................... 280

AVI.BioPharma.........................................................280Oncomyc-NG............................................................. 280

Bayer.........................................................................281BAY.59-8862.(IDN.5109).......................................... 281

Biomira.....................................................................281L-BLP25....................................................................... 281

BioNumerik.Pharmaceuticals.................................283Karenitecin.BNP1350............................................... 283

Bristol-Myers.Squibb./.ImClone./.Merck.KGaA......283Erbitux........................................................................ 283

Cephalon..................................................................285SDX-102...................................................................... 285

Cyclacel.....................................................................285Seliciclib..................................................................... 285


Epimmune................................................................287EP-2101....................................................................... 287

GlaxoSmithKline......................................................288Mage.3.(249553)....................................................... 288Ispinesib..................................................................... 288SB-715992.................................................................. 289

Idera.Pharmaceuticals............................................289IMOxine...................................................................... 289

ImmunoGen.............................................................291huN901-DM1............................................................. 291

INEX.Pharmaceuticals.............................................292Marqibo...................................................................... 292

Introgen.Therapeutics............................................292Advexin...................................................................... 292

Lung cancer ..............................................................................293INGN.225.................................................................... 293INGN.401.................................................................... 294

Keryx.Biopharmaceuticals.....................................294KRX-0403................................................................... 294

Kosan.Biosciences...................................................294KOS-862/R1492......................................................... 294

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Ligand.Pharmaceuticals.........................................295Panretin...................................................................... 295

Lorus.Therapeutics..................................................295GTI-2040..................................................................... 295

MedImmune............................................................296Ethyol.......................................................................... 296

Merck.KGaA..............................................................297EMD.273066/EMD.273063...................................... 297

Millenium.Pharmaceuticals....................................297Velcade....................................................................... 297

NeoPharm................................................................298LE-SN38...................................................................... 298

Novacea....................................................................299DN-101........................................................................ 299

Pfizer.........................................................................300Celebrex/Celebra/Onsenal..................................... 300Prinomastat............................................................... 301CI-1033........................................................................ 301CP-547,632................................................................. 301

PharmaMar..............................................................302Aplidin........................................................................ 302Kahalalide.F............................................................... 302

Progen.Industries....................................................303PI-88............................................................................ 303

Roche........................................................................304Omnitarg................................................................... 304

sanofi-aventis..........................................................304Meclinertant.............................................................. 304

Schering...................................................................305MS-275........................................................................ 305ZK.222584.................................................................. 305

SuperGen.................................................................305Orathecin................................................................... 305

Telik...........................................................................306Telcyta........................................................................ 306

Transgene.................................................................306MVA-MUC1-IL2.(TG4010)........................................ 306

Vion.Pharmaceuticals.............................................308Triapine...................................................................... 308


Strategic.Alliances.in.Lung.Cancer.-.June.2004.to.December.2005........................................................311

Significant.Events.in.Lung.Cancer.Drugs-.June.2004.to.December.2005.................................. 317

June.2004.................................................................317Alimta.receives.CHMP.positive.opinion.for.MPM.and.LC.............................................................. 317Tarceva.accepted.into.FDA’s.Pilot.1.Program...... 317

July.2004..................................................................317

Alimta.receives.positive.endorsement.for.LC.approval.from.ODAC................................................ 317

August.2004.............................................................318OSI/Genentech.complete.NDA.for.FDA.approval.of.Tarceva................................................................... 318FDA.approves.Lilly’s.Alimta.for.the.second-line.treatment.of.advanced.NSCLC............................... 318Roche.files.MAA.for.European.approval.of.Tarceva.to.treat.advanced.NSCLC........................................ 319

September.2004......................................................319Alimta.approved.in.the.EU.for.two.cancer.indications................................................................. 319FDA.grants.fast.track.status.for.BLP25.Liposome.Vaccine....................................................................... 320Tarceva.NDA.accepted.for.FDA.review................. 320

November.2004.......................................................320Alimta.approved.in.UK.as.first.licensed.treatment.for.mesothelioma..................................................... 320FDA.approves.Tarceva.for.advanced.NSCLC........ 320OSI.launches.Tarceva............................................... 321

January.2005............................................................321Iressa.MAA.withdrawn.in.EU.................................. 321

March.2005..............................................................321Tarceva.receives.first.European.approval.for.NSCLC......................................................................... 321

April.2005.................................................................321APP.receives.approval.for.vinorelbine................. 321

May.2005..................................................................322Fujirebio.submits.application.to.FDA.for.approval.of.Mesomark............................................................. 322CeMines.files.510(k).application.with.FDA.for.LC.detection.kit.............................................................. 322

June.2005.................................................................322Tarceva.receives.positive.EU.opinion.for.advanced.NSCLC......................................................................... 322

July.2005..................................................................322Tarceva.granted.approval.in.Canada.for.treatment.of.advanced.NSCLC.................................................. 322

August.2005.............................................................323SMC.accepts.pemetrexed.for.restricted.use.in.the.treatment.of.mesothelioma................................... 323Sanyo.launches.diagnostic.for.small.cell.lung.cancer......................................................................... 323

September.2005......................................................323Tarceva.approved.in.Europe.for.NSCLC................ 323Genzyme.launches.exclusive.NSCLC.test............. 324CeMines.Estonia.files.CE.mark.registration.seeking.clearance.to.distribute.Cell.Correct.LAb.............. 324

October.2005...........................................................325Oncotech.offers.new.genomic.test.for.LC............ 325NCCN.releases.updated.treatment.guidelines.for.

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NSCLC......................................................................... 325OVARIAN.CANCER.............................................. 327

OVERVIEW.................................................................... 327PREVALENCE................................................................ 328

Cancer of the Ovaries in Selected Countries, 2002 ...........................328Deaths from Cancer of the Ovaries in Selected Countries, 2002 ......329Incidence of Cancer of the Ovaries per 100,000 population, in Selected Countries in 2002 ..............................................................330Death Rate from Cancer of the Ovaries per 100,000 female population, in Selected Countries in 2002 ......................................331

OVARIAN.CANCER.DRUGS.IN.USE............................ 332Companies.&.Products.............................................. 333

Aventis......................................................................333Taxotere..................................................................... 333

Bristol-Myers.Squibb..............................................333Taxol............................................................................ 333

Markets/indications .................................................................334Agreements..............................................................................334Generic competition ................................................................334

Paraplatin.................................................................. 335Megace....................................................................... 336


Eli.Lilly.......................................................................337Gemzar....................................................................... 337

GlaxoSmithKline......................................................338Hycamtin.................................................................... 338

MGI.Pharma.............................................................338Hexalen.Capsules..................................................... 338

Schering-Plough......................................................339Caelyx......................................................................... 339

R&D.–.PHASE.III........................................................... 340AltaRex.....................................................................340

OvaRex.MAb.............................................................. 340Cell.Therapeutics.....................................................341

Xyotax......................................................................... 341GlaxoSmithKline......................................................343

Hycamtin.................................................................... 343PharmaMar..............................................................343

Yondelis...................................................................... 343Roche........................................................................344

Avastin........................................................................ 344Telik...........................................................................345

Telcyta........................................................................ 345R&D.–.PHASE.II............................................................ 347

Access.Pharmaceuticals..........................................347AP5280....................................................................... 347

Aphton......................................................................348GnRH.pharmaccine.................................................. 348

AVAX.Technologies..................................................348O-Vax.......................................................................... 348

Bayer.........................................................................349BAY.59-8862.(IDN.5109).......................................... 349

BioNumerik.Pharmaceuticals.................................349Karenitecin.BNP1350............................................... 349

Bristol-Myers.Squibb..............................................350Javlor.......................................................................... 350

Cell.Therapeutics.....................................................350PG-CPT....................................................................... 350


Eli.Lilly.......................................................................351Alimta......................................................................... 351

Endocyte..................................................................352FolateScan................................................................. 352

Marshall.Edwards....................................................352Phenoxodiol.............................................................. 352

Merck.KGaA..............................................................354EMD.72000................................................................ 354EMD.273066/EMD.273063...................................... 354

MGI.Pharma.............................................................355Irofulven..................................................................... 355

OXIGENE...................................................................356Combretastatin.A4P................................................ 356

Novartis....................................................................357PTK787....................................................................... 357

Pfizer.........................................................................357CP-547,632................................................................. 357

Roche........................................................................358Omnitarg................................................................... 358

Wilex.........................................................................358WX-UK1...................................................................... 358


Strategic.Alliances.in.Ovarian.Cancer.-.June.2004.to.December.2005..........................................360

Significant.Events.in.Ovarian.Cancer.Drugs-.June.2004.to.December.2005................................... 363

July.2004..................................................................363Gemzar+carboplatin.receives.EU.approvals.to.treat.OC................................................................................ 363

October.2004...........................................................363Bedford.receives.approval.for.carboplatin.injection..................................................................... 363APP.and.Pharmachemie.gain.approval.for.carboplatin.for.injection......................................... 364APP.receives.approval.for.carboplatin.injection.364

February.2005..........................................................364FDA.grants.full.approval.to.Doxil.following.submission.of.Phase.III.data................................... 364Mayne.adds.carboplatin.600mg/60mL.injection.to.its.product.line............................................................... 365

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May.2005..................................................................365NICE.issues.guidance.for.treatment.of.advanced.OC................................................................................ 365

July.2005..................................................................366Mayne.receives.FDA.approval.for.multi-dose.carboplatin................................................................ 366

September.2005......................................................366IBEX.launches.OC.hK6.assay.for.research.purposes.................................................................... 366

PANCREATIC.CANCER......................................... 367OVERVIEW.................................................................... 367PREVALENCE................................................................ 368

Cancer of the Pancreas in Selected Countries, 2002 ........................368Deaths from Cancer of the Pancreas in Selected Countries, 2002 ...369Incidence of Cancer of the Pancreas per 100,000 population, in Selected Countries in 2002 ..............................................................370Death Rate from Cancer of the Pancreas per 100,000 population, in Selected Countries in 2002 ..........................................................371

PANCREATIC.CANCER.DRUGS.IN.USE....................... 372Companies.&.Products.............................................. 373

Bristol-Myers.Squibb..............................................373Erbitux........................................................................ 373

Eli.Lilly.......................................................................373Gemzar....................................................................... 373

Markets/indications .................................................................373SuperGen.................................................................374

Mitozytrex................................................................. 374R&D.–.PHASE.III........................................................... 375

Aphton......................................................................375Insegia........................................................................ 375

AVI.BioPharma.........................................................378Avicine........................................................................ 378

Daiichi.Sankyo.........................................................378Eli.Lilly.......................................................................379

Alimta......................................................................... 379ImClone.Systems.....................................................379

Erbitux........................................................................ 379ImClone Systems Pancreatic Cancer Trial ........................................379

Lorus.Therapeutics..................................................380Virulizin...................................................................... 380

OSI.Pharmaceuticals...............................................382Tarceva....................................................................... 382

Roche........................................................................383Avastin........................................................................ 383

sanofi-aventis..........................................................383Eloxatin...................................................................... 383

SuperGen.................................................................384Orathecin/CZ.112...................................................... 384Avicine........................................................................ 385

Therion.Biologics.....................................................386Panvac........................................................................ 386

R&D.–.PHASE.II............................................................ 387Antigenics................................................................387

Oncophage.(HSPPC-96)........................................... 387QS-21........................................................................... 387

Biomira.....................................................................388Enhanzyn................................................................... 388

Cell.Genesys.............................................................388GVAX.cancer.vaccines.............................................. 388GVAX.Pancreatic.Cancer.Vaccine........................... 388

Genta........................................................................389GenVec......................................................................390

TNFerade.................................................................... 390GlycoGenesys...........................................................391

GCS-100...................................................................... 391Kyowa.Hakko...........................................................392

KT5555/CEP-701........................................................ 392NeoPharm................................................................393

LE-SN38...................................................................... 393Novartis....................................................................394

PTK787....................................................................... 394Oxford.BioMedica...................................................394

MetXia........................................................................ 394Peregrine.Pharmaceuticals....................................395

Cotara......................................................................... 395PharmaMar..............................................................395

Aplidin........................................................................ 395Cephalon..................................................................396

SDX-102...................................................................... 396SuperGen.................................................................396

Orathecin/CZ.112...................................................... 396Vion.Pharmaceuticals.............................................398

Triapine...................................................................... 398Wilex.........................................................................399

WX-UK1...................................................................... 399Phase.II.–.Others......................................................... 400INDUSTRY.DEVELOPMENTS.2003/2004.................. 401

Strategic.Alliances.in.Pancreatic.Cancer.-.June.2004.to.December.2005..........................................401

Significant.Events.in.Pancreatic.Cancer.Drugs-.June.2004.to.December.2005................................... 403

June.2004.................................................................403Aphton.begins.regulatory.submission.in.Switzerland.for.G17DT.monotherapy.in.PC......... 403

July.2004..................................................................403EuroGen.files.MAA.for.approval.of.Orathecin.to.treat.PC....................................................................... 403

August.2004.............................................................403Aphton.submits.regulatory.application.in.Canada.for.Insegia.................................................................. 403

May.2005..................................................................404OSI.files.sNDA.for.Tarceva.in.PC............................. 404

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June.2005.................................................................404FDA.agrees.to.rolling.NDA.for.Virulizin................ 404

July.2005..................................................................405FDA.accepts.Tarceva.sNDA.in.PC............................ 405

September.2005......................................................405ODAC.recommends.Tarceva.for.PC....................... 405

November.2005.......................................................405Tarceva.receives.FDA.approval.for.treatment.of.advanced.PC.in.combination.with.gemcitabine.............................................................. 405

PROSTATE.CANCER............................................. 407OVERVIEW.................................................................... 407PREVALENCE................................................................ 408

Cancer of the Prostate in Selected Countries, 2002 .........................408Deaths from Cancer of the Prostate in Selected Countries, 2002 ....409Incidence of Cancer of the Prostate per 100,000 population, in Selected Countries in 2002 ..............................................................410Death Rate from Cancer of the Prostate per 100,000 male population, in Selected Countries in 2002.......................................411

PROSTATE.CANCER.DRUGS.IN.USE........................... 412Chemotherapy.........................................................412Hormonal.therapy...................................................412

Companies.&.Products.............................................. 413Abbott......................................................................413

Lupron.Depot/Lucrin............................................... 413Amgen......................................................................413AstraZeneca.............................................................413

Zoladex....................................................................... 413Zoladex.LA................................................................. 414Casodex...................................................................... 414

Aventis......................................................................416Suprefact/Suprecur................................................. 416Anandron/Nilandron............................................... 416

Bayer.........................................................................416Viadur......................................................................... 416

OSI.Pharmaceuticals...............................................417Novantrone............................................................... 417

Pfizer.........................................................................417Estracyt...................................................................... 417

Praecis.Pharmaceuticals.........................................417Plenaxis...................................................................... 417

sanofi-aventis..........................................................419Eligard........................................................................ 419

Schering...................................................................420Androcur.................................................................... 420

Schering-Plough......................................................420Eulexin........................................................................ 420

Generic competition ................................................................420Takeda......................................................................421

Leuplin/Lupron/Enantone..................................... 421R&D.–.PHASE.III........................................................... 422

Abbott......................................................................422Xinlay.......................................................................... 422

Cell.Genesys.............................................................423GVAX.cancer.vaccines.............................................. 423GVAX.Prostate.Cancer.Vaccine............................... 423

Dendreon.................................................................425Provenge.................................................................... 425

GlaxoSmithKline......................................................428Avodart...................................................................... 428

GPC.Biotech..............................................................428Satraplatin................................................................. 428

GTx............................................................................430Acapodene................................................................ 430

Northwest.Biotherapeutics....................................431DCVax-Prostate........................................................ 431

Novacea....................................................................431DN-101........................................................................ 431

Novartis....................................................................432Glivec/Gleevec.......................................................... 432

Spectrum.Pharmaceuticals....................................433Satraplatin................................................................. 433

R&D.–.PHASE.II............................................................ 434Abgenix....................................................................434

ABX-EGF..................................................................... 434AEterna.Zentaris......................................................434

Ozarelix...................................................................... 434Teverelix..................................................................... 435RC-3095...................................................................... 435Neovastat................................................................... 436

AnorMED..................................................................436NX473......................................................................... 436

Aphton......................................................................437GnRH.pharmaccine.................................................. 437

Attenuon..................................................................438ATN-224...................................................................... 438

AVI.BioPharma.........................................................438Oncomyc-NG............................................................. 438

Bioenvision..............................................................439Abetafen.................................................................... 439Modrenal................................................................... 439Gossypol.................................................................... 439

Celgene.....................................................................440Actimid....................................................................... 440Thalomid.................................................................... 440

Eli.Lilly.......................................................................441Vitaxin........................................................................ 441

EntreMed..................................................................441Panzem....................................................................... 441

Genta........................................................................442Genasense................................................................. 442

GlaxoSmithKline......................................................443

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©Espicom Business Intelligence xvDecember 2005


GnRH.pharmaccine.................................................. 443ImmunoGen.............................................................444

MLN2704.................................................................... 444Micromet..................................................................445

MT201......................................................................... 445Millenium.Pharmaceuticals....................................445

Velcade....................................................................... 445MLN2704/MLN591RL............................................... 446

NeoPharm................................................................447LE-SN38...................................................................... 447Liposome.Encapsulated.Doxorubicin.(LED)........ 447

Northwest.Biotherapeutics....................................448MDX-070.................................................................... 448

Novartis....................................................................448PTK787....................................................................... 448

Oncolytics.Biotech...................................................449Reolysin...................................................................... 449

Onyvax.....................................................................451Onyvax-P................................................................... 451

OSI.Pharmaceuticals...............................................452OSI-461....................................................................... 452

Hormone-Refractory Prostate Cancer (HRPCA) .....................452OXIGENE...................................................................453

Combretastatin.A4P................................................ 453PharmaMar..............................................................454

Aplidin........................................................................ 454Procyon.Biopharma................................................454

PCK3145..................................................................... 454Roche........................................................................456

Omnitarg................................................................... 456sanofi-aventis..........................................................456

SR.31747..................................................................... 456Therion.....................................................................456

PROSTVAC-VF/TRICOM............................................ 456YM.BioSciences........................................................457

Tesmilifene................................................................ 457Norelin........................................................................ 458


Strategic.Alliances.in.Prostate.Cancer.-.June.2004.to.December.2005...................................................461

Significant.Events.in.Prostate.Cancer.Drugs-.June.2004.to.December.2005................................... 469

July.2004..................................................................469Atrix’.Eligard.six-month.PCA.product.submitted.for.Canadian.marketing.authorisation................ 469Paladin.files.NDS.for.Histrelin.Hydrogel.Implant....................................................................... 469

October.2004...........................................................469FDA.approves.Valera’s.Vantas.PCA.implant........ 469

November.2004.......................................................470

EU.approves.Taxotere.for.PCA............................... 470New.caesium-131.treatment.used.in.prostate.cancer......................................................................... 470

December.2004.......................................................470Abbott.submits.Xinlay.NDA.for.advanced.PCA.. 470FDA.approves.Eligard.six-month.formulation.for.PCA.............................................................................. 470Praecis.issued.draft.national.coverage.determination.for.Plenaxis..................................... 471Eligard.gains.approvals.in.24.European.countries.................................................................... 471Signet.expands.product.portfolio.for.2005........ 471

February.2005..........................................................472FDA.agrees.to.file.Abbott’s.NDA.for.Xinlay.......... 472Expert.report.highlights.use.of.combination.therapy.for.PCA........................................................ 472Eligard.45mg.launched.in.US.for.advanced.PCA.............................................................................. 473Sosei.files.MAA.for.SOT-375.................................... 473

March.2005..............................................................473Praecis’.obtains.NCD.to.allow.consistent.access.to.Plenaxis.in.US............................................................ 473Praecis.provides.update.on.MAA.for.Plenaxis.in.Germany.................................................................... 474Tessera.launches.new.PCA.test.............................. 474

April.2005.................................................................475Watson.launches.Trelstar.Depot.and.Trelstar.LA.475

June.2005.................................................................475Oncura.introduces.RAPID.Strand.Rx..................... 475Valera.commences.regulatory.filing.process.for.European.approvals.of.Vantas............................... 475

August.2005.............................................................476Theragenics.restructures.to.focus.on.core.business.units............................................................................ 476Dendreon.signs.agreement.to.lease.manufacturing.facility.in.NJ............................................................... 476

September.2005......................................................476ODAC.does.not.recommend.Xinlay.HRPCA.treatment................................................................... 476Dendreon.to.submit.Provenge.BLA.for.the.treatment.of.advanced.PCA................................... 476Praecis.gains.German.approval.for.Plenaxis;.Schering.collaboration.terminated...................... 477

October.2005...........................................................477Abbott.receives.not-approvable.letter.for.Xinlay.......................................................................... 477

November.2005.......................................................478MediGene.to.receive.milestone.payment.for.launch.of.Eligard.in.Spain.................................................... 478Valera.receives.marketing.authorisation.in.Denmark.for.Vantas................................................................... 478

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December.2005........................................................478GPC.begins.rolling.NDA.submission.for.satraplatin................................................................. 478QLT.reports.partial.result.in.Eligard.patent.litigation..................................................................... 478

BIBLIOGRAPHY............................................................ 479

Contents

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