Breast Cancer Drug Discoveries: What the Future Holds

Sep 05, 2011, 04:35 ET from Reportlinker

NEW YORK, Sept. 5, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Breast Cancer Drug Discoveries: what the future holds

http://www.reportlinker.com/p0610486/Breast-Cancer-Drug-Discoveries-what-the-future-holds.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

In 2010, almost 50% of breast cancer sales were due to three branded targeted therapies. With a large unmet clinical need, further agents are required to increase survival and delay disease progression.

Unique breast cancer market share, sales forecasts by launched and Phase III products to 2017

A comprehensive and critical examination and scoring of 72 major breast cancer treatments

Comprehensive market assessment of therapeutic approaches, company share, portfolios and prospects

Breast Cancer Therapy Sales Forecast 2010 - 2017

'What's the story behind this chart?'

The changing competitive landscape

By 2017, Espicom forecasts a modest increase in the number of players in the market-place compared to 2010, with Roche, and GlaxoSmithKline to a lesser extent, triumphing with targeted therapies directed against the specific subset of BC patients with HER2-positive disease. AstraZeneca, Novartis and Pfizer will face widespread generic competition for their hormonal therapies, leading to a loss of market share. Similarly, Sanofi and Eli Lilly will face declining sales for their chemotherapies.

The market in 2010...

In recent years, more effective treatments have decreased mortality and improved survival rates, resulting in a longer duration of therapy for an increased patient population. In the US, five-year relative survival rates have improved from 63% in the early 1960s to 90% in recent years, while in England, rates for women diagnosed with BC in 2001-2006 reached 82%, compared to 52% 1971-1975. This report estimates that sales of leading brands achieved sales of US$12.7 billion in 2010, with growth due to expanding sales for a number of existing treatments rather than the launch of new products. Sales were split between chemotherapies, hormonal therapies and novel molecular targeted therapies, with the majority of these agents used in combination.

And 2017: how things might change Hormonal therapies

The aromatase inhibitors will suffer from patent expiries in all major markets by 2012, and the report expects significant generic competition and sales for this group to decline by over 92% from US$3.4 billion in 2010, to just US$259 million in 2017. With widespread generic versions of the leading selective oestrogen receptor modulator, tamoxifen, the overall market share of branded hormonal therapies will decline as sales fall from US$4 billion to US$1.4 billion, a drop of 65%. These declines will be tempered by the relative success of AstraZeneca's Faslodex.

Chemotherapies

By 2017, most chemotherapies will be available as generics. In addition to patent expirations for Sanofi's Taxotere (docetaxel) and Eli Lilly's Gemzar (gemcitabine) in 2009/2010, the US patent on Roche's Xeloda (capecitabine) will expire in 2013. As a direct result, sales will decrease by almost 40% from over US$2.4 billion in 2010 to around US$1.5 billion in 2017, with market share continuing to decline, from 19 to 12%. This general trend is mitigated somewhat by the newer chemotherapies, which are demonstrating sales growth and carving out market share due to their improved safety and efficacy compared to older more established agents.

Targeted therapies – moving beyond HER2

By 2017, Espicom estimates that a total of ten products will command a 77% market share, with the current therapies, Roche's Herceptin and Avastin, along with GSK's Tykerb/Tyverb, accounting for over 80% of these sales. Herceptin will continue as the clear market leader. But what about patients who are HER2 negative? There is an urgent need for more therapies and just a handful are likely to be launched by 2017:

Bayer's Nexavar is a multi-targeted kinase inhibitor already marketed for the treatment of renal cell carcinoma and hepatocellular carcinoma.

Eli Lilly's anti-VEGFr2 monoclonal antibody, ramucirumab, an angiogenesisinhibitor, may be able to pick up market share from Avastin if the company can demonstrate an improved survival advantage.

There has been considerable optimism over a novel class of agents, the PARP inhibitors, including Sanofi's iniparib, which is under development for triplenegative breast cancer. Nevertheless, doubt has been cast over the effectiveness of this class following the termination of the development of AstraZeneca's olaparib.

About the Author: This report has been written by Sue Viney, a senior writer on Espicom's oncology analysis team. Sue has been evaluating companies, products and drugs in research for 12 years. She is editor of Cancer Drug Futures and, in addition, has also produced management reports on the lung, colorectal, prostate and renal cancer areas as well as studies on Rheumatoid Arthritis and CNS drug development.

Contents

Executive Summary...1

Current Treatments2

Surgery....2

Radiation Therapy...2

Hormonal Therapy..3

Current Products' Patent Exposure.5

Chemotherapy ..6

Current Products' Patent Exposure.7

Molecular Targeted Therapy....8

Current Products' Patent Exposure.8

Market Analysis...9

The Breast Cancer Market in 2010.9

Targeted Therapies.10

Hormonal Therapies.....10

Chemotherapies 12

The Players... 13

The Breast Cancer Market in 2017.....15

Hormonal Therapies.....16

Chemotherapies 17

Targeted Therapies.18

The Players...20

Drug Growth Drivers and Dampeners.22

Drug Growth Drivers...22

Drug Growth Dampeners.22

Sales Forecasts (2010 Actual - 2017 Estimates).....24

Competitive Analysis....27

Rese arch and Development ...29

Research and Development Strategies..29

Targeting ErbB ..29

Targeting VEGF..29

Targeting PAR P..30

Targeting IG F-1r.30

Therapeutic Vaccines....30

Research and Development Pipelines...31

Background Information34

What is Breast Cancer?34

Risk Factors for Breast Cancer34

Stages of Breast Cancer....35

Diagnosis and Screening..35

Factors Influencing Survival..36

Patients Statistics...37

Worldwide Variation in Breast Cancer Incidence and Mortality..39

Breast Cancer Products..43

Targeted Therapies .45

Approved Products.45

Avastin.45

Herceptin..61

Tykerb/Tyverb .....71

Phase III Products....79

Afinitor ..... 79

Iniparib..... 87

Neratinib...91

Nexavar.... 94

Omnitarg ..... 104

Ramucirumab... 109

Tovok .114

Trastuzumab emtansine....118

Votrient .. 123

Phase II Products...129

AE37.. 129

AMG 386..132

AZD8931..135

Bavituximab.137

BMS-690514.141

BMS-754807 143

Cabozantinib..... 145

CDX-011...151

Cixutumab... 153

Dalotuzumab.... 156

Dinaciclib..... 159

Dovitinib 162

Entinostat.... 165

Enzastaurin.. 168

Erbitux.....171

Ganetespib...179

AMG 479. 183

INCB7839 185

Linifanib. 187

Mesupron..... 190

MetMAb. 192

Motesanib.... 195

NeuVax... 199

OPT-822.. 203

PF-1367338..205

Ridaforolimus.... 207

SAR256212....211

Sprycel ....213

Tarceva ....218

TSU-68....225

Vandetanib.. 227

Vectibix... 231

Veliparib.238

Zolinza.... 241

YM155.....246

Hormonal Therapies . 249

Approved Products.... 249

Arimidex 249

Aromasin256

Evista 260

Fareston.264

Faslodex. 269

Femara....274

Nolvadex280

Zoladex...284

Phase III Products..291

Orazol..... 291

Decapeptyl..294

Zometa...298

Phase II Products...302

TAS-108... 302

Chemotherapies .... 304

Approved Products.... 304

Abraxane304

Gemzar....312

Halaven...319

Ixempra.. 323

Taxotere. 329

Xeloda .... 342

Phase II Products...351

Imetelstat..... 351

LEP-ETU.. 354

Tasisulam..... 356

Telcyta ... 358

Tesetaxel 363

Thermodox.. 367

Yondelis.. 370

Appendix.375

Phase Transition Probability..... 375

Glossary.... 376

Acronyms.378

Source Material...379

Websites.....379

General Bibliography..379

Product Bibliography. 380

List of Tables

Current Major Hormonal Therapies....3

Major Patent Exposure of Leading Brands5

Major Patent Exposure of Leading Brands7

Major Patent Exposure of Leading Brands8

Breast Cancer Therapy Sales Forecasts (2010-2017).25

Competitor Ratio Analysis Total Scores...27

Products under Phase III Development for Breast Cancer.....31

The Launch Landscape for Phase III Targeted Therapies.32

Products under Phase II Development for Breast Cancer32

Products under Phase I Development for Breast Cancer.33

TMN Classification of Breast Cancer..35

Five-year Relative Survival Rates by Stage at Diagnosis (US)36

Five-year Relative Survival Rates by Tumour Size (US)....36

Targeted Therapies for Breast Cancer43

Hormonal Therapies for Breast Cancer.. 44

Chemotherapies for Breast Cancer... 44

Avastin Sales by Company (2009-2017).57

Avastin Sales by Indication (2009-2017).58

Breast Cancer Drug Discoveries: What the future holds

Herceptin Sales by Company (2009-2017)...69

Herceptin Sales by Indication (2009-2017)..70

Tykerb/Tyverb Sales by Indication (2009-2017).77

Afinitor Sales by Indication (2009-2017).....86

Nexavar Sales by Indication (2009-2017)..102

Omnitarg Sales by Indication (2013-2017).108

Ramucirumab Sales by Indication (2015-2017)113

LUX-Lung Trials 114

Tovok Sales by Indication (2014-2017)..117

Trastuzumab Emtansine Sales (2014-2017).....122

Votrient Sales by Indication (2009-2017).. 128

Efficacy Results for Erlotinib+Gemcitabine in the Treatment of Pancreatic Cancer....220

FDA ANDA Approvals for Anastrozole..253

Arimidex Total Sales (2009-2017)..255

FDA ANDA Approvals for Exemestane..258

Aromasin Sales (2009-2017)....259

Fareston Sales (2009-2017).....268

Faslodex Sales (2009-2017).....273

FDA ANDA Approvals for Letrozole.277

Tentative ANDA Approvals for Letrozole.....277

Femara Sales by Company (2009-2017)....279

Nolvadex Sales (2009-2017)....283

Zoladex Sales by Indication (2009-2017)...289

Abraxane Sales by Company (2009-2017)..311

Abraxane Sales by Indication (2009-2017).311

FDA ANDA Approvals for Gemcitabine. 317

Tentative ANDA Approvals for Gemcitabine..... 317

Gemzar Sales By Indication (2009-2017)... 318

Halaven Sales by Indication (2010-2017)..322

Ixempra Sales by Indication (2009-2017)..328

Efficacy of Docetaxel in the Treatment of NSCLC Patients Previously Treated with a Platinum-Based CT Regimen (Intent-to-Treat Analysis) 332

FDA NDA Approvals.....338

Taxotere Sales by Indication (2009-2017)..339

Xeloda Sales by Company (2009-2017).....349

Xeloda Sales by Indication (2009-2017).....349

Probability of Launch... 375

List of Charts

Breast Cancer Sales by Therapy Class (2010)...9

Targeted Therapy Sales (2010)....10

Hormonal Therapy Sales by Class (2010)11

Hormonal Therapy Sales (2010)..11

Chemotherapy Sales (2010)..12

Market Share of Breast Cancer Players by Sales (2010)..13

Breast Cancer Sales by Therapy Class (2017).15

Hormonal Therapy Sales (2017)..16

Chemotherapy Sales (2017)..17

Targeted Therapy Sales (2017)....18

Targeted Therapy Market Share by Sales (2017).18

Major Breast Cancer Players (2017)..20

Market Share of Breast Cancer Players by Sales (2017)...21

Breast Cancer Therapy Sales Forecasts (2010-2017)24

Targeted Therapy Sales (2010-2017).24

Hormonal Therapy Sales Forecasts (2010-2017)26

Chemotherapy Sales Forecasts (2010-2017)26

Incidence of Major Cancers Worldwide (2008)..37

Mortality of Major Cancers Worldwide (2008) .37

Worldwide Female Breast Cancer Incidence Rates by Region (2008)....39

Worldwide Female Breast Cancer Mortality Rates by Region (2008)....40

Female Breast Cancer Incidence Rates by EU Country (2008)....41

Female Breast Cancer Mortality Rates by EU country (2008)....42

Avastin Mode of Action..45

Avastin Sales by Company (2009-2017)57

Avastin Sales by Indication (2010)...59

Avastin Sales by Indication (2017)...60

HER2 Signalling Pathway....61

Herceptin Sales (2009-2017).....69

Herceptin Sales by Indication (2017)70

Tykerb/Tyverb Total Sales (2009-2017)..77

Tykerb Sales by Indication (2017).....78

Afinitor Mode of Action..79

Afinitor Sales (2009-2017)...86

Nexavar's Dual Mode of Action..94

Nexavar Sales (2009-2017)101

Nexavar Sales by Indication (2010)102

Nexavar Sales by Indication (2017)103

Omnitarg Sales (2013-2017)....108

Ramucirumab Sales (2015-2017)....112

Ramucirumab Sales by Indication (2017)...113

Tovok Sales (2014-2017)117

HER2 Signalling Pathway.. 118

Trastuzumab Emtansine Sales (2014-2017)..... 121

Votrient Total Sales (2009-2017).... 127

Votrient Sales By Indication (2017) 128

Upregulation of MET as a Response to Treatment. 145

Dovitinib Mode of Action....162

Epigenetic Modification of a Histone...165

Ganetespib Mode of Action 179

MetMAb Mechanism of Action 192

NeuVax Mode of Action199

Schematic of EGFr Inhibition in Tumourigenesis....231

Vorinostat Mechanism of Action.... 241

Arimidex Total Sales (2009-2017)..254

Aromasin Sales (2009-2017)...259

Evista - Invasive BC Incidence - STAR Trial..261

Fareston Sales (2009-2017).....268

Faslodex Sales (2009-2017)....272

Femara Sales by Company (2009-2017)....278

Nolvadex Sales (2009-2017)...282

Zoladex Sales (2009-2017).289

Zoladex Sales By Indication (2010)290

Zoladex Sales By Indication (2017).290

Abraxane Sales by Company (2009-2017) 310

Gemzar Sales (2009-2017). 318

Halaven Sales (2010-2017)322

Ixempra Sales (2009-2017)327

TAX 317 Survival K_M Curves - Docetaxel 75mg/m2 vs Best Supportive Care 333

TAX 320 Survival K_M Curves - Docetaxel 75mg/m2 vs Vinorelbine or Ifosfamide Control.....334

Taxotere Sales (2009-2017)339

Taxotere Sales by Indication (2010).....340

Taxotere Sales by Indication (2017)340

Xeloda Sales (2009-2017)..349

Xeloda Sales by Indication (2010)..350

Xeloda Sales by Indication (2017)..350

Canfosfamide Mode of Action..359

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