Cancer Therapies

Content

• I.Introduction, Methodology & Product Definitions
  • Study Reliability and Reporting Limitations
  • Disclaimers
  • Data Interpretation & Reporting Level
  • Quantitative Techniques & Analytics
  • Product Definitions and Scope of Study
  • Chemotherapy
  • Targeted Therapy
  • Hormonal Therapy
  • Immunotherapy
• II. Executive Summary
  • 1. Industry Overview
    • Cancer Therapies: A Prelude
    • Patent Expiries of Branded Drugs to Trigger Generic Competition
    • New Cancer Therapies Appear over the Horizon
    • New Generation Cancer Drugs and Their Area of Use
    • The New Era of Cancer Treatment
    • Biotech Cancer Therapies Yet to Overcome Teething Issues
    • Targeted Therapy: The New Frontier of Cancer Treatment
    • Top Rated Targeted Cancer Therapeutics with the Potential to become Blockbuster Drugs Include:
    • Oncology Drugs Approved for Use in the Targeted Cancer Therapeutics Sector in the years 2006, 2007, and 2008.
    • Combination Therapy: A Double Whammy Success
    • Small Cap Companies: A Target of Private Capital Financing
    • Drugs (that are both available and under pipeline) Developed by the Four Small-Cap Companies
    • Shifting Therapeutic Preferences
    • Innovations in Cancer Drug Delivery: A Key Factor in Product Differentiation
    • Personalized Medicine: Gain in Importance
    • Growth Drivers in a Capsule
    • Rise in Cancer Incidences & Access to Modern Therapeutics Foster Growth
    • Demographics & Lifestyles Raise the Risk of Cancer
    • Cancer Prone Sites based on Age
    • Unmet Needs Leave Scope for Further Research and Development
    • Low Entry Barriers in Cancer Research Encourages Breakthrough Developments
    • Increasing Investments by National Health Authorities
    • Efficiency & High Prices Magnetize Manufacturers
    • Supportive Cancer Drugs Contribute to Growth
    • Improved Screening, Diagnosis & Patient Survival Rates Trigger Growth
    • Molecular Imaging of Cancer: Critical in Improving Patient Outcomes
    • Innovations, Improvements, and Approvals Propel Growth
    • Growth Restraints
    • High Prices of Targeted Therapies Act as a Speed Breaker
    • Limited Tumor Specificity and Toxicity
    • Complicated Treatment Protocols: A Major Stumbling Block in Patient Compliance
    • Reduced Smoking
    • Reimbursement and Coverage Remains a Major Challenge
    • Changes in Reimbursement Policies Influence Market Prospects
    • Multiple Drug Resistance
    • Stringent Regulations Delay Market Approval
    • Challenges Encountered in Clinical Trials
    • High Development Costs Retracts Manufacturers in Developing Countries
    • Notes from across the Globe
    • United States
    • Medicare Restructures its Coverage for Chemotherapy
    • Personalized Care for Cancer Treatment in US
    • Drugs in Development in the US
    • Chemotherapy Drugs Undergoing Trials for Breast Cancer Treatment in United States (as of 2007)
    • Hormonal Therapy Drugs Undergoing Trials for Breast Cancer Treatment in United States (as of 2007)
    • Targeted Therapy Drugs Undergoing Trials for Breast Cancer Treatment in United States (as of 2007)
    • Statistical Findings
    • Canada
    • Australia
    • Asia
    • India
    • Japan
    • Korea
    • Malaysia
    • Europe
    • Advancements in Breast Cancer Treatment in Europe
    • New Formulations that are under Clinical Trials
    • Drugs Undergoing Trials for Bladder Cancer Treatment in Europe as of 2006
    • Latin America
    • Brazil
    • Mexico
    • Argentina
    • Cancer Incidences Worldwide
  • 2. Product Overview
    • Cancer: A Major Health Crises in the Modern World
    • Types of Cancers
    • Prostate Cancer
    • Key Prostate Cancer Drugs & Companies
    • Breast Cancer
    • Key Breast Cancer Drugs & Companies
    • Cervical Cancer
    • Colorectal Cancer
    • Key Colorectal Cancer Drugs & Companies
    • Lung Cancer
    • Key Lung Cancer Dugs & Companies
    • Renal Cancer
    • Key Renal Cancer Drugs and Companies
    • Skin Cancer
    • Non-Hodgkin's Lymphoma
    • Leukemia
    • Pancreatic Cancer
    • Bladder Cancer
    • Endometrial Cancer
    • Cancer Therapies: A Review
    • Monoclonal Antibodies Open up A New Era in Cancer Treatment
    • List of Approved Monoclonal Antibodies Used in Treating Various Cancers
    • Therapeutic Cancer Vaccines: Harnessing the Immune System to Fight Cancer
    • Cancer Vaccine Strategies
    • Therapeutic Cancer Vaccine Products under Clinical Trials as of 2007
    • Gene Therapy
    • Types of Cancer Therapies
    • Chemotherapy
    • Chemotherapy Drugs Require Careful Handling
    • Types of Chemotherapy
    • Chemotherapy Drug Classes
    • Risks Associated with Chemotherapy
    • When Chemotherapy Fails...
    • Targeted Therapy
    • Hormonal Therapy
    • Hormonal Therapy Strategies
    • Drug Classes in Hormone Therapy
    • Drugs Used in Hormone Therapy and Their Uses
    • Side-Effects Associated with the Use of Various Drugs in Hormone Therapy
    • Immunotherapy
    • A Primer
    • Immunotherapy Treatment Strategies
    • Second-Generation Immunotherapies
  • 3. Drug Approvals and Clinical Trials
    • ABRAXANE Gains Marketing Approval in Korea, Australia and Other Countries
    • GlaxoSmithKline's Cervarix Finds Place in UK National Immunization Programme
    • Biogen Idec and Elan Commence Clinical Trial of TYSABRI
    • Calistoga Pharmaceuticals Starts Phase I Clinical Trial of CAL-101
    • Progen Pharmaceuticals Continues Phase 1 Development of PG-11047
    • GlaxoSmithKline Receives Conditional EU Approval for Marketing Lapatinib
    • Roche's Xeloda Gains EU Approval for Use in Colorectal Cancer Treatment
    • Genentech Secures FDA Approval for Avastin
    • EU Approves Four Biosimilar Versions of Neupogen
    • Russia Approves Oncophage for Kidney Cancer Treatment
    • Eisai to Start Clinical Testing of MORAb-028
    • Threshold Pharmaceuticals Starts Phase I/II Clinical Trials of TH-302
    • AVEO Commences Phase 1b Clinical Study of AV-951 and FOLFOX6
    • GSK's Tykerb Receives USFDA Approval
    • Seattle Genetics Initiates Phase 1b Clinical Trials of SGN-40 with Gemzar and Rituxan
    • S*Bio Initiates Phase I Clinical Trials of SB1518
    • Merck Serono Initiates Phase III Trials of Cladribine
    • BioCurex Receives Patent for RECAF Technology Applications
    • Chidamide/HBI-8000 Completes Phase I Clinical Trials in China
    • AVEO Initiates Phase I Trials of AV 299
    • Exelixis Completes Phase I Trials of XL765
    • Infinity Pharmaceuticals Starts Phase I Clinical Trial of IPI-926
    • Cell Genesys Terminates its VITAL-1 Phase 3 Trial of GVAX
    • GTx Completes Phase II Clinical Trials of Ostarine
    • Imclone Awaits Approval for Erbitux from US Medicine Regulator
    • Kuhnil and Daiichi Sankyo Initiate Phase II Clinical Trial of Nimotuzumab
    • Peplin Starts Phase III Clinical Trials of PEP005 Gel
    • ERBITUX Receives Marketing Approval in Japan
    • Progenics Starts Phase I Clinical Study of PSMA ADC
    • FDA Awards Orphan Drug Designation for the Use of Stem Cell Technology in Bone Marrow Transplantations
    • Roche, OSI and Chugai Receive Approval for Tarceva in Japan
    • Eisai Receives FDA Approval for ONTAK
    • Genmab Terminates the Development of HuMax-CD4
    • Teva Pharmaceutical Acquires EU Authorization to Market Neutropenia Drug
    • Novartis' Everolimus Awaits Approvals from US FDA, Swissmedic, and EMEA
    • Abraxis BioScience, AstraZeneca, and NCCN to Conduct Anti-cancer Drug Studies
    • Sanofi-Aventis Receives Japanese Approval for Taxotere Injection
    • Roche's Avastin Bags European Approval for Renal Cancer Treatment
    • Roche Announces European Approval of Herceptin
    • GSK's Hycamtin Obtains FDA Approval
    • Avastin Receives European Approval for Breast Cancer Treatment
    • Roche's Tarceva Obtains European Approval
    • Roche's NeoRecormon Gains European Approval
    • Northwest Biotherapeutics' DCVax-Brain Gains Swiss Approval
    • Alfacell's ONCONASE Receives Orphan Drug Designation from US
    • Cougar Biotechnology Commences Phase II Trial of CB7630
    • Lorus Therapeutics Receives Orphan Drug Designation for its LOR-2040
    • Merck Serono Receives EU Approval for mCRC Treatment with Erbitux
    • MGI PHARMA and HELSINN Receive FDA Approval for Aloxi
    • FDA Grants Approval for Sutent, a Kidney and Gastrointestinal Cancer Drug
    • Wyeth Pharmaceuticals' TORISEL Receives FDA Approval
    • Dabur Pharma Acquires FDA Approval for Paclitaxel Injection
    • EUSA's CAPHOSOL Finds Application in Treating Oral Mucositis
    • European Commission Approves Amgen's Vectibix for Metastatic Colorectal Cancer
    • GPC Biotech Starts Phase 2 Trials of Satraplatin plus with Tarceva
    • FDA Approves Vectibix as Treatment for Metastatic Colorectal Cancer
    • FDA Approves IND Indication for CYT-500 of Cytogen
    • FDA Clears Rituxan for New Indications
    • Epeius Receives BFAD Approval for Expanded Access Program for Rexin- G
    • BioMedicines Initiates Phase 1b Study of Biomed 101
    • Avastin Obtains FDA Approval for Treating Recurrent Colorectal Cancer
    • Genentech's Herceptin Gains FDA Nod for Treating Early stage Cancer after Surgery
    • Epeius Starts Phase I and II Trials of the New Tri-Rex Vaccination Protocol
    • Sonus Begins Phase 1 Clinical Trial of TOCOSOL Camptothecin
    • Dynavax Begins Phase 1 Clinical Trial of TLR9 agonist Combined with Chemotherapy Regimen
    • Morphotek's MORAb-009 Receives Orphan Drug Designation
    • Morphotek's MORAb-003 Receives Orphan Drug Status from the US FDA
    • Morphotek Grants FDA Approval of the IND for MORAb-009
    • MannKind Receives IND Clearance for MKC1106-PP Immunotherapy
    • Pharmexa Initiates Phase II trials of GV 1001
    • Wyeth Pharmaceuticals Declares Discontinuation of Phase III Clinical Trials for Temsirolimus
    • OXiGENE Announces Clinical Trials of CA4P
    • Glaxo SmithKline's Hycamtin Gains FDA Approval for Treating Cervical Cancer
    • Cell Genesys Announces the Initiation of Amplified Phase I Trial of CG0070
    • Genentech's Avastin Receives FDA Approval for Lung Cancer Treatment
    • Vorinostat Acquires FDA Approval for Skin Cancer Treatment
    • Callisto Launches the First Clinical Trial of Landmark Discovery, L-Annamycin for ALL
    • Shanghai Sunway Biotech's H101 Receives Marketing Approval in China
    • Northwest Biotherapeutics Gains Patent for CXCR4
    • Biocon's Cancer Drug Initiates Phase II Trials
  • 4. New Drug Developments and Launches
    • GSK Launches Cervarix in Singapore
    • Abeome Launches New Stem Cell Monoclonal Antibody
    • Dabur Pharma Launches a New Drug Delivery System, Nanoxel
    • Epeius Biotechnologies Develops New Targeted Anti-Cancer Drugs
    • Monash University Scientists Develop siRNA for Cancer Treatment
    • Cytogen Introduces SOLTAMOX, the First Hormonal Breast Cancer Therapy
  • 5. Recent Industry Activity
    • Avexa to Acquire Progen Pharmaceuticals
    • Abraxis Takes over Platco and Shimoda
    • WEHI Collaborates with Abbott and Genentech
    • Novartis Inks a Production Deal with Lonza
    • Roche to Take over UK-Based Biotech Company, Piramed
    • Pfizer Acquires Encysive
    • Eden Biodesign Inks a Marketing Services Deal with Human Genome Sciences
    • FivePrime Join Hands with Pfizer for Cancer and Diabetes Research
    • Sanofi-Aventis and Dyax Ink Two Antibody Pacts
    • Pfizer and AVANT Ink a Global Licensing Agreement for CDX-110
    • Takeda Inks an Exclusive Partnership Agreement with Amgen
    • Genentech and Roche Ink a Licensing Agreement with Glycart
    • Bristol-Myers Squibb to Acquire Kosan Biosciences
    • Nabi Biopharmaceuticals Collaborates with NIAID
    • Pfizer to Acquire Serenex
    • Morphotek Signs an Agreement with Pivotal BioSciences
    • GE Healthcare Inks a Three-Year Agreement with Eli Lilly
    • ArQule Signs Two Agreements with Daiichi Sankyo
    • Circadian Completely Acquires Vegenics Limited
    • Lpath Inks an Accord with Merck Serono
    • Topex Expands its Distribution Deal with Therapy Remarketing
    • Unibioscreen Inks a Partnership Agreement with Drais Pharmaceuticals
    • Avant Immunotherapeutics to Become Celldex Therapeutics
    • Abraxis Enters into Definitive License Agreements with ProMetic Life Sciences
    • Biovest International to Receive US$1.6 Million Funding for Biomedical Research
    • Access Completes the Acquisition of Somanta
    • Clinical Data Inks an Agreement to Take over Avalon Pharmaceuticals
    • EUSA Pharma Acquires Cytogen Corporation
    • Oncologic Merges with Triton BioSystems
    • Eli Lilly to Take over ImClone Systems
    • CEL-SCI Establishes a New Manufacturing Unit
    • ZaBeCor Establishes Biothorpe Pharmaceuticals, a New Subsidiary
    • Takara Bio Signs a Research Agreement with a Chinese University
    • Shanghai Roche Expands its MabThera Marketing Activities
    • Merck Completes the Acquisition of Majority Stake in Serono
    • Merck Enters into Licensing and Collaboration Agreement with Idera
    • Sanofi-Aventis Inks a Global Licensing Deal with Oxford BioMedica
    • WEHI to Collaborate with Genentech and Roche
    • AstraZeneca Acquires MedImmune
    • Antisoma Enters into a Global Accord with Novartis
    • Sanofi-Aventis and Astellas Pharma to Restructure their JV Operations in Japan
    • Biomira Amends its Agreements with Merck
    • AstraZeneca Takes over Canadian Biologics Plant
    • Pfizer to Acquire Coley Pharmaceutical Group
    • Abraxis Takes over Watson's Manufacturing Facility
    • Abraxis Takes over Pfizer's Cruce Davila Manufacturing Facility
    • Bristol-Myers Squibb to Take over Adnexus Therapeutics
    • Merck to Partner with a Florida-based Research Center
    • Organon to Partner with Medarex
    • Genzyme to Acquire Bioenvision
    • Genentech Inks a Deal with Seattle Genetics
    • TopoTarget Takes over Apoxis
    • Roche to Acquire CuraGen's Subsidiary
    • GPC Biotech Inks an Agreement with Yakult
    • MediGene Acquires Avidex
    • Sanofi-Aventis Inks an Agreement with Taiho
    • Biogen Inks Merger Agreement with Conforma
    • Roche Signs a Merger Agreement with Ventana
    • Roche Takes over THP to Enhance Its Therapeutic Antibody Profile
    • ImClone Systems and Merck Revise ERBITUX Agreement
    • GSK Invests €500 Million in France
    • Amgen Takes over Avidia
    • Moores Cancer Center Collaborates with Medarex
    • ADITUS Medical Forms an Alliance with IGEA
    • Callisto Opens Site for Phase-II Clinical Trials of Atiprimod
    • XOMA Inks an Agreement with Attenuon
    • AstraZeneca Joins Schering to Develop a Novel Breast Cancer Drug
    • Nventa to Procure Hiltonol from Oncovir Incorporated
    • MaxCyte and Medinet Sign an Agreement for Immuno-Cell Therapy
    • Receptor Acquires Cancer Vaccine 'G17DT' from Aphton
    • Enzon Collaborates with Santaris for Joint Development ff Novel RNA Antagonists
    • Epeius Receives Funding from Lazarex for Rexin-G Trials
    • Callisto Inks a Deal with M.D. Anderson Cancer Center
    • AstraZeneca Inks an Agreement with Abraxis BioScience
    • diaDexus and BVF Establish CFD Therapeutics
    • Merck to Acquire US Rights for Liposome Vaccine
    • Genentech Enters into Alliance with Inotek
    • AstraZeneca to Take over KuDOS Pharmaceuticals
    • Genentech Collaborates with Accelerate Brain Cancer Cure
    • Sonus and Schering Enter into a Global Licensing Agreement
    • Abgenix Inks Merger Agreement with Amgen
    • AstraZeneca and Astex Enter into an Alliance
    • Pfizer Inks Global License Pact with Coley Pharmaceutical Group
    • Genzyme Takes over ILEX Oncology
    • Genentech and CGI Enter into an Exclusive Agreement
    • Genzyme to Acquire AnorMED
  • 6. Focus on Select Players
    • Abraxis BioScience, Inc. (USA)
    • Amgen, Inc. (USA)
    • AstraZeneca PLC (UK)
    • Bayer Schering Pharma (Germany)
    • Biogen Idec Inc (USA)
    • Bristol-Myers Squibb Company (USA)
    • Celgene Corporation (USA)
    • Cell Therapeutics, Inc. (USA)
    • Cephalon, Inc. (USA)
    • Chugai Pharmaceutical Co., Ltd. (Japan)
    • Eli Lilly and Company (USA)
    • F. Hoffmann-La Roche Ltd (Switzerland)
    • Genentech, Inc. (USA)
    • Genzyme (USA)
    • GlaxoSmithKline (UK)
    • Imclone Systems, Inc (USA)
    • Merck KGaA (Germany)
    • Novartis AG (Switzerland)
    • Ortho Biotech Products, L.P (USA)
    • OSI Pharmaceuticals, Inc. (USA)
    • Pfizer (USA)
    • Sanofi-Aventis (France)
    • Schering Plough Corporation (USA)
    • Seattle Genetics, Inc. (USA)
    • Takeda Pharmaceutical Company Limited (Japan)
    • Wyeth (USA)
  • 7. Market Perspective
• III. Competitive Landscape
• List of Tables
  • Table 1: Global Market for Biotech-Enabled Cancer Therapies (2004 & 2008): Percentage Breakdown of Revenues by Application - Hematological, Solid Tumors, and Conditions related to Chemotherapy (includes corresponding Graph/Chart)
  • Table 2: Molecular Targeted Therapies Worldwide: Percentage Breakdown of Molecular Targeted Therapies under Pipeline by Drug Class as of 2006 (includes corresponding Graph/Chart)
  • Table 3: Venture Capital Investment (in US$ Millions) Made in Research and Development of Biotechnology for the years 2004 and 2009 (includes corresponding Graph/Chart)
  • Table 4: Global Market for Antihormonal Therapy (2005 and 2014): Percentage Breakdown of Revenues by Drug Class - LHRH Analogs, Aromatase Inhibitors, Anti-androgens, Anti-estrogens, and Other Hormone Antagonists(includes corresponding Graph/Chart)
  • Table 5: Population of People Aged More than 65 Years in United States for the years 2000, 2010, and 2020 (includes corresponding Graph/Chart)
  • Table 6: Global Cancer Diagnostics Market (2004): Breakdown of Sales by Geographic Region (in US$ Billion) (includes corresponding Graph/Chart)
  • Table 7: Average Costs of Cancer Therapies in the US as of the Year 2005 in US$
  • Table 8: US Market for Hospital Cancer Therapies (2004 and 2009): Percentage Breakdown of Revenues by Treatment Type - Surgery, Chemotherapy Drugs, Radiation Therapy, Biotechnology-Based Drugs, and Others (includes corresponding Graph/Chart)
  • Table 9: US Demand for Chemotherapy Drugs (2004 and 2009): Percentage Breakdown of Revenues by Drug Class - Alkylating Agents & Related, Antimetabolites & Related, Mitotic Inhibitors, and Others (includes corresponding Graph/Chart)
  • Table 10: US Market for Multiple Myeloma (2006): Percentage Revenue Breakdown of Leading Players - Celgene Corporation, Millennium Pharmaceuticals, Inc., Ortho Biotech, and Others (includes corresponding Graph/Chart)
  • Table 11: New Cancer Cases and Deaths in United States in the year 2006 (includes corresponding Graph/Chart)
  • Table 12: US Market for Cancer Therapies (2004): Percentage Revenue Breakdown of Leading Players - Genentech, Sanofi-Aventis, AstraZeneca, Bristol-Myers Squibb, Pfizer, Eli Lilly, Novartis, Roche and Others (includes corresponding Graph/Chart)
  • Table 13: US Market for Breast Cancer Therapeutics (2006): Percentage Breakdown of Revenues by Segment: Cytotoxic Therapeutics, Hormonal Therapeutics, and Targeted Therapeutics (includes corresponding Graph/Chart)
  • Table 14: New Cases of Cancer Incidences and Deaths in Canada in the year 2006 (includes corresponding Graph/Chart)
  • Table 15: Imports of Cancer Diagnostic and Therapy Equipment (2004): Percentage Breakdown of Import Value by Country of Origin (includes corresponding Graph/Chart)
  • Table 16: European Market for Breast Cancer Therapeutics (2006): Percentage Breakdown of Revenues by Drug Class: Cytotoxic Drugs, Hormonal Drugs, and Biologics (includes corresponding Graph/Chart)
  • Table 17: New Incidences of Liver Cancer (in '000) Worldwide for the years 2008 and 2012
  • Table 18: New Incidences of Breast Cancer (in '000) Worldwide for the years 2008 and 2012
  • Table 19: New Incidences of Prostate Cancer (in '000) Worldwide for the years 2008 and 2012
  • Table 20: New Incidences of Bladder Cancer (in '000) Worldwide for the years 2008 and 2012
  • Table 21: Cancer Causes in Developed and Developing Countries (2006): Percentage Breakdown by Risk Factors - Diet or Nutrition, Infections, Tobacco, and Other Factors (includes corresponding Graph/Chart)
  • Table 22: Targeted Therapies Market Worldwide (2006): Percentage Breakdown of Targeted Therapeutic Drugs under Various Stages of Development (includes corresponding Graph/Chart)
  • Table 23: Global Market for Immunotherapy (2007 and 2012): Percentage Breakdown of Revenues by Drug Class -Monoclonal Antibodies, Biological Response Modifiers, Vaccines, and Other Immunotherapy Products (includes corresponding Graph/Chart)
  • Table 24: Global Recent past, Current & Future Analysis for Cancer Therapies by Type - Targeted Therapy, Chemotherapy, Hormone Therapy, and Immunotherapy Markets Independently Analyzed with Annual Sales Figures in US$ Billion for Years 2006 through 2015 (includes corresponding Graph/Chart)
  • Table 25: Global Historic Review for Cancer Therapies by Type - Targeted Therapy, Chemotherapy, Hormone Therapy, and Immunotherapy Markets Independently Analyzed with Annual Sales Figures in US$ Billion for Years 2000 through 2005 (includes corresponding Graph/Chart)
  • Table 26: Global 10-Year Perspective for Cancer Therapies by Type - Percentage Breakdown of Dollar Sales for Targeted Therapy, Chemotherapy, Hormone Therapy, and Immunotherapy for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)