Lung Cancer Therapeutics

Table of Contents

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 Drugs
• Targeted Drugs

II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW

• Lung Cancer Therapeutics - Driven by Next Generation Drugs
• New Therapies Drive NSCLC Market
• Market Value of Taxanes to Decrease by 2015
• Lung Cancer - The Killer Disease
• Lung Cancer - A Quick Glance at Global Statistics
• Asia Heading for Possible Lung Cancer Epidemic
• Table 1: Global Incidence of Lung Cancer (2008): Percentage Share Breakdown by Region (includes corresponding Graph/Chart)

2. LUNG CANCER - AN INSIGHT

• Lungs - Critical for Oxygen Supply
• Lung Cancer - An Introduction
• Common Symptoms of Lung Cancer
• Types of Lung Cancer
• Non-Small Cell Lung Cancer
• NSCLC - At a Glance
• Small Cell Lung Cancer
• Risk Factors for Lung Cancer
• Female Smokers at Higher Risk of Developing Lung Cancer
• Lung Cancer Diagnostics
• Lung Cancer Staging
• Staging for Non-Small Cell Lung Cancer
• Staging for Small Cell Lung Cancer

3. LUNG CANCER TREATMENT MODALITIES

• Surgery
• Radiation Therapy
• Chemotherapy
• Combination Therapy
• Photodynamic Therapy
• Vaccines
• Common Treatment Modalities for SCLC and NSCLC Lung Cancers
• Pain Management

4. INTRODUCTION TO LUNG CANCER THERAPEUTICS

• Chemotherapy
• Drug Administration
• Overview of Chemotherapy Regimens and Drugs
• Side Effects of Chemotherapy
• Targeted Therapy
• Chemotherapy Drugs for SCLC Treatment
• Chemotherapy Drugs for NSCLC Treatment
• Major Chemotherapy Drugs
• Select Chemotherapy Drugs Used in the Treatment of Lung Cancer by Brand and Generic Name
• Overview of Select Chemotherapeutic Drugs
• Alimta
• Carboplatin and Cisplatin
• Docetaxel
• Paclitaxel
• Xyotax
• Gemcitabine
• Gefitinib
• Irinotecan
• Vinorelbine (Navelbine(r))

5. PRODUCT DEVELOPMENT IN NSCLC THERAPEUTICS

• R&D Focus in NSCLC Treatment
• Drug Development Process - Growth Opportunities & Challenges
• Product Pipeline for NSCLC Treatment
• Product Pipeline for NSCLC Treatment
• Select (Ongoing/Completed) Clinical Trials for NSCLC Treatment
• Companies Focus on Molecular Targeted Therapies
• Molecular Targeted Therapies - Overview of Select Product Candidates
• Aflibercept (VEGF-Trap) - Sanofi Aventis/ Regeneron
• BIBW 2992 - Boehringer Ingelheim
• Erbitux (cetuximab) - ImClone/Merck Serono/Bristol- Myers Squibb
• Nexavar (sorafenib) - Bayer Schering
• Recentin (cediranib) - AstraZeneca
• Sutent (sunitinib) - Pfizer
• Zactima (vandetanib) - AstraZeneca
• Zolinza (vorinostat) - Merck & Co
• Pipeline for Cytotoxic Therapy - Overview of Select Products
• Abraxane (albumin-bound paclitaxel) - Abraxis
• Glutoxim (NOV-002) - Novelos
• Javlor (vinflunine) - Pierre Fabre
• Lipoplatin (liposomal cisplatin) - Regulon
• Xyotax (paclitaxel polyglumex) - Cell Therapeutics/ Novartis

6. PRODUCT APPROVALS/INNOVATIONS/LAUNCHES

• Intas Biopharmaceuticals to Introduce Gefitinib in India
• Celgene Receives FDA Fast Track Product Designation for Amrubicin
• EMEA Approves ALIMTA for First-Line Therapy of Advanced NSCLC
• Celgene' s Cancer Drug Receives Orphan Drug Status from European Commission
• Alimta Receives FDA Approval
• Roche Receives Approval from European Authorities for Avastin
• OSI Pharmaceuticals Introduces Tarceva in Japan
• Shanghai Medipharm Introduces TNT Antibody for Treating Lung Cancer
• Natco Pharma Unveils an Injectible Drug for Lung Cancer, Pemnat
• Roche Scientific Introduces Tarceva in the Indian Market
• GlaxoSmithKline' s HYCAMTIN(r) Receives Marketing Approval from EC
• Genzyme Launches New Genetic Mutation Test to Aid Lung Cancer Treatment
• UT Southwestern Medical Center Researchers Discover New Anti-Cancer Drug
• Agennix' s Talactoferrin Alfa Program Obtains Fast Track Designation from FDA
• Novelos Therapeutics' NOV-002 Receives Fast Track Designation from FDA

7. RESEARCH & CLINICAL TRIALS

• Novartis Commences Phase III Clinical Trial of ASA404
• Results of BR.21 Trials
• Genentech Announces Results of Phase III BETA Lung Trial
• Results of SATURN Clinical Trial
• Results of Zactima' s Clinical Trials
• Results of Erbitux' s Phase III Trials
• Results of Roche' s AVAiL Clinical Trial
• GlaxoSmithKline Conducts Phase III Clinical Trial of Lung Cancer Vaccine
• FASgen Announces Research Results of FAS093
• The Cuban Regulatory Agency Registers a New Therapeutic Lung Cancer Vaccine
• Gemin X Commences Clinical Trials of GX15-070
• Antisoma and Biomira Announce Clinical Trial Results of Lung Cancer Drugs
• OSI Pharmaceuticals Commences Phase III Clinical Trials of Tarceva(r)
• Northwest Gets FDA Clearance to Conduct Clinical Trials for Lung Cancer Vaccine
• University of Kentucky Conducts Clinical Trials on Lung Cancer Vaccine
• Poniard Enrolls in Phase II Small Cell Lung Cancer Clinical Trials of Picoplatin
• Sunesis Pharmaceuticals Starts Phase II Clinical Trials of SNS-595
• Ligand Pharmaceuticals Tables Clinical Results of Targretin(r)
• Bayer and Onyx Start Phase III Trial of Nexavar(r)
• Abraxis Announces Clinical Results of ABRAXANE(r)
• Introgen Conducts Phase II Clinical Trials of INGN 225
• YM BioSciences Commences Clinical Trial of Nimotuzumab

8. RECENT INDUSTRY ACTIVITY

• Merck Agrees to Merge with Shering-Plough
• Abbott Molecular Signs Agreement with Genentech, OSI and Roche
• IMUC Acquires Monoclonal Antibody Technology from MDC
• Quest PharmaTech Enters into Collaboration with BC Cancer Agency
• Daiichi Sankyo Acquires U3 Pharma
• MacroGenics Takes Over Raven Biotechnologies
• Roche Acquires Piramed
• Bristol-Myers Squibb Acquires Kosan Biosciences
• Point Therapeutics and DARA Biosciences Ink Merger Agreement
• Celgene Acquires Pharmion
• Pfizer to Takeover Serenex
• ATS Acquires Majority Stake in GANYMED Pharmaceuticals
• NCCN, AstraZeneca and Abraxis Enter into Collaboration
• Eli Lilly Agrees to Take Over ImClone Systems
• CytRx Takes Over Innovive Pharmaceuticals
• Abbott Extends Discovery Partnership with Caprion
• Bristol-Myers and ImClone to Expand the Clinical Development Program for ERBITUX
• Biomoda and New Mexico Tech Enter into a Collaborative Agreement
• Binex Inks Sponsored Research Agreement with MaxCyte
• Simcere Pharmaceutical Acquires Master Luck
• Dako Enters into Collaboration with OSI, Roche, and Genentech
• Biomira and Merck Sign Revised Supply and Collaboration Agreements
• ImClone Systems Terminates Development Agreement with UCB
• Astellas Pharma' s US Subsidiary Acquires Agensys
• Antisoma Enters into an Agreement with Novartis
• Pharmacyclics Files NDA for Xcytrin(r) Injection

9. FOCUS ON SELECT GLOBAL PLAYERS

• AstraZeneca PLC (UK)
• Bristol-Myers Squibb Co. (US)
• Eli Lilly & Co. (US)
• F. Hoffmann-La Roche Ltd (Switzerland)
• Genentech, Inc. (US)
• GlaxoSmithKline Plc (UK)
• Novartis Pharmaceuticals Corporation (US)
• OSI Pharmaceuticals, Inc. (US)
• Sanofi-Aventis (France)
• Companies with Pipeline Drugs
• AbGenomics International Inc. (US)
• ImClone Systems, Inc. (US)
• Pfizer, Inc. (US)
• Merck Serono International S.A. (Switzerland)
• Merck & Co. Ltd. (US)
• Telik, Inc. (US)
• Woomera Therapeutics, Inc. (US)

10. GLOBAL MARKET PERSPECTIVE

• Table 2: World Recent Past, Current & Future Analysis for Non-Small Cell Lung Cancer Therapeutics Market by Geographic Region - US, Europe and Rest of World Independently Analyzed with Annual Revenues in US$ Million for Years 2005 through 2015 (includes corresponding Graph/Chart)
• Table 3: World 10-Year Perspective for Non-Small Cell Lung Cancer Therapeutics by Geographic Region - Percentage Breakdown of Annual Revenues for US, Europe and Rest of World Markets for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)

III. MARKET

1. THE UNITED STATES

• A. Market Analysis
• NSCLC Drug Market to Rise Sharply
• Lung Cancer Prevalence
• A Major Cause of Death among US Women
• Statistics
• Market Scenario
• FDA Places New Restrictions on Iressa
• Innovative Technology Enables Early Diagnosis of Lung Cancer
• Avastin to Emerge as the Preferred NSCLC Drug in the US
• Product Approvals/Clinical Trials/Introductions/ Launches
• Strategic Corporate Developments
• Key Players
• B. Market Analytics
• Table 4: US Recent Past, Current & Future Analysis for Non-Small Cell Lung Cancer Therapeutics by Segment - Chemotherapy Drugs and Targeted Drugs Markets Independently Analyzed with Annual Revenues in US$ Million for Years 2005 through 2015 (includes corresponding Graph/Chart)
• Table 5: US 10-Year Perspective for Non-Small Cell Lung Cancer Therapeutics by Segment - Percentage Breakdown of Annual Revenues for Chemotherapy Drugs and Targeted Drugs Markets for Years 2006, 2009 & 2015

2. EUROPE

• A. Market Analysis
• Lung Cancer Therapeutics Market to Witness Robust Growth
• Product Approvals
• Clinical Trials
• B. Market Analytics
• Table 6: European Recent Past, Current & Future Analysis for Non-Small Cell Lung Cancer Therapeutics by Geographic Region - France, Germany, Italy, UK and Rest of Europe Independently Analyzed with Annual Revenues in US$ Million for Years 2005 through 2015 (includes corresponding Graph/Chart)
• Table 7: European 10-Year Perspective for Non-Small Cell Lung Cancer Therapeutics Market by Geographic Region - Percentage Breakdown of Annual Revenues for France, Germany, Italy, UK and Rest of Europe Markets for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)

2a. FRANCE

• A. Market Analysis
• Overview of Lung Cancer Market
• Key Player
• B. Market Analytics
• Table 8: French Recent Past, Current & Future Analysis for Non-Small Cell Lung Cancer Therapeutics Market Analyzed with Annual Revenues in US$ Million for Years 2005 through 2015 (includes corresponding Graph/Chart)

2b. GERMANY

• A. Market Analysis
• Lung Cancer Scenario
• Chemotherapy Gains Preference
• Strategic Corporate Developments
• B. Market Analytics
• Table 9: German Recent Past, Current & Future Analysis for Non-Small Cell Lung Cancer Therapeutics Market Analyzed with Annual Revenues in US$ Million for Years 2005 through 2015 (includes corresponding Graph/Chart)

2c. ITALY

• A. Market Analysis
• Incidence in Women on Rise
• Treatment
• B. Market Analytics
• Table 10: Italian Recent Past, Current & Future Analysis for Non-Small Cell Lung Cancer Therapeutics Market Analyzed with Annual Revenues in US$ Million for Years 2005 through 2015 (includes corresponding Graph/Chart)

2d. THE UNITED KINGDOM

• A. Market Analysis
• British Women at Higher Risk
• Fast Facts
• Proposed Cancer Care Improvements Mulled by British Government
• NICE Recommends Use of Erlotinib in NSCLC Treatment
• Strategic Corporate Developments
• Key Players
• B. Market Analytics
• Table 11: UK Recent Past, Current & Future Analysis for Non-Small Cell Lung Cancer Therapeutics Market Analyzed with Annual Revenues in US$ Million for Years 2005 through 2015 (includes corresponding Graph/Chart)

2e. REST OF EUROPE

• A. Market Analysis
• Outlook
• Strategic Corporate Developments
• Key Player
• B. Market Analytics
• Table 12: Rest of Europe Recent Past, Current & Future Analysis for Non-Small Cell Lung Cancer Therapeutics Market Analyzed with Annual Revenues in US$ Million for Years 2005 through 2015 (includes corresponding Graph/Chart)

3. REST OF WORLD

• A. Market Analysis
• Australia
• Fast Facts
• Brazil
• China
• Overview of NSCLC Drug Market
• India
• Japan
• Product Launches
• Strategic Corporate Development
• B. Market Analytics
• Table 13: Rest of World Recent Past, Current & Future Analysis for Non-Small Cell Lung Cancer Therapeutics Market Analyzed with Annual Revenues in US$ Million for Years 2005 through 2015 (includes corresponding Graph/Chart)

IV. COMPETITIVE LANDSCAPE