Multiple Myeloma 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

II. A US MARKET REPORT

1. Industry Overview

• Hematological Cancer Therapies: A Prelude
• Treatment Regimes: The Golden Rule
• Multiple Myeloma: A Second Most Common Hematological Cancer
• Table 1: Hematological Malignancies in the US (2007): Number of Incidences and Deaths by Type of Cancer - Lymphoma (Hodgkin' s Lymphoma and Non-Hodgkin' s Lymphoma), Multiple Myeloma, Leukemia (Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Acute Myeloid Leukemia, Chronic Myeloid Leukemia, and Other Leukemia), and Myelodysplastic Syndromes (MDS) (includes corresponding Graph/Chart)
• Table 2: Blood Cancer Statistics in the US (2008E): Percentage Breakdown of Hematological Cancer Cases by Type: Lymphoma, Myeloma, and Leukemia (includes corresponding Graph/Chart)
• Table 3: Multiple Myeloma Statistics in the US (2008E): Number of Persons Undergoing Initial Diagnosis and Monitoring (includes corresponding Graph/Chart)
• Treatment Therapies: Move Up the Learning Curve
• Risk-Adapted Therapy: The New Norm of Future Treatment
• New Generation Drugs in the Arsenal Against Multiple Myeloma
• Velcade(r) (Bortezomib)
• Thalomid(r) (Thalidomide)
• Revlimid(r) (Lenalidomide)
• Alkeran (Melphalan)
• Doxil (Liposomal Doxorubicin)
• Trisenox(r) (Arsenic trioxide)
• Noteworthy Issues Related to Major Drugs: An Evaluation of Pros and Cons
• Revlimid Overtakes Thalomid: Why?
• How Effective Will Thalomid Be in the 3rd Line Setting? Skepticism Overflows...
• Revlimid Impedes Stem Cell Harvesting!!: What' s the Truth?
• 1st & 2nd Generation Geldanamycin Analog to Do Wonders for Myeloma Treatment
• Other Trends & Issues
• Approval of New Generation Drugs Push the Market Into the Bulge Bracket
• Growth Fundamentals Get Stronger
• Table 4: Key Drug Regimens in the US Multiple Myeloma Market (2006): Breakdown of Typical Length of Treatment Cycle and Cost per Cycle (In US$) (includes corresponding Graph/Chart)
• Multidrug Resistance: A Challenge to Reckon With
• Gene Therapy Exudes Hope
• Challenges Encountered in Clinical Trials
• FDA' s Antidotes
• Europe Lagging Behind in Drug Approvals
• Table 5: Multiple Myeloma Market in Europe (2006): Percentage Breakdown of Drugs Used in First Line Treatment - Melphalan, Thalidomide, Velcade, Doxorubicin, and Others (includes corresponding Graph/Chart)
• Table 6: Multiple Myeloma Market in Europe (2006): Percentage Breakdown of Drugs Used in Second Line Treatment - Melphalan, Thalidomide, Velcade, and Doxorubicin (includes corresponding Graph/Chart)
• Table 7: Multiple Myeloma Market in Europe (2006): Percentage Breakdown of Drugs Used in Third Line Treatment - Melphalan, Thalidomide, Velcade, Doxorubicin, and Others (includes corresponding Graph/Chart)
• Market Share Statistics
• Present Batting Order
• Table 8: US Market for Multiple Myeloma Therapeutics (2006): Percentage Breakdown of Revenues by Company - Celgene Corporation, Millennium Pharmaceuticals, Ortho-Biotech, and Others (includes corresponding Graph/Chart)
• Looking Through the Crystal Ball: Year 2013
• Table 9: US Market for Multiple Myeloma Therapeutics (2013P): Percentage Breakdown of Revenues by Company - Celgene Corporation, Millennium Pharmaceuticals Inc, Kosan Biosciences, Ortho Biotech, Ziopharm Oncology Inc and Others (includes corresponding Graph/Chart)
• Oncology and Hematology Market
• Table 10: Leading Players in the Oncology and Hematology Market in the US (2008E): Percentage Breakdown of Value Sales by Company - Amgen, Roche, Novartis, DNA, AstraZeneca, and Others (includes corresponding Graph/Chart)
• Drugs Approved & In Pipeline: A Review
• Multiple Myeloma Drugs Approved by the FDA As of the Year 2008
• Multiple Myeloma Drugs in Pipeline in the US As of the Year 2008
• Phase III Drugs in Pipeline
• Phase II Drugs in Pipeline
• Phase I Drugs in Pipeline
• Key Non-Profit Organizations in the US
• Multiple Myeloma Research Foundation (MMRF)
• National Coalition for Cancer Survivorship (NCCS)
• National Marrow Donor Program (NMDP)
• Oregon Health and Science University Cancer Institute

2. Disease & Treatment Overview

• Cancer: A Definition
• Hematological Cancers
• Types of Hematological Cancer
• Multiple Myeloma
• Multiple Myeloma Stages
• Stage I
• Stage II/III
• Treatment Procedures
• Diagnosis
• Treatment
• Initial Treatment Regimen
• Induction Therapy for SCT Candidates
• Induction Therapy for Non-SCT Candidates
• Therapy for Relapsed or Refractory Myeloma
• Maintenance Therapy for Relapsed or Refractory Myeloma
• Treatment Pros & Cons
• Others Types of Hematological Cancers
• Leukemia
• Acute Lymphocytic Leukemia
• Chronic Lymphocytic Leukemia
• Acute Myeloid Leukemia
• Chronic Myeloid Leukemia
• Lymphoma
• Non-Hodgkin' s Lymphoma
• Hodgkin' s Lymphoma
• Myelodysplastic Syndromes
• Hematological Cancer Therapies
• Chemotherapy
• Radiation Therapy
• Stem Cell Transplants
• Biological Therapy
• Targeted Therapy
• Gene Therapy
• Immunotherapy
• Monoclonal Antibody Treatment
• Vaccines
• Donor Lymphocyte Infusion
• Hematological Cancer Drug Classes
• Hypomethylating Agents & Antimetabolites
• Bisphosphonates
• Alkylating Agents and DNA-Damaging Agents
• DNA-Repair Enzyme Inhibitors
• Histone Deacetylase Inhibitor
• Immunomodulators
• Proteasome Inhibitor
• Tyrosine Kinase Inhibitors

3. Clinical Trials and Drug Approvals

• NICE Grants Approval for Use of Revlimid(r)
• SWOG Announces Closure of Phase III Trial (S0232) for Paitents with Multiple Myeloma
• Fujimoto Pharmaceutical Receives Approval to Market Thalidomide
• Celgene Obtains Health Canada Approval for Revlimid Oral Cancer Drug
• FDA Grants Orphan-Drug Designation to Melphalan
• Merck Commences Phase II-b and Phase III Clinical Trial of Zolinza
• Clavis Initiates Phase II Trial of Elacytarabine
• Gilead Sciences Commences GS 9219 Phase I Clinical Trial
• AstraZeneca Carries Out AZD 0530 Phase II trial
• European Commission Grants Approval of Thalidomide for Multiple Myeloma
• EMEA Issues Positive Opinion for Thalidomide Use in Multiple Myeloma
• Global Regulatory Developments for the Use of Revlimid(r) in Multiple Myeloma
• Takeda Gains FDA Approval to Promote Velcade
• Health Canada Approves VELCADE
• Genzyme Receives FDA Certification for Mozobil
• Celgene' s Thalidomide Pharmion Receives Marketing Authorization
• Ziopharm Commences Phase II Clinical Trial of ZIO-101
• FDA Approves Pluristem' s Pre-IND Application of PLX-I
• Merck Pharmaceuticals Commences Phase I Study for R763 Kinase Inhibitor
• Swissmedic Approves Celgene' s REVLIMID Oral Cancer Drug
• Celgene' s REVLIMID Receives EU' s Marketing Authorization
• FDA Approves Application of Piramal' s IND-P276 Multiple Myeloma Drug
• Millennium Pharmaceuticals and Johnson & Johnson Initiate Velcade(r) Phase II Trial
• FDA to Consider the New Drug Application Filed for Use of Doxil(r) Combined with Velcade(r) in Patients with Multiple Myeloma
• Ortho Biotech Files Application with FDA for Approval of Combination Drug DOXIL(r) and VELCADE(r)
• Caraco' s Allopurinol Receives FDA Approval
• FDA Approves Thalomid(r) as Combination Therapy for Multiple Myeloma
• Revlimid(r) Obtains Regulatory Approval for the Treatment of Multiple Myeloma
• LymphoSign Inc. Announces Successful Completion of LS104 Drug' s Pre-Clinical Testing
• Seattle Genetics Commences SGN-40 Phase I Clinical Trial
• FDA Approves Use of Revlimid(r) for Multiple Myeloma
• US FDA Approves Use of Thalidomide for Multiple Myeloma
• Ziopharm Oncology Receives Approval to Commence ZIO-101 and ZIO-201 Trial
• FDA Grants Approval for Use of VELCADE(r) for Patients with Mantle Cell Lymphoma

4. Recent Industry Activity

• CytRx to Acquire Innovive
• Launch of Epoetin alfa Hexal
• PDL and Bristol-Myers Signs Agreement
• MNKD and LLS Conclude Joint Research Agreement
• MorphoSys and DSM Enter into Agreement
• StemCyte Enters into Joint Venture with Cadila and Apollo Hospitals in India
• ImmunoCellular Acquires Molecular Antibody Technology
• US House of Representatives Sanction the Hematological Cancer Research Investment and Education Act
• Bayer and Cell Therapeutics Enter into Mutual Agreement
• Bristol-Myers to Take Over Kosan Biosciences
• Bristol and PDL BioPharma Enter into Agreement
• Gamida Cell Enters Into a Agreement with Amgen
• Circadian Acquires Complete Stake in Vegenics
• Takeda Acquires Millennium Pharmaceuticals
• GlaxoSmithKline Forms Alliance with OncoMed for Developing Cancer Therapeutics
• Cyclacel Signs Agreement to Acquire ALIGN Pharmaceuticals
• Biogen and Genentech to Jointly Develop and Commercialize New Blood Cancer Drug
• Aegera Therapeutics Acquires LymphoSign Inc
• Velcade Gains Subsidy
• Inex Pharmaceuticals Spins Off Biotechnology Business into Tekmira Pharmaceuticals
• MilleGen Enters into Collaboration with LFB
• Access Pharmaceuticals to Acquire Somanta
• TopoTarget to Acquire Apoxis SA
• Genentech Inks Exclusive Global Licensing Agreement with Seattle Genetics
• Celgene Agrees to Acquisition of Pharmion
• PerkinElmer Plans Acquisition of ViaCell
• Favrille Announces Acquisition of Monoclonal Antibody Range from Diversa
• Johnson & Johnson Secures Contract worth US$112 Million
• Bioniche Pharma to Acquire Branded Pharmaceutical from Nabi Biopharmaceuticals
• Takara Bio' s RetroNect Used for Clinical Trials of Gene Therapy in Australia
• Millennium Pharmaceuticals to Take Over AnorMED
• MDS Pharma Services Becomes Recommended CRO for Multiple Myeloma Drug R&D
• Celgene Certifies McKesson Specialty to Launch Revlimid
• Medarex and PacMab to Co-Develop Blood Cancer Therapies
• Gamida Cell and Teva to Co-Develop Therapy for Hematological Malignancies
• GlaxoSmithKline to Take Over Praecis Pharmaceuticals
• Biotest Acquires ImmunoGen Anticancer Technology Rights
• Hana Signs Licensing Agreement with Inex
• Cephalon Acquires Zeneus

5. Focus on Select Players

• Amgen Inc (USA)
• Avalon Pharmaceuticals, Inc. (USA)
• Bristol-Myers Squibb Company (USA)
• Kosan Biosciences, Inc. (USA)
• Celgene Corporation (USA)
• F. Hoffmann-La Roche Ltd (Switzerland)
  • Genentech, Inc. (USA)
  • Genta Incorporated (USA)
  • Millennium Pharmaceuticals (USA)
  • Ortho Biotech Products, LP (USA)
  • Seattle Genetics (USA)
  • Ziopharm Oncology, Inc. (USA)

6. Market Perspective

• Table 11: US Recent Past, Current & Future Analysis for Multiple Myeloma Therapeutics by Drug - Thalomid, Revlimid, Velcade, and Others Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
• Table 12: US 10-Year Perspective for Multiple Myeloma Therapeutics by Drug - Percentage Breakdown of Dollar Sales for Thalomid, Revlimid, Velcade, and Others for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)
• Table 13: US Recent Past, Current & Future Analysis for Multiple Myeloma Therapeutics by Line of Treatment - Induction Therapy for SCT Candidates, Induction Therapy for Non-SCT Candidates, and Therapy for Relapsed or Refractory Myeloma Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
• Table 14: US 10-Year Perspective for Multiple Myeloma Therapeutics by Line of Treatment - Percentage Breakdown of Dollar Sales for Induction Therapy for SCT Candidates, Induction Therapy for Non-SCT Candidates, and Therapy for Relapsed or Refractory Myeloma for Years 2006, 2009 & 2015 (includes corresponding Graph/Chart)

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