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This report analyzes the US market for Multiple Myeloma Therapeutics in Millions of US$. The market for multiple myeloma therapeutics is analyzed by the following Drugs: Thalomid, Revlimid, Velcade, and Others. The market for multiple myeloma therapeutics is also analyzed by the Lines of Treatment - Induction Therapy for SCT Candidates, Induction Therapy for Non-SCT Candidates, and Therapy for Relapsed or Refractory Myeloma. Annual forecasts are provided for the period of 2006 through 2015. The report profiles 98 companies including many key and niche players such as Amgen Inc., Avalon Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Kosan Biosciences, Inc., Celgene Corporation, F. Hoffmann-La Roche Ltd, Genentech, Inc., Genta Incorporated, Millennium Pharmaceuticals, Ortho Biotech Products, LP, Seattle Genetics, and Ziopharm Oncology, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.
TABLE OF CONTENTS
MULTIPLE MYELOMA THERAPEUTICS
A US MARKET REPORT MCP-1857
CONTENTS
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
II. A US MARKET REPORT
1. Industry Overview II-1
Hematological Cancer Therapies: A Prelude II-1
Treatment Regimes: The Golden Rule II-1
Multiple Myeloma: A Second Most Common Hematological Cancer II-2
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) II-3
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) II-3
Table 3: Multiple Myeloma Statistics in the US (2008E):
Number of Persons Undergoing Initial Diagnosis and Monitoring
(includes corresponding Graph/Chart) II-4
Treatment Therapies: Move Up the Learning Curve II-4
Risk-Adapted Therapy: The New Norm of Future Treatment II-5
New Generation Drugs in the Arsenal Against Multiple Myeloma II-5
Velcade® (Bortezomib) II-5
Thalomid® (Thalidomide) II-5
Revlimid® (Lenalidomide) II-6
Alkeran (Melphalan) II-6
Doxil (Liposomal Doxorubicin) II-6
Trisenox® (Arsenic trioxide) II-6
Noteworthy Issues Related to Major Drugs: An Evaluation of
Pros and Cons II-7
Revlimid Overtakes Thalomid: Why? II-7
How Effective Will Thalomid Be in the 3rd Line Setting?
Skepticism Overflows II-7
Revlimid Impedes Stem Cell Harvesting!!: What’s the Truth? II-7
1st & 2nd Generation Geldanamycin Analog to Do Wonders for
Myeloma Treatment II-8
Other Trends & Issues II-8
Approval of New Generation Drugs Push the Market Into the
Bulge Bracket II-8
Growth Fundamentals Get Stronger II-8
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) II-9
Multidrug Resistance: A Challenge to Reckon With II-9
Gene Therapy Exudes Hope II-9
Challenges Encountered in Clinical Trials II-10
FDA’s Antidotes II-10
Europe Lagging Behind in Drug Approvals II-11
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) II-11
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) II-11
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) II-12
Market Share Statistics II-12
Present Batting Order II-12
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) II-12
Looking Through the Crystal Ball: Year 2013 II-12
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) II-12
Oncology and Hematology Market II-13
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) II-13
Drugs Approved & In Pipeline: A Review II-13
Multiple Myeloma Drugs Approved by the FDA As of the Year 2008 II-13
Multiple Myeloma Drugs in Pipeline in the US As of the Year
2008 II-14
Phase III Drugs in Pipeline II-14
Phase II Drugs in Pipeline II-15
Phase I Drugs in Pipeline II-21
Key Non-Profit Organizations in the US II-25
Multiple Myeloma Research Foundation (MMRF) II-25
National Coalition for Cancer Survivorship (NCCS) II-25
National Marrow Donor Program (NMDP) II-25
Oregon Health and Science University Cancer Institute II-25
2. Disease & Treatment Overview II-26
Cancer: A Definition II-26
Hematological Cancers II-26
Types of Hematological Cancer II-26
Multiple Myeloma II-26
Multiple Myeloma Stages II-27
Stage I II-27
Stage II/III II-27
Treatment Procedures II-27
Diagnosis II-27
Treatment II-28
Initial Treatment Regimen II-28
Induction Therapy for SCT Candidates II-28
Induction Therapy for Non-SCT Candidates II-29
Therapy for Relapsed or Refractory Myeloma II-29
Maintenance Therapy for Relapsed or Refractory Myeloma II-29
Treatment Pros & Cons II-29
Others Types of Hematological Cancers II-30
Leukemia II-30
Acute Lymphocytic Leukemia II-30
Chronic Lymphocytic Leukemia II-31
Acute Myeloid Leukemia II-31
Chronic Myeloid Leukemia II-31
Lymphoma II-31
Non-Hodgkin’s Lymphoma II-32
Hodgkin’s Lymphoma II-32
Myelodysplastic Syndromes II-32
Hematological Cancer Therapies II-33
Chemotherapy II-33
Radiation Therapy II-33
Stem Cell Transplants II-33
Biological Therapy II-34
Targeted Therapy II-34
Gene Therapy II-34
Immunotherapy II-34
Monoclonal Antibody Treatment II-35
Vaccines II-35
Donor Lymphocyte Infusion II-35
Hematological Cancer Drug Classes II-35
Hypomethylating Agents & Antimetabolites II-35
Bisphosphonates II-36
Alkylating Agents and DNA-Damaging Agents II-36
DNA-Repair Enzyme Inhibitors II-36
Histone Deacetylase Inhibitor II-36
Immunomodulators II-36
Proteasome Inhibitor II-36
Tyrosine Kinase Inhibitors II-36
3. Clinical Trials and Drug Approvals II-37
NICE Grants Approval for Use of Revlimid® II-37
SWOG Announces Closure of Phase III Trial (S0232) for Paitents
with Multiple Myeloma II-37
Fujimoto Pharmaceutical Receives Approval to Market Thalidomide II-37
Celgene Obtains Health Canada Approval for Revlimid Oral
Cancer Drug II-37
FDA Grants Orphan-Drug Designation to Melphalan II-38
Merck Commences Phase II-b and Phase III Clinical Trial of
Zolinza II-38
Clavis Initiates Phase II Trial of Elacytarabine II-38
Gilead Sciences Commences GS 9219 Phase I Clinical Trial II-38
AstraZeneca Carries Out AZD 0530 Phase II trial II-39
European Commission Grants Approval of Thalidomide for
Multiple Myeloma II-39
EMEA Issues Positive Opinion for Thalidomide Use in Multiple
Myeloma II-39
Global Regulatory Developments for the Use of Revlimid® in
Multiple Myeloma II-39
Takeda Gains FDA Approval to Promote Velcade II-40
Health Canada Approves VELCADE II-40
Genzyme Receives FDA Certification for Mozobil II-40
Celgene’s Thalidomide Pharmion Receives Marketing Authorization II-41
Ziopharm Commences Phase II Clinical Trial of ZIO-101 II-41
FDA Approves Pluristem’s Pre-IND Application of PLX-I II-41
Merck Pharmaceuticals Commences Phase I Study for R763 Kinase
Inhibitor II-41
Swissmedic Approves Celgene’s REVLIMID Oral Cancer Drug II-42
Celgene’s REVLIMID Receives EU’s Marketing Authorization II-42
FDA Approves Application of Piramal’s IND-P276 Multiple
Myeloma Drug II-42
Millennium Pharmaceuticals and Johnson & Johnson Initiate
Velcade® Phase II Trial II-42
FDA to Consider the New Drug Application Filed for Use of
Doxil® Combined with Velcade® in Patients with Multiple
Myeloma II-42
Ortho Biotech Files Application with FDA for Approval of
Combination Drug DOXIL® and VELCADE® II-43
Caraco’s Allopurinol Receives FDA Approval II-43
FDA Approves Thalomid® as Combination Therapy for Multiple
Myeloma II-43
Revlimid® Obtains Regulatory Approval for the Treatment of
Multiple Myeloma II-43
LymphoSign Inc. Announces Successful Completion of LS104
Drug’s Pre-Clinical Testing II-43
Seattle Genetics Commences SGN-40 Phase I Clinical Trial II-44
FDA Approves Use of Revlimid® for Multiple Myeloma II-44
US FDA Approves Use of Thalidomide for Multiple Myeloma II-44
Ziopharm Oncology Receives Approval to Commence ZIO-101 and
ZIO-201 Trial II-44
FDA Grants Approval for Use of VELCADE® for Patients with
Mantle Cell Lymphoma II-44
4. Recent Industry Activity II-45
CytRx to Acquire Innovive II-45
Launch of Epoetin alfa Hexal II-45
PDL and Bristol-Myers Signs Agreement II-45
MNKD and LLS Conclude Joint Research Agreement II-45
MorphoSys and DSM Enter into Agreement II-46
StemCyte Enters into Joint Venture with Cadila and Apollo
Hospitals in India II-46
ImmunoCellular Acquires Molecular Antibody Technology II-46
US House of Representatives Sanction the Hematological Cancer
Research Investment and Education Act II-46
Bayer and Cell Therapeutics Enter into Mutual Agreement II-47
Bristol-Myers to Take Over Kosan Biosciences II-47
Bristol and PDL BioPharma Enter into Agreement II-47
Gamida Cell Enters Into a Agreement with Amgen II-47
Circadian Acquires Complete Stake in Vegenics II-48
Takeda Acquires Millennium Pharmaceuticals II-48
GlaxoSmithKline Forms Alliance with OncoMed for Developing
Cancer Therapeutics II-48
Cyclacel Signs Agreement to Acquire ALIGN Pharmaceuticals II-49
Biogen and Genentech to Jointly Develop and Commercialize New
Blood Cancer Drug II-49
Aegera Therapeutics Acquires LymphoSign Inc II-49
Velcade Gains Subsidy II-50
Inex Pharmaceuticals Spins Off Biotechnology Business into
Tekmira Pharmaceuticals II-50
MilleGen Enters into Collaboration with LFB II-50
Access Pharmaceuticals to Acquire Somanta II-50
TopoTarget to Acquire Apoxis SA II-51
Genentech Inks Exclusive Global Licensing Agreement with
Seattle Genetics II-51
Celgene Agrees to Acquisition of Pharmion II-51
PerkinElmer Plans Acquisition of ViaCell II-51
Favrille Announces Acquisition of Monoclonal Antibody Range
from Diversa II-52
Johnson & Johnson Secures Contract worth US$112 Million II-52
Bioniche Pharma to Acquire Branded Pharmaceutical from Nabi
Biopharmaceuticals II-52
Takara Bio's RetroNect Used for Clinical Trials of Gene
Therapy in Australia II-52
Millennium Pharmaceuticals to Take Over AnorMED II-53
MDS Pharma Services Becomes Recommended CRO for Multiple
Myeloma Drug R&D II-53
Celgene Certifies McKesson Specialty to Launch Revlimid II-53
Medarex and PacMab to Co-Develop Blood Cancer Therapies II-53
Gamida Cell and Teva to Co-Develop Therapy for Hematological
Malignancies II-54
GlaxoSmithKline to Take Over Praecis Pharmaceuticals II-54
Biotest Acquires ImmunoGen Anticancer Technology Rights II-54
Hana Signs Licensing Agreement with Inex II-54
Cephalon Acquires Zeneus II-54
5. Focus on Select Players II-55
Amgen Inc (USA) II-55
Avalon Pharmaceuticals, Inc. (USA) II-55
Bristol-Myers Squibb Company (USA) II-55
Kosan Biosciences, Inc. (USA) II-55
Celgene Corporation (USA) II-56
F. Hoffmann-La Roche Ltd (Switzerland) II-56
Genentech, Inc. (USA) II-56
Genta Incorporated (USA) II-56
Millennium Pharmaceuticals (USA) II-57
Ortho Biotech Products, LP (USA) II-57
Seattle Genetics (USA) II-57
Ziopharm Oncology, Inc. (USA) II-57
6. Market Perspective II-59
Table 11: US Recent Past, Current & Future Analysis for
Multiple Myeloma Therapeutics by Drug - Thalomid, Revlimid,
Velcade, and Others Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2006 through 2015 (includes
corresponding Graph/Chart) II-59
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) II-59
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) II-60
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) II-60
III. COMPETITIVE LANDSCAPE
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