Global Acute Myeloid Leukemia (AML) Therapeutics Industry

  • July 2012
  • -
  • Global Industry Analysts
  • -
  • 486 pages

This report analyzes the worldwide markets for Acute Myeloid Leukemia (AML) Therapeutics in US$ Million. The report provides separate comprehensive analytics for the US, Japan, Europe, and Rest of World. European market for AML Therapeutics is further analyzed by the following countries/regions - France, Germany, Italy, UK, and Rest of Europe. Annual estimates and forecasts are provided for the period 2009 through 2018. The report profiles 68 companies including many key and niche players such as Ambit Biosciences Inc., Aprea AB, Astellas Pharma Inc., Astex Pharmaceuticals, Inc., Bio-Path Holdings, Inc., BioSante Pharmaceuticals, Inc., Celator Pharmaceuticals, Inc., Celgene Corp., Clavis Pharma ASA, Cyclacel Pharmaceuticals, Inc., EpiCept Corp., Genzyme Corporation, Lorus Therapeutics, Inc., Novartis AG, Onconova Therapeutics, Inc., and Sunesis Pharmaceuticals, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

Table Of Contents





I. INTRODUCTION, METHODOLOGY and PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation and Reporting Level I-2
Quantitative Techniques and Analytics I-3
Product Definitions and Scope of Study I-3


II. EXECUTIVE SUMMARY

1. GLOBAL MARKET OVERVIEW II-1
Acute Myeloid Leukemia (AML): A Disease, Predominantly of the
Elderly II-1
Market Outlook II-1
Noteworthy Growth Drivers/Trends and Issues II-2
Growing Aging Population - A Major Driver II-2
Opportunity Indicator II-3
Table 1: 2011 Global Population Statistics for the 65+ Age
Group II-3
High Unmet Needs Characterize the AML Market II-3
High Relapse Rates Demand Immediate Attention II-4
Influence of Cytogentics Increasing in AML Treatment II-4
Orphan Drug and Fast Track Designations Provide Impetus for
AML Therapeutics II-4
Select AML Drugs Awarded Orphan Drug/Fast Track Designation II-5
Robust Pipeline of AML Therapeutics to Spur Market Growth II-5
Select AML Drugs in Phase III Clinical Trials II-6
Select AML Drugs in Phase II Clinical Trials II-6
Select AML Drugs in Phase I Clinical Trials II-7
Pediatric AML: Focus Increasing II-7
Future Refinements to aid in Increasing Adoption of HSCT II-8
Reduced-Intensity Allogeneic Transplant: An Underutilized
Procedure with Potential II-8
New Combination Therapies Gaining Ground II-8
Targeted Therapies: Momentum Continues II-9
Failed Drug Targets Slowdown the Growth Prospects II-9
Select AML Drugs Failing to Make a Mark II-10
Will the Second Chance Hold Good for Mylotarg? II-10
Epigenetic Therapeutics: New Treatment on the Block for AML II-11
Will Vaccines Prove to be a Breakthrough for AML Treatment? II-11
Can the Success of APL Treatments be Duplicated for Other Sub
Types of AML? II-11

2. SELECT APPROVED AND POTENTIAL AML DRUGS II-12
Ceplene and Vidaza - The Approved Drugs II-12
Ceplene (EpiCept) II-12
VIDAZA (Celgene Corp) II-12
A Review of Select Aml Drugs under Development II-12
AKN-028 (Akinion Pharmaceuticals) II-12
ALT-801 (Altor Bioscience Corporation) II-13
Quizartinib (Ambit/Astellas) II-13
APR-246 (Aprea AB) II-13
Dacogen (Astex Pharmaceuticals/Eisai) II-13
SGI-110 (Astex Pharmaceuticals, Inc.) II-13
BP-100-1.01 (Liposomal Grb-2) (Bio-Path Holdings, Inc) II-14
GVAX AML (BioSante Pharmaceuticals, Inc.) II-14
Volasertib or BI 6727 (Boehringer Ingelheim GmbH) II-14
CPX-351 (Celator Pharmaceuticals, Inc) II-14
Tosedostat (formerly CHR-2797) (Chroma Therapeutics Ltd) II-15
Elacytarabine (CP-4055) (Clavis Pharma ASA) II-15
Sapacitabine (Cyclacel) II-15
Aezea (Cenersen) (Eleos, Inc) II-16
Clolar (Genzyme/Sanofi) II-16
IPH2102 (Innate Pharma S.A) II-16
LOR-2040 (Lorus Therapeutics, Inc.) II-16
Midostaurin (Novartis) II-17
Panobinostat (Novartis) II-17
PR104 (Proacta, Inc.) II-17
SB1317 (S*BIO Pte Ltd) II-17
Vosaroxin (Sunesis Pharmaceuticals, Inc.) II-17
ONCOHIST (SymbioTec GmbH) II-18
Elesclomol (Synta Pharmaceuticals, Inc.) II-18
MLN8237 (Takeda Pharmaceuticals Co., Ltd) II-18

3. ACUTE MYELOID LEUKEMIA - THE DISEASE, EPIMEDIOLOGY, ETIOLOGY,
SYMPTOMS, AND DIAGNOSIS II-19
Understanding the Bone Marrow, and the Blood Cells II-19
Blood Cells II-19
White Cells II-19
Red Cells II-19
Platelets II-20
Cancer - The Deadly Disease II-20
Leukemia - A Disease of the Bone Marrow II-20
Acute Leukemia II-20
Chronic Leukemia II-21
History II-21
Cancer Incidence - Statistics on New Cases II-22
Table 2: Global Cancer Incidence by Region: 2009 (includes
corresponding Graph/Chart) II-22

Table 3: Global Cancer Incidence by Income Group: 2009
(includes corresponding Graph/Chart) II-22

Table 4: Cancer Incidence in Upper Middle Income Countries by
Site: 2009 (includes corresponding Graph/Chart) II-23

Table 5: Cancer Incidence in Lower Middle Income Countries by
Site: 2009 (includes corresponding Graph/Chart) II-24

Table 6: Cancer Incidence in High Income Countries by Site:
2009 (includes corresponding Graph/Chart) II-25
Acute Myeloid Leukemia II-26
Acute Myeloid Leukemia (AML) Types II-26
The FAB Classification of AML II-26
WHO AML Classification II-27
AML with Certain Genetic Abnormalities II-27
AML with Multilineage Dysplasia II-27
AML Related to Previous Chemotherapy or Radiation II-27
AML Not Otherwise Specified II-27
Undifferentiated or Biphenotypic Acute Leukemias II-28
Epidemiology II-28
Etiology of AML II-28
Chemicals II-28
Radiation II-28
Smoking II-28
Pre-existing Blood Disorders II-28
Genetic Factors II-29
AML Symptoms II-29
Increased Bruising or Bleeding II-29
Repeated or Frequent Infection II-29
Anemia II-29
AML Diagnosis II-29
Full Blood Count II-29
Bone Marrow Examination II-29
Other Tests II-30

4. TREATMENT OVERVIEW II-31
Chemotherapy - The First-Line Treatment for AML II-31
Induction Therapy II-31
Post Remission or Consolidation Therapy II-32
Hematopoietic Stem Cell Transplantation II-32
Treatment for Relapsed AML II-32
Maintenance II-32
Side-Effects of AML Treatment II-32
Effects on Bone Marrow, Platelets, Red Cells, and White Cells II-33
Other Common Side-Effects II-33
Changes in Smell and Taste II-33
Vomiting and Nausea II-33
Changes in Bowel II-34
Mucositis II-34
Loss of Hair II-34
Loss in Fertility II-34
Early Menopause II-34
Fatigue II-34
Body Image II-35
Therapies to Complement AML Medical Treatment II-35

5. FDA AND OTHER REGULATORY APPROVALS II-36
Sunesis Pharmaceuticals Secures Orphan Drug Designation for
Vosaroxin in EU II-36
Cyclacel Pharmaceuticals Receives US Patent for Sapacitabine II-36
Celator Pharmaceuticals Receives US Patent for CPX-351 II-36
Abbott Laboratories Receives US FDA Clearance for Vysis EGR1
FISH Probe Kit II-37
Sunesis Pharmaceuticals Secures US FDA Fast Track Designation
for Vosaroxin in Treating AML II-37
US Patent and Trademark Office Approves New Patent for LOR-
2040 Cancer Drug by Lorus Therapeutics II-37
Sunesis Pharmaceuticals Secures European Patent for Vosaroxin
Formulation II-38
EpiCept Files for Marketing Approval of Ceplene in US II-38
EntreMed’s ENMD-2076 Obtains Orphan Drug Designation II-38
Clavis Pharma Obtains Fast Track Designation for Elacytarabine
by US FDA II-39
EpiCept Corp. Launches Ceplene for AML in the UK II-39
EpiCept Obtains Marketing Approval for Ceplene in Israel II-39
Celgene Obtains Approval for VIDAZA from Health Canada II-39
Gamida Cell-TEVA JV Obtains Orphan Drug Designation for StemEx
from European Commission II-39
Critical Outcome Technologies Obtains US Patent for AML Therapy II-40

6. SELECT CLINICAL TRIALS II-41
Akinion Pharmaceuticals Initiates Phase I/II Clinical Study of
AKN-028 II-41
Celgene International Completes Phase I Study of Oral Azacitidine II-41
Aprea Conducts Phase I/II Study of APR-246 II-41
Astellas Pharma and Ambit Biosciences Conduct Interim Results
from Phase II Study of AC220 II-41
OXiGENE Publishes Preclinical Data on OXi4503 II-42
Pfizer’s Mylotarg Fails second Phase III Trial in AML Treatment II-42

7. RECENT INDUSTRY ACTIVITY II-43
Cyclacel and Daiichi-Sankyo Amends License Agreement for
Sapacitabine Drug II-43
Bristol-Myers Squibb Signs Worldwide License Contract with
Innate Pharma II-43
Cell Therapeutics Signs Co-Development cum Licensing Deal with
Chroma Therapeutics for Tosedostat II-43
Supergen Enters into Merger Agreement with Astex Therapeutics II-44
Celator® Pharmaceuticals Extends Research Agreement with Cephalon II-44
Skyline Diagnostics and TrovaGene Enter into Agreement II-45
EpiCept and MEDA Ink Agreement II-45
Astellas Acquires Development and Sale Rights for AC220
Leukemia Drug of Ambit Biosciences II-45
Biovitrum and Karolinska Development to Establish Joint Venture II-46
Ambit Biosciences Enters into Partnership with Astellas Pharma II-46
ChemGenex Pharmaceuticals Inks Deal with Hospira II-47
Celator Pharmaceuticals Enters into Partnership with Leukemia
and Lymphoma Society II-47
Genzyme Signs Agreement with Bayer II-47
Tragara Pharmaceuticals and S*BIO Ink Licensing Agreement II-48

8. FOCUS ON SELECT KEY PLAYERS II-49
Ambit Biosciences Inc. (US) II-49
Aprea AB (Sweden) II-49
Astellas Pharma Inc. (Japan) II-49
Astex Pharmaceuticals, Inc. (US) II-49
Bio-Path Holdings, Inc. (US) II-50
BioSante Pharmaceuticals, Inc. (US) II-50
Celator Pharmaceuticals, Inc. (US) II-50
Celgene Corp. (US) II-51
Clavis Pharma ASA (Norway) II-51
Cyclacel Pharmaceuticals, Inc. (US) II-51
EpiCept Corp. (US) II-52
Genzyme Corporation (US) II-52
Lorus Therapeutics, Inc. (Canada) II-52
Novartis AG (Switzerland) II-53
Onconova Therapeutics, Inc. (US) II-53
Sunesis Pharmaceuticals, Inc. (US) II-53

9. GLOBAL MARKET PERSPECTIVE II-55
Table 7: World Recent Past, Current and Future Analysis for
Acute Myeloid Leukemia Therapeutics by Geographic Region - US,
Japan, Europe, and Rest of World Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2009 through 2018 (includes corresponding Graph/Chart) II-55

Table 8: World 10-Year Perspective for Acute Myeloid Leukemia
Therapeutics by Geographic Region - Percentage Breakdown of
Dollar Sales for US, Japan, Europe, and Rest of World Markets
for Years 2009, 2012 and 2018 (includes corresponding
Graph/Chart) II-56


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Overview III-1
Select AML Drugs Awarded Orphan Drug Designation in the US III-1
Select AML Drugs Awarded Fast Track Designation in the US III-2
Statistical Findings III-2
Table 9: US Market for Hospital Cancer Therapies (2004 and
2010): Percentage (include corresponding Graph/Chart) III-2
US Leukemia Statistics III-3
Leukemia Incidence Statistics III-3
Table 10: Leukemia Cases in the US (2011): Percentage
Share Breakdown of New Cases by Site (includes
corresponding Graph/Chart) III-3

Table 11: Leukemia Cases in the US by Affected Site: 2009
(includes corresponding Graph/Chart) III-3

Table 12: Leukemia Cases in the US by Affected Site: 2011
(includes corresponding Graph/Chart) III-4
Leukemia Mortality Statistics III-4
Table 13: Leukemia Related Deaths in the US By Affected
Site: 2009 (includes corresponding Graph/Chart) III-4

Table 14: Leukemia Related Deaths in the US By Affected
Site: 2011 (includes corresponding Graph/Chart) III-5
Regulatory Approvals/Patents III-5
Select Clinical Trials III-8
Strategic Corporate Initiatives III-9
Focus on Select Major Players III-12
B.Market Analytics III-16
Table 15: The US Recent Past, Current and Future Analysis
for Acute Myeloid Leukemia Therapeutics Analyzed with Annual
Sales Figures in US$ Million for Years 2009 through 2018
(includes corresponding Graph/Chart) III-16

2. JAPAN III-17
A.Market Analysis III-17
Current and Future Analysis III-17
Strategic Corporate Developments III-17
Astellas Pharma Inc - A Major Player III-18
B.Market Analytics III-18
Table 16: Japanese Recent Past, Current and Future Analysis
for Acute Myeloid Leukemia Therapeutics Analyzed with Annual
Sales Figures in US$ Million for Years 2009 through 2018
(includes corresponding Graph/Chart) III-18

3. EUROPE III-19
A.Market Analysis III-19
Overview III-19
Select AML Drugs Awarded Orphan Drug Designation in Europe III-19
Current and Future Analysis III-19
Statistics III-20
Table 17: European Population Statistics for the 65+ Age
Group: 2011 III-20

Table 18: Cancer Incidence in Europe by Site (2009)
(includes corresponding Graph/Chart) III-21
Regulatory Approvals/Patents III-21
Select Clinical Trails III-23
Strategic Corporate Developments III-24
Focus on Select Major Players III-26
B.Market Analytics III-27
Table 19: European Recent Past, Current and Future Analysis
for Acute Myeloid Leukemia Therapeutics Market by
Country/Region Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2009 through 2018 (includes
corresponding Graph/Chart) III-27

Table 20: European 10-Year Perspective for Acute Myeloid
Leukemia Therapeutics by Country/Region - Percentage
Breakdown of Dollar Sales for France, Germany, Italy, UK,
and Rest of Europe Markets for Years 2009, 2012 and 2018
(includes corresponding Graph/Chart) III-28

3a. FRANCE III-29
Market Analysis III-29
Table 21: French Recent Past, Current and Future Analysis
for Acute Myeloid Leukemia Therapeutics with Annual Sales
Figures in US$ Million for Years 2009 through 2018 (includes
corresponding Graph/Chart) III-29

3b. GERMANY III-30
Market Analysis III-30
Table 22: German Recent Past, Current and Future Analysis
for Acute Myeloid Leukemia Therapeutics with Annual Sales
Figures in US$ Million for Years 2009 through 2018 (includes
corresponding Graph/Chart) III-30

3c. ITALY III-31
Market Analysis III-31
Table 23: Italian Recent Past, Current and Future Analysis
for Acute Myeloid Leukemia Therapeutics with Annual Sales
Figures in US$ Million for Years 2009 through 2018 (includes
corresponding Graph/Chart) III-31

3d. THE UNITED KINGDOM III-32
Market Analysis III-32
Table 24: UK Recent Past, Current and Future Analysis for
Acute Myeloid Leukemia Therapeutics with Annual Sales
Figures in US$ Million for Years 2009 through 2018 (includes
corresponding Graph/Chart) III-32

3e. REST OF EUROPE III-33
Market Analysis III-33
Table 25: Rest of Europe Recent Past, Current and Future
Analysis for Acute Myeloid Leukemia Therapeutics with Annual
Sales Figures in US$ Million for Years 2009 through 2018
(includes corresponding Graph/Chart) III-33

4. REST OF WORLD III-34
A.Market Analysis III-34
Current and Future Analysis III-34
Regional Market Overview III-34
Australia III-34
Incidence Rates III-34
Canada III-34
Table 26: Estimated New Cancer Cases by Type/Site Among
Canadian Men: 2010 (includes corresponding Graph/Chart) III-34

Table 27: Estimated New Cancer Cases by Type/Site Among
Canadian Women: 2010 (includes corresponding Graph/Chart) III-35

Table 28: Estimated Cancer Deaths by Type/Site Among
Canadian Men: 2010 (includes corresponding Graph/Chart) III-35

Table 29: Estimated Cancer Deaths by Type/Site Among
Canadian Women: 2010 (includes corresponding Graph/Chart) III-36
Asia III-37
Table 30: Cancer Incidence in Asia-Oceania by Site: 2009
(includes corresponding Graph/Chart) III-37
Regulatory Approvals III-38
Strategic Corporate Developments III-38
Lorus therapeutics, Inc. (Canada) - A Key Player III-39
B.Market Analytics III-40
Table 31: Rest of World Recent Past, Current and Future
Analysis for Acute Myeloid Leukemia Therapeutics Analyzed
with Annual Sales Figures in US$ Million for Years 2009
through 2018 (includes corresponding Graph/Chart) III-40


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 68 (including Divisions/Subsidiaries - 74)

The United States (42)
Canada (5)
Japan (4)
Europe (20)
- France (3)
- Germany (2)
- The United Kingdom (5)
- Spain (1)
- Rest of Europe (9)
Asia-Pacific (Excluding Japan) (1)
Middle East (2)

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