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TO ORDER:Web: InsightPharmaReports.com
Phone: 781-972-5444
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E-mail: [email protected]
Mail: Cambridge Healthtech Institute Rose LaRaia 250 First Avenue, Suite 300 Needham, MA 02494
INSIGHT PHARMA REPORTS A Division of Cambridge Healthtech Institute250 First Avenue • Suite 300 • Needham, MA 02494 • 781-972-5444
Hematological Cancer Therapies:Pipelines, Markets, and Business Considerations
offer on our New Hematological Cancer Therapies Report!
SPECIAL 10%Discount
JUST RELEASED March 2012
Over 250 pages of market data, expert interviews, 16 tables, plus over 200 companies, including:
n Abbottn AstraZenecan Boehringer Ingelheimn Bristol-Myers Squibbn Eli Lillyn GlaxoSmithKlinen Novartisn Pfizern Rochen Sanofi
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INSIGHT PHARMA REPORTSA Division of Cambridge Healthtech Institute
250 First Avenue • Suite 300 • Needham, MA 02494 • 781-972-5444 • InsightPharmaReports.com
Hematological Cancer Therapies:Pipelines, Markets, and Business Considerations
Lucy J. Sannes, PhD, MBA recent years, newer and more specific therapies for hematological cancers have been developed, such as targeted small-molecule drugs and biological therapies including monoclonal antibodies. However,
there remains significant need from a clinical perspective, as well as challenges and opportunities for pharmaceutical companies. This report discusses:
•Thedifferenttypesofhematologicalcancers,includinginformationaboutthespecificdisease,itsepidemiology,subtypesand/orstagingifappropriate,currenttherapies,andpatientprognosis.
•Pipelinesofemergingdrugsfortreatmentofhematologicalcancersincludingleukemia,lymphoma,myeloma,myelodysplasticsyndromes,andmyeloproliferativediseases.
•Businessandstrategicconsiderationsrelatingtopharmacologicaltherapyforhematologicalcancers,includingassessmentofthecurrentmarketaswellaspotentialmarketsforemergingnewtherapies.
•Majorchallengesandhurdlesforcompaniesdevelopinghematologicalcancertherapies.
•Interviewswithexpertsinthefieldofhematologicalcancers,whichwereconductedexclusivelyforthisreport.
JUST RELEASEDMarch 2012
O V E R V I E W ABOUT THE AUTHOR
Hematological cancers arise from and are found in the blood, bone marrow, and lymphatic systems. The first hematological cancer to be identified was Hodgkin’s disease, or Hodgkin lymphoma, in 1832. Since that time, many different hematological cancers have been identified, including the various types of leukemia, lymphoma, and myeloma, plus the myelodysplastic syndromes and myeloproliferative diseases. Altogether, hematological cancers represent a significant medical problem: The American Cancer Society estimated that there would be 140,310 new cases of leukemia, lymphoma, and myeloma, combined, in the United States in 2011, and that 53,010 people would die of these diseases that year.
In this Insight Pharma Report, Hematological Cancer Therapies: Pipelines, Markets, and Business Considerations, we focus on the many different types of leukemia, lymphoma, and myeloma, and myelodysplastic syndromes and myeloproliferative diseases. Current pharmacological therapies that are used to treat these various hematological cancers are discussed. In addition, there is significant activity on the part of pharmaceutical companies to further develop a number of the currently available therapies for additional indications.
A primary focus of this Insight Pharma Report is on pipelines of emerging therapies in development for treatment of hematological cancers. Specifically, the clinical development pipelines for leukemia, lymphoma, myeloma, myelodysplastic syndromes, and myeloproliferative diseases are reviewed. Selected emerging therapies that are in Phase II or later stages of development are discussed in the text, while the extensive accompanying tables include these emerging therapies plus many additional earlier-stage therapies that are in development.
Despite the smaller number of patients who develop hematological cancers (compared to solid tumors and certain other, non-oncology markets), it is possible to develop and commercialize hematological cancer therapies that become blockbuster drugs (i.e., with sales exceeding $1 billion per year). Hematological Cancer Therapies: Pipelines, Markets, and Business Considerations reviews the current market for hematological cancer drugs and includes sales data for selected drugs. Also addressed are major challenges and hurdles, in addition to other strategic considerations such as personalized medicine, that companies in this market must address. Full transcripts of interviews with experts in the field of hematological cancers are included in this report.
Lucy J. Sannes, PhD, MBA, is president of Sannes &
Associates, a consulting firm specializing in evaluation
and management of the biosciences. Before forming
Sannes & Associates, she held management positions
at Genetic Systems and Abbott Laboratories in product development, product support, and
technical marketing. Dr. Sannes received her PhD in
biological chemistry from the University of Michigan and her MBA from Seattle
Pacific University.
SOURCE: Sannes & Associates, Inc.
ABOUT INSIGHT PHARMA REPORTS
CHI’s Insight Pharma Reports are written by experts who
collaborate with CHI to provide a series of reports that
evaluate the salient trends in pharmaceutical technology,
business, and therapy markets. Insight Pharma Reports are used
by senior decision makers at life sciences companies to keep abreast of the latest advances in pharmaceutical R&D, their
potential applications and business impacts. Our clients
include the top 50 pharmaceutical companies, top 100 biotechnology
companies, and top 100 vendors of life science products and
services. Typical purchasers are managers, directors, and VPs in
business development, discovery research, clinical develop ment,
strategic planning, portfolio management, new product
planning, and marketing.
INSIGHT PHARMA REPORTSA division of Cambridge Healthtech Institute
250 First Avenue • Suite 300 • Needham, MA 02494 • 781-972-5444 • InsightPharmaReports.com
TABLE OF CONTENTS
EXECUTIVE SUMMARY
CHAPTER 1 INTRODUCTION
1.1. Background1.2. Scope of the Report
CHAPTER 2 REVIEW OF HEMATOLOGICAL CANCERS (BLOOD CANCERS)
2.1. LeukemiaAcute Lymphocytic Leukemia (ALL)
Chronic Lymphocytic Leukemia (CLL)
Acute Myelogenous (Myeloid) Leukemia (AML)
Chronic Myelogenous (Myeloid) Leukemia (CML)
Other Types of Leukemia
2.2. LymphomaHodgkin’s Disease
Non-Hodgkin’s Lymphoma (NHL)
2.3. Myeloma2.4. Myelodysplastic Syndromes (MDS)2.5. Myeloproliferative Diseases
CHAPTER 3 CURRENT PHARMACOLOGICAL TREATMENT OPTIONS
3.1. LeukemiaAcute Lymphocytic Leukemia (ALL)
Chronic Lymphocytic Leukemia (CLL)
Acute Myelogenous (Myeloid) Leukemia (AML)
Chronic Myelogenous (Myeloid) Leukemia (CML)
Other Types of Leukemia
3.2. LymphomaHodgkin’s Disease
Non-Hodgkin’s Lymphoma (NHL)
3.3. Myeloma3.4. Myelodysplastic Syndromes (MDS)3.5. Myeloproliferative Diseases
CHAPTER 4 EMERGING THERAPIES FOR LEUKEMIA
4.1. Abbott’s and Genentech/Roche’s Navitoclax4.2. ARIAD Pharmaceuticals’ Ponatinib4.3. Astellas Pharma’s and Ambit Biosciences’
Quizartinib4.4. AstraZeneca’s AZD11524.5. BioCryst Pharmaceutical’s Forodesine4.6. Boehringer Ingelheim’s Volasertib4.7. Celator Pharmaceutical’s CPX-3514.8. Celgene’s REVLIMID4.9. Chroma Therapeutics’ and Cell Therapeutics’
Tosedostat4.10. Clavis Pharma’s Elacytarabine4.11. Cyclacel Pharmaceuticals’ Sapacitabine4.12. CytRx’ Bafetinib4.13. Eisai’s and Janssen-Cilag’s Dacogen4.14. EpiCept’s Ceplene4.15. Genzyme’s/Sanofi’s Clolar4.16. Gilead Sciences’ GS 1101
4.17. GlaxoSmithKline’s ARZERRA4.18. Medac GmbH’s Treosulfan4.19. Memgen’s ISF354.20. Micromet’s Blinatumomab4.21. Novartis’ Midostaurin4.22. Pfizer’s Bosutinib4.23. Roche’s RG7159 (Obinutuzumab)4.24. Sunesis Pharmaceuticals’ Vosaroxin4.25. Syndax Pharmaceuticals’ Entinostat4.26. Talon Therapeutics’ Marqibo
CHAPTER 5 EMERGING THERAPIES FOR LYMPHOMA
5.1. 4SC AG’s Resminostat5.2. Abbott’s and Genentech/Roche’s Navitoclax5.3. Allos Therapeutics’ Folotyn5.4. Astellas Pharma’s YM1555.5. BioCryst Pharmaceutical’s Forodesine5.6. Biovest International/Accentia
Biopharmaceuticals’ BiovaxID5.7. Celgene’s REVLIMID5.8. Cell Therapeutics’ Pixantrone5.9. Eli Lilly’s Enzastaurin5.10. Gilead Sciences’ GS 11015.11. GlaxoSmithKline’s ARZERRA5.12. Kyowa Hakko Kirin’s KW-07615.13. Memgen’s ISF355.14. Novartis’ Afinitor5.15. Novartis’ Panobinostat5.16. Pfizer’s Inotuzumab Ozogamicin5.17. Pharmacyclics’ PCI-327655.18. Plexxikon’s (and Daiichi Sankyo’s) PLX33975.19. Roche’s RG7159 (Obinutuzumab)5.20. Sanofi’s SAR2454095.21. Spectrum Pharmaceuticals’ and Topotarget’s
Belinostat5.22. Syndax Pharmaceuticals’ Entinostat5.23. Telik’s TELCYTA5.24. Teva Pharmaceutical Industries’ and CureTech’s
CT-011
CHAPTER 6 EMERGING THERAPIES FOR MYELOMA
6.1. Æterna Zentaris’ and Keryx Biopharmaceuticals’ Perifosine (KRX-1401)
6.2. Bristol-Myers Squibb’s and Abbott’s Elotuzumab6.3. Celgene’s Actimid6.4. Geron’s Imetelstat6.5. Janssen Biotech’s Siltuximab (CNTO 328)6.6. Novartis’ BHQ8806.7. Novartis’ Panobinostat6.8. Onyx Pharmaceuticals’ Carfilzomib6.9. PharmaMar’s Aplidin
CHAPTER 7 EMERGING THERAPIES FOR MYELODYSPLASTIC
SYNDROMES7.1. Amgen’s Nplate (Romiplostim)7.2. Celgene’s REVLIMID7.3. Cyclacel Pharmaceuticals’ Sapacitabine7.4. Medac GmbH’s Treosulfan7.5. Onconova Therapeutics’ ESTYBON (Rigosertib);
SymBio Pharmaceuticals’ Rigosertib7.6. Telik’s TELINTRA
CHAPTER 8 EMERGING THERAPIES FOR MYELOPROLIFERATIVE DISEASES
8.1. Celgene’s Actimid8.2. Geron’s Imetelstat8.3. Gilead Sciences’ GS 66248.4. Incyte’s and Novartis’ Ruxolitinib8.5. Infinity Pharmaceuticals’ IPI-9268.6. Sanofi’s SAR3025038.7. YM Biosciences’ CYT387
CHAPTER 9 BUSINESS CONSIDERATIONS
9.1. Current Sales of Drugs for Treatment of Hematological Cancers
9.2. Personalized Medicine in the Field of Hematological Cancers
9.3. Selected Challenges and Hurdles Being Faced by Companies in the Field of Hematological Cancers
CHAPTER 10EXPERT INTERVIEWS
10.1. Patrick A. Baeuerle, PhD, Chief Scientific Officer and Senior Vice President, Research & Development, Micromet
10.2. Steven A. Kriegsman, President and Chief Executive Officer David J. Haen, Vice President, Business Development, CytRx Corporation
10.3. Peter Nielsen, President and Chief Executive Officer, Bio-Path Holdings
10.4. Spiro Rombotis, President and Chief Executive Officer, Cyclacel Pharmaceuticals
10.5. Dan Weinseimer, Director, Strategic Marketing and Corporate Development, Sunesis Pharmaceuticals
10.6. David E. Weng, M.D., Ph.D., Chief Medical Officer, TetraLogic Pharmaceuticals
REFERENCES
APPENDIX: SELECTED COMPANIES DEVELOPING DRUGS FOR HEMATOLOGICAL CANCERS (GENERAL)
COMPANY INDEX
Also included are extensive tables describing selected drugs in development for the various types of hematological cancer as well as drugs that have been FDA-approved, including sales data for selected drugs.