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Myelodysplastic Syndrome - An underserved population offers commercial opportunityPublished by: Datamonitor Published: Oct. 18, 2005 - 70 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Introduction 3 Scope and coverage of the brief 3 Key findings 3 CHAPTER 2 DISEASE OVERVIEW 3 MDS is a clonal hematopoietic stem cell disorder 3 MDS diagnosis, classification and staging: unresolved controversies remain 3 MDS epidemiology: a poorly monitored disease on the rise 3 Range of risk factors linked to MDS 3 MDS prognosis is particularly poor for Int-2/high-risk patients 3 CHAPTER 3 CURRENT TREATMENT CONTROVERSIES 3 Bone marrow transplantation: potentially curative MDS treatment only available to small patient subgroup 3 MDS treatment goals highlight major unmet needs 3 The three treatment approaches to MDS 3 Supportive care therapies address MDS symptoms only 3 Low-intensity therapies may improve hematological status 3 High-intensity therapies are associated with increased morbidity and mortality 3 Supportive care alone is the standard treatment for the majority of MDS patients 3 Pharmion’s Vidaza (azacitadine): the first FDA approved MDS therapeutic 3 Toxicity of Celgene/Pharmion’s Thalomid (thalidomide) limits it’s utility in refractory low or Int-1MDS treatment 3 Cephalon’s Trisonex (arsenic trioxide) may confer improved hematological improvement over Thalomid in refractory high-risk MDS 3 CHAPTER 4 THE TWO NEWCOMERS: SUPERGEN/MGI PHARMA’S DACOGEN AND CELEGENE’S REVLIMID 3 FDA approval of SuperGen/MGI Pharma’s Dacogen (decitabine) deferred pending analysis of transfusion data 3 Celgene’s Revlimid (lenalidomide) NDA under review for 5q- MDS 3 The market impact of Revlimid and Dacogen upon Vidaza sales 3 CHAPTER 5 MDS PIPELINE FOCUSED ON HEMATOLOGICAL IMPROVEMENT RATHER THAN AML PROGRESSION 3 Review of MDS pipeline drugs in Phase III development 3 Opportunities exist for developers wanting to join this niche market 3 APPENDIX 3 Bibliography 3 Disclaimer 3 AbstractIntroductionSuperGen/MGI Pharma's Dacogen and Celgene's Revlimid are in pre-registration for treatment of myelodysplastic syndrome (MDS). However, the former's similar efficacy and toxicity to Pharmion's Vidaza, the first drug indicated for MDS, coupled with the limited target population of the Revlimid, will leave a significant proportion of the MDS population underserved by pharmacotherapy. Scope Overview of MDS epidemiology, classification and staging, prognosis and risk factors Examination of unmet needs in MDS treatment and market opportunities for drug developers Review of current treatment controversies and physician opinion of existing and future treatment strategies Profile of the therapeutic and commercial potential of pipeline drugs Highlights MDS can affect all ages but is predominantly found in the elderly, with the Aplastic Anemia & MDS International Foundation estimating that 80% of those affected are over 60 years of age. Consequently as a result of the elderly suffering more co-morbidities and poorer prognosis, the current treatment of MDS consists mainly of supportive care. In the years following Dacogen's anticipated US launch in 2006, Datamonitor predicts the sales margin between it and Vidaza will narrow as physicians gain familiarity with Dacogen and SuperGen/MGI Pharma establish more convenient dosing regimens. However, Vidaza is still predicted to maintain a market lead over its closest direct competitor. Recently recommended by the FDA's Advisory Committee for accelerated approval, Revlimid looks certain to enter the MDS market in 2006. Indicated for lower-risk MDS in the presence of a chromosome abnormality known as 5q-, Revlimid will quickly become the standard treatment in this patient cohort with additional off-label use also predicted. Reasons to Purchase Understand current controversies in MDS treatment and adopt knowledge from this report to drive strategic planning for novel MDS therapeutics Assess opportunities and risks for innovative treatments within the MDS market Gain insight into current treatment paradigms, as reported by leading oncologists/ hematologists Get Full Details About This Report >> |
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