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Blood Cancer Drug Discoveries: what the future holds

Published by: Espicom Healthcare Intelligence

Published: Apr. 11, 2008 - 245 Pages


Table of Contents


Blood Cancers

US incidence of blood cancers, 2007

Unmet Medical Need

New Agents In Development

New mechanisms of action under investigation for the development of blood cancers:

Monoclonal antibodies in development for treatment of blood cancers

Major Players

2007

Market share of players in the worldwide blood cancers market, 2007

2012

Market share of players in the worldwide blood cancers market, 2012

Global Sales

Estimated and forecast worldwide sales in the treatment of blood cancers (US$ millions)

Regional breakdown of blood cancer market by sales - 2007 and 2012



Chronic Lymphocytic Leukaemia

Background

Patient Statistics

patient model

Estimated prevalence of CLL in major markets, 2005-2012

Drug Growth Drivers

Drug Growth Dampeners

The Market

Global market

Forecast CLL market growth (US$ millions)

major players

Current drugs commonly used in the treatment of CLL

Major players in CLL by sales - 2007

Forecast major players in CLL by sales - 2012

The Drugs

Current Drugs

Selected response rates from studies of first line treatment of CLL:

Fludara

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Fludara sales in CLL by region (US$ millions)

Forecast Fludara sales in CLL by use (US$ millions)

Competitor ratio analysis

Rituxan

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Rituxan sales in CLL by use (US$ millions)

Forecast Rituxan sales in CLL by region (US$ millions)

Competitor ratio analysis

Campath

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Campath sales in CLL by use (US$ millions)

Competitor ratio analysis

Agents in Development

Drugs in development for the treatment of CLL

Agents in late stage development for CLL:

Treanda

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Treanda sales in CLL (US$ millions)

Competitor ratio analysis

Genasense

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Genasense in CLL efficacy summary:

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Genasense sales in CLL by region (US$ millions):

Forecast Genasense sales in CLL by use (US$ millions):

Competitor ratio analysis

Ofatumumab

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast ofatumumab sales in CLL by region (US$millions):

Forecast ofatumumab sales in CLL by use (US$millions):

Competitor ratio analysis

Alvocidib

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast alvocidib sales in CLL (US$ millions)

Competitor ratio analysis

Lumliximab

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast lumiliximab sales in CLL (US$ millions)

Competitor ratio analysis

Revlimid

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Revlimid CLL sales by use (US$ millions):

Forecast Revlimid CLL sales by region (US$ millions):

Competitor ratio analysis



Chronic Myeloid Leukaemia

Background

Patient Statistics

Trends in US CML incidence:

Estimated incidence in worldwide CML prevalence:

Drug Growth Drivers

Drug Growth Dampeners

The Market

Global market

Forecast worldwide CML market (US$ millions)

major players - 2007

Major players in CML by sales - 2007

major players - 2012

Forecast major players in CLL by sales - 2012

The Drugs

CML treatment timeline:

Current drugs

Current drugs used in the treatment of CML:

Gleevec/Glivec

Novelty/rationale for mechanism of action

Proof of concept/clinical data

IRIS study: 18-Month Response Rates Determined by Intent-to-Treat Analysis

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Gleevec sales in CML (US$ millions) - excludes sales in GIST

Competitor ratio analysis

Sprycel

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Sprycel CML sales (US$ millions):

Competitor ratio analysis

Tasigna

Novelty/rationale for mechanism of action

Proof of concept/clinical data

management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Tasigna CML sales forecast (US$ millions)

Competitor ratio analysis

Agents in Development

Drugs in development for the treatment of CML:

Agents in late stage development for CML:

Bosutinib

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast bosutinib sales in CML (US$ millions)

Competitor ratio analysis

Panobinostat

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Competitor ratio analysis

MK-0457/ VX 680

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Competitor ratio analysis



Acute Myeloid Leukaemia

Background

French-American-British (FAB) Classification of AML

WHO AML classification:

Selected risk factors associated with AML:

Common chromosomal abnormalities in AML:

Patient Statistics

Forecast incidence of AML by region:

Drug Growth Drivers

Drug Growth Dampeners

The Market

Global market

Forecast worldwide adult AML market

major players - 2007

major players - 2012

Forecast major players in AML by sales - 2012

The Drugs

Treatment naïve patients

Relapsed & refractory AML

Current drugs used in the treatment of AML:

Therapeutic strategies in AML and relapsed/refractory AML:

Mylotarg

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Summary of response rates in Mylotarg studies:

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Competitor ratio analysis

Agents in Development

Agents in late stage development for AML:

Clolar/Evoltra

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast sales of Clolar/Evoltra in adult AML (US$ millions):

Competitor ratio analysis

Cloretazine

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast sales of Cloretazine in AML (US$ millions)

Competitor ratio analysis

Zarnestra

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Competitor ratio analysis

Dacogen

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Dacogen sales in adult AML (US$ millions)

Competitor ratio analysis

lestaurtinib

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast lestaurtinib sales in AML (US$ millions)

Competitor ratio analysis

midostaurin

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast midostaurin sales in AML (US$ millions)

Competitor ratio analysis

tandutinib

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Competitor ratio analysis

zosuquidar

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Competitor ratio analysis

Xanafide

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Xanafide sales in AML (US$ millions)

Competitor ratio analysis

Ceplene

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Ceplene sales in AML (US$ millions)

Competitor ratio analysis



Multiple Myeloma

Background

Patient Statistics

patient model

Estimated prevalence of multiple myeloma in selected markets

Drug Growth Drivers

Drug Growth Dampeners

The Market

Global market

Forecast worldwide multiple myeloma market (US$ millions):

major players

Major players in multiple myeloma by sales - 2007

Major players in multiple myeloma by sales - 2012

Current drugs used in the treatment of multiple myeloma:

The Drugs

Thalomid

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Thalomid sales in multiple myeloma (US$ millions)

Competitor ratio analysis

Revlimid

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Data summary of MM-009 and MM - 010 studies:

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Front line myeloma comparison:

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Competitor ratio analysis

Velcade

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Velcade sales in multiple myeloma (US$ millions)

Competitor ratio analysis

Agents in Development

Drugs in development for the treatment of multiple myeloma:

Agents in late stage development for multiple myeloma:

Tanespimycin

Novelty/rationale for mechanism of action

Proof of concept/clinical data

management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast tanespimycin sales in relapsed/refractory multiple myeloma (US$ millions)

Competitor ratio analysis

mapatumumab

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Competitor ratio analysis

Belinostat

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Competitor ratio analysis

Perifosine

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Competitor ratio analysis

Carfilzomib

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Competitor ratio analysis



Non Hodgkin’s Lymphoma

Background

Frequency of NHL subtypes in adults:

1) B-cell Cll/small lymphocytic lymphoma

2) marginal zone lymphoma

3) lymphoplasmocytic lymphoma (Waldenstrom macroglobulinemia):

4) Follicular lymphoma:

1) Cutaneous t-cell lymphoma:

1) diffuse large B-cell lymphoma (dlBCl):

2) mantle cell lymphoma:

3) Burkitt lymphoma/Burkitt-like lymphoma:

4) precursor B-cell leukaemia/lymphoma

1) anaplastic large t/null-cell lymphoma:

2) precursor t-lymphoblastic lymphoma/leukaemia:

3) peripheral t-cell lymphomas:

Staging Systems

Patient Statistics

patient model

Forecast NHL incidence and prevalence (000s)

Drug Growth Drivers

Drug Growth Dampeners

The Market

Global market

Forecast NHL market (excluding CTCL) - US$ millions

Forecast CTCL market - US$ millions

major players

Current drugs commonly used in the treatment of NHL

Major players in NHL by sales - 2007

Major players in NHL by sales - 2012

The Drugs

Low Grade or Indolent NHL

Treatment options in indolent/low-grade NHL:

Intermediate- and high-grade lymphomas:

T-cell lymphomas:

Summary of common therapies in NHL



Marketed Agents For Use In NHL

Rituxan

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Rituxan penetration rates, Q3-Q4 2005

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Rituxan sales in NHL indications by region (US$ millions)

Forecast Rituxan sales in NHL indications by use (US$ millions)

Competitor ratio analysis

Fludara

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Fludara sales in NHL indications (US$ millions)

Competitor ratio analysis

Bexxar

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Bexxar sales (US$ millions):

Competitor ratio analysis

Zevalin

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Zevalin sales (US$ millions)

Competitor ratio analysis



Marketed Agents For Cutatenous T-Cell Lymphoma

Zolinza

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Zolinza sales in CTCL (US$ millions)

Competitor ratio analysis

Agents in Development

Drugs in development for the treatment of NHL:

Agents in late stage development for NHL:

Treanda

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Treanda US sales forecasts in NHL indication (US$ millions)

Competitor ratio analysis

ofatumumab

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Phase I/II trial results summary:

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast sales of ofatumumab in NHL by region (US$ millions):

Forecast sales of ofatumumab in NHL by use (US$ millions):

Competitor ratio analysis

galiximab

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast galiximab sales in NHL (US$ millions)

Competitor ratio analysis

pixantrone

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast pixantrone NHL sales by region (US$ millions):

Forecast pixantrone sales in NHL by use (US$ millions)

Competitor ratio analysis

Revlimid

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Revlimid sales forecasts in NHL (US$ millions)

Competitor ratio analysis

Torisel

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Torisel sales in MCL (US$ millions)

Competitor ratio analysis

Velcade

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast Velcade sales in MCL (US$ millions)

Forecast Velcade sales in follicular NHL (excludes MCL) by region (US$ millions)

Forecast Velcade sales in follicular NHL (excludes MCL) by use (US$ millions)

Competitor ratio analysis

Inotuzumab Ozogamicin

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Competitor ratio analysis



Agents In Late Stage Development For Cutaneous T-Cell Lymphoma

Zanliumumab

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast sales of zanolimumab in CTCL (US$ millions)

Competitor ratio analysis

belinostat

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast sales of belinostat in CTCL (US$ millions)

Competitor ratio analysis

Fodosine

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Forecast sales of Fodosine in CTCL (US$ millions)

Competitor ratio analysis

Epratuzumab

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Competitor ratio analysis

enzastaurin

Novelty/rationale for mechanism of action

Proof of concept/clinical data

Management/clinical expertise

Competition within the marketplace/gaining share of voice

Risks associated with developing a drug within a therapeutic class

Filings and approval

Sales forecasts and assumptions

Competitor ratio analysis



CRA Analysis: AML

CRA summary



CRA Analysis: CML

CRA summary



CRA Analysis: CLL



CRA Analysis: Multiple Myeloma

CRA Summary



CRA Analysis: NHL

CRA analysis - NHL

CRA analysis - NHL (continued)…includes CTCL



Acronyms

Abstract

This new strategic report from Espicom provides a comprehensive review of current and future treatments for major blood cancer therapy areas: chronic lymphocytic leukaemia, chronic myeloid leukaemia, acute myeloid leukaemia, multiple myeloma and non-Hodgkin's lymphoma.

Over 275 pages of product analysis, market statistics and forecasts Unique market share and 5-year sales forecasts for leading products & pipeline prospects. A comprehensive examination of major blood cancer therapy areas. Critical competitive evaluation and scoring of current and future products.

Providing…

  • Detailed analysis and 5-year forecasts for current leading products by value
  • A detailed review and assessment of up and coming products
  • Unique product assessment and scoring
  • An evaluation of the current understanding of blood cancers

THE REPORT COVERS MAJOR BLOOD CANCER AREAS

  • Chronic lymphocytic leukaemia
  • Chronic myeloid leukaemia
  • Acute myeloid leukaemia
  • Multiple myeloma
  • Non-Hodgkin’s lymphoma

THE MARKET

  • Risk factors, how the disease affects patients, diagnosis and stages of the disease
  • The market in 2007 and 2012
  • Growth drivers and dampeners

PATIENT STATISTICS

  • Prevalence
  • Diagnosis rates
  • Unmet clinical need

CURRENT TREATMENT OPTIONS

  • Interventions by type
  • Unique five point competitive assessment and scoring of current therapies and companies involved
  • 5-year sales forecasts for key products

R&D: DRUGS IN LATE STAGE DEVELOPMENT

  • Focus on new classes of drugs and the companies involved
  • Unique competitive assessment and scoring of new therapies and companies involved
  • 5-year sales forecasts for key products from year of launch



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