Market Report Source

Overview

Introduction
In 2007, more than 3 million new cases of solid tumors are forecast to be diagnosed across the seven major pharmaceutical markets, obviously representing an enormous market potential. Lower incidence tumor types are becoming increasingly attractive to drug developers, due to high levels of unmet need which can result in significant financial rewards.

Scope

• Examination of the solid cancer pipeline with in-depth clinical and commercial profiles of Phase III candidates for 17 tumor types
• Seven major pharmaceutical sales forecasts for Phase III pipeline products through to 2016 with product-specific assumptions
• Segmentation and analysis of the current solid tumor pipeline by developmental phase, drug class and indication Insight and analysis of market potential including commercial opportunity, epidemiology, commonalities across cancers and discussion of unmet needs

Highlights
The current solid tumor pipeline contains at least 707 unique agents, 9% of which are in late-phase development. These products cover a vast array of anticancer drug classes, including antihormonal therapies, cytotoxics, gene therapies, immunotherapies, photodynamic therapies, radiotherapeutics, targeted therapies and therapeutic vaccines. The late-phase pipeline contains equal amounts of cytotoxics and targeted therapies. The Phase I and II pipelines contain more than twice as many targeted therapies as cytotoxics. As such, it is clear that increasing diversity in terms of drug targets may result in greater treatment options in years to come if positive clinical data is generated. Despite high levels of unmet need and relatively healthy pipelines for most indications, no major breakthroughs are expected by current late-phase products aside from incremental increases in efficacy and reduced toxicity. This indicates a heavy reliance on the earlier-phase pipeline for further breakthroughs in terms of treatment of solid tumors.

Reasons to Purchase

• Identify key drugs and companies within the oncology pipeline based on sales forecasts to 2016 and Datamonitor drug assessment
• Characterize unmet need and poorly served markets within oncology and assess the potential for pipeline products to provide satisfaction
• Assess the shifting oncology market dynamic and how future treatment of solid tumors will incorporate pipeline products

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the cancer market

Related reports

Upcoming reports

CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS

Pipeline overview

Novel agents

Marketed products

Pipeline by developmental phase and indication

The big four tumor types are still the most popular R&D targets, although brain cancer, melanoma, ovarian cancer, pancreatic cancer and RCC are increasing in relevance

Pipeline split by phase

Only 9% of the current pipeline is in late-phase development

Pipeline by drug class

Novel therapies constitute a greater proportion of the pipeline in the early phases of development

Solid tumor commonalities

To show applicability for use in numerous indications, a pipeline drug must affect a target that is expressed across a range of tumor types

Key companies involved in the solid tumor pipeline

The top three companies in terms of marketed and pipeline drugs for solid tumors are Pfizer, AstraZeneca and Novartis

Pfizer

AstraZeneca

Novartis

CHAPTER 3 R&D APPROACH

Classification of pipeline products

Cytotoxics

Antihormonal therapies

Molecular targeted therapies

Single-target signal transduction inhibitors

Angiogenesis inhibitors

Apoptosis inducers

Cell cycle inhibitors

Multi-targeted inhibitors

Epigenetic modulators

Immunotherapeutic agents

Oncology clinical trial design

Patient selection

Increasingly significant in the era of targeted treatment

Clinical trial duration

Sufficient follow-up is necessary to establish true clinical benefit

The advent of novel therapies

Diversity of targeted therapies will require an evolution in clinical trial design

Clinical trial endpoints in oncology

Most oncology clinical trials designate multiple endpoints

Survival

Quality of life

Tumor response rates

Toxicity

Time to tumor progression

CHAPTER 4 BLADDER CANCER

Overview of bladder cancer

Definition

Bladder cancer remains a common tumor type in males

Epidemiology

Incidence of bladder cancer will rise due to an increase in industrialization, lifestyle factors and an ageing population

Mortality from bladder cancer is very low in the early stages, however, rises dramatically once the tumor spreads

Treatment of bladder cancer

Unmet need in bladder cancer

Summary of unmet needs

Increase early diagnosis to enhance survival

Agents with better routes of administration in comparison with intravesical therapy

A better ‘standard’ for advanced disease with less toxicity is needed

Salvation of the bladder is the ideal

Pipeline overview

Spectrum Pharmaceuticals’ EOquin (apaziquone)

Drug overview

Clinical trial data

Datamonitor comments

Forecasts to 2016

Datamonitor drug assessment summary

Satisfaction of unmet needs

Some satisfaction of unmet needs will occur, however, further research is needed in advanced disease

CHAPTER 5 PRIMARY BRAIN CANCER

Overview of primary brain cancer

Definition

Glioma is the most common type of primary brain cancer

Epidemiology

Incidence of brain cancer is rising in line with the ageing population

Mortality from brain cancer is very high in comparison to its incidence

Treatment of primary brain cancer

Unmet need in primary brain cancer

Summary of unmet needs

More effective chemotherapy options needed

Blood-brain barrier may prove an obstacle to overcome

Need for neuroprotective therapy

Pipeline overview

Ark Therapeutics’ Cerepro (sitimagene ceradenovec)

Drug overview

Clinical trial data

Datamonitor comments

Peregrine Pharmaceuticals’s Cotara (131I-chTNT-1/B)

Drug overview

Clinical trial data

Datamonitor comments

YM Biosciences/Biocon Biopharmaceuticals’ Theraloc (nimotuzumab)

Drug overview

Clinical trial data

Datamonitor comments

NeoPharm’s cintredekin besudotox

Drug overview

Clinical trial data

Datamonitor comments

Forecasts to 2016

Datamonitor drug assessment summary

Satisfaction of unmet needs

Temodar will retain its leading status for some time to come in the primary brain cancer market

CHAPTER 6 BREAST CANCER

Overview of breast cancer

Definition

Breast cancer remains the most common cancer and second most common cause of cancer-related death in women worldwide

Epidemiology

Incidence of breast cancer will continue to rise as lifestyles associated with risk factors are increasingly adopted, rates of screening increase in some countries and in line with the ageing population

While mortality rates are low in comparison to incidence, absolute mortality shows breast cancer remains a leading cause of death in women

Treatment of breast cancer

Unmet need in breast cancer

Summary of unmet needs

Effective treatment for metastatic disease still remains elusive

A wider range of treatment options is necessary for hormone receptor-negative patients

Elderly patients remain underserved in terms of treatment options

More convenient and better tolerated therapies are needed

Earlier diagnosis improves prognosis but awareness must remain high

Pipeline overview

Bristol-Myers Squibb’s ixabepilone (BMS-247550)

Drug overview

Clinical trial data

Datamonitor comments

Sonus Pharmaceuticals/Bayer Schering’s Tocosol paclitaxel (emulsion paclitaxel)

Drug overview

Clinical trial data

Datamonitor comments

Eisai’s eribulin (E7389)

Drug overview

Clinical trial data

Datamonitor comments

Sanofi-Aventis’s larotaxel (XRP-9881)

Drug overview

Clinical trial data

Datamonitor comments

Forecasts to 2016

Datamonitor drug assessment summary

Satisfaction of unmet needs

Ixabepilone has a real chance of fulfilling some unmet need in the breast cancer market

CHAPTER 7 CERVICAL CANCER

Overview of cervical cancer

Definition

Cervical cancer constitutes 17% of all gynecological tumors

Epidemiology

Incidence will rise in line with the ageing population

Mortality is relatively high in comparison to incidence of cervical cancer given its propensity for early diagnosis

Treatment of cervical cancer

Unmet need in cervical cancer

Summary of unmet needs

A major healthcare burden in developing countries

Less invasive surgery is required for early-stage tumors

Better systemic therapy is required for metastatic and recurrent disease

More large-scale, randomized clinical trials are necessary to define optimal treatment strategies across cervical cancer

The cervical cancer pipeline is relatively sparse

Pipeline overview

Sanofi-Aventis/National Cancer Institute’s Tirazone (tirapazamine)

Drug overview

Clinical trial data

Datamonitor comments

Forecasts to 2016

Datamonitor drug assessment summary

Satisfaction of unmet needs

Unmet needs are unlikely to be fulfilled by the current pipeline

CHAPTER 8 COLORECTAL CANCER

Overview of colorectal cancer

Definition

Colorectal cancer is the third most common tumor type and cause of cancer-related death in both men and women

Epidemiology

Incidence continues to rise with an increase in prevalence of risk factors and the ageing population

Mortality from colorectal cancer is relatively high due to a tendency for later diagnosis

Treatment of colorectal cancer

Unmet need in colorectal cancer

Summary of unmet needs

Lack of identifiable risk factors and effective screening tools

Prognosis remains poor, despite significant advances in therapy

A high rate of disease recurrence illustrates the need for more effective therapies

Pipeline overview

Pro-Pharmaceuticals’ Davanat (drug delivery system)

Drug overview

Clinical trial data

Datamonitor comments

ADVENTRX Pharmaceuticals’s CoFactor (ANX-510)

Drug overview

Clinical trial data

Datamonitor comments

AstraZeneca’s Recentin (cediranib, AZD-2171)

Drug overview

Clinical trial data

Datamonitor comments

Forecasts to 2016

Datamonitor drug assessment summary

Satisfaction of unmet needs

Improvements in efficacy and prognosis are unlikely to be made by current late-phase pipeline products

CHAPTER 9 HEAD AND NECK CANCER

Overview of head and neck cancer

Definition

Head and neck cancers comprise around 6% of all tumors worldwide

Epidemiology

Incidence will continue to rise in line with the ageing population

Mortality is high due to frequent late-stage diagnosis and lack of effective treatments

Treatment of head and neck cancer

Unmet need in head and neck cancer

Summary of unmet needs

Currently available therapies induce modest response rates

High level of treatment-related morbidity and poor quality of life

Early-stage diagnosis is limited, thereby compromising survival

High economic burden

Pipeline overview

Regulon’s Lipoplatin (liposomal cisplatin)

Drug overview

Clinical trial data

Datamonitor comments

Medarex/Genmab’s zalutumumab (HuMax-EGFR)

Drug overview

Clinical trial data

Datamonitor comments

CEL-CSI’s Multikine (mixture of naturally occurring cytokines)

Drug overview

Clinical trial data

Datamonitor comments

Viventia Biotech’s Proxinium (VB4-845)

Drug overview

Clinical trial data

Datamonitor comments

Introgen Therapeutics’ Advexin (contusugene, INGN-201)

Drug overview

Clinical trial data

Datamonitor comments

Introgen Therapeutics’ INGN-241

Drug overview

Clinical trial results

Datamonitor comments

Forecasts to 2016

Datamonitor drug assessment summary

Satisfaction of unmet needs

Superiority over current standard therapies is unlikely to be shown by the current pipeline

CHAPTER 10 HEPATOCELLULAR CARCINOMA

Overview of HCC

Definition

Hepatitis is a known risk factor for HCC

Epidemiology

Japan accounts for nearly half of all new HCC cases in the seven major markets due to a high prevalence of hepatitis

Mortality from HCC is high, although prognosis is steadily improving

Treatment of HCC

Unmet need in HCC

Summary of unmet needs

Curbing the increasing incidence of HCC

Better systemic therapy is required

Clinical trials are currently poorly designed