Lung Cancer Drug Discoveries: What the future holds 2009: Chapter

Date: March 22, 2009
Pages: 206
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Publisher: Espicom Business Intelligence
Report type: Strategic Report
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Lung Cancer Drug Discoveries: What the future holds 2009:  Chapter
A comprehensive examination of the non-small cell lung cancer market and therapeutic approaches

Although a plethora of platinum-based chemotherapy combinations may be prescribed for the treatment of non-small cell lung cancer (NSCLC), the market is currently driven by chemotherapeutic agents such as the taxanes and antimetabolites, and the increasing use of targeted therapies. Some of the newer chemotherapy agents, such as Eli Lilly’s Gemzar and Alimta, have become the standard of care in combination with cisplatin or carboplatin and may be used in addition to or instead of the taxanes, Taxotere or Taxol/generic paclitaxel.

As researchers begin to understand the processes involved in NSCLC formation, several new targeted therapies have evolved that modulate growth factor pathways. Roche/Genentech's small-molecule tyrosine kinase inhibitor, Tarceva (erlotinib), and its anti-angiogenic VEGF inhibitor, Avastin (bevacizumab), are gaining credence in second- and first-line therapy, respectively.

Intense research is producing new approaches

NSCLC is one of the most actively researched cancers, with approximately 110 drugs in the US being evaluated in clinical trials. The drugs span a variety of drug classes and whilst some represent new formulations of existing brands, others offer novel approaches to targeting angiogenesis or cell death. The much awaited cancer vaccines are now in Phase III, with first launch expected in 2012.

By 2014, it is expected that at least five new chemotherapeutic agents will be launched to be used in combination with existing treatment protocols and, in some cases, may replace older products, including: Abraxis BioSciences' Abraxane and Cell Therapeutics/Novartis' Opaxio, both new formulations of paclitaxel; the third-generation platinum-based therapies, sanofi-aventis’ Eloxatin and GPC Biotech's satraplatin; and Bristol-Myers Squibb's epothilone analogue, Ixempra.


The addressable NSCLC market will increase by 9.8% by 2014. What are the current and new products that will drive commercial growth and what are the therapeutic approaches to watch?

Lung cancer affects over 1.4 million patients. Non-small cell lung cancer, which accounts for approximately 87% of all lung cancers, is one of the leading causes of death, killing more patients than breast, colon and prostate cancer together and accounting for nearly 30% of all cancer deaths. Survival rates are among the worst for any cancer with a large and growing unmet clinical need.

A changing approach

The NSCLC market is set for radical change. A number of current first-line therapies will become subject to generic competition in the short term and, although chemotherapy will continue to play a significant if diminishing role, industry attention is firmly on the better tolerated biologics, which are already setting the pace in the market and whose influence will grow over the coming years. In 2007, chemotherapy treatments accounted for 68% of the market, but are forecast to account for only 36% by 2014. Targeted treatments are forecast to increase from 32% to 60% over the same period.

Impact on the industry

Roche/Genentech – currently the dominant player in the sector – will move into an even more commanding position, accounting for 42% of the market through the ongoing sales and development of leading products such as Avastin and Tarceva. The market will be more diverse, with 12 companies taking more than 1% market share in 2014, as opposed to 6 in 2007.

Vaccines

The benefits of lung cancer vaccines remain significant, but without launch and experience of large patient populations in post-launch, they remain just a promise. Of the candidates in Phase III, Merck’s Stimuvax is expected to be first to market in 2012, with GSK’s MAGE-A3/GSK1572932A following on.

On the horizon: new Phase II approaches show promise
Targeting TRAIL (TNF-related apoptosis-inducing ligand) receptors is one avenue that is currently being explored by a number of companies. TRAIL induces apoptosis via two death domain-containing receptors, TRAIL-R1 (DR4) and TRAIL-R2 (DR5). Human Genome Sciences' mapatumumab is the most advanced death receptor activator currently under development, while other candidates with potential include: Amgen's AMG 655, Amgen/Genentech's AMG 951 and Genentech's apomab.
This unbeatable executive report provides…

A comprehensive review of the market, disease incidence and growth

An evaluation of the current understanding of non-small cell lung cancer

A comparison of the corporate and competitive landscape in 2007 and 2014

Detailed analysis and 5-year sales forecasts for current products by value

A detailed review of up and coming products with 5-year forecasts from year of launch

Unique product assessment and scoring

CURRENT PRODUCTS EVALUATED & FORECAST

- Taxol (BMS)
- Taxotere (sanofi-aventis)
- Alimta (Eli Lilly)
- Gemzar (Eli Lilly)
- Iressa (AstraZeneca)
- Tarceva (Roche/Genentech/OSI)
- Avastin (Roche/Genentech/Chugai)

LATE-PHASE PRODUCTS EVALUATED AND FORECAST

- Abraxane (Abraxis)
- Opaxio (Novartis)
- Erbitux (Eli Lilly/BMS)
- Figitumumab (Pfizer)
- Aflibercept (sanofi-aventis/Regeneron)
- Nexavar (Bayer/Onyx)
- Sutent (Pfizer)
- Tovok (Boehringer Ingelheim)
- Vargatef (Boehringer Ingelheim)
- Zactima (AstraZeneca)
- ASA404 (Novartis)

Vaccines

- Lucanix (NovaRx)
- MAGE-A3 (GSK)
- Stimuvax (Merck KGaA)

NOVEL PHASE II PRODUCTS EVALUATED INCLUDE

- Angiogenesis Inhibitors
- Recentin (AstraZeneca)
- Armala (GSK)
- ABT-869 (Abbott/Genentech)
- Axitinib (Pfizer)
- IMC-1121B (Eli Lilly)
- Death Receptor Agonists
- AMG 655 (Amgen/Genentech)
- AMG 951 (Amgen/Genentech)
- Apomab (Genentech)
- Mapatumumab (Human Genome Sciences)
EXECUTIVE SUMMARY

THE FACTS

WHAT IS NSCLC AND HOW DOES IT AFFECT PATIENTS?
PATIENT STATISTICS
  Incidence, Diagnosis Rates and Treatment; Now and in the Future
  The US
  Europe
  Japan

PATIENT MODEL

  The Addressable NSCLC Market Will Increase by 9.8 per cent by 2014
DRUG GROWTH DRIVERS
DRUG GROWTH RISKS/DAMPENERS

THE NSCLC MARKET

GLOBAL NSCLC SALES SPLIT
  US Market
  European Market
  Japanese Market
THE PLAYERS
  Players and Products in 2007
  Players and Products in 2014

CURENT TREATMENTS

SURGERY
RADIATION
CHEMOTHERAPY
  Leading Brands
  Chemotherapy Regimens
  Current Products' Patent Exposure
Novel Targeted Therapies
  Targeting EGFr
  Targeting VEGF
  Current Products' Patent Exposure

ANALYSIS OF LEADING BRANDS

CHEMOTHERAPY
  Taxanes
    Taxol
    Taxotere
  Antimetabolites
    Alimta
    Gemzar
NOVEL TARGETED THERAPIES
  EGFr Inhibitors
    Iressa
    Tarceva
  VEGF Inhibitor
    Avastin

SALES FORECASTS OF CURENT NSC LC DRUGS

RESEARCH & DEVELO PMENT OF NSCLC DRUGS

ANALYSIS OF LATE-PHASE DRUGS

CHEMOTHERAPY
  Taxanes
    Abraxane
  Opaxio
TARGETED THERAPY
  EGFr Inhibitors
    Erbitux
  IGF-1r Inhibitors
    Figitumumab
  Multi-action Inhibitors
    Aflibercept
    Nexavar
    Sutent
    Tovok
    Vargatef
    Zactima
  Tumour Vascular Disrupting Agents
    ASA404
VACCINES
  Lucanix
  MAGE-A3
  Stimuvax
Other Phase III Drugs
  AMG 706
  NOV-002
  Telcyta

GLOBAL SALES FORECASTS OF LATE-PHASE NSCLC DRUGS

Model Assumptions

ANALYSIS OF PHASE II DRUGS

Chemotherapy
  Eloxatin
  Ixempra
  Satraplatin
Angiogenesis Inhibitors
  Recentin
  Armala
  ABT-869
  Axitinib
  IMC-1121B
Death Receptor Agonists
  AMG 655
  AMG 951
  Apomab
  Mapatumumab
Other Classes
  Bavituximab
  Enzastaurin
  OGX-011
  Perifosine
  PF-3512676
  Velcade
Vaccines
  IDM-2101
  TG 4010

COMPETITOR RATIO ANALYSIS

Competitor Ratio Analysis Criteria
COMPETITOR RATIO ANALYSIS - PRODUCTS
COMPETITOR RATIO ANALYSIS - COMPANIES
WINNERS & LO SERS
Winners
Losers

DISCONTINUATION OF NSCLC DRUGS

APPENDIX 1: PATIENT MODEL

APPENDIX 2: GLO BAL NSCLC DRUGS SALES

APPENDIX 3: PHASE TRANSITION PROBABILITY

BIBLIOGRAPHY

GLOSSARY

ACRONYMNS

INDEX OF TABLES

Stages of NSCLC and Survival Rates
Male and Female Lung Cancer Incidence Rates (Top Five Countries)
Summary of Global NSCLC Patient Population Forecasts in Top Seven Countries (2007E-2014E)
Standard NSCLC Therapy
Platinum-Based Regimens
FDA-Approved Regimens for Advanced NSCLC
Doublet Regimens
EGFr Expression in Solid Tumours
Patent Exposure of Leading Brands
Efficacy of Taxotere in the Treatment of NSCLC Patients Previously Treated with a Platinum-Based Chemotherapy Regimen (Intent-to-Treat Analysis)
Proposed NSCLC Filings for Avastin
Avastin Development
Proposed Filings of New Indications for Avastin
Global NSCLC Sales of Leading Brands 2007A-2014E (US$ millions)
Products In Clinical Development for the Treatment Of NSCLC
New Drugs in Late-Phase Development to Treat NSCLC
Sales Forecasts of Late-Phase Developmental NSCLC Drugs (US$ million)
New Drugs in Phase II Development to Treat NSCLC
Axitinib Treatment-Related Adverse Events
Key NSCLC Drugs Analysed
Summary of Key Companies and Drugs in the NSCLC Market by 2014
NSCLC Drugs Discontinued During Development
Summary of US NSCLC Patient Population Forecasts
Summary of Europe (Top Five) NSCLC Patient Population Forecasts
Summary of Japan NSCLC Patient Population Forecasts
Global NSCLC Drugs Sales 2007A-2014E
Probability of Launch

INDEX OF CHARTS

Schematic of the Lung
New Cancer Deaths Estimates (2008)*
Tobacco use in the US 1900-2002
Global NSCLC Market by Therapy Class (2007A)
Global NSCLC Market by Therapy Class (2014E)
Global NSCLC Market by Region (2007A)
US NSCLC Major Drugs Sales Split (2007A)
European NSCLC Major Drugs Sales Split (2007A)
Market Share of NSCLC Players by Sales (2007A)
Market Share of NSCLC Players by Sales (2014E)
EGFr Signal Transduction in Tumour Cells
Angiogenesis is the Formation of New Blood Vessels
Agents Targeting the VEGF Pathway
Efficacy Parameters in Phase III Trials
Taxol NSCLC Sales (2007E-2014E)
TAX317 Survival K_M Curves - Taxotere 75mg/m2 vs. Best Supportive Care
TAX320 Survival K_M Curves - Taxotere 75mg/m2 vs. Vinorelbine or Ifosfamide Control
Taxotere-Treated Patients as % of Patient Popluation (Top 7)
Taxotere NSCLC Sales (2007E-2014E)
Alimta NSCLC Sales (2007A-2014E)
Gemzar NSCLC Sales (2007E-2014E)
Iressa NSCLC Sales (2007A-2014E)
Tarceva NSCLC Sales (2007E-2014E)
Avastin NSCLC Sales (2007E-2014E)
2008 Survey: Medicines in Development for Cancer
Abraxane NSCLC Sales (2011E-2014E)
Opaxio NSCLC Sales (2009E-2014E)
Erbitux NSCLC Sales (2009E-2014E)
Pfizer's NSCLC Clinical Development Programme
CP-751,871 NSCLC Sales (2013E-2014E)
Aflibercept NSCLC Sales (2012E-2014E)
Nexavar NSCLC Sales (2012E-2014E)
Sutent NSCLC Phase II Results and Phase III (SUN 1087) Study Design
Pfizer's NSCLC Clinical Development Programme
Sutent NSCLC Sales (2012E-2014E)
Tovok NSCLC Sales (2013E-2014E)
Vargatef NSCLC Sales (2013E-2014E)
Zactima’s Triple Mechanism of Action
Zactima NSCLC Sales (2010E-2014E)
ASA404 NSCLC Sales (2012E-2014E)
Stimuvax NSCLC Sales (2012E-2014E)
Ixabepilone: Preclinical Synergy With Targeted Therapies
AZD2171 Mechanism Of Action
Efficacy and Pharmacokinetic Profile of AZD2171 Compared to Avastin
AZD2171 Dose-Dependent Efficacy in NSCLC
Axitinib in First-Line NSCLC
Mechanism of Action of HGS-ETR1
PF-3512676 Mechanism of Action Through TLR modulation
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