Targeted Cancer Drugs The Launch Landscape to 2018

Published: February 2012
No. of Pages: 306
  

As the cancer therapy market evolves, interest is growing in novel approaches which may supersede the current portfolio. In the short term, the market will be dominated by established therapeutic approaches, but the question is – “What next?”

A sign of things to come?
The end of 2011 saw the US approval of two new molecularly-targeted cancer drugs, alongside companion diagnostic tests that identify the patients most likely to benefit from treatment. Pfizer's Xalkori (crizotinib) and Roche's Zelboraf (vemurafenib) were both approved following a priority review, highlighting the importance that the FDA has placed on hastening the passage of these therapies to market. These approvals reflect the trend of treating cancers based on their molecular and genetic characteristics, rather than their location within the body.

Such developments have long been heralded as marking the future of cancer therapies and the benefits to patients, clinicians and health payers is clear – but are these approvals the benchmark for future developments?

With sales of many blockbuster drugs being cannibalised by generic competitors, pharmaceutical and biotechnology companies are populating their pipelines with candidates directed at novel targets, enhancing development and commercialisation potential. The opportunities for small and medium-sized companies is increasing as the dynamic of the market changes.

This new report provides a complete assessment of the targeted cancer therapy landscape
Packed with statistics, competitive rankings, timelines and sector share comparisons, this report examines the current market for targeted cancer drugs, with an overview of both products and players. Looking ahead, the report identifies 79 new candidates that are currently under a minimum of Phase II development for solid tumours and provides a timeline detailing estimated launch dates to 2018. There is a review of the molecular targets on which industry attention is focused, and the companies involved in the development and commercialisation of the products directed against these targets. Finally, each product is considered individually in terms of its mode of action, current developmental status, clinical data, risks associated with development, developer and potential competition within the marketplace.

The global cancer market is changing fundamentally as broad spectrum drugs are superseded by advanced targeted therapies

Current therapeutic approaches for targeted agents will dominate...

With the success of products directed against established targets, such as ErbB (HER) and VEGF, the search continues for new and improved agents within these groups. For example, Roche is capitalising on the success of its HER2 inhibitor, Herceptin (trastuzumab), with the development of an antibody-drug conjugate, trastuzumab emtansine, which consists of the monoclonal antibody, trastuzumab, linked to the antimicrotubule agent, DM1. Pfizer has developed a multi-kinase inhibitor, dacomitinib, that targets HER1, 2 and 4, and has shown superiority to Roche's Tarceva (erlotinib) in extending progression-free survival in advanced non-small cell lung cancer patients. In addition, a variety of smallmolecule kinase inhibitors that target multiple components of the VEGF pathway and/or other angiogenic pathways are progressing through clinical trials.

...but will candidates directed at novel targets gain ground?
By 2018, Espicom expects that these new developmental candidates will account for 50% of targeted agents on the market by number. Among the pathways - and the products being developed - examined in the report are:

  • The Met pathway plays an important role in the development of cancer, so interfering with Met signalling would seem to be a promising therapeutic approach and a number of targeted agents are under development.
  • There is significant research interest in the PI3k/Akt signalling pathway which has shown an impressive improvement in overall survival.
  • A phosphatidylserine-targeting monoclonal antibody has the potential to be effective against a wide range of solid tumours.
  • Heat shock proteins are over-expressed in a wide range of human cancers and have been considered a promising target for cancer therapy, although the early Hsp inhibitors were dogged by drug-related toxicities. Those now progressing through clinical trials appear to show greater efficacy and less off-target activity.

How will the competitive landscape be affected?

A number of the larger players will continue to dominate the marketplace into 2018 with Roche, Takeda, Eli Lilly and BMS all estimated to have achieved five or more launches. However, significant opportunities exist for many smaller innovative pharma companies and biotechs, which by their very nature are proficient and well-suited to product development in niche markets.

Questions answered by the report

  • How many products are profiled treating lung, breast and colorectal cancer?
  • Which developmental pathways are much fancied to provide significant clinical advances and which companies are involved?
  • BMS, Eli Lilly, Roche, and Takeda all have five or more products in latestage expected to launch – what are they, what do they target and when are they expected?
  • What are the prospects for Teva Pharmaceutical Industries’ oncology portfolio?
  • Emerging opportunities: with whom are the smaller companies working and how many have yet to secure development/marketing collaborations?

About the Author: This report has been written by Sue Viney, a senior writer on Espicom’s oncology analysis team. Sue has been evaluating companies, products and drugs in research for 12 years. She is editor of Cancer Drug Futures and, in addition, has also produced management reports on the lung, colorectal, prostate and renal cancer areas, as well as studies on rheumatoid arthritis and CNS drug development.

More Information...

Use this new highly detailed and insightful report to...

  • Evaluate the prospects for established approaches such as VEGF and EGFr
  • Identify and understand the action and prospects for emerging new therapies
  • Understand the changes in the competitive landscape to 2018
  • Assess the products and companies developing novel therapies
  • Consider the timelines for each company’s product launch(es)
  • Examine in detail, for each of the 79 products assessed, key aspects related to:
    • Mode of Action
    • Current Status
    • Clinical Data
    • Development Risks
    • Developers
    • Competition within the
    • Marketplace
  • Evaluate which cancer areas are being targeted and by which products, approaches and companies

Targeted Cancer Drugs The Launch Landscape to 2018

Table Of Contents

Executive Summary

Targeted Cancer Therapies
What Are Targeted Cancer Therapies?
Why Are New Targeted Cancer Therapies Needed?
Approved Targeted Cancer Therapies
Products and Players

What the Future Holds
The Research and Development Pipeline
The Launch Landscape to 2018
Drug Launches By Target
The Players
The Current Players
The New Players
Drug Launches By Indication
Non-small Cell Lung Cancer
Breast Cancer
Colorectal Cancer
Renal Cell Carcinoma
Prostate Cancer
New Indications
Drug Launches By Type
Future Trends

Molecular Targets
Established Targets
Novel Targets

Targeted cancer Therapies under development
Vascular Endothelial Growth Factor Inhibitors
Angiocept
Axitinib
BMS-690514
Brivanib
Dovitinib
Linifanib
Motesanib
Ramucirumab
Regorafenib
Telatinib
Tivozanib
Vargatef
Zaltrap
Epidermal Growth Factor Receptor Inhibitors
AZD8931
Dacomitinib
Necitumumab
Neratinib
Omnitarg
RG7160
SAR256212
Tovok
Trastuzumab emtansine

Mammalian Target of Rapamycin Inhibitors
OSI-027
Ridaforolimus

Histone Deacetylase Inhibitors
Entinostat
Panobinostat

Heat Shock Protein Inhibitors
AUY922
Ganetespib
OGX-427
Retaspimycin

Insulin-like Growth Factor Receptor Inhibitors
BMS-754807
Cixutumumab
Dalotuzumab
Ganitumab
OSI-906

Met and Hepatocyte Growth Factor Inhibitors
Cabozantinib
Ficlatuzumab
Foretinib
MetMAb
MGCD265
Tivantinib

Poly-ADP-ribose Polymerase Inhibitors
CO-338
Iniparib
Olaparib
Veliparib

Phosphoinositide 3-kinase and Akt Inhibitors
BKM120
Enzastaurin
MK-2206
Perifosine
PX-866
SAR245408

Tumour Necrosis Factor Apoptosis-inducing Ligand Agonists
Mapatumumab
Tigatuzumab

Tumour Vasculature Inhibitors
AMG 386
Arenegyr
Bavituximab
BNC105
Carlumab
Cilengitide
DI17E6
E7820
Olaratumab
TASQ

Miscellaneous Novel Inhibitors
Alisertib
Amatuximab
Anyara
CDX-011
Custirsen sodium
Efatutazone
Farletuzumab
Imetelstat
KX2-391
LY2181308
Mesupron
Obatoclax
Rencarex
Selumetinib
Talactoferrin alpha
Vismodegib

Bibliography
Espicom Publications
Websites
Publications

List Of Tables

Launch Timeline for Targeted Cancer Therapies (1997-2011)
Research and Development Pipeline
The Launch Landscape for Targeted Cancer Therapies (2011-2018)
Roche Timeline
Bristol-Myers Squibb Timeline
Eli Lilly Timeline
Novartis Timeline
Amgen/Takeda Timeline
AstraZeneca Timeline
Daiichi Sankyo Timeline
Pfizer Timeline
Sanofi Timeline
Astellas Pharma Timeline
GlaxoSmithKline Timeline
Merck & Co Timeline
Merck KGaA Timeline
Johnson & Johnson Timeline
Bayer Timeline
Abbott Timeline
Boehringer Ingelheim Timeline
Exelixis Timeline
Teva Pharmaceutical Industries Timeline
AEterna Zentaris Timeline
Peregrine Pharmaceuticals Timeline
Other New Company Timelines
Development and Commercialisation Status of New Players in Targeted Cancer Drug Market ? 30
Non-small Cell Lung Cancer Products
Breast Cancer Products
Colorectal Cancer Products
Renal Cell Carcinoma Products
Prostate Cancer Products
First Launches for New Indications
Vascular Endothelial Growth Factor (VEGF)
Epidermal Growth Factor Receptor (EGFr)
Mammalian Target of Rapamycin (mTOR)
Histone Deacetylase (HDAC)
Heat Shock Proteins (Hsps)
Insulin-Like Growth Factor Receptor (IGFr)
Met and Hepatocyte Growth Factor (HGF)
Poly-ADP-ribose polymerase (PARP)
Phosphoinositide 3-kinase (PI3K) and Akt
Tumour Necrosis Factor Apoptosis-inducing Ligand (TRAIL)
Tumour Vasculature
Other Novel Targets
Development Products Targeting VEGF/VEGFr
Development Products Targeting ErbB Receptors
LUX-Lung Trials
Development Products Targeting mTOR
Development Products Targeting HDAC
Development Products Targeting Hsps
Development Products Targeting IGFr
Development Products Targeting Met
Development Products Targeting PARP
Development Products Targeting PI3K and Akt
Development Products Targeting TRAIL
Development Products Targeting Tumour Vasculature
Miscellaneous Development Products

List Of Charts

Sales of Major Targeted Drugs, 2010
Sales of Major Targeted Drugs by Company, 2010
Drug Targets by Market Share, 2010
Drug Targets by Value, 2010
Drug Type by Market Share and Value, 2010
Number of Approved Drugs by Target (2011)
Estimated Launches of New Agents by Target (2012-2018)
Targets by Number of Approved Drugs (2018)
Number of Drugs Directed Against Novel Targets (2018)
Approved Targeted Agents by Company (2012)
Estimated Launches of New Agents by Company (2012-2018)
Companies with Launched Targeted Agents by 2018
First Launches by Indication (2012-2018)
Targeted Therapy Breast Cancer Sales (2010)
Drug Type by Number of Approved Agents (2011)
Drug Type by Number of Approved Agents (2018)
Estimated Launches of New Agents by Drug Type (2012-2018)
Dovitinib Mode of Action
HER2 Signalling Pathway
Epigenetic Modification of a Histone
Panobinostat Mode of Action
AUY922 Mode of Action Within a Cancer Cell
Ganetespib Mode of Action
Upregulation of Met as a Response to Treatment
Onartuzumab Mechanism of Action
Perifosine Mechanism of Action
PX-866 Mode of Action
Mapatumumab Mode of Action
Arenegyr Structure
Naptumomab Mode of Action
Girentuximab Mode of Action
Talactoferrin Alpha Mode of Action in Cancer

Published By: Espicom Limited
Product Code: Espicom Limited425


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