Targeted Cancer Drugs The Launch Landscape to 2018

Date: February 3, 2012
Pages: 306
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US$ 2,265.00
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Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: T156EB826CFEN
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Targeted Cancer Drugs The Launch Landscape to 2018
As the cancer therapy market evolves, interest is growing in novel approaches that 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, timelines and sector share comparisons, this report examines the current market for targeted cancer drugs, and provides an overview of both products and players into 2018. 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?
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
  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 �
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)

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
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
Arenegyr Structure
Naptumomab Mode of Action
Girentuximab Mode of Action
Talactoferrin Alpha Mode of Action in Cancer
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