The Complete Guide to Companion Diagnostics: Market Environment Products and Companies

Introduction

Are companion diagnostics a win-win-win?

Over the last 2-3 years companion diagnostics have risen in topicality and importance. The drivers for their growth can easily be identified, and despite some industry fears, their impact has generally been favourable. So is everyone a winner?

While ‘personalised medicine' (or theranostics) is not new it is only relatively recently that diagnostics companies and pharma have converged to explore and exploit its potential benefits. By using companion diagnostics, companies can identify those patients who will benefit most from, or suffer fewer side effects from targeted therapies, and thereby present a more compelling approval and prescribing case to regulators and clinicians.

It could prove to be a lifesaver for a company. For the last few years, the leading players have had some success with line extensions through launches or improved formulations or combinations. However, the lack of new novel products coming through their pipelines means that even these are no longer guaranteed to provide sufficient income in the medium term, let alone the long term.

The first fact for the pharma industry to acknowledge is that the genie is out of the bottle: having seen the therapeutic and cost saving benefits of using companion diagnostics, regulators, clinicians and health payers will want to use the technology as a practice standard. Interestingly, at the end of 2011 two new molecularly-targeted cancer drugs, Pfizer's Xalkori (crizotinib) and Roche's Zelboraf (vemurafenib) were both launched alongside companion diagnostic tests.

And here is the trade off. Companion diagnostics will ensure closer scrutiny of efficacy and cost benefit by regulators, users and health payers but also will end any revenue generating speculative prescribing. With the days of blockbuster drugs such as Lipitor (atorvastatin) and Avastin (bevacizumab) becoming fewer and farther between, companies have been forced to look to other revenue sources and security, and having prescribing assurance may well prove to be of great benefit. Only time will tell.

All you need to know in this comprehensive and concise report

This compelling new market study from Espicom provides a complete appraisal of the competitive, regulatory and product issues shaping the fast-growing companion diagnostics sector. Essential reading for pharma and diagnostic company executives!

Companion diagnostics are here to stay. It is unthinkable that, in time, biologic drugs will be approved without them.

Impact on stakeholders in companion diagnostics

There are numerous stakeholders in the companion diagnostic market from technology developers to the clinicians using them. How are they affecting these groups?

Benefits for clinicians:

Clinician confidence is also crucial when it comes to prescribing a product. Why pay for costly diagnostic tests when there are cheaper, established products available which do not require genetic testing? However, if a specific subset of patients that will benefit from the therapy can be readily and accurately identified, companies will be better able to convince prescribers that these benefits are worth the extra expense. The use of companion diagnostics should, therefore, increase both physician and patient confidence in the products, as well as satisfying the requirements of regulatory bodies and smoothing the path to market.

Benefits for pharma: improving clinical trial results and supporting new applications

Limiting the patient population based on genomic analysis with companion diagnostics can improve clinical trial data for a new drug and strengthen the case for regulatory approvals for use in targeted patient populations. This use of biomarkers to enhance trial results is expected to become the norm rather than the exception and may expand the use of the product by seeking a higher level of regulatory approval.

Furthermore, the use of companion diagnostics may reinvigorate interest in the back file of products that failed to jump regulatory hurdles related to efficacy in larger patient populations if it can be proven that specific patient subsets would benefit.

Benefits for payers: more assurance that money will be well spent

With a couple of notable exceptions, the rise of targeted therapies has been hampered by their relatively poor improvements in real-world therapeutic benefits relative to their sometimes eye-watering expense. The role played by pharmacoeconomics cannot be understated: health payers do not want to pay for expensive medicines unless there is confidence that the therapeutic benefit will be achieved. Companion diagnostics go a long way to providing that confidence by determining the appropriateness of a drug to a given disease state.

The challenge for regulators

The companion diagnostics market has grown very rapidly, and regulators have been running to catch up. Drug developers need clear guidance which sets out the regulatory bodies' expectations and standards for approval. So far, there has been little attempt by regulatory agencies to impose too many restrictions or enforce a parallel approval process. While this policy looks set to continue, however, we are already seeing an increase in companion diagnostic tests being stipulated as a requirement within the approval process and it may be inevitable that some standardisation of the guidelines is necessary.

An example of the regulatory muddle can be seen in drug labels. From an analysis of labels of previously-approved products it is possible to identify drugs that require companion diagnostics, although the lack of clear regulatory guidance means that there is considerable variation in how this information is presented in the drug label.

This is a developing area. The FDA is currently in Phase III of its programme to provide guidance for personalised medicine. Final guidance for in vitro companion diagnostic devices was anticipated for the end of June 2012. However, at the time of publication of this report, this had not materialised.

Providing....

A detailed understanding of the situation relating to companion diagnostics submission, approval and labelling in the US and Europe

An understanding of the challenges facing regulators and the impact on the market

Listings of 30 products which might benefit commercially from having a companion diagnostic

A detailed review of 27 drugs and their current status in respect to companion diagnostics

An examination of 26 pharmaceutical companies and the strategic deals they have with diagnostic companies

Analysis of diagnostics companies and their alliances

Listings of approved companion diagnostics and their developers

A good example of the positive role played by companion diagnostics and gene profiling is Amgen's colorectal cancer treatment Vectibix.

In clinical trials for late-stage therapy, researchers identified that some tumours with KRAS mutations did not respond to treatment by the drug. The ongoing Phase III studies for first and second-line therapy were altered to exclude these patients in order to support the use of the drug earlier in the treatment cycle.

When launched in September 2006, there was no selection for KRAS mutations. However, it turns out that around 60% of patients have the normal, wild-type form of KRAS which is responsive to Vectibix.

Armed with this new information, Amgen filed Vectibix for first- and second-line therapy of metastatic colorectal cancer in Europe in April 2010 and the US in October and November 2010. The FDA indicated that in order for Vectibix to be approved for these indications, there must be a commercially-available, FDA-approved KRAS test kit and Amgen worked with Qiagen to fulfil this requirement.

In November 2011, the EC approved a variation to the marketing authorisation for Vectibix to include indications for the treatment of patients with wild-type KRAS mCRC in first- and second-line in combination with chemotherapy.

These extended indications should enable Vectibix to enhance its position in the market place.

So everybody's happy?

Gaining a wider indication is no guarantee of commercial success. Vectibix must still compete with other products which have already gained approval. In such situations healthcare providers may well tend to favour those therapies with the broadest labels such as Avastin.

In 2009, when available as a third-line therapy, sales of Vectibix totalled US$233 million. Sales of Vectibix amounted to US$322 million in 2011 and in the first half of 2012.

Table of Contents

FOREWORD

EXECUTIVE SUMMARY

COMPANION DIAGNOSTICS

• Towards Personalised Medicine
  • Pharmacogenomics and Targeted Therapies
  • What Are Biomarkers?
    • Biomarkers in Clinical Diagnostics
    • Genomic Biomarkers for Clinical Diagnostics
  • What Are In Vitro Diagnostics?
    • Clinical Chemistry
    • Immunochemistry
    • Haematology
    • Haemostasis
    • Microbiology
    • Molecular Diagnostics
  • What Are Companion Diagnostics?
  • Advantages of Companion Diagnostics
    • Narrowing the Patient Population
    • Reducing Development Costs
    • Increased Sales
  • A Cautionary Tale
  • Drug Labels

REGULATORY FRAMEWORK

• Pharmaceutical Products
  • United States
  • European Union
• Companion Diagnostics
  • United States
    • What is a Premarket Approval (PMA)?
    • What is a 510(k) Premarketing Notification?
  • European Union
• Proposed Changes to the Regulatory Framework

PRODUCTS

• Pharmaceuticals
  • Erbitux (cetuximab)
  • Faslodex (fulvestrant)
  • Glivec/Gleevec (imatinib)
  • Herceptin (trastuzumab)
  • Iressa (gefitinib)
  • Kalydeco (ivakaftor)
  • Perjeta (pertuzumab)
  • Poteligeo (mogamulizumab)
  • Selzentry (maraviroc)
  • Sprycel (dasatinib)
  • Tarceva (erlotinib)
  • Tasigna (nilotinib)
  • Tykerb/Tyverb (lapatinib)
  • Tysabri (natalizumab)
  • Vectibix (panitumumab)
  • Xalkori (crizotinib)
  • Xeloda (capecitabine)
  • Zelboraf (vemurafenib)
• In Vitro Companion Diagnostics
  • Inform HER2 Dual ISH
  • My5-FU
  • OncoCEE-BR
  • OncoDefender
  • Therascreen KRAS RGQ PCR Kit
  • Vysis ALK Break Apart FISH Probe Kit
• What's in the Pipeline?

COMPANIES

• Agreements
• Pharmaceutical/Biotechnology Companies
  • AEterna Zentaris
  • Amgen
  • ARIAD Pharmaceuticals
  • Astellas Pharma
    • Agreement with Cell Signaling Technologies
    • Agreement with Roche
    • Agreement with Dako (Agilent)
  • AstraZeneca
    • Agreement with Roche Diagnostics
    • Agreement with Dako
    • Agreement with QIAGEN
  • Bayer Healthcare
    • Agreement with QIAGEN
    • Agreement with Ventana Medical Systems
  • Biogen Idec & Elan
    • Tysabri and STRATIFY JCV Antibody ELISA Test
    • Biogen Idec's Agreement with Regulus Therapeutics
  • Boehringer Ingelheim
    • Agreement with QIAGEN
  • Bristol-Myers Squibb
    • Agreement with Life Technologies
    • Agreement with Saladax Biomedical
    • Agreement with Dako
    • Agreement with QIAGEN
  • Celldex Therapeutics
  • Clovis Oncology
    • Agreement with Array BioPharma
    • Agreement with Roche
    • Agreement with MDxHealth
  • Eisai
    • Morphotek Agreement with Biocare
  • Eli Lilly
    • Agreement with PrimeraDx
    • Agreement with QIAGEN
  • GlaxoSmithKline
    • Agreements with Abbott
    • Agreements with bioMerieux
    • Agreement with Life Technologies
  • Ipsen
  • Johnson & Johnson
  • Merck & Co
    • Agreement with Abbott
    • Agreement with BGI
    • Agreements with Roche
  • Merck KGaA
    • Agreement with MDxHealth
  • Novartis
    • Agreement with InVivoScribe Technologies
  • Pfizer
    • Xalkori (crizotinib) and the Vysis ALK Break Apart FISH Probe Kit
    • Agreement with Ventana Medical Systems (Roche) and Cell Signaling Technology
    • Agreement with QIAGEN
    • Agreement with Oxford BioMedica
  • Roche
    • Agreements with Dako (Agilent)
    • Agreement with Psynova Neurotech
  • SuppreMol
  • Syndax Pharmaceuticals
  • Tocagen
  • Transgene
  • UCB
  • ViiV Healthcare
• Diagnostic Companies
  • Abbott
    • Agreements
  • BioGenex Laboratories
  • Clarient Diagnostic Services (a GE Company)
  • CompanDX Ltd
  • Dako (Agilent Technologies)
    • Agreements
  • Everist Genomics
  • Genomic Health
  • HTG Molecular Diagnostics
  • Life Technologies
  • MDxHealth
  • Myriad Genetics
  • Prometheus Laboratories
  • QIAGEN
    • Agreements
  • Roche Diagnostics
    • Roche Tissue Diagnostics (Ventana Medical Systems)
    • Roche Molecular Diagnostics
    • Roche Professional Diagnostics
    • Siemens Healthcare Diagnostics

SOURCES

• Approved Targeted Cancer Drugs; Pharmacogenomic Data (US labels)
• Biomarkers in Drug Labels
• Selected Approved Therapeutic Products with Identified Biomarkers
• FDA-Approved HER2 Tests
• FDA Approved In Vitro Companion Diagnostics
• Products in Clinical Development with Associated Companion Diagnostics
• Roche Diagnostics' Key Approved Companion Diagnostic Tests
• Ventana Medical Systems' Diagnostic Agreements
• Roche Molecular Diagnostics Agreements
• Roche Professional Diagnostics Agreements

• Pharmacogenomic Data for Approved Targeted Cancer Drugs (US Labels)
• US Drug Labels with Pharmacogenomic Information, Number by Therapeutic Area
• Pharmacogenomic Biomarkers in US Drug Labels
• US Drug Labels with Pharmacogenomic Test Requirements by Therapeutic Area
• Sales of Major Therapeutic Products (2011)
• Companion Diagnostics Agreement Activity, 2009- Q3 2012
• Agreement Activity by Year, 2009-Q3 2012
• Agreement Activity by Therapeutic Area, 2009-Q3 2012
• Pharmaceutical/Biotechnology Company Agreement Activity, 2009-Q3 2012
• Diagnostic Company Agreement Activity, 2009-Q3 2012

The Complete Guide to Companion Diagnostics: Market Environment Products and Companies published by Espicom Business Intelligence in November 21, 2012. This report consists of Pages: 78 and the price starts from US $ 1740.

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