Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges

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Key Trends In Drug-diagnostic Co-development: Identifying
collaborative opportunities and navigating regulatory challenges
Published on June 2009

Report Summary

Key Trends in Drug-Diagnostic Co-Development
Identifying collaborative opportunities and navigating regulatory challenges

Report Overview

The development of genomics-based molecular diagnostics that are linked to therapeutic products is critical to targeted drug
developments of the future. The potential for molecular diagnostics to be used as companion products for personalized treatments
that are based on patient characteristics will contribute to a growing trend for new partnerships between drug companies and
diagnostic firms. 'Key Trends in Drug-Diagnostic Co-Development' is a report published by Business Insights that explores the
potential for applying genomic-based diagnostics to new drug developments, and the resultant implications for the pharma/biotech
and diagnostic industries. This report examines the commercial and regulatory challenges facing drug-diagnostic combinations and
evaluates emerging business models to identify the most effective forms of pharmacodiagnostic partnership. This report also reviews
28 collaborative agreements for the co-development of drug-diagnostics and determines which combinations can be expected to
result in commercial products in the near future.

Key Findings

There have been 28 Rx-Dx co-development projects identified, of which 17 are in the oncology area. The remainder have been found
to cover cardiovascular, CNS, autoimmune, infectious diseases, HIV and growth factors.

There is a growing trend for co-development partnerships to be made during the early stages of drug development. An analysis of
ongoing co-development projects indicates that more deals are being concluded well in advance of Phase II clinical trial completion.

Gaining physicians' support is crucial to ensure clinical adoption for drug-test combinations, although labelling is also of great
importance. It is estimated that 80-90% of US prescriptions are being written for cetuximab or panitumumab based on a K-Ras
negative test result.

Third-party studies will be a significant driver in gaining acceptance for the use of pharmacogenomic information to optimize drug
usage. Work currently being done by US PBM Medco to generate data in the real-world setting will support manufacturers' own
initiatives.

Roche's 'one-stop shop' model is being emulated by a number of companies across the pharma industry. Novartis is the latest major
company to establish a molecular diagnostics business.

Use this report to...

' Identify recent regulatory trends in the field of Rx-Dx co-development and determine how these will affect the use of biomarker data
at different stages of drug development with this report's analysis of the US and EU regulatory landscape.

Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges Page 1/8


' Understand how to overcome the commercial challenges associated with drug-diagnostic combinations and evaluate the benefits
and disadvantages of emerging business models and collaborative agreements.

' Compare 28 Rx-Dx co-development projects at various stages of development with this report's review of collaborative agreements
involving 15 diagnostic companies and 17 pharma companies.

' Assess the future outlook for pharma and diagnostic collaborations by analyzing the impact of pharmacogenomics-based patient
management and changing approaches to pharma R&D.

Explore issues including...

Technology is outpacing regulatory guidance on Rx-Dx co-development. Pharma and diagnostic companies face numerous regulatory
hurdles when developing combination products. Although final US FDA guidance is pending, the EU is developing a reflection paper
on the co-development of PGx biomarkers and test platforms, which is due by the end of 2009.

Personalized medicine becoming a reality. The use of PGx information in drug development will contribute to individualized medical
treatments and a shift away from the 'onesize fits all' drug. The increasing number of drugs with genetic biomarkers will foster
collaborations with diagnostic partners.

The evolving pharma R&D model. The shift from the blockbuster model towards targeted therapies will require a different strategic
approach to R&D. With pharma spending on biomarker R&D more than doubling over 2003-09, new alliances with diagnostic players
will become common. More drugs will be granted orphan status as target patient populations become better defined.

Discover...

' What are the key regulatory and commercial challenges in co-developing drug-test combinations'

' What type/amount of data is needed to support product labelling using biomarkers'

' How will the emergence of new biomarker data impact drug development programmes'

' What are the advantages of having drug and diagnostic development based at one location'

' Why is it important to complete analytic validation of an IVD test before applying the test to specimens in clinical trials that will be
used for regulatory review'

' How can companies work with payors to encourage uptake of tests'

' What factors need to be considered to ensure that tests to guide clinical decisions do not impede patient access to treatment'

Table of Content

Table of Contents
Key Trends in Drug-Diagnostic Co-Development Executive summary 10



Introduction to drug-diagnostic co-development 10
Regulatory challenges 11
Commercial challenges 12
Emerging business models 13
Rx-Dx collaborations 14
Future trends 15
Chapter 1 Introduction to drug-diagnostic co-development 18
Summary 18
Introduction 19
Technology driving change 19
Biomarkers & personalized medicine 20
Convergence of players 22
The role of Dx in personalized medicine 23
Targeted therapeutic developments 25
New industry partnerships 26
Companion test development models 27
Chapter 2 Regulatory challenges 32
Summary 32
Introduction 33
US regulatory landscape 34
Voluntary genomic data submissions (VGDS) 34
Rx-Dx co-development guidance 34
IVDMIA guidance 35
Dx usage determines risk 37
Study design 40
EU regulatory process 41
IVD regulatory framework under discussion 41
Pharmacogenomics in drug development 42
Potential advantages of the EU system 43
Case Study: K-RAS 44
Chapter 3 Key commercial challenges 48
Summary 48
Introduction 49
Reimbursement 50
Information requirements 51
European situation 52
Case Study: Oncotype DX 52
Role of health economics 54
Third-party studies 55
Clinical use 57
Different clinical settings 58
Intellectual property 59
Chapter 4 Emerging business models 62
Summary 62
Introduction 63
One-stop shop 63
Case Study: Roche 66
Acquisitions 66
Alignment of business areas 67
Companion Dx programs 69



Rx-Dx industry partnerships 70
Drivers of co-development partnerships 71
Types of agreements 72
Case Study: Pfizer-Monogram Biosciences 73
Collaborations underway 76
Chapter 5 Rx-Dx collaborations 78
Summary 78
Introduction 79
Asuragen 81
Background 81
Collaboration 81
Merck & Co 81
BG Medicine 82
Background 82
Collaboration 82
Cordex Pharma 82
bioMérieux 82
Background 82
Collaboration 83
Ispen 83
Merck & Co 83
ADNA project 83
Celera 84
Background 84
Collaboration 85
Abbott 85
Merck & Co 85
Ipsen 86
Curidium 86
Background 86
Collaboration 86
Takeda 86
Dako 87
Background 87
Collaboration 87
OSI Pharmaceuticals 87
Genentech 87
Bristol-Myers Squibb 88
DxS 88
Background 88
Collaboration 88
Amgen 89
Roche Molecular Diagnostics 89
GE Healthcare 90
Background 90
Collaboration 90
Eli Lilly 90
Genomic Health 91
Background 91
Collaboration 91



Pfizer 91
Bristol-Myers Squibb and Imclone Systems 91
HistoRx 92
Background 92
Collaboration 93
Lilly 93
LabCorp 93
Background 93
Collaboration 93
ARCA biopharma 94
Vanda Pharmaceuticals 95
Medco Health Solutions 95
Monogram Biosciences 96
Background 96
Collaboration 96
Pfizer HIV partnership 96
Oncology 97
OncoMethylome Sciences 97
Background 97
Collaboration 97
Merck KGaA 98
Schering-Plough 98
GlaxoSmithKline Biologicals 98
Abbott 98
Source MDx 98
Background 98
Collaboration 99
Pfizer 99
XDx 99
Background 99
Collaboration 100
Bristol-Myers Squibb 100
Chapter 6 Future trends 102
Summary 102
Introduction 103
New paradigm for pharma R&D 104
Rx-Dx combinations in pipeline 105
Changing dynamics of the IVD industry 107
Biomarker discovery for existing drugs 108
Next generation tests 109
Conclusions 110
Appendix 112
Research methodology 112
Glossary 112
Index 114
List of Figures
Figure 1.1: Biomarker discovery is comparable to drug discovery 21
Figure 1.2: Convergence of drug and diagnostic industries 22
Figure 1.3: Main therapy areas for Rx-Dx co-development (number of diagnostic tests) 27
Figure 1.4: Ideal Rx-Dx co-development scenario 28



Figure 1.5: Alternative co-development scenarios 29
Figure 2.6: Regulatory pathways for diagnostics in the US 36
Figure 2.7: Problems when patient accrual is gated via non-final IVD 39
Figure 3.8: Pre and post-approval challenges of Rx-Dx co-development 49
Figure 3.9: Difference between obtaining reimbursement in US and Europe 52
Figure 4.10: Roche Group sales by type (% of revenues), 2008 67
Figure 4.11: Diagnostic input for pharma projects 68
Figure 4.12: Rx-Dx partnership opportunities 70
Figure 6.13: Biomarker R&D expenditure ($bn), 2003 vs 2009 105
Figure 6.14: Forecast sales in IVD market ($bn), 2007-2012 107
List of Tables
Table 1.1: Drugs for which testing is recommended/required in the US 25
Table 1.2: Co-developed Rx-Dx combinations on market 26
Table 4.3: Biomarker strategy for Phase I/II oncology drugs 68
Table 4.4: Summary of Rx-Dx Co-Development Projects 76
Table 5.5: Rx-Dx co-development projects under review 80
Table 6.6: Patient population in whom selected drugs do not work (% population) 103



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Key Trends In Drug-diagnostic Co-development: Identifying collaborative opportunities and navigating regulatory challenges