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Strategies for Effective Partnerships Between Pharmaceutical and Diagnostic
Companies

Published:October 2011
No.Of Pages:100
Price:US $ 3835




Introduction

This report examines the various models that are being adopted by players and uses case
studies to highlight the risks and rewards of different approaches to Pharmaceutical and
Diagnostic Companies Partnership Strategies. The challenges facing companies when
entering into a collaboration and factors that should be taken into account when selecting a
partner are reviewed and recommendations given as to best practices in partnering.

Features and benefits

* With the use of case studies understand the various approaches to pharma-diagnostic
collaboration and decide the best fit for your company.
* Evaluate the benefits and disadvantages of emerging business models and collaborative
agreements for drug diagnostic co-development.
* Evaluate alternative partnership models that can drive revenue growth for both diagnostic
and pharma players.
* Understand regulatory trends that will influence the reimbursement status of both the
drug and diagnostic in any combined offering.
* Learn how to get the most out of a deal from both the pharma and the diagnostic
company's perspective.

Highlights

* The need for tropism testing to select patients for Pfizer’s maraviroc, prompted a co-
development collaboration with Monogram Biosciences, that’s laboratory-developed test was
the only clinically validated tropism assay. The partnership underlines the need for
education of physicians and the role of guidelines to support use of the assay.
* Prometheus achieved a five-fold increase in sales in six years for AstraZeneca’s treatment
for Crohn’s disease, Entocort EC, by promoting its IBD serology test in conjunction with the
therapy. The sales and marketing model focused on both diagnosis and treatment of
irritable bowel disease, an area in which differential diagnosis is difficult.
* Entering into a partnership early will facilitate a coordinated approach to simultaneous
approval and availability of the Rx and companion Dx. Formal working processes and
dedicated project teams engender transparency and good communication channels between
both partners.

Browse All Pharmaceuticals Market Research Reports
Table Of Contents

About the author
Disclaimer

EXECUTIVE SUMMARY

The personalized medicine paradigm
Co-development partnerships
Retrospective development alliances
Alternative partnership models
Best practices in RxDx partnering
Future trends influencing RxDx partnerships

The personalized medicine paradigm

Summary
Introduction
Drivers of Rx/Dx partnerships
Regulatory drivers
EU regulatory initiatives
A convergence of different industry sectors
Partnership trends
Scope of report

Co-development partnerships

Summary
Introduction
Genentech/Dako: Herceptin/HercepTest
The partnership
The results
Observations
Pfizer/Monogram Biosciences: Selzentry/Trofile
The partnership
Results
Observations
Plexxikon/Roche: Zelboraf/BRAF test
The partnership
Results
Observations
Bayer Schering/Prometheus
The partnership
Observations
Novartis/Invivoscribe: midostaurin/FLT3
The partnership
Observations
Retrospective development alliances

Summary
Introduction
Vectibix/Erbitux:KRAS
The partnerships
Observations
Iressa (AstraZeneca)/Qiagen
The partnership
Observations

Alternative partnership models

Summary
Introduction
Prometheus/Entocort
The partnership
The results
Observations
Takeda/Zinfandel: pioglitazone/TOMM40 assay
Background
The partnership
Observations
GSK/Enigma Diagnostics
The partnership
Observations
Dako/Quintiles
Background
The partnership
Observations
Medco/MolecularMD
The partnership
Observations

Best practices in RxDx partnering
Summary
Introduction
What are pharma companies looking for?
What are Dx companies looking for?
Negotiating the deal
Ingredients of a successful relationship
Start early
Sharing a common goal
Mutual understanding of different business models
Understanding risks
Good working processes
Reimbursement
Commercialization

Future trends influencing RxDx partnerships
Summary
Introduction
Industry dynamics
Regulators take proactive role
Pricing and reimbursement environment
UK Stratified Medicine initiative
Appendix
Bibliography/References
Abbreviations

LIST OF TABLES

Table: Scope of Rx-Dx partnership deals in Jan-August 2011

LIST OF FIGURES

Figure:   Therapeutic categories of drugs with pharmacogenomic biomarkers in US label
Figure:   Ideal Rx-Dx co-development scenario
Figure:   Rx-Dx partnership deals 2007-2011
Figure:   Zelboraf & CDx – From discovery to approval
Figure:   KRAS timeline
Figure:   Percentage of mCRC patients tested for KRAS
Figure:   Sales of Entocort EC, 2005-2010, $m
Figure:   Key considerations when choosing a Dx partner
Figure:   Key considerations when choosing a Rx partner

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Strategies for effective partnerships between pharmaceutical and diagnostic companies

  • 1. Strategies for Effective Partnerships Between Pharmaceutical and Diagnostic Companies Published:October 2011 No.Of Pages:100 Price:US $ 3835 Introduction This report examines the various models that are being adopted by players and uses case studies to highlight the risks and rewards of different approaches to Pharmaceutical and Diagnostic Companies Partnership Strategies. The challenges facing companies when entering into a collaboration and factors that should be taken into account when selecting a partner are reviewed and recommendations given as to best practices in partnering. Features and benefits * With the use of case studies understand the various approaches to pharma-diagnostic collaboration and decide the best fit for your company. * Evaluate the benefits and disadvantages of emerging business models and collaborative agreements for drug diagnostic co-development. * Evaluate alternative partnership models that can drive revenue growth for both diagnostic and pharma players. * Understand regulatory trends that will influence the reimbursement status of both the drug and diagnostic in any combined offering. * Learn how to get the most out of a deal from both the pharma and the diagnostic company's perspective. Highlights * The need for tropism testing to select patients for Pfizer’s maraviroc, prompted a co- development collaboration with Monogram Biosciences, that’s laboratory-developed test was the only clinically validated tropism assay. The partnership underlines the need for education of physicians and the role of guidelines to support use of the assay. * Prometheus achieved a five-fold increase in sales in six years for AstraZeneca’s treatment for Crohn’s disease, Entocort EC, by promoting its IBD serology test in conjunction with the therapy. The sales and marketing model focused on both diagnosis and treatment of irritable bowel disease, an area in which differential diagnosis is difficult. * Entering into a partnership early will facilitate a coordinated approach to simultaneous approval and availability of the Rx and companion Dx. Formal working processes and dedicated project teams engender transparency and good communication channels between both partners. Browse All Pharmaceuticals Market Research Reports
  • 2. Table Of Contents About the author Disclaimer EXECUTIVE SUMMARY The personalized medicine paradigm Co-development partnerships Retrospective development alliances Alternative partnership models Best practices in RxDx partnering Future trends influencing RxDx partnerships The personalized medicine paradigm Summary Introduction Drivers of Rx/Dx partnerships Regulatory drivers EU regulatory initiatives A convergence of different industry sectors Partnership trends Scope of report Co-development partnerships Summary Introduction Genentech/Dako: Herceptin/HercepTest The partnership The results Observations Pfizer/Monogram Biosciences: Selzentry/Trofile The partnership Results Observations Plexxikon/Roche: Zelboraf/BRAF test The partnership Results Observations Bayer Schering/Prometheus The partnership Observations Novartis/Invivoscribe: midostaurin/FLT3 The partnership Observations
  • 3. Retrospective development alliances Summary Introduction Vectibix/Erbitux:KRAS The partnerships Observations Iressa (AstraZeneca)/Qiagen The partnership Observations Alternative partnership models Summary Introduction Prometheus/Entocort The partnership The results Observations Takeda/Zinfandel: pioglitazone/TOMM40 assay Background The partnership Observations GSK/Enigma Diagnostics The partnership Observations Dako/Quintiles Background The partnership Observations Medco/MolecularMD The partnership Observations Best practices in RxDx partnering Summary Introduction What are pharma companies looking for? What are Dx companies looking for? Negotiating the deal Ingredients of a successful relationship Start early Sharing a common goal Mutual understanding of different business models Understanding risks Good working processes Reimbursement Commercialization Future trends influencing RxDx partnerships Summary
  • 4. Introduction Industry dynamics Regulators take proactive role Pricing and reimbursement environment UK Stratified Medicine initiative Appendix Bibliography/References Abbreviations LIST OF TABLES Table: Scope of Rx-Dx partnership deals in Jan-August 2011 LIST OF FIGURES Figure: Therapeutic categories of drugs with pharmacogenomic biomarkers in US label Figure: Ideal Rx-Dx co-development scenario Figure: Rx-Dx partnership deals 2007-2011 Figure: Zelboraf & CDx – From discovery to approval Figure: KRAS timeline Figure: Percentage of mCRC patients tested for KRAS Figure: Sales of Entocort EC, 2005-2010, $m Figure: Key considerations when choosing a Dx partner Figure: Key considerations when choosing a Rx partner About Us: ReportsnReports is an online library of over 100,000+ market research reports and in-depth market research studies & analysis of over 5000 micro markets. We provide 24/7 online and offline support to our customers. Get in touch with us for your needs of market research reports. Follow us on Twitter: http://twitter.com/marketsreports Our Facebook Page: http://www.facebook.com/pages/ReportsnReports/191441427571689 Contact: Mr.Priyank 7557 Rambler road, Suite727,Dallas,TX75231 Tel: + 1 888 391 5441 E-mail: sales@reportsandreports.com http://www.reportsnreports.com Visit our Market Research Blog