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Partnering Agreements In Diagnostics

Trends in diagnostics partnering deals Diagnostic partnering agreement structure Diagnostic partnering contract documents Top diagnostic deals by value Most active diagnostic dealmakers

Publication Date September 2009
Publisher CurrentPartnering
Product Type Report
Pages 209
ISBN Number not applicable
Product Code CTP00113

Summary

The report provides a detailed understanding and analysis of how and why companies enter diagnostic partnering deals. The majority of deals are development stage whereby the licensee obtains a right or an option right to license the licensors diagnostic technology or product candidates. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes.

There are also a significant number of late stage and marketed diagnostic product partnering deals announced each year, where the licensor is seeking a partner to manufacture, supply, market, distribute or co-promote the product to enhance market coverage. This is particularly prevalent in diagnostics as partners often rely on diagnostic specialists to manufacture, distribute and supply products to the market.

A relatively unique characteristic of diagnostic partnering is the amount of acquisition activity relative to the total number of partnering deals, especially in recent years. It would appear that many biopharma companies have sought to acquire rather than partner diagnostic intellectual property, providing access to ready-made development expertise.

Another unique characteristic of diagnostic partnering is the number of litigation and settlement agreements relative to the total number of partnering deals.

This report provides details of the latest diagnostics agreements announced in the healthcare sectors.

Understanding the flexibility of a prospective partner’s negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered – contract documents provide this insight where press releases and databases do not.

This report contains a comprehensive listing of all diagnostics partnering contract agreements announced since 2003 including financial terms plus over 500 links to online copies of actual diagnostic contract documents as submitted to the Securities Exchange Commission by companies and their partners.

Contract documents provide the answers to numerous questions about a prospective partner’s flexibility on a wide range of important issues, many of which will have a significant impact on each party’s ability to derive value from the deal.

For example, analyzing actual company agreements allows assessment of the following:
o What is actually granted by the agreement to the partner company?
o What exclusivity is granted?
o What are the precise co-promotion and co-marketing rights granted or optioned?
o What is the payment structure for the deal?
o How are sales and payments audited?
o What is the deal term?
o How are the key terms of the agreement defined?
o How are IPRs handled and owned?
o Who is responsible for commercialization?
o Who is responsible for development, supply, and manufacture?
o How is confidentiality and publication managed?
o How are disputes to be resolved?
o Under what conditions can the deal be terminated?
o What happens when there is a change of ownership?
o What sublicensing and subcontracting provisions have been agreed?
o Which boilerplate clauses does the company insist upon?
o Which boilerplate clauses appear to differ from partner to partner or deal type to deal type?
o Which jurisdiction does the company insist upon for agreement law?
The initial chapters of this report provide an orientation of diagnostic dealmaking and business activities.

Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of diagnostic dealmaking since 2000. The chapter includes numerous case studies to enable understanding of diagnostic dealmaking.

Chapter 3 provides an overview of the trends in diagnostic dealmaking since 2000.

Chapter 4 provides a review of the leading diagnostic deals since 2000. Deals are listed by headline value, signed by bigpharma, most active bigpharma, and most active of all biopharma companies. Where the deal has an agreement contract published at the SEC a link provides online access to the contract.

Chapter 5 provides a comprehensive listing of the top 50 bigpharma companies with a brief summary followed by a comprehensive listing of diagnostic contract documents available in the public domain. Where available, each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand.

Chapter 6 provides a comprehensive and detailed review of diagnostic partnering deals signed and announced since 2003, where a contract document is available in the public domain. The chapter is organized by company A-Z, stage of development at signing, deal type (collaborative R&D, co-promotion, licensing etc), and specific therapy focus. Each deal title links via Weblink to an online version of the actual contract document, providing easy access to each contract document on demand.

The report also includes numerous tables and figures that illustrate the trends and activities in diagnostic partnering and dealmaking since 2000.

In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of diagnostic technologies and products.

Content

Executive Summary

Chapter 1 – Introduction

Chapter 2 – Overview of diagnostic dealmaking
2.1. Introduction
2.2. The anatomy of diagnostic partnering
2.2.1. The anatomy of a diagnostic deal
2.2.1.a. Case study 1: Sequenom – Lenetex – January 2007
2.2.1.b. Case study 2: Celera – Siemens Medical Solutions – July 2007
2.2.1.c. Case study 3: US Genomics – Rosetta Genomics – May 2006
2.3. Litigation and settlement in diagnostics

Chapter 3 – Trends in diagnostic dealmaking
3.1. Introduction
3.2. Diagnostic partnering over the years
3.3. Most active diagnostic dealmakers
3.4. Bigpharma diagnostic dealmaking activity
3.5. Bigpharma not active in diagnostics
3.6. Diagnostic partnering by deal type
3.6.1. Option and evaluation diagnostic partnering
3.8. Diagnostic partnering by disease type
3.9. Diagnostic M&A activity since 2000

Chapter 4 – Leading diagnostic deals
4.1. Introduction
4.2. Top diagnostic deals by value
4.3. Top diagnostic deals involving bigpharma
4.4. Leading diagnostics M&A deals by value

Chapter 5 – Bigpharma diagnostic deals
5.1. Introduction
5.2. How to use bigpharma diagnostic partnering deals
5.3. Bigpharma partnering company profiles
Abbott
Actavis
Alcon Labs
Allergan
Amgen
Astellas
AstraZeneca
Baxter International
Bayer
Biogen Idec
Boehringer Ingelheim
Bristol-Myers Squibb
Cephalon
Chugai
CSL
Daiichi Sankyo
Dainippon Sumitomo
Eisai
Eli Lilly
Forest Laboratories
Genentech
Genzyme
Gilead Sciences
GlaxoSmithKline
Hospira
Johnson & Johnson
Lundbeck
Menarini
Merck & Co
Merck – Serono KGaA
Mitsubishi Tanabe
Mylan
Novartis
Novo Nordisk
Nycomed Pharma
Otsuka
Pfizer
Procter & Gamble
Ratiopharm
Roche
Sanofi-Aventis
Schering Plough
Servier
Shire
Solvay
Takeda
Teva
UCB
Watson
Wyeth

Chapter 6 – Diagnostic dealmaking directory
6.1. Introduction
6.2. Company A-Z
3M
454 Life Sciences
Abaxis
Abbott
Access Business
Acuity Pharmaceuticals
Acusphere
Adeza Biomedical
AdnaGen
Affymetrix
Agencourt Bioscience
Alliance Pharmaceutical
Alpha Innotech
Alteon
Ambion
America's Blood Centers
American Red Cross
AmeriPath
Amersham Biosciences
Amphastar
Amplimedical
Ani Biotech
Aphton
Applera
Applied Biosystems
Argonaut Technologies
Arizona State University
AstraZeneca
Asuragen
Atria Genetics
Bayer
Bayer Diagnostics
Beckman Coulter
Berkeley HeartLab
Bio-Rad
Biofield
bioMerieux
BioRap Technologies
Biosite
Biotage
Boule Diagnostic
Bridgetech Holdings
Bruker Daltonics
Caliper Life Sciences
Caltech
Calypte Biomedical
Cardinal Health
Celera
Cepheid
Chembio Diagnostic Systems
Chiron
Cholestech
Ciphergen
Corixa
Critical Therapeutics
Cytokinetics
Cytyc
CyVera
Daiichi Pure Chemicals
deCODE Genetics
diaDexus
DiagnoCure
Diatron Messtechnik
Digene
DioGenix
Discovery Labware
Draxis Health
DRI Capital
DxS
Endocardial Solutions
Enzo Biochem
Epix Pharmaceuticals
Epoch Biosciences
Eurogentec
Exact Sciences
Fisher Scientific
Garching Innovation
GE Healthcare
Gen-Probe
Genaissance Pharmaceuticals
Genicon Sciences
Genomic Health
Georgetown University
GlaxoSmithKline
Haematologic Technologies
HaptoGuard
Harvard Bioscience
Helicos BioSciences
HemoSense
Heska
Hycor Biomedical
I-Stat
Ibis Biosciences
Igen
Illumina
Imcor Pharmaceutical
Immunicon
Inamed
Inhibitex
Interleukin Genetics
Inverness Medical Innovations
Invitrogen
ISIS Innovation
iviGene
Kreatech Biotechnology
LabOne
Lantheus Medical Imaging
Lenetix
Lifecodes
Luminex
Lynx Therapeutics
Mallinckrodt
Manteia
Matritech
Maxim Biomedical
MDS Nordion
Medi-Physics
Medline Industries
Molecular Devices
Molecular Insight Pharmaceuticals
Molecular Probes
Monogram Biosciences
Nanogen
Nerveda
Northrop Grumman
Nycomed Pharma
Opko Health
Oragenics
Organon
Pall Corporation
ParAllele Bioscience
Pfizer
Pharmasset
Primagen Holding
Prometheus Laboratories
PSS World Medical
Pyxis Innovations
Qiagen
Quality Assured Services
Quest Diagnostics
Quidel
R&D Systems
Raytel Cardiac Services
Respironics
Response Genetics
Roche
Roche Diagnostics
Roche Molecular Systems
Rockefeller University
Rosetta Genomics
Sangtec Molecular Diagnostics
Schering AG
Sciona
Sequenom
Serologicals
Shanghai Biochip
Siemens Medical Solutions
Spectral Diagnostics
SpectRx
St. Jude Medical
StatSure Diagnostic Systems
Stratagene
SYN-X Pharma
Synbiotics
Tel Hashomer
Tepnel
TheraSense
TM Bioscience
Tosoh
University College London
University of Western Ontario
University of Utah
Upstate
US Genomics
Vermillion
Vertex
Xsira Pharmaceuticals
Xtrana
Zymark
6.3. By stage of development
Discovery
Pre-clinical
Phase I
Phase II
Phase III
Registration
Marketed

6.4. By deal type
Asset and product purchase
Collaborative R&D
Co-development
Co-marketing
Co-promotion
Development
Distribution
Joint venture
Licensing
M&A
Manufacturing
Marketing
Promotion
Research
Supply

6.5. By therapy area
Cardiovascular
Central nervous system
Dermatology
Gastrointestinal
Genitourinary
Hematology
Immunology
Infection
Inflammatory
Metabolic
Musculoskeletal
Oncology
Ophthalmics
Respiratory
Animal health

Chapter 7 – Diagnostic partnering resource center
7.1. Online diagnostic partnering
7.2. Diagnostic partnering events
7.3. Further reading on diagnostic dealmaking

Appendices

Appendix 1 – Deal type definitions

Appendix 2 – Example diagnostics partnering agreement

Delivery Details

PDF:Immediate delivery

PRINT/CD-ROM:Despatched within 1 to 2 working days.

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