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Clinical Stage Partnering Terms and Agreements in Pharma and Biotech Product Image

Clinical Stage Partnering Terms and Agreements in Pharma and Biotech

  • Published: February 2014
  • Region: Global
  • 2509 Pages +
  • CurrentPartnering

FEATURED COMPANIES

  • Abbott
  • Biogen Idec
  • Eli Lilly
  • Hospira
  • Mylan
  • Sanofi
  • MORE

The Clinical Stage Partnering Terms and Agreements in Pharma and Biotech report provides comprehensive understanding and unprecedented access to the clinical stage partnering deals and agreements entered into by the worlds leading healthcare companies.

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

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 do not.

This report contains over 2,000 links to online copies of actual clinical stage deals and contract documents as submitted to the READ MORE >

Executive Summary

Chapter 1 – Introduction

Chapter 2 – Why do companies partner clinical stage compounds?

2.1. Introduction

2.2. The role of clinical stage partnering
2.2.1. In-licensing at clinical stage
2.2.2. Out-licensing at clinical stage

2.3. Difference between phase I, II and III stage deals

2.4. Reasons for entering into clinical stage partnering deals

2.4.1. Licensors reasons for entering clinical stage deals
2.4.2. Licensees reasons for entering clinical stage deals

2.5. The future of clinical stage partnering deals

Chapter 3 – Clinical stage deal strategies and structure

3.1. Introduction

3.2. At what stage do companies partner?

3.2.1. Partnering early in pharmaceutical/biotech
3.2.1.1. Discovery and preclinical stage partnering case studies
3.2.1.1.a. Case study: LEO Pharma - 4SC
3.2.1.1.b. Case study: Heptares Therapeutics - Cubist
3.2.1.1.c. Case study: Pfizer - Repligen
3.2.1.1.d. Case study: Janssen Pharmaceutical - Evotec
3.2.2. Partnering later in pharmaceutical/biotech
3.2.2.1. Clinical stage partnering case studies
3.2.2.1.a. Case study: Roche – Genentech - Chiasma
3.2.2.1.b. Case study: Teva – Xenon Pharmaceuticals
3.2.2.1.c. Case study: AstraZeneca - Ardelyx
3.2.2.1.d. Case study: Baxter – Onconova Therapeutics

3.3. Early and later stage partnering – a risk/cost comparison

3.4. What do companies spend on clinical stage partnering?

3.5. Pure versus multi-component partnering deals

3.6. Pure licensing agreement structure

3.6.1. Example pure licensing agreements
3.6.1.a. Case study : Argos Therapeutics – Medinet
3.6.1.b. Case study : Pfizer – GlycoMimetics

3.7. Multicomponent clinical stage partnering agreements

3.7.1. Example multicomponent clinical stage clauses
3.7.1.a. Case study: Gilead Sciences – GlobeImmune

Chapter 4 – Clinical stage partnering payment strategies

4.1. Introduction
4.2. Clinical stage payment strategies
4.3. Payment options
4.3.1. Headline values
4.3.2. Upfront payments
4.3.2.1. Conditionality of upfront payments
4.3.3. Loans
4.3.4. Convertible loans
4.3.5. Equity
4.3.6. R&D funding
4.3.7. Licensing fees
4.3.8. Milestone payments
4.3.9. Royalty payments
4.3.9.1. Issues affecting royalty rates
4.3.9.2. Royalties on combination products
4.3.9.2.a. Case study: Scripps Research Institute-Cyanotech
4.3.9.3. Guaranteed minimum/maximum annual payments
4.3.9.4. Royalty stacking
4.3.9.5. Royalties and supply/purchase contracts
4.3.10. Quids
4.3.11. Option payments

Chapter 5 – Trends in clinical stage deal making

5.1. Introduction

5.2. Clinical stage partnering over the years

5.2.1. Trends in phase I deals since 2009
5.2.1.1. Attributes of phase I deals
5.2.2. Trends in phase II deals since 2009
5.2.2.2. Attributes of phase II deals
5.2.3. Trends in phase III deals since 2009
5.2.3.1. Attributes of phase III deals

5.3. Big pharma clinical stage dealmaking activity

5.4. Big biotech clinical stage dealmaking activity

5.5. Clinical stage partnering by deal type

5.6. Clinical stage partnering by disease type

5.7. Partnering by clinical stage technology type

Chapter 6 – Average payment terms for clinical stage partnering

6.1. Introduction

6.2. Guidelines for clinical stage payment terms

6.2.1. Upfront payments
6.2.2. Milestone payments
6.2.3. Royalty payments

6.3. Clinical stage payment terms – deal data analysis

6.3.1. Public data
6.3.2. Survey data

6.4. Payment terms analysis

6.4.1. Clinical stage headline values
6.4.2. Clinical stage upfront payments
6.4.3. Clinical stage milestone payments
6.4.4. Clinical stage royalty rates

Chapter 7 – Leading clinical stage deals

7.1. Introduction

7.2. Top clinical stage deals by value

Chapter 8 – Big pharma and big biotech clinical stage partnering deals

8.1. Introduction

8.2. How to use big pharma/big biotech clinical stage partnering deals

8.3. Big pharma clinical stage partnering company profiles

Abbott
Abbott Japan
Actavis
Actavis (acquired by Watson)
Watson Pharmaceuticals
Allergan
Amgen
Astellas
Astellas Pharma US
AstraZeneca
Baxter International
Bayer
Bayer Healthcare
Bayer Innovation
Bayer Schering Pharma
Bayer Vital
Biogen Idec
Boehringer Ingelheim
Bristol-Myers Squibb
Celgene
CSL
Daiichi Sankyo
Dainippon Sumitomo
Eisai
Eisai Inc
Eli Lilly
Endo Pharmaceuticals
Forest Laboratories
Forest Laboratories Ireland
Galderma
Gilead Sciences
GlaxoSmithKline
Grifols
Hospira
Johnson & Johnson
Janssen Biotech
Janssen Pharmaceutica NV
Janssen Pharmaceutical
Janssen Research & Development
Kyowa Hakko Kirin
Lundbeck
Merck & Co
Merck KGaA
Merck Serono
Mitsubishi Tanabe
Mylan
Novartis
Novo Nordisk
Otsuka
Pfizer
Pfizer Japan
Purdue
Ranbaxy Laboratories
Roche
Genentech
Sanofi
Sanofi-Aventis
Sanofi-Pasteur
Servier
Shionogi
Shionogi Pharma
Shire
Takeda
Teva
UCB
Valeant
Warner Chilcott

8.4. Big biotech clinical stage partnering company profiles

Acorda Therapeutics
Alkermes
Array Biopharma
Biocon
Biogen Idec
BioMarin Pharmaceuticals
Cangene
Cubist
Dendreon
Elan
Emergent BioSolutions
Enzo Biochem
Galapagos
Genmab
Grifols461
Ipsen
Isis Pharmaceuticals
LFB Group
Medivation
Morphosys
Nektar Therapeutics
Novo Nordisk
NPS Pharmaceuticals
Onyx Pharmaceuticals
Optimer
PDL BioPharma
Questcor Pharmaceuticals
Regeneron Pharmaceuticals
SciClone Pharmaceuticals
Seattle Genetics
Spectrum Pharmaceuticals
Swedish Orphan Biovitrum
The Medicines Company
United Therapeutics
Vertex Pharmaceuticals
ViroPharma

Chapter 9 – Clinical stage partnering contracts directory
9.1. Introduction
9.2. Company A-Z

3M
3M Drug Delivery Systems
Abbott Japan
Abbott Laboratories
ABT Holding Company
ABX-CRO Advanced Pharmaceutical Services
ACADIA Pharmaceuticals
Acelrx Pharmaceuticals
Achillion Pharmaceuticals
Acorda Therapeutics
Acusphere
Adeona Pharmaceuticals
Adherex Technologies
Adolor
Advanced Life Sciences
Advaxis
AEterna Zentaris
Alexza Pharmaceuticals
Alfacell
Alkermes
Allergan
Almirall
Alnylam Pharmaceuticals
Alseres Pharmaceuticals
Alza
Amarillo Biosciences
Amarin
Ambit Biosciences
Amgen
Amicus Therapeutics
Amylin Pharmaceuticals
Anavex Life Sciences
Anesiva
Anthera Pharmaceuticals
Aradigm
ARCA Biopharma
Archemix
Ardea Biosciences
Arena Pharmaceuticals
Argos Therapeutics
Ariad Pharmaceuticals
Array Biopharma
Asahi Kasei
Ascent Therapeutics
Aslan Pharma
Astellas Pharma
AstraZeneca
AtheroNova
Athersys
Atlantic Healthcare
Audeo Oncology
Auxilium Pharmaceuticals
Avecia Biologics
AVEO Pharmaceuticals
Basilea Pharmaceutica
Bayer
Beaufour Ipsen
Bio-GAL
BioArray Solutions
BioAxone Therapeutic
BioClinica
Biocon Group
BioCryst Pharmaceuticals
BioDelivery Sciences
Biogen Idec
BioHeart
BiolineRX
BioMarin Pharmaceutical
BioMedica Life Sciences
Biomedical Advanced Research and Development Authority
Bioniche Pharma
Biovail
Boehringer Ingelheim
Bristol-Myers Squibb
Calixa Therapeutics
Cara Therapeutics
Cardium Therapeutics
Catalyst Pharmaceutical Partners
Celera
Celgene
Cell Therapeutics
ChemoCentryx
Chimerix
China State Institute of Pharmaceutical Industry (CIPI)
Chong Kun Dang
Chroma Therapeutics
Clarus Therapeutics
Clovis Oncology
Columbia Laboratories
CombinatoRx
Coronado Biosciences
Cortex Pharmaceuticals
Cubist Pharmaceuticals
Curis
Cyclacel Pharmaceuticals
Cypress Bioscience
Cytokinetics
Dainippon Sumitomo Pharma
DARA BioSciences
DARA Therapeutics
Debiopharm
Defiante Farmaceutica
Delcath Systems
Dendreon
Department of Health and Human Services
Desitin
Diosynth
DOR BioPharma
Dov Pharmaceutical
Dr. Falk Pharma
Drugs for Neglected Diseases Initiative
Durata Therapeutics
Durect
Dyax
Dynavax Technologies
Eckert & Ziegler
Eisai
Elan
Eleison Pharmaceuticals
Eli Lilly
Elite Pharmaceuticals
Emergent BioSolutions
EntreMed
Epic Pharmaceuticals
EPIX Pharmaceuticals
Erin Mills Investment
Evotec
Exact Sciences
Exelixis
Facet Biotechnology
Finorga
Forest Laboratories
Fovea Pharmaceuticals
Furiex Pharma
Galderma
GCA Therapeutics
GE Healthcare
Genentech
Genesis BioPharma
Genzyme
Gilead Sciences
GlaxoSmithKline
Global Health Ventures
Globe Laboratories
GlobeImmune
GlycoMimetics
Green Cross
Green Vision
Grifols
Gynecologic Oncology Group
Hadasit Medical Research Services and Development
Halozyme Therapeutics
Harbor Therapeutics
Horizon Therapeutics
Hospira
Hyperion Therapeutics
Idenix Pharmaceuticals
Idera Pharmaceuticals
Ikaria
ImmunoCellular Therapeutics
Immunovative Therapies
Impax Laboratories
Incyte
Insmed Inc
Inspire Pharmaceuticals
Intas Biopharmaceuticals
Intellect Neurosciences
Intendis
Intercept Pharmaceuticals
InterMune
Ipsen
Ironwood Pharmaceuticals
Isis Pharmaceuticals
ISTA Pharmaceuticals
Janssen Pharmaceutica NV
Janssen Research & Development
Japan Tobacco
JDRF
Jewish General Hospital
Johnson & Johnson
KaloBios Pharmaceuticals
Keryx Biopharmaceuticals
Kythera Biopharmaceuticals
La Jolla Pharmaceutical
LG Life Sciences
Ligand Pharmaceuticals
Lightlake Therapeutics
Lonza
Lorus Therapeutics
Los Angeles Biomedical Research Institute
LP Clover
Lpath
Lupin Pharmaceuticals
Macrogenics
Madrona Ventures
Mallinckrodt Pharmaceuticals
MannKind Biopharmaceuticals
Marina Biotech
Massachusetts Biologic Laboratories
Massachusetts General Hospital
Maxwell Biotech
Maxwell Biotech Venture Fund
Maxygen
MDRNA
MDS Nordion
Meda
Medarex
Medgenics
Medicis Pharma
Medigen Biotechnology
Medinet
Medivation
Medpace
Medtronic
Merck and Co
Merck KGaA
Merck Serono
Merck Sharpe & Dohme
Merrimack Pharmaceuticals
Micromet
Millennium
Mirna Therapeutics
Molecular Insight Pharmaceuticals
Molecular Partners
MorphoSys
Mundipharma
Myriad Pharmaceuticals
Nabi Biopharmaceuticals
National Cancer Institute
National Institutes of Health
Nektar Therapeutics
Neotope
NerPharMa
Neurobiological Technologies
Neurocrine Biosciences
NeurogesX
Neuromed
Newlink Genetics
Nippon Kayaku
Nordic Bioscience
Nordmark Arzneimittel
Norgine
NovaBay Pharmaceuticals
Novartis
Novasep
Novavax
Novelos Therapeutics
Novo Energies
NPS Pharmaceuticals
Numoda
Nycomed
Oceana Therapeutics
OCT Group
OncoGenex Pharmaceuticals
OncoGenex Technologies
Ono Pharmaceutical
Onyx Pharmaceuticals
OOO CardioNova
Opexa Therapeutics
Ophthotech
OPKO Health
Optimer Pharmaceuticals
Oramed Pharmaceuticals
Orexigen Therapeutics
OvaMed
OXiGENE
Oxygen Biotherapeutics
Pacific Beach Biosciences
Panacos Pharmaceuticals
Par Pharmaceutical
ParinGenix
Patheon
PDL BioPharma
Peregrine Pharmaceuticals
Perseid Therapeutics
Pfizer
Pharmacopeia
Pharmacyclics
PharmaEngine
PharmAthene
Pharmos
Pharmstandard
Pipex Pharmaceuticals
Planned Systems International (PSI)
Polypeptide Laboratory
Pozen
PPD
Prev AbR
Pro Pharmaceuticals
Procaps
Progen Pharmaceuticals
Progenics Pharmaceuticals
Protalix BioTherapeutics
Proteoderm
Proteonomix
Psynova Neurotech
Quark Pharmaceuticals
Radius Health
Regeneron Pharmaceuticals
Reperio Pharmaceuticals
Revance Therapeutics
Rigel Pharmaceuticals
Roche
Rules-Based Medicine
S-Bio
Salix Pharmaceuticals
Sangamo BioSciences
Sankyo Pharmaceutical
Sanofi-Aventis
Sanofi-Pasteur
Santarus
Schering-Plough
Seattle Genetics
Selected Value Therapeutics
Senju Pharmaceutical
Serenity Pharmaceuticals
Servier
Shire Pharmaceuticals
Siegfried
Sigma-Tau
SLA Pharma
Soligenix
Spectrum Pharmaceuticals
Stason Pharmaceuticals
Strativa Pharmaceuticals
Sucampo Pharmaceuticals
Sunshine Biopharma
SurModics
Symphony Allegro
Symphony Dynamo
Symphony ViDA
Synerx Pharma
Synta Pharmaceuticals
Synthetic Biologics
Takeda Pharmaceutical
Targacept
Targepeutics
Tarsa Therapeutics
Tesaro
Teva Pharmaceuticals
The Medical Research, Infrastructure, and Health Services Fund of the Tel Aviv Medical Center
The Medicines Company
The Regents of the University of California
Threshold Pharmaceuticals
Tibotec
TopoTarget
Torii Pharmaceutical
Transdel Pharmaceuticals
Transition Therapeutics
Tranzyme Pharma
Trevena
Trius Therapeutics
Trubion
UCB
Ucyclyd Pharma
Unigene Laboratories
University of Cincinnati
University of Miami
University of Minnesota
Urigen
Valeant Pharmaceuticals
Ventrus Biosciences
Verastem
Vical
ViiV Healthcare
Viropharma
Waratah Pharmaceuticals
Watson Pharmaceuticals
Wyeth
Xencor
Xenoport
Xoma
XTL Biopharmaceuticals
Ziarco Pharma
Zogenix
ZymoGenetics

9.3. By deal type

Asset purchase
Assignment
Bigpharma outlicensing
Co-development
Collaborative R&D
Co-market
Contract service
Co-promotion
CRADA
Development
Distribution
Equity purchase
Grant
Interests
Joint venture
Licensing
Litigation
Loan
Manufacturing
Marketing
Material transfer
Option
Promotion
Research
Settlement
Sub-license
Supply
Technology transfer
Termination
Warranty

9.4. By stage of development

Phase I
Phase II
Phase III

9.5. By therapy area

Anaesthetics
Respiratory depression
Cardiovascular
Atherosclerosis
Cardiomyopathy (heart muscle disease)
Congestive heart failure
Hypercholesterolemia
Myocardial Infarction
Central Nervous System
Epilepsy
Migraine
Multiple sclerosis
Neuropathy
Pain
Fibromyalgia
Neuralgia
Parkinson's disease
Spinal cord
Stroke
Traumatic Brain Injury
Dermatology
Acne
Angioedema
Burns
Cosmetics
Impetigo
Itching
Wound healing
Wrinkles
Gastrointestinal
Inflammatory bowel disease
Crohn's disease
Ulcerative colitis
Irritable bowel syndrome
Gastric ulcer
Bowel movement
Constipation
Diarrhea
Genetic disorders
Cystic Fibrosis (CF)
Hereditary angioedema
Rare genetic disorders
Sickle cell disease
Genitourinary
Chronic kidney disease (CKD)
Incontinence
Nocturia
Prostate diseases
Renal failure
Urinary tract infection (UTI)
Gynaecology
Cervical Intraepithelial Neoplasia (CIN)
Endometriosis
Fibroids
Pelvic pain
Menopause
Hematology
Neutropenia
Hospital care
Accident and emergency
Surgery
Orthopedics
Transplantation
Immunology
Allergy
Graft versus host disease
Inflammation
Systemic lupus erythematosus
Infectives
Bacterial
Anthrax
Clostridium difficile
Methicillin-resistant Staphylococcus aureus (MRSA)
Pseudomonas aeruginosa
Onychomycosis (Nail infection)
Parasitic
Viral
Cytomegalovirus
B

C
HIV
Influenza
Respiratory syncytial virus (RSV)
Metabolic
Cirrhosis
Diabetes
Liver disease
Lysosomal storage disorders
Musculoskeletal
Osteoarthritis
Psoriatic arthritis
Rheumatoid arthritis
Muscular pain
Weakness
Osteoporosis
Spinal muscular atrophy
Obstetrics
Oncology
Bladder cancer
Brain cancer
Breast cancer
Cervical cancer
Colorectal cancer
Gastric cancer
Kidney cancer
Leukemia
Acute lymphoblastic leukemia
Acute myelogenous leukemia
Chronic lymphocytic leukemia
Chronic myelogenous leukemia
Liver cancer
Lung cancer
Non small cell lung cancer
Lymphoma
Non Hodgkin's lymphoma
Melanoma
Metastases
Multiple myeloma
Ovarian cancer
Pancreatic cancer
Prostate cancer
Renal cell carcinoma
Solid tumors
Cancer pain
Chemotherapy
Nausea
Vomiting
Ophthalmics
Age-related macular degeneration
Conjunctivitis
Retinopathy
Orphan disease
Pediatrics
Psychiatry
Anxiety disorder
Attention deficit hyperactivity disorder
Bipolar disorder
Cognitive impairment
Alzheimers
Depression
Moderate
Severe
Autism
Schizophrenia
Sleep disorders
Public Health
Addiction
Obesity
Respiratory
Acute respiratory distress syndrome
Chronic obstructive pulmonary disease
Sexual dysfunction

Chapter 10 – Clinical stage dealmaking by development stage

10.1. Introduction
10.2. Deals by clinical stage
10.2.1. Phase I deals
10.2.2. Phase II deals
10.2.3. Phase III deals

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Appendices

Introduction

Appendix 1 – Directory of clinical stage deals by company A-Z 2007-2013
Appendix 2 – Directory of clinical stage deals by deal type 2007-2013
Appendix 3 – Directory of clinical stage deals by therapy area 2007-2013
Appendix 4 – Partnering resource center
Online partnering
Partnering events
Further reading on dealmaking

Table of figures

Figure 1: Definition of clinical phases in dealmaking
Figure 2: Agreements signed by phase of development (2009-2013), % of all deals
Figure 3: Components of the pure licensing deal structure
Figure 4: Payment options for clinical stage partnering deals
Figure 5: Issues affecting royalty rates
Figure 6: Clinical stage partnering frequency 2009-2013
Figure 7: Phase I clinical stage partnering since 2009
Figure 8: Phase II clinical stage partnering since 2009
Figure 9: Phase III clinical stage partnering since 2009
Figure 10: Big pharma – top 50 – clinical stage deals 2009 to 2013
Figure 11: Big pharma clinical stage deal frequency – 2009 to 2013
Figure 12: Big biotech – top 50 – clinical stage deals 2009 to 2013
Figure 13: Big biotech clinical stage deal frequency – 2009 to 2013
Figure 14: Clinical stage partnering by deal type since 2009
Figure 15: Clinical stage partnering by disease type since 2009
Figure 16: Clinical stage partnering by technology type since 2009
Figure 17: Review of upfront payments for clinical stage deals 2009-2013, US$m
Figure 18: Review of milestone payments for clinical stage deals, median US$m
Figure 19: Review of royalty payments for clinical stage deals, median%
Figure 20: Clinical stage deals with a headline value
Figure 21: Clinical stage deal headline value distribution, US$million – phase I stage
Figure 22: Clinical stage deal headline value distribution, US$million – phase II stage
Figure 23: Clinical stage deal headline value distribution, US$million – phase III stage
Figure 24: Summary median headline value by clinical stage of development, 2009-2013
Figure 25: Clinical stage deals with upfront payment values
Figure 26: Clinical stage deal upfront payment distribution, US$million – phase I stage
Figure 27: Clinical stage deal upfront payment distribution, US$million – phase II stage
Figure 28: Clinical stage deal upfront payment distribution, US$million – phase III stage
Figure 29: Summary median upfront payments by clinical stage of development, 2009-2013
Figure 30: Clinical stage deals with milestone payments
Figure 31: Clinical stage deal milestone distribution, US$million – phase I stage
Figure 32: Clinical stage deal milestone distribution, US$million – phase II stage
Figure 33: Clinical stage deal milestone distribution, US$million – phase III stage
Figure 34: Summary median milestone payments by stage of development, 2009-2013
Figure 35: Clinical stage deals with royalty rates, %
Figure 36: Clinical stage deal royalty rate distribution, US$million – phase I stage
Figure 37: Clinical stage deal royalty rate distribution, US$million – phase II stage
Figure 38: Clinical stage deal royalty rate distribution, US$million – phase III stage
Figure 39: Summary median royalty rate by stage of development, 2009-2013
Figure 40: Top clinical stage deals by value since 2009

Abbott
Actavis
Allergan
Amgen
Astellas
AstraZeneca
Baxter
Bayer
Biogen Idec
Boehringer Ingelheim
Bristol-Myers Squibb
Celgene
CSL
Daiichi Sankyo
Dainippon Sumitomo
Eisai
Eli Lilly
Endo
Forest
Fresenius
Galderma
Gilead Sciences
GlaxoSmithKline
Grifols
Hospira
Johnson & Johnson
Kyowa Hakko Kirin
Lundbeck
Menarini
Merck & Co
Merck KGaA
Mitsubishi Tanabe
Mylan
Novartis
Novo Nordisk
Otsuka
Pfizer
Purdue
Ranbaxy
Roche
Sanofi
Servier
Shionogi
Shire
Stada
Takeda
Teva
UCB view
Valeant
Warner Chilcott

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