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Table of contents

Executive Summary

Chapter 1 – Introduction

Chapter 2 – Trends in drug delivery dealmaking 2.1. Introduction 2.2. Drug delivery partnering over the years 2.3. Bigpharma drug delivery dealmaking activity 2.4. Big biotech drug delivery dealmaking activity 2.5. Most active drug delivery dealmakers 2.6 Drug delivery partnering by deal type 2.7. Drug delivery partnering by disease type 2.8. Partnering by drug delivery technology type 2.9. Average deal terms for drug delivery partnering 2.9.1 Drug delivery headline values 2.9.2 Drug delivery upfront payments 2.9.3 Drug delivery milestone payments 2.9.4 Drug delivery royalty rates 2.10. The anatomy of drug delivery partnering 2.11. Drug delivery or specialty pharma? 2.11.1. Is specialty pharma the only way for drug delivery? 2.11.2. Best practice for optimizing drug delivery program development 2.11.3. The anatomy of a drug delivery deal 2.11.3.a. Case study 1: Alpharma – Durect 2.11.3.b. Case study 2: Bayer – MDRNA 2.11.3.c. Case study 3: Endo Pharmaceuticals – BioDelivery Sciences

Chapter 3 – Leading drug delivery deals 3.1. Introduction 3.2. Top drug delivery deals by value

Chapter 4 – Bigpharma drug delivery deals 4.1. Introduction 4.2. How to use bigpharma drug delivery partnering deals 4.3. Big pharma drug delivery partnering company profiles Abbott Inc (formerly Watson Pharmaceuticals) Actavis (merged with Watson Pharmaceuticals Oct 2012) Astellas AstraZeneca Bayer Idec Boehringer Ingelheim Bristol-Myers Squibb Celgene CSL Daiichi Sankyo Dainippon Sumitomo Eisai Eli Lilly Endo Pharmaceuticals Galderma GlaxoSmithKline Grifols Johnson & Johnson Kyowa Hakko Kirin Lundbeck Menarini Merck & Co Merck KGaA Novo Nordisk Otsuka Purdue Roche Shionogi Shire Takeda Teva UCB Valeant Warner Chilcott

Chapter 5 – Bigbiotech drug delivery deals 5.1. Introduction 5.2. How to use bigbiotech partnering deals 5.3. Bigbiotech drug delivery partnering company profiles Actelion AMAG Pharmaceuticals Amgen Pharmaceuticals Biocon BioCryst Pharmaceuticals Biogen Idec Biota Holdings BioMarin Pharmaceuticals Cangene Celgene CSL Cubist Elan Emergent BioSolutions Enzon Pharmaceuticals Gilead Sciences Immunomedics Intermune Isis Pharmaceuticals Morphosys Nektar Therapeutics NPS Pharmaceuticals PDL BioPharma Roche SciClone Pharmaceuticals Seattle Genetics The Medicines Company UCB ViroPharma

Chapter 6 – Drug delivery partnering contracts directory 6.1. Introduction Anesiva Biomedical Advanced 6.2. Company A-Z Anesta Research and 3M Angiodynamics Development Authority 3M Drug Delivery Systems Angiotech BioMerieux 3SBio Pharmaceuticals BioMimetic Therapeutics AnorMed Biopure Abraxis BioScience AP Pharma BioSante Pharmaceuticals Accentia Aradigm BioSpecifics Technologies Aristos Pharmaceuticals Biovail Accredo Health Group Arius Pharmaceuticals Biovail Laboratories Acorda Therapeutics ArQule Actavis Arrow International BioZone Laboratories Actient Pharmaceuticals ARYx Therapeutics Brand Builders Acura Pharmaceuticals Astellas International Acusphere AstraZeneca Brand Builders Rx Adams Respiratory Atley Pharmaceuticals Breath Therapeutics Auxilium Pharmaceuticals Bristol-Myers Squibb Adeona Pharmaceuticals AVANT Brookwood Adolor Immunotherapeutics Pharmaceuticals Advanced Life Sciences AVI Pharma Brotech Alchemia Azur Pharma Caleco Pharma Alexion Pharmaceuticals Banner Pharmacaps Caleco Pharma Europe Alexza Pharmaceuticals Barrier Therapeutics Callisto Pharmaceuticals Alfacell Bausch & Lomb Cambridge Laboratories Baxter Healthcare Caraco Pharmaceuticals Alkermes Baxter Oncology GmbH Cardinal Health Allergan Bayer Cardium Therapeutics Allos Therapeutics Bayer Healthcare Cary Pharmaceuticals Alnylam Pharmaceuticals Ben Venue Laboratories Catalent Pharma Solutions Alpharma Bentley Pharmaceuticals Cato BioVentures Alpharma Ireland Biken Celsion Altus Pharmaceuticals BioAlliance Pharma Amag Pharmaceuticals BioArray Solutions Cepheid Amarillo Biosciences BioCryst Pharmaceuticals Cerus Amarin BioDelivery Sciences Chrysalis Technologies Amicus Therapeutics Biofield Clarus Therapeutics Ampio Pharmaceuticals Biogen Idec Coating Place BiolineRX CollaGenex Anacor Pharmaceuticals Columbia Laboratories ANDRx CombinatoRx Contract Pharmaceuticals Emergent BioSolutions Imprimis Pharmaceuticals Control Delivery Systems Emisphere Inalco Biochemicals CorMedix Endo Pharmaceuticals Inalco Group Cornerstone Biopharma Enzon Pharmaceuticals Incyte Cornerstone Therapeutics Epic Pharmaceuticals Indevus Pharmaceuticals Cortex Pharmaceuticals EpiCept Inex Pharmaceuticals Cosmo Technologies Esprit Pharma Inovio Pharmaceuticals Cowen Healthcare Royalty Evonik Industries InSite Vision Partners Facet Insmed Inc CP Pharmaceuticals Ferndale Pharmaceuticals Inspire Pharmaceuticals CPEX Pharmaceuticals Finorga Institut Biochimique Crawford Healthcare Fleet Laboratories Intas Biopharmaceuticals Critical Therapeutics Flynn Pharma IntelGenx Forbes Medi-Tech Intendis Cumberland Fovea Pharmaceuticals Intergen Pharmaceuticals Genaera InterMune CV Therapeutics Ipsen CyDex Generex Biotechnology ISTA Pharmaceuticals Cypress Bioscience Ivax Daewoong Pharmaceutical GenVec Jagotec Daiichi Sankyo Genzyme Javelin Pharmaceuticals Dainippon Sumitomo Ghent University Pharma GlaxoSmithKline JDS Pharmaceutical Dalian Wande Electronics GlobeImmune JHP Pharmaceuticals Dechra Veterinary GPC Biotech Jiangsu Yabang Products Graceway Pharmaceuticals Defense Threat Reduction Pharmaceuticals Johns Hopkins University Agency Green Vision Johnson & Johnson Dehaier Medical Systems Grunenthal JPI Commercial Department of Homeland Hadasit Medical Research KCI International Security Services and Development Kensey Nash DepoMed Halozyme Therapeutics Keryx Biopharmaceuticals Desitin Hangzhou Zhencheng Dey Pharma Pharmaceuticals Kiwa Bio-Tech Products Diomed Hebei Huaxing Klarogen Biotherapeutics Discovery Laboratories Pharmaceuticals Kunwha Pharmaceuticals DoctorDirectory Hebei Kiwa Huaxing Bio- KV Pharmaceutical DOR BioPharma Pharmaceuticals Kyowa Hakko Kogyo Dov Pharmaceutical Helix BioMedix Kythera Dow Pharmaceutical Helix BioPharma Biopharmaceuticals Sciences HemispheRx Biopharma Lees Pharmaceutical DPT Laboratories Heraeus Lenetix Draxis Pharma Hermes BioScience Ligand Pharmaceuticals Drugs for Neglected Horizon Pharma AG Lonza Diseases Initiative Horizon Pharma Inc Los Angeles Biomedical Duramed Hospira Research Institute Durect Hunan Jiuwang Lung Rx DUSA Pharmaceuticals Pharmaceuticals Lupin Pharmaceuticals Dyax Hydron Technologies Macrochem Echo Therapeutics Idea ECR Pharmaceuticals IDIS Pharma MAP Pharmaceuticals EDK Therapeutics Ikaria Marina Biotech EKR Therapeutics ImaRX Massachusetts Institute of Elan ImClone Systems Technology Eli Lilly Immunomedics McCoy Enterprises Elite Pharmaceuticals Impax Laboratories McKesson McNeil PPC Novasep PSivida MD Anderson Cancer Noven Pharmaceuticals Center Novo Nordisk QLT MDRNA Novozymes Biopharma QLT USA Meda NuGlow Cosmaceuticals QuatRx Pharmaceuticals Medgenics NuPathe Radius Health Medical Futures Nycomed Rechon Life Sciences MediciNova Obagi Medical Products Reckitt Benckiser Medicis Ocimum Biosolutions RedHill Biopharma Medtronic Oculus Innovative Repligen Meiji Seika Sciences RevImmune Memorial Sloan Kettering Oklahoma Medical Rib-X Pharmaceuticals Cancer Center Research Foundation Rigel Pharmaceuticals Memory Pharmaceuticals OncoSec Medical Roche Menarini Ono Pharmaceutical Rodan and Fields Merck and Co Ophthalmic Research Rohto Pharmaceuticals Merial Associates Royalty Securitization Merrimack Oradisc Trust Pharmaceuticals Oramed Pharmaceuticals S2 Therapeutics Mglas Ore Pharmaceuticals Sagent Pharmaceuticals Microbix Biosystems Orexigen Therapeutics MiddleBrook Orion Sam Amer Pharmaceutical Oso Bio Pharmaceuticals Sangamo BioSciences Mikah Pharma Pacific Beach Biosciences Sanofi-Aventis Millennium Pacira Pharmaceuticals Santarus Mist Acquisition Paladin Labs Santen Pharmaceutical Mova Pharmaceuticals Panion Savient Pharmaceuticals Mundipharma Par Pharmaceutical Schering-Plough Mutual Pharmaceutical Paramount Biosciences Scolr Pharma Mylan Laboratories Patheon Seattle Genetics National Institute of Allergy PDL BioPharma Select Vaccines and Infectious Diseases Pfizer Senetek National Institute of Pharmaceutical Sepracor Infectious Diseases Innovations Sequenom ND Partners Pharmacopeia Serenity Pharmaceuticals Nektar Therapeutics PharmaEngine Shaanxi Aoxing Neos Therapeutics Philip Morris Products Pharmaceutical NeurogesX Pipex Pharmaceuticals Shaanxi Jiali Neurokine Polymun Scientific Pharmaceuticals Pharmaceuticals Immunbiologische Shandong Yaoshan Neuromed Poniard Pharmaceuticals Pharmaceuticals NeuroMed Devices Porex Shijiazhuang-Unigene Neuronex Pozen Pharmaceuticals NexMed Shijiazhuang Nitec Pharma Precision Pharma Pharmaceutical NitroMed Services Shionogi Nof Prestige Brands Shire Pharmaceuticals Norgine Procter & Gamble SIGA Technologies Northern Lipids Procter & Gamble Sigma-Aldrich Nova Biomedical Pharmaceuticals Sigma-Tau NovaBay Pharmaceuticals Professional SignPath Pharmaceuticals NovaCardia Compounding Centers of SK Biopharmaceuticals Novacea America SkyePharma NovaDel Pharma Progenics SLA Pharma Novartis Pharmaceuticals Solvay Novartis Consumer Health Proteolix Southern Research Ventrus Biosciences Marketing Institute VeroScience Material transfer Sovereign VetCure Option Pharmaceuticals VIA Pharmaceuticals Promotion Spectrum Pharmaceuticals Victory Pharma Research Spring Creek Capital Viropharma Royalty financing SRI International Vivus Settlement Strakan WA 32609 Spin out Strativa Pharmaceuticals Wanbang Anesiva Sub-license Sun Pharmaceutical (Jiangsu) Biotech Supply Sunovion Pharmaceuticals Wanbang Technology transfer SurModics Biopharmaceuticals Termination SurModics Warner Chilcott Warranty Pharmaceuticals Washington Research 6.4. By stage of Symphony Allegro Foundation development Takeda Pharmaceutical Watson Laboratories Discovery Tanabe Seiyaku Watson Pharmaceuticals Formulation Targanta Therapeutics Wockhardt Marketed Tarsa Therapeutics Phase I Teikoku Pharma USA Xianyang Materia Medica Phase II Teikoku Seiyaku Xi’an Zaolutang Kushidai Phase III Tekmira Pharmaceuticals Pharmaceuticals Preclinical Tercica XTL Biopharmaceuticals Regulatory Teva Pharmaceuticals Yakult Honsha 6.5. By therapy area The Medical Research, Yamasa Anaesthetics Infrastructure, and Health Zogenix Cardiovascular Services Fund of the Tel ZymoGenetics Central Nervous System Aviv Medical Center 6.3. By deal type Dental The Medicines Company Asset purchase Dermatology The Regents of the Assignment Gastrointestinal University of California Bigpharma outlicensing Genetic disorders Therabel Co-development Genitourinary TPG Capital Collaborative R&D Gynaecology Transcept Co-market Hematology Pharmaceuticals Contract service Hospital care Transdel Pharmaceuticals Co-promotion Immunology Transition Therapeutics CRADA Infectives Tranzyme Pharma Development Metabolic Triax Aesthetics Distribution Musculoskeletal Tris Pharma Equity purchase Obstetrics TTY Biopharm Evaluation Oncology UCB Grant Ophthalmics Uluru Joint venture Pediatrics Unigene Labs Licensing Psychiatry United Therapeutics Litigation Public Health Valeant Pharmaceuticals Loan Respiratory Vanda Pharmaceuticals Manufacturing Sexual Health

Chapter 7 – Drug delivery dealmaking by technology type 7.1. Introduction 7.2. Deals by drug delivery type Drug delivery About Wildwood Ventures Current Partnering Current Agreements Recent titles from CurrentPartnering

See accompanying volume for:

Appendices

Introduction

Appendix 1 – Directory of drug delivery deals by company A-Z 2007-2012

Appendix 2 – Directory of drug delivery deals by stage of development 2007-2012

Appendix 3 – Directory of drug delivery deals by deal type 2007-2012

Appendix 4 – Directory of drug delivery deals by therapy area 2007-2012

Appendix 5 – Drug delivery partnering resource center Online drug delivery partnering Drug delivery partnering events Further reading on drug delivery dealmaking

Table of figures

Figure 1: Drug delivery partnering since 2007 Figure 2: Bigpharma – top 50 – drug delivery deals 2007 to 2013 Figure 3: Bigpharma drug delivery deal frequency – 2007 to 2013 Figure 4: Bigpharma – top 50 – drug delivery deals 2007 to 2013 Figure 5: Big biotech drug delivery deal frequency – 2007 to 2013 Figure 6: Active drug delivery dealmaking activity– 2007 to 2013 Figure 7: Drug delivery partnering by deal type since 2007 Figure 8: Drug delivery partnering by disease type since 2007 Figure 9: Drug delivery partnering by technology type since 2007 Figure 10: Drug delivery deals with a headline value Figure 11: Drug delivery deal headline value distribution, US$million – discovery stage Figure 12: Drug delivery deal headline value distribution, US$million – preclinical stage Figure 13: Drug delivery deal headline value distribution, US$million – phase I stage Figure 14: Drug delivery deal headline value distribution, US$million – phase II stage Figure 15: Drug delivery deal headline value distribution, US$million – phase III stage Figure 16: Drug delivery deal headline value distribution, US$million – regulatory stage Figure 17: Drug delivery deal headline value distribution, US$million – marketed stage Figure 18: Summary median headline value by stage of development, 2007-2013 Figure 19: Drug delivery deals with upfront payment values Figure 20: Drug delivery deal upfront payment distribution, US$million – discovery stage Figure 21: Drug delivery deal upfront payment distribution, US$million – preclinical stage Figure 22: Drug delivery deal upfront payment distribution, US$million – phase I stage Figure 23: Drug delivery deal upfront payment distribution, US$million – phase II stage Figure 24: Drug delivery deal upfront payment distribution, US$million – phase III stage Figure 25: Drug delivery deal upfront payment distribution, US$million – regulatory stage Figure 26: Drug delivery deal upfront payment distribution, US$million – marketed stage Figure 27: Summary median upfront payments by stage of development, 2007-2013 Figure 28: Drug delivery deals with milestone payments Figure 29: Drug delivery deal milestone distribution, US$million – discovery stage Figure 30: Drug delivery deal milestone distribution, US$million – preclinical stage Figure 31: Drug delivery deal milestone distribution, US$million – phase I stage Figure 32: Drug delivery deal milestone distribution, US$million – phase II stage Figure 33: Drug delivery deal milestone distribution, US$million – phase III stage Figure 34: Drug delivery deal milestone distribution, US$million – regulatory stage Figure 35: Drug delivery deal milestone distribution, US$million – marketed stage Figure 36: Drug delivery deals with royalty rates, % Figure 37: Drug delivery deal royalty rate distribution, US$million – discovery stage Figure 38: Drug delivery deal royalty rate distribution, US$million – preclinical stage Figure 39: Drug delivery deal royalty rate distribution, US$million – phase I stage Figure 40: Drug delivery deal royalty rate distribution, US$million – phase II stage Figure 41: Drug delivery deal royalty rate distribution, US$million – phase III stage Figure 42: Drug delivery deal royalty rate distribution, US$million – regulatory stage Figure 43: Drug delivery deal royalty rate distribution, US$million – marketed stage Figure 44: Summary median royalty rate by stage of development, 2007-2013 Figure 45: Components of the typical drug delivery deal structure Figure 46: Best practice for drug delivery program development Figure 47: Top drug delivery deals by value since 2007 Figure 48: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Anaesthetics) Figure 49: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Cardiovascular) Figure 50: Recent deals (Jan 2007 to Apr 2013) - By therapy area (CNS) Figure 51: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Dental) Figure 52: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Dermatology) Figure 53: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Gastrointestinal) Figure 54: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Genetic disorders) Figure 55: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Genitourinary) Figure 56: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Gynaecology) Figure 57: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Hematology) Figure 58: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Hospital care) Figure 59: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Immunology) Figure 60: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Infectives) Figure 61: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Metabolic) Figure 62: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Musculoskeletal) Figure 63: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Obstetrics) Figure 64: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Oncology) Figure 65: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Ophthalmics) Figure 66: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Pediatrics) Figure 67: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Psychiatry) Figure 68: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Public Health) Figure 69: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Respiratory) Figure 70: Recent deals (Jan 2007 to Apr 2013) - By therapy area (Sexual Health)