Rimonabant: The first of the Cannabinoid blockbusters

Table of Contents

Executive Summary

• E.1 Introduction to the Cannabinoids Market
• E.2 Cannabinoid Potential Therapeutic Areas
• E.3 GW Pharmaceuticals: The Cannabinoid Company

Chapter 1. Introduction

• 1.1 Purpose of Report
• 1.2 Objectives of Report
• 1.3 Scope of Report

Chapter 2. Introduction to Cannabinoids

• 2.1 A Historical Background to Cannabinoid Therapies
• 2.2 An Overview of Cannabinoids
  • 2.2.1 Herbal Cannabinoids
  • 2.2.2 Endogenous Cannabinoids
  • 2.2.3 Synthetic Cannabinoids
• 2.3 How do Cannabinoids Differ to Cannabis?
• 2.4 An Overview of Cannabinoid Receptors
• 2.5 Marinol, Nabilone, Sativex & Rimonabant: The four Medicinal Cannabinoids of Importance
• 2.6 The Therapeutic Potential of Cannabinoids
• 2.7 Major Questions Regarding Cannabinoids
  • 2.7.1 Are They Safe?
  • 2.7.2 What Routes of Administration Will be Used for Therapeutics?

Chapter 3. Potential Cannabinoid Therapies

• 3.1 Cannabinoids of Therapeutic Value
• 3.2 The Cannabinoid Drugs currently on the Global Market
• 3.3 The Potential Clinical Uses of Cannabinoids Overview
• 3.4 Cannabinoids and Pain: An Alternative to Opioids?
  • 3.4.1 Experimentally Induced Acute Pain
  • 3.4.2 Post Surgical Acute Pain
  • 3.4.3 Chronic Pain
  • 3.4.4 Chronic Non-malignant Pain
  • 3.4.5 Neuropathic Pain
    • 3.4.5.1 European Journal of Pain
    • 3.4.5.2 European trials of Sativex
    • 3.4.5.3 Marijuana linked with Peripheral Neuropathy with AIDS sufferers.
  • 3.4.6 Migraine
  • 3.4.7 Cannabinoids and Pain: A Lucrative Market to R&D?
• 3.5 Neurological
  • 3.5.1 Dystonia
  • 3.5.2 Huntington' s Disease
  • 3.5.3 Parkinson' s Disease
    • 3.5.3.1 Cannabinoid Receptors in GP1
    • 3.5.3.2 New Target for Parkinson' s Discovered
  • 3.5.4 Tourette' s Syndrome
  • 3.5.5 Cannabinoids and Movement Disorders: The Future
  • 3.5.6 Cannabinoids and Alzheimer' s Disease: A High Potential
  • 3.5.7 Cannabinoids and Epilepsy: No Trials Performed, Yet
  • 3.5.8 Cannabinoids and Depression: Future Looks Good
  • 3.5.9 Cannabinoids and Traumatic Brain Injury: Prospects Injured
• 3.6 Cancer
  • 3.6.1 Cannabinoids and Cancer-Associated Cachexia/Anorexia: Prospects Look Promising
  • 3.6.2 Cannabinoids and Cancer: A New Hope
    • 3.6.2.1 Skin Cancer
    • 3.6.2.2 Tumour
    • 3.6.2.3 General Cannabinoid Treatments
    • 3.6.2.4 Cannabinoids as antineoplastic agents?
• 3.7 Eating Disorders
  • 3.7.1 Cannabinoids and Obesity: A Large Potential
• 3.8 Dysfunction of the Immune System
  • 3.8.1 Cannabinoids and Multiple Sclerosis: The Most Likely Therapeutic Use
  • 3.8.2 Cannabinoids and Rheumatoid Arthritis: A Possible Use
  • 3.8.3 Cannabinoids and Chron' s Disease/Ulcerative Colitis: Experimental Data Looks Good
• 3.9 Respiratory
  • 3.9.1 Cannabinoids and Asthma: Numerous Studies Performed
  • 3.9.2 Cannabinoids and Intractable Breathlessness: A Rare Answer to an Unknown Disease?
• 3.10 Anti Addiction
  • 3.10.1 Cannabinoids and Drug Withdrawal: A New High?
• 3.11 Miscellaneous
  • 3.11.1 Cannabinoids and Glaucoma: Temporary Relief Found
  • 3.11.2 Cannabinoids and Obstetrics/Gynaecology: Centuries Old Remedies May Hold Potential
  • 3.11.3 Cannabinoids and Diabetes
• 3.12 Visiongain' s Perspective of Cannabinoid Therapeutics

Chapter 4. The Worldwide Cannabinoids Market: Current Cannabinoids and Potential Products

• 4.1 Overview of Today' s Global Cannabinoids Market: A Potential Blockbuster?
• 4.2 Total Global Cannabinoid Market
• 4.3 Marinol
  • 4.3.1 Unimed Pharmaceuticals Inc Markets the Leading Cannabinoid Product Marinol
  • 4.3.2 Marinol was the Standard for Cannabinoid Therapies
  • 4.3.3 Marinol' s Patient Population is Driven by AIDS Wasting
  • 4.3.4 Alzheimer' s Disease Set to Compete With AIDS Wasting Patient Population
  • 4.3.5 Marinol Revenues Boosted by Market Exclusivity and Approval in Various International Markets
  • 4.3.6 Global Marinol Market: First Half of 2004 Revenues Drop Due to Unimed Subsidiaries Distribution Contract Renegotiation
  • 4.3.7 Market Drivers of Marinol
  • 4.3.8 Market Restraints of Marinol
  • 4.3.9 Added Indications of Marinol Will Aid Market Revenues
  • 4.3.10 Unimed and Nektar Therapeutics' Phase I Study of Metered Dose Inhaler (MDI) Holds Promise
  • 4.3.11 Metered Dose Inhaler Formulation of Marinol (Dronabinol)
  • 4.3.12 Cost of Marinol vs. Cannabis
  • 4.3.13 Stages of Development of Marinol
  • 4.3.14 Revenue Forecast 2006 - 2011
• 4.4 Nabilone
  • 4.4.1 Nabilone' s European Market Dominance
  • 4.4.2 Nabilone' s Sales Will Approach the $16.3 million mark in 2007
  • 4.4.3 Cambridge Labs Must Act Now to Maximise Nabilone' s Profits
  • 4.4.4 THC Pharma and Delta 9 Pharma Compete to Supply Germany with Dronabinol (Delta-9- Tetrahydrocannabinol)
  • 4.4.5 Launch of Cesamet oral capsules in USA
  • 4.4.6 Valeant Files Investigational New Drug Application for Cesamet in Cancer Chemotherapy-Induced Neuropathic Pain
  • 4.4.7 Stages of development of Nabilone
  • 4.4.8 Revenue Forecast 2006 - 2012
• 4.5 Sativex
  • 4.5.1 Market Prospects for Cannabinoids Will Decided by Sativex
  • 4.5.2 UK MS Spasticity Status Application of Sativex Rests With MHRA
  • 4.5.3 Dexanabinol' s Traumatic Brain Injury Phase III Results Hinder Cannabinoids Potential?
  • 4.5.4 The Potential Value of the Cannabinoid Market
  • 4.5.5 Stages of development of Sativex
  • 4.5.6 Sativex Revenue Forecast: 2006-2011
• 4.6 Rimonabant
  • 4.6.1 Market Prospects for Cannabinoids Will be Decided by Acomplia
  • 4.6.2 New data shows Acomplia benefited patients with type II diabetes
  • 4.6.3 Acomplia diet pill delayed a third time
  • 4.6.4 Stages of development of Acomplia
  • 4.6.5 Phase III testing of Diabetes
  • 4.6.6 Rimonabant Life-Cycle
  • 4.6.7 Rimonabant Revenue Forecast: 2006-2011
• 4.8 Cannabinoids Potential to Gain Blockbuster Status: Visiongain' s Perspective
• 4.9 Will Cannabinoids Achieve Blockbuster Status? A Survey of Industry Representatives
• 4.10 GW Pharmaceuticals Perspective on Cannabinoids Achieving Blockbuster Status

Chapter 5. Pipeline Cannabinoid Products

• 5.1 Introduction to Cannabinoid Companies
• 5.2 Impressive Cannabinoids Pipeline
• 5.3 Growing Interest of Big Pharmaceuticals in Cannabinoid R&D
• 5.4 Almirall Prodesfarma
  • 5.4.1 Agreement between Almirall and GW
  • 5.4.2 Key Financial Data
• 5.5 Atlantic Technology Venture Inc and Indevus
  • 5.5.1 Indevus acquires and commences Phase II Trials for IP 751 (CT-3)
  • 5.5.2 Indevus' s Pipeline
• 5.6 Bayer Healthcare AG
  • 5.6.1 Bayer has licence to Sativex in the UK
  • 5.6.2 Bayer HealthCare & GW in $41 Million Marketing Agreement
  • 5.6.3 Key Financial Data
• 5.7 GW Pharmaceuticals
  • 5.7.1 GW Pharmaceuticals: The Innovative Leading Cannabinoids Company
  • 5.7.2 GW' s Advance Delivery System (ADS) Received AiM Stock Exchange Award
  • 5.7.3 GW Pharmaceuticals instrumental in developing Sativex
  • 5.7.4 GW Pharmaceuticals to work on Obesity Fighting Drug
  • 5.7.5 Phase III trials of Sativex for neuropathic pain
  • 5.7.6 GW Pharmaceuticals Product Pipeline is Extensive
  • 5.7.7 GW Pharmaceuticals in strategic alliance with Otsuka
• 5.8 MakScientific/Endo Pharmaceuticals Inc
  • 5.8.1 Novel Selective CB2 Agonists from MakScientific/Endo Pharmaceuticals Inc
  • 5.8.2 BTG begin interest in developing CB2 receptor
  • 5.8.3 Total Endo Sales by Region
• 5.9 Novartis
  • 5.9.1 Novartis' Interest in Cannabinoid Agonists for Pain Control
  • 5.9.2 Key Financial Data
• 5.10 Par Pharmaceuticals
  • 5.10.1 Par Pharmaceuticals entered agreement with Valeant
  • 5.10.2 Par Pharmaceuticals announced that Valeant exercised the right to terminate agreement
  • 5.10.3 Key Financial Data
• 5.11 Pharmos Corporation
  • 5.11.1 Pharmos' Cannabinor development
• 5.12 Pfizer
  • 5.12.1 Pfizer' s Four CB1 Candidates
  • 5.12.2 Key Financial Data
• 5.13 Sanofi-Aventis
  • 5.13.1 Sanofi-Aventis' Anti-Obesity /Anti-Smoking Drug Acomplia is a Potential Blockbuster
  • 5.13.2 Rimonabant update in the US
  • 5.13.3 Key Financial Data
• 5.14 Solvay
  • 5.14.1 Bristol-Myers Squibb and Solvay Pharmaceutical' s SLV319 Compound
  • 5.14.2 Key Financial Data
• 5.15 Valeant Pharmaceuticals
  • 5.15.1 Valeant receives two PDUFA dates
  • 5.15.2 Valeant acquires Nabilone
  • 5.15.3 Key Financial Data
• 5.16 Yissum
  • 5.16.1 Yissum Drive Cannabinoid Market Progress with Collaborations and Research Efforts
  • 5.16.2 Yissum from Dexanabinol Agreement Now Under Question

Chapter 6. Regulatory Issues of Cannabinoids and Medically Approved Cannabis

• 6.1 The Politics of Therapeutic Cannabinoid and Cannabis Use
• 6.2 The US
  • 6.2.1 Two FDA Programmes Aid Cannabinoid Drug Development
  • 6.2.2 The DEA Rescheduling of Marinol to Schedule III Increases Availability for Patients
  • 6.2.3 Cannabis Remains under Schedule I of the US 1971 Convention on Psychotropic Substances
  • 6.2.4 Medical Cannabis Legal in Eleven US States
  • 6.2.5 Medical Cannabis Compassion Clubs in the US have Grown in Popularity
  • 6.2.6 New Cannabinoids and Scheduling Regulations in the U.S: Will They Be Subject to Scheduling?
• 6.3 Canada
  • 6.3.1 Regulations Amending the Marihuana Medical Access Regulations (MMAR)
  • 6.3.2 Remaining Acts and Regulations
  • 6.3.2 The first country to approve Sativex
• 6.4 The UK
  • 6.4.1 Schedule I Classification of Misuse of Drugs Act 1971-' No Therapeutic Value'
  • 6.4.2 Dronabinol Rescheduled to Schedule II by UK Government
  • 6.4.3 Cannabinoid Therapeutics: UK Government Willing to Permit Introduction
  • 6.4.4 Home Office License Required to Research Cannabinoids in UK
  • 6.4.5 The House of Lords Science & Technology Committee' s Report on Cannabinoids
  • 6.4.6 Abstract from The House of Lords Science & Technology Committee' s ' Cannabis: The Scientific and Medical Evidence' Report
• 6.5 Japan
  • 6.5.1 Japan' s Cannabis Control Act 1948 Illegalises Medicinal Cannabis and Cannabinoid Research
• 6.6 France
  • 6.6.1 List IV of Decree Law 1990
  • 6.6.2 French Medics Allowed To Prescribe Cannabinoids Under Temporary Use Authorisations
• 6.7 Germany
  • 6.7.1 Schedule II of the Narcotics Act 1996
  • 6.7.2 German Federal Government Breaks Its Promise on Medical Cannabis
  • 6.7.3 German Administrative Court Rejects Law Suits Against the Federal Institute for Pharmaceuticals and Medical Products
• 6.8 Italy
  • 6.8.1 List IV of Decree Law 1992
  • 6.8.2 Four Italian Regions Request Medicinal Cannabis and Its Derivatives
  • 6.8.3 Italian Judge Forces Italy' s NHS to Supply Cannabinoids
  • 6.8.4 Italians Restricted Supplies of Nabilone and Marinol
• 6.9 Spain
  • 6.9.1 No specific Legal Definition of Cannabinoids
  • 6.9.2 Spanish Health Minister Announces Intention of Medical Cannabis Extract Availability

Chapter 7. Conclusion to Cannabinoids

• 7.1 A Potential Blockbuster?

List of figures

• Figure 2.1 Chemical Structures of the Major Cannabinoids
• Figure 4.1 Valeant' s Drug Pipeline
• Figure 5.1 Indevus' s Pipeline

List of graphs

• Graph E.1 Total Cannabinoid Market Revenue Forecast ($bn)
• Graph E.2 Sativex Revenue Forecast ($m)
• Graph E.3 Rimonabant Revenue Forecast ($bn)
• Graph 4.1 Revenues of Cannabinoid Market ($m)
• Graph 4.2 Marinol Revenue Forecast 2006-2012 ($thousands)
• Graph 4.3 Marinol Percentage Growth
• Graph 4.4 Nabilone Revenue Forecast 2006 - 2012 ($)
• Graph 4.5 Nabilone Percentage Growth
• Graph 4.6 Sativex Revenue Forecast 2006 - 2012 ($m)
• Graph 4.7 Sativex Percentage Growth
• Graph 4.8 Rimonabant Revenue Forecast 2006 - 2012 ($bn)
• Graph 4.9 Investment Banks' Revenue Forecast on Rimonabant ($bn)
• Graph 5.1 Alimrall Sales (EUm)
• Graph 5.2 Almirall R&D Costs (EUm)
• Graph 5.3 Almirall Sales By Region (EUm)
• Graph 5.4 Bayer Sales (EUm)
• Graph 5.5 Bayer Net Profit (EUm)
• Graph 5.6 Bayer R&D Costs (EUm)
• Graph 5.7 Bayer Regional Sales ($m)
• Graph 5.8 Novartis Sales ($m)
• Graph 5.9 Novatis Net Profit ($m)
• Graph 5.10 Novartis R&D Costs ($m)
• Graph 5.11 Novartis Sales by Region ($m)
• Graph 5.12 Par Sales ($ thousands)
• Graph 5.13 Par Net Profit ($ thousands)
• Graph 5.14 Par R&D Costs ($m)
• Graph 5.15 Pfizer Sales ($m)
• Graph 5.16 Pfizer Net Profit ($m)
• Graph 5.17 Pfizer R&D Costs ($m)
• Graph 5.18 Pfizer Sales By Region ($m)
• Graph 5.19 Sanofi-Aventis Sales (EUm)
• Graph 5.20 Sanofi-Aventis Net Profit (EUm)
• Graph 5.21 Sanofi-Aventis R&D Costs (EUm)
• Graph 5.22 Sanofi-Aventis Sales By Region (EUm)
• Graph 5.23 Solvay Sales (EUm)
• Graph 5.24 Solvay Net Profit (EUm)
• Graph 5.25 Solvay R&D Costs (EUm)
• Graph 5.26 Solvay Sales By Region (EUm)
• Graph 5.27 Valeant Sales ($m)
• Graph 5.28 Valeant Net Profit ($m)
• Graph 5.29 Valeant R&D Costs ($m)
• Graph 5.30 Valeant Sales By Region ($m)

List of Tables

• Table E.1 Potential Diseases All Cannabinoids May Treat
• Table 2.1 The Major Cannabinoids in Cannabis
• Table 2.2 Properties of the Major Cannabinoids in Cannabis
• Table 2.3 Synthetic Cannabinoids and Their Characteristics
• Table 2.4 Potential Therapeutic Areas of Cannabinoid Therapies
• Table 2.5 Acute and Chronic Adverse Effects of THC
• Table 3.1 Potential Diseases All Cannabinoids May Treat, 2007
• Table 3.2 Cannabinoid Clinical Trial Outcomes of Various Diseases
• Table 3.3 Background to Diseases in Which Cannabinoids may Have a Use
• Table 3.4 The Potential Circumstances for Cannabinoid Use in Pain Control
• Table 3.5 Neuropathic Pain Disorders
• Table 3.6 Target Patients for Cannabinoid Pain Relief
• Table 3.7 Visiongain' s Perspective of the Therapeutic Potential of Cannabinoids by Disease, 2007
• Table 4.1 Revenues of Cannabinoid Market ($m)
• Table 4.2 Top Products in the same Therapeutic Area
• Table 4.3 Stages of Development
• Table 4.4 Countries where Nabilone is Marketed by Cambridge Labs Distribution Partners
• Table 4.5 THC Pharma Cannabinoid Catalogue Products, 2007
• Table 4.6 Stages of Development
• Table 4.7 Stages of Development
• Table 4.8 Stages of Development
• Table 4.9 Investment Banks' Revenue ($bn)
• Table 5.1 Endo Sales by Region
• Table 5.2 Pfizer CB1 Candidates in R&D, 2007
• Table 6.1 Schedule III Benefits of Marinol Compared to Schedule II
• Table 6.2 11 US States That Have Legalised Medical Use of Cannabis

Organisations Listed

• AFT
• Alcasynn Pharmaceuticals
• AOP
• Almirall Prodesfarma
• AstraZeneca
• Atlantic Technology Venture Inc.
• Bayer Healthcare
• Biogen Idec
• BMS
• BTG
• Cambridge Laboratories
• Cedarburg Pharmaceuticals
• Celltech
• Chiesl
• Delta 9 Pharmaceuticals
• Dov Pharmaceuticals
• Eli Lilly
• Endo Pharmaceuticals
• GSK
• GW Pharmaceuticals
• MakScientific
• Medifront
• Medilink
• MegaPharm
• Metaphore Pharmaceuticals
• Nektar Therapeutics
• Novartis
• Orphan Australia
• Otsuka Pharmaceuticals
• Par Pharmaceuticals
• Pfizer
• Pharmos
• Prestwick Pharmaceuticals
• Sanofi-Aventis
• Serb Laboratories
• Serono
• Schering-AG
• Solvay Pharmaceuticals
• Teva Pharmaceuticals
• THC Pharmaceuticals
• Unimed Pharmaceuticals
• Valeant Pharmaceuticals
• Yissum Research Development Co.