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Cannabinoid Market Forecasts & Analysis to 2012

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 Crohn'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 Obstetics/Gynaecology: Centuries Old Remedies May Hold Potential
  • 3.11.3   Cannabinoids and Diabetes
• 3.12     Visiongain's Prespective 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 Therapeutic's Phase I Studyof 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-Avenits 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

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