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Cannabinoids: A potential blockbuster

Today's cannabinoid market is undergoing rapid expansion. Currently just two products are available on this controversial market:

• Marinol from Unimed Pharmaceuticals
• Nabilone marketed by Cambridge Laboratories.

Both indicated for the control of chemotherapy- induced nausea and vomiting, Marinol has additional approval as an appetite stimulant to treat anorexia associated with HIV/AIDS. However, the next coming months will witness the arrival of the world's first whole-cannabis plant derived pharmaceutical product, Sativex.

The approval of Sativex upon the Canadian neuropathic pain associated Multiple Sclerosis market is imminent. Developed by the innovative cannabinoid company GW Pharmaceuticals, Sativex is expected to transform the market and aid recovery of loss of revenue following Pharmo's recent announcement of Dexananbinol's failure to show efficacy for Traumatic Brain Injury. The profile of the market will also be raised by the expected mid-2006 launch of Acomplia by Sanofi-Aventis for obesity. With such developments, cannabinoids are set to become pharmaceutical rather than political products and will encourage further R&D into this up-and coming area of industry. The DEA's decision to reschedule Marinol from Schedule II to Schedule III and the acceptance of medicinal cannabis in 11 US states demonstrates the shifting attitude required for the cannabinoids to achieve blockbuster status.

Visiongain values todays limited cannabinoid market at just $110.5m in 2005. Having grown 6.3% from 2004's revenues of $104 m, growth of the market will continue over the forecast period 2002-2010. Two forecast projections are made by visiongain in this report: if no comers arrive and the potential value following launch of the key future products.

Designed as an essential business aid, Cannabinoids: A Potential Blockbuster provides a thorough evaluation of the market. The report focuses on the following aspects:

• An Introduction to Cannabinoids
• Potential Cannabinoid Therapies
• The Worldwide Cannabinoid Market- Current and Future Products
• Pipeline Cannabinoid Products
• Cannabinoid Company Information
• Regulatory Issues of Cannabinoids and Medically Approved Cannabis in the Seven Major Markets

The report provides in-depth market analysis for current and potential products. The report extensively identifies cannabinoid drugs market potential by analysing the latest clinical trial research as well as the challenges faced by potential cannabinoid companies.

Five key questions this report answer's are:

• What is the market potential for cannabinoids treating various diseases?
• What latest clinical trials/experimental research has been performed to develop cannabinoids for therapeutic uses?
• What is the global cannabinoid market value of today and the future worth?
• Will the cannabinoid market gain blockbuster status and why?
• What are the regulatory issues surrounding cannabinoids and medicinal cannabis use in the seven major markets?

Table of Contents

 

Chapter 1: Executive Summary of Cannabinoids: A Potential Blockbuster?

 

• 1.1 Introduction to the Cannabinoids Market
• 1.2 Cannabinoid Potential Therapeutic Areas
• 1.3 GW Pharmaceuticals: The Cannabinoid Company
• 1.4 Overview of Cannabinoids: A Potential Blockbuster?

 

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: The 3 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 Marinol and Nabilone: The Only 2 Cannabinoid Drugs on the Global Market
• 3.3 The Potential Clinical Uses of Cannabinoids Overview
• 3.4 Cannabinoids and Pain: An Alternative to Opioids?
• 3.5 Experimentally Induced Acute Pain
• 3.6 Post Surgical Acute Pain
• 3.7 Chronic Pain
• 3.8 Chronic Non-malignant Pain
• 3.9 Neuropathic Pain
• 3.10 Migraine
• 3.11 Cannabinoids and Pain: A Lucrative Market to R&D?
• 3.12 Cannabinoids and Cancer-Associated Cachexia/Anorexia: Prospects Look Promising
• 3.13 Cannabinoids and Multiple Sclerosis: The Most Likely Therapeutic Use
• 3.14 Cannabinoids and Movement Disorders: The Good and Bad
• 3.15 Dystonia
• 3.16 Huntington's Disease
• 3.17 Parkinson's Disease
• 3.18 Tourette's Syndrome
• 3.19 Cannabinoids and Movement Disorders: The Future
• 3.20 Cannabinoids and Alzheimer's Disease: A High Potential
• 3.21 Cannabinoids and Epilepsy: No Trials Performed, Yet
• 3.22 Cannabinoids and Rheumatoid Arthritis: A Possible Use
• 3.23 Cannabinoids and Glaucoma: Temporary Relief Found

 

Cannabinoids and Cancer: A New Hope

Cannabinoids and Asthma: Numerous Studies Performed

Cannabinoids and Chron's Disease/Ulcerative Colitis: Experimental Data Looks Good

Cannabinoids and Depression: Future Looks Good

Cannabinoids and Obstetics/Gynaecology: Centuries Old Remedies May Hold Potential

Cannabinoids and Drug Withdrawal: A New High?

Cannabinoids and Intractable Breathlessness: A Rare Answer to an Unknown Disease?

Cannabinoids and Traumatic Brain Injury: Prospects Injured

Cannabinoids and Obesity: A Large Potential

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 Unimed Pharmaceuticals Inc Markets the Leading Cannabinoid Product Marinol
• 4.3 Marinol is the Standard for New Cannabinoid Therapies
• 4.4 Marinol's Patient Population is Driven by AIDS Wasting
• 4.5 Alzheimer's Disease Set to Compete With AIDS Wasting Patient Population
• 4.6 Marinol Revenues Boosted by Market Exclusivity and Approval in Various International Markets
• 4.7 Global Marinol Market: 2004 Revenues Drop Due to Unimed Subsidiaries Distribution Contract Renegotiation
• 4.8 Market Drivers of Marinol
• 4.9 Market Restraints of Marinol
• 4.10 Added Indications of Marinol Will Aid Market Revenues
• 4.11 Unimed and Nektar Therapeutic's Phase I Study of Metered Dose Inhaler (MDI) Holds Promise
• 4.12 Cost of Marinol v's Cannabis
• 4.13 Nabilone's European Market Dominance
• 4.14 Nabilone's Sales Will Approach the $20 Million Mark in 2005
• 4.15 Cambridge Labs Must Act Now to Maximise Nabilone's Profits
• 4.16 THC Pharma and Delta 9 Pharma Compete to Supply Germany with Dronabinol (Delta-9- Tetrahydrocannabinol)
• 4.17 Total Global Cannabinoid Market Worth Almost $200 Million by 2010
• 4.18 The Potential Therapeutic Market for Cannabinoids is Diverse
• 4.19 Market Prospects for Cannabinoids Will be Decided by Sativex and Acomplia
• 4.20 GW Pharmaceuticals Spokesperson: " We are Commencing Sativex Approval Activities in the US in 2005 "
• 4.21 Dexanabinol's Traumatic Brain Injury Phase III Results Will Limit Cannabinoid Market Value
• 4.22 Potential Value of the Cannabinoid Market
• 4.23 Sativex MS Revenue Forecast: 2005-2010
• 4.24 Acomplia AntiObesity Revenue Forecast: 2006-2010

 

Cannabinoids Potential to Gain Blockbuster Status: Visiongain's Prespective

 

• 4.26 Will Cannabinoids Achieve Blockbuster Status? A Survey of Industry Representatives
• 4.27 GW Pharmaceuticals Prespective on Cannabinoids Achieving Blockbuster Status

 

Chapter 5: Pipeline Cannabinoid Products

 

• 5.1 Impressive Cannabinoids Pipeline 2005 is a Far-Cry From That of 1999's
• 5.2 Growing Interest of Big Pharma in Cannabinoid R&D
• 5.3 GW Pharmaceuticals Product Pipeline is Extensive
• 5.4 UK MS Spasticity Status Application of Sativex Rests With MHRA
• 5.5 Future GW Approval Applications
• 5.6 Sanofi-Aventis' Anti Obesity /Anti Smoking Drug Acomplia is a Potential Blockbuster
• 5.7 Pharmos' " Most Unlikely " to Develop Lead Candidate Dexanabinol Following Disappointing Phase III Traumatic Brain Injury Results
• 5.8 Atlantic Technology Venture Inc. Commence Phase II Trials for CT-3
• 5.9 Yissum Drive Cannabinoid Market Progress with Collaborations and Research Efforts
• 5.10 Pfizer's Four CB1 Candidates
• 5.11 Norvartis' Interest in Cannabinoid Agonists for Pain Control
• 5.12 Novel Selective CB2 Agonists from MakScientific/Endo Pharmaceuticals Inc
• 5.13 BMS and Solvay Pharma's SLV319 Compound

 

Chapter 6: Cannabinoid Companies

 

• 6.1 Introduction to Cannabinoid Companies
• 6.2 GW Pharmaceuticals: The Innovative Leading Cannabinoids Company
• 6.3 GW's Advance Delivery System (ADS) Receives AiM Stock Exchange Award
• 6.4 Bayer HealthCare & GW in $41 Million Marketing Agreement
• 6.5 The Israelin Company Pharmos, Dexanabinol and Its Cannabinoid Library
• 6.6 $50 million for Yissum Research Development Co. from Dexanabinol Agreement Now Under Question
• 6.7 MakScientific/Endo Pharmaceuticals Inc. and CB2 Agonists
• 6.8 BMS and Solvay Pharma in AntiObesity Cannabinoid Development and Commercialisation Agreement

 

Chapter 7: Regulatory Issues of Cannabinoids and Medically Approved Cannabis

 

• 7.1 The Politics of Therapeutic Cannabinoid and Cannabis Use: An Introduction
• 7.2 The US: Two FDA Programmes Aid Cannabinoid Drug Development
• 7.3 The DEA Rescheduling of Marinol to Schedule III Increases Availability for Patients
• 7.4 Cannabis Remains under Schedule I of the US 1971Convention on Psychotropic Substances
• 7.5 Medical Cannabis Now Legal in Eleven US States
• 7.6 Medical Cannabis Compassion Clubs in the US Growing in Popularity
• 7.7 New Cannabinoids and Scheduling Regulations in the U.S: Will They Be Subject to Scheduling?
• 7.8 The UK and Cannabinoids: Schedule I Classification of Misuse of Drugs Act 1971-'No Therapeutic Value'
• 7.9 Dronabinol Rescheduled to Schedule II by UK Government
• 7.10 New Cannabinoid Therapeutics: UK Government Willing to Permit Introduction
• 7.11 Home Office License Required to Research Cannabinoids in UK
• 7.12 The House of Lords Science & Technology Committee Reports Back Cannabinoids
• 7.13 Abstract from The House of Lords Science & Technology Committee's 'Cannabis: The Scientific and Medical Evidence' Report
• 7.14 Japan's Cannabis Control Act 1948 Illegalises Medicinal Cannabis and Cannabinoid Research
• 7.15 France and Cannabinoids: List IV of Decree Law 1990
• 7.16 French Medics Allowed To Prescribe Cannabinoids Under Temporary Use Authorisations
• 7.17 Germany and Cannabinoids: Schedule II of the Narcotics Act 1996
• 7.18 German Federal Government Breaks Its Promise on Medical Cannabis
• 7.19 German Administrative Court Rejects Law Suits Against the Federal Institute for Pharmaceuticals and Medical Products
• 7.20 Italy and Cannabinoids: List IV of Decree Law 1992
• 7.21 Four Italian Regions Request Medicinal Cannabis and Its Derivatives Approval in 2002

 

Italian Judge Forces Italy's NHS to Supply Cannabinoids

Italians Restricted Supplies of Nabilone and Marinol

Spain: No specific Legal Definition of Cannabinoids

Spanish Health Minister Announces Intention of Medical Cannabis Extract Availability

Chapter 8: Conclusion to Cannabinoids: A Potential Blockbuster?

 

• 8.1 Conclusion

 

Tables

Table 1.1: Current Cannabinoid Pharmaceuticals Available on the World Market, 2005

Table 1.2 Marinol and Nabilone Indications and Approval Dates

Table 1.3: Potential Cannabinoid Therapeutic Areas

Table 2.1: The Major Cannabinoids in Cannabis

Table 2.2: Properties of the Major Cannabinoids Found 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, 2005

Table 3.2: Globally Marketed Cannabinoids, 2005

Table 3.3: Cannabinoid Clinical Trial Outcomes of Various Diseases

Table 3.4: Disease Background of Cannabinoid Therapeutic Uses

Table 3.5: The Potential Circumstances of Cannabinoid Use in Pain Control

Table 3.6: Neuropathic Pain Disorders

Table 3.7: Target Patients for Cannabinoid Pain Relief

Table 3.8: Visiongain's Prespective of the Therapeutic Potential of Cannabinoids by Disease, 2005

Table 4.1: Marinol Global Availability, 2005

Table 4.2: Total Global Market Revenue Forecast of Marinol ($m), 2002- 2010

Table 4.3: Countries where Nabilone is Marketed by Cambridge Labs Distribution Partners

Table 4.4: Total Global Market Revenue Forecast of Nabilone ($m), 2002-2010

Table 4.5: THC Pharma GmbH Cannabinoid Catalogue Products, 2005

Table 4.6: Total Global Market Revenue Forecast of Cannabinoids (Marinol, Nabilone and Dronabinol Combined Sales), $m, 2002- 2010

Table 4.7:Sativex Combined Canadian, UK & US MS Market Revenue Forecast ($m), 2005-2010

Table 4.8: Multiple Sclerosis Market Leading Therapeuitcs, 2003

Table 4.9: Acomplia AntiObesity Market Revenue Forecast ($m), 2006-2010

Table 5.1: Cannabinoids Pipeline, 2005

Table 5.2: Pfizer CB1 Candidates in R&D, 2005

Table 7.1: Schedule III Benefits of Marinol Compared to Schedule II

Table 7.2: 11 US States That Have Legalised Medical Use of Cannabis

Graphs

Graph 4.1: Total Global Market Revenue Forecast of Marinol ($m), 2002- 2010

Graph 4.2: Total Global Marinol Market Revenue Change Forecast (%), 2003-2010

Graph 4.3: Total Global Market Revenue Forecast of Nabilone ($m), 2002- 2010

Graph 4.4: Total Global Nabilone Market Revenue Change Forecast (%), 2003-2010

Graph 4.5: Total Global Market Revenue Forecast of Cannabinoids (Marinol, Nabilone and Dronabinol Combined Sales), $m, 2002- 2010

Graph 4.6: Total Global Market of Cannabinoids (Marinol, Nabilone and Dronabinol Combined Sales), Revenue Change Forecast (%), 2003-2010

Graph 4.7: Sativex Combined Canadian, UK & US MS Market Revenue Forecast ($m), 2005-2010

Graph 4.8: Sativex Combined Canadian, UK & US MS Market Growth Forecast (%), 2006-2010

Graph 4.9: Acomplia AntiObesity Market Revenue Forecast ($m), 2006- 2010

Graph 4.10: Acomplia AntiObesity Market Growth Forecast (%), 2007- 2010

Charts

Chart 2.1: Chemical Structures of the Major Cannabinoids

Chart 4.1: Marinol Patient Population, 2003

Chart 4.2: Marinol Patient Population, 2010

Chart 4.3: Cambridge Labs Distribution Network, 2005

Chart 4.4: Survey Results: Will New Cannabinoid Drugs Achieve Blockbuster Status?

Chart 5.1: GW Pharmaceuticals Product Pipeline, 2005

 

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