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Cannabinoids and the pharmaceutical industry

Only two products are available on this controversial yet growing market: Marinol from Unimed Pharmaceuticals and Nabilone marketed by Cambridge Laboratories. However coming soon is the worlds first whole-cannabis derived product – Sativex. This market is growing and you need to know how to take advantage of it – NOW.

The approval of Sativex is imminent. Developed by GW Pharmaceuticals, Sativex is expected to transform the market. The profile of the market will increase further by the expected mid-2006 launch of Acomplia by Sanofi-Aventis for obesity. Will a cannabinoid become the leading product for obesity? Find out in this report.

This says that the market has already grown 6.3% from 2004’s revenues and growth of the market will continue over the forecast period 2005-2010. it’s examines two potential markets: 1) if no comers arrive and 2)the potential value following launch of the key future products.

Five key questions this report answers are:

Is there a potentially large enough market for cannabinoids?
Which therapeutic areas are most likely to be responsive to cannabinoid products?
What is the global cannabinoid market value of today and over the next 5 years?
How will the cannabinoid market gain blockbuster status and when?
How do you overcome the regulatory and social issues medicinal cannabis use in the 7 major markets?

The report provides in-depth market analysis for current and potential products. This is the leading report in its field and cannot be ignored. The report extensively identifies cannabinoid drugs market potential by analysing the latest clinical trial research. The study also assesses the challenges faced by potential cannabinoid companies.

Today therapeutic proteins are used to relieve patients suffering from many conditions, including:

Various cancers (Monoclonal antibodies, Interferons)
Heart attacks, strokes, cystic fibrosis, Gaucher’s disease (Enzymes, Blood factors)
Diabetes (Insulin)
Anaemia (Erythropoietin)
Haemophilia (Blood clotting factors)
The leading therapeutic protein treatments in 2003 were:
Johnson & Johnson’s anaemia treatment Procrit
Amgen’s anaemia treatment Epogen
Schering-Plough’s hepatitis treatments Intron A and Peg-Intron
The leading classes of therapeutic proteins in 2003 were:
Monoclonal antibodies
While the top companies on the market were:
Johnson & Johnson
With over 80 graphs and figures, plus almost 60 tables, this report represents a key tool for companies wishing to enter into or expand in the therapeutic protein market. The reader will be left with a clear idea of:
The challenges faced by the therapeutic protein market, and how these are being overcome
The current and future market leaders in terms of brand, class, category and company, covering the period 2003-2010
Therapeutic targets currently being developed in the field and who is responsible for this development
The competition that companies will face during the forecast period from current and pipeline products

Table of Content

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 Obstetrics/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
it’s’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 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 Therapeutics’ 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
4.25 Cannabinoids Potential to Gain Blockbuster Status: it’s’s Perspective
4.26 Will Cannabinoids Achieve Blockbuster Status? A Survey of Industry Representatives
4.27 GW Pharmaceuticals Perspective 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?

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: it’s’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

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

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

List of Companies
Alcasynn Pharmaceuticals
Atlantic Technology Venture Inc.
Bayer Healthcare
Biogen Idec
Cambridge Laboratories
Cedarburg Pharmaceuticals
Delta 9 Pharmaceuticals
Dov Pharmaceuticals
Eli Lilly
Endo Pharmaceuticals
GW Pharmaceuticals
Metaphore Pharmaceuticals
Nektar Therapeutics
Orphan Australia
Prestwick Pharmaceuticals
Salvoy Pharmaceuitcals
Serb Laboratories
Teva Pharmaceuticals
THC Pharmaceuticals
Unimed Pharmaceuticals
Yissum Research Development Co.