Abstract
This invaluable briefing provides a critical and far-reaching examination of
current cannabinoid products and areas of unmet clinical need where the use of
cannabinoids could be clinically beneficial and commercially profitable.
The psychotropic effects of Cannabis have been known for millennia - as have
its medical uses, with the relief of cramps, rheumatic and menstrual pain
being reported as early as 2,600 BC. The analgesic, appetite stimulant,
anti-emetic, muscle relaxant and anticonvulsant properties of Cannabis were
described by William O' Shaughnessy in 1839, leading to an expansion in its
medical use. Today, with greater understanding of the cannabinoid receptor
system, more targeted and specific agents are being developed with potential
in a wide range of indications.
CB1 antagonists
The industry has been excited most recently by the clinical and commercial
success of sanofi-aventis' Acomplia (rimonabant) for the treatment of obesity
(and with studies also undertaken in smoking cessation). High hopes for
Acomplia' s sales potential in the rapidly-growing obese patient population
have led to an increase in research and development activity in this area, and
obesity and related metabolic disorders remain key indications of interest. In
addition, CNS indications such as Parkinson' s disease and schizophrenia are
being investigated in early stage development.
CB2 agonists: Pain control...
But considerable opportunities exist elsewhere. For example, the CB2 receptors
are found primarily in the cells of the immune system, and have potential use
in a range of indications, including pain and inflammation, allergies and
cancer.
The report identifies three CB2 agonists which have entered Phase II clinical
trials, and a number more in preclinical studies. The vast majority are being
examined for their potential use in the treatment of pain and inflammation -
high value markets where there are significant patient numbers and current
therapies are less than ideal.
...to blood cancers
Studies with ligands of the cannabinoid receptors have shown to inhibit the
proliferation in a number of cancer types. As CB2 receptors are found
primarily in the cells of the immune system, it has been postulated that CB2
agonists may be able to induce apoptosis in transformed immune cells, leading
to the development of a novel class of anticancer agents. Preclinical studies
have confirmed this action in lymphoma and acute lymphocytic leukaemia (ALL)
cell lines.
Clinical development of CB2 agonists in blood cancers has yet to take place.
Nonetheless, the report highlights this as an area of potentially interesting
future development.
Questions answered
- Who is developing synthetic cannabinoid agents and for what conditions?
- What regulatory and safety hurdles must Merck and Pfizer overcome if they
are to launch taranabant and otenabant against sanofi-aventis' Acomplia?
- In a competitive and crowded market, which therapy areas offer the best
opportunities for cannabinoid agents?
Opportunity areas
These are examined in terms of disease understanding, market environment, competitive positioning and prospects.
- Emesis
- Cachexia
- Pain & Inflammation
- Traumatic brain injury
- Cancer
- Obesity
- Smoking cessation
- Schizophrenia
- Parkinson' s disease
Products analysed and forecast in detail
- Acomplia
- Taranabant
- Otenabant
- Ibipinabant
- Surinabant
- Marinol
- Cesamet
- Sativex
- Cannabinor
- KN38-7271
- Drinabant
Table of Contents
- Introduction
- CB1 agonists
- Cannabinoid agonists and CB1 specific agonists in development
- Emesis
- Market size and growth
- Growth drivers and market risks
- Current and future drug therapies
- Cachexia
- Market size and growth
- Population forecasts
- HIV/AIDS cachexia:
- Forecast number of patients with cachexia associated with HIV/AIDS
(' 000s)
- Cancer cachexia:
- Growth drivers and market risks
- HIV/AIDS cachexia:
- Cancer cachexia:
- Current and future drug therapies
- HIV/AIDS cachexia:
- Cancer cachexia:
- Pain
- Market size and growth
- Neuropathic pain:
- Population forecasts
- Growth drivers and market risks
- Current and future drug therapies
- Traumatic brain injury
- Cancer
- CB2 agonists
- CB2 agonists in development
- Pain and inflammation
- Market size and growth
- Population forecasts
- Forecast number of patients with osteoarthritis (millions)
- Growth drivers and market risks
- Current and future drug therapies
- Blood cancers
- CB1 antagonists
- CB1 antagonists in development
- Obesity
- Market size and growth
- Increasing prevalence of obesity in the US
- Rates of obesity in five major European countries
- Population forecasts
- Forecast number of obese adults in millions
- Growth drivers and market risks
- Current and future agents
- Smoking cessation
- Market size and growth
- Trends in per capita cigarette consumption
- Population forecasts
- Forecast number of smokers (in millions) in major developed markets
- Growth drivers and market risks
- Current and future agents
- Schizophrenia
- Parkinson' s disease
- CB2 antagonists
- Endocannabi noid deactivation i nhibi tors
- FAAH inhibitors in development
- Drug p rofiles
- Acomplia (rimonabant)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Forecast Acomplia sales by use (US$ millions):
- Competitor ratio analysis
- taranabant (MK 0364)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Forecast taranabant sales by use (US$ millions):
- Competitor ratio analysis
- otenabant (CP-945,598)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Forecast otenabant sales by use (US$ millions):
- Competitor ratio analysis
- ibipinabant (BMS-646256; SLV-319)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Forecast ibipinabant sales by use (US$ millions):
- Competitor ratio analysis
- surinabant (SR-147778)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- Marinol (dronabinol)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Marinol Dose: Response Frequency and Adverse Experiences*
- (N = 750 treatment courses)
- Cachexia in A IDS patients:
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Forecast Marinol sales by use (US$ millions):
- Competitor ratio analysis
- Cesamet (nabilone)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Forecast Cesamet sales by use (US$ millions):
- Competitor ratio analysis
- Sativex (tetrahydrocannabinol and cannabidiol)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sativex development overview
- Sales forecasts and assumptions
- Forecast Sativex sales by use (US$ millions):
- Competitor ratio analysis
- cannabinor (PRS-211,375)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- KN38-7271
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- drinabant (AVE 1625)
- Novelty/rationale for mechanism of action
- Proof of concept/clinical data
- Management/clinical expertise
- Competition within the marketplace/gaining share of voice
- Risks associated with developing a drug within a therapeutic class
- Filings and approval
- Sales forecasts and assumptions
- Competitor ratio analysis
- CRA analysis
- Methodology
- Overview
- Cannabinoid agonists
- CRA for cannabinoid agonists
- CB1 antagonists
- CRA for CB1 antagonists
- Cannabinoids on the market and in development
- APPEND IX I
