Pipeline Insight: Substance Dependence - Part I: Nicotine

Introduction

The high prevalence of nicotine dependence, strong uptake of Pfizer's Chantix (varenicline), and the launch of new innovative therapies will cause the nicotine dependence prescription drug market to grow to $4.6 billion across the seven major markets by 2016. Innovative therapies are set to offer patients a convenient dosing regimen and thereby carrying the potential for improved compliance.

Scope

• Analysis of patient potential, unmet needs and clinical trial design in nicotine dependence
• Overview of the current nicotine dependence market, covering both prescription and OTC products
• Overview of drugs in late stage clinical development for nicotine dependence
• Profiles of key compounds in development for use in nicotine dependence, with forecasts of drug revenues to 2016 and insight from key opinion leaders

Highlights

Nicotine vaccines are the most prevalent drug class in the late-stage pipeline. This represents a move away from nicotine replacement and nicotine agonist therapies, which have historically dominated the market. Datamonitor predicts nicotine vaccine companies will be important players in the market by 2016, led by Novartis's NIC-002.

Nicotine vaccines are designed to prevent nicotine from entering the brain and thus reduce the pleasurable effect of smoking. The utility of vaccines in nicotine dependence lies in the long-term protection they provide along with minimal patient compliance and carry the potential for prophylactic use.

With two compounds in late-stage development for the treatment of nicotine dependence, it is evident that Sanofi-Aventis is keen to penetrate this market. Although possessing a similar mechanism of action to Chantix, Datamonitor believes that the drug's shorter treatment course than the market leader represents a strong competitive advantage.

Reasons to Purchase

• Understand unmet needs and opportunities in this market based on the comments of interviewed key opinion leaders.
• Benchmark key late-stage nicotine dependence compounds against the current market leader.
• Assess the seven major market total sales forecasts of key late-stage pipeline drugs; and examine their clinical and commercial potential

• Table Of Contents
• Chapter 1 Executive Summary
  • Scope Of The Analysis
  • Datamonitor Insight Into The Nicotine Dependence Market
  • Key Metrics
  • Datamonitor Pipeline Assessment Summary
  • Contributing Experts
  • Upcoming Reports
• Chapter 2 Nicotine Dependence - Market Potential
  • Definition Of Nicotine Dependence
  • Epidemiology Of Nicotine Dependence
  • Nicotine Dependence Is Estimated To Affect Over 115 Million People In The Seven Major Markets
  • Prevalence Is Expected To Slowly Decrease Over Time
  • Few Nicotine Dependent Individuals Seek Help With Quitting From Their Primary Care Physician
  • Diagnostic Criteria For Nicotine Dependence Are Rarely Used In Clinical Practice
  • Current Market Overview
  • Nicotine Dependence Market Demonstrates Sharp Growth After A Period Of Decline
  • The Us Dominates Sales Revenue Of The Nicotine Dependence Market
  • These Is An Absence Of Prescription Nicotine Dependence Products In Japan
  • The Uk Has Overtaken France As The Largest Nicotine Dependence Market In The 5eu
  • Only Two Prescription Treatments Are Currently Marketed For Nicotine Dependence
  • Over-The-Counter Products Represent Barrier To Prescription Market Growth
  • Unmet Need In Nicotine Dependence
  • Reduction In Relapse Rate
• Chapter 3 Pipeline Overview And Dynamics
  • Pipeline Overview
  • Vaccines Are The Most Prevalent Drug Class In The Current Pipeline
  • Definition Of Current Comparator Therapy
  • Pfizer's Chantix Is Datamonitor's Comparator Therapy
  • Forecasts To 2016
  • Clinical Trials
  • Phase Ii Study
  • Phase Iii Comparative Trials: Chantix Versus Bupropion
  • Long-Term Abstinence
  • Chantix's Major Competitors And Key Strengths And Weaknesses
  • Classification Of Pipeline Products
  • Recently Discontinued Or Failed Projects
  • Adx10061
  • Rimonabant
  • Taranabant
  • Nc-001
  • Clinical Trial Design
  • Primary And Secondary Endpoints
  • Patient Populations
  • Inclusion Criteria Require Participants To Smoke Ten Or More Cigarettes Per Day
  • Opinion Leaders Recommend Inclusion Of More Heterogeneous Participant Samples
• Chapter 4 Vaccine Late-Stage Drug Analysis & Forecasts
  • Overview For Vaccine Class
  • Pipeline Summary
  • Nicvax (Nicotine Conjugate Vaccine)
  • Drug Overview
  • Forecasts To 2016
  • Datamonitor Drug Assessment Summary
  • Marketing Factors
  • Nabi Will Benefit From The Expertise Of The Commercialization Partner It Is Seeking
  • Novel Mechanism Of Action Will Generate Strong Interest Among Physicians
  • Patient Potential
  • Individual Variability In Immunological Response
  • Nicvax Has Potential For Prophylactic Use
  • Satisfaction Of Unmet Needs
  • Nicvax Demonstrates Comparable Efficacy To Chantix
  • Convenient Dosing Regimen Will Increase Compliance
  • Long-Term Irreversibility Of Nicvax Will Reduce Relapse Rate
  • Favorable Side-Effect And Safety Profile
  • Clinical Trial Data
  • Phase Iib Data At 12 Months
  • Phase Iib Data At 9 Months
  • Nic-002
  • Drug Overview
  • Forecasts To 2016
  • Datamonitor Drug Assessment Summary
  • Marketing Factors
  • Novartis's Marketing And Sales Experience Bodes Well For The Launch Of Nic-002
  • Second-To-Market Vaccine For Nicotine Dependence
  • Patient Potential
  • High Immunological Response Will Lead To High Patient Potential
  • Nic-002 Has Potential For Prophylactic Use
  • Satisfaction Of Unmet Needs
  • Nic-002 Demonstrates Strong Efficacy
  • Convenient Dosing Regimen Will Increase Compliance
  • Long-Term Irreversibility Of Nic-002 Will Reduce Relapse Rate
  • Favorable Side-Effect Profile
  • Clinical Trial Data
  • Clinical Dose-Optimization Study
  • Phase Ii Trial - 6 Month And 12 Month Follow-Up
• Ta-Nic
  • Drug Overview
• Chapter 5 Other Late-Stage Drug Analysis And Forecasts
  • Overview For Other Pipeline Nicotine Dependence Drugs
  • Pipeline Summary
  • Dianicline
  • Drug Overview
  • Forecasts To 2016
  • Datamonitor Drug Assessment Summary
  • Marketing Factors
  • Seven Week Treatment Course Is A Strong Competitive Advantage
  • Sanofi-Aventis Has Established Relations With Key Prescribers
  • Dianicline Will Experience Fierce Competition From Established Brands
  • Patient Potential
  • Satisfaction Of Unmet Needs
  • Dosing Regimen
  • Dianicline Does Not Satisfy The Need For A Reduction In Relapse Rates
  • Side-Effect And Safety Profile
  • Clinical Trial Data
  • Ongoing Clinical Trials
  • Nalmefene
  • Drug Overview: Opioid Antagonist
  • Gw-468816
  • Drug Overview: Glycine Receptor Antagonist
  • Ongoing Clinical Trials
  • Surinabant
  • Drug Overview: Cannabinoid Receptor Antagonist
  • Ongoing Clinical Trials
• Bibliography
• Appendix A
  • Methodology
  • Datamonitor Forecast Methodology
  • Epidemiology Forecasts
  • Product Forecasts
  • Definition Of A Standard Unit
  • Contributing Experts
• Appendix B
  • Methodology
  • Definition Of Nicotine Dependence Market
  • About Datamonitor
  • About Datamonitor Healthcare
  • Datamonitor Healthcare's Therapy Area Capabilities
  • About The Disease Analysis Team
  • Disclaimer