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Pipeline Insight: Breakthrough Pain - Fast-acting Players Will Capture Majority Market Share

Published by: Datamonitor

Published: Nov. 15, 2006 - 140 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE
About the Central Nervous System pharmaceutical analysis team


CHAPTER 1 EXECUTIVE SUMMARY
Scope of the analysis
Datamonitor insight into the breakthrough pain market
Summary


CHAPTER 2 PATIENT POTENTIAL
Definition of breakthrough pain
Epidemiology of breakthrough pain
Breakthrough cancer pain
Breakthrough pain is more prevalent in advanced cancer stages
Patients have between four to seven episodes per day
Breakthrough pain is a common cause of hospital admissions
Breakthrough pain in non-malignant diseases
Breakthrough pain also occurs in neuropathic, musculoskeletal, visceral and postoperative pain syndromes
Market sizing assumptions and caveats
Unmet need in breakthrough pain
Need for an analgesic that acts rapidly, predictably, and just for the duration of a breakthrough pain episode
Need for quick, simple, and safe drug administration
Need for improved convenience, cost, and safety of patient-controlled analgesia
Need to reduce the abuse and overdosing potential of opioids
Need to minimize opioid-related adverse events
Need for standardized diagnosis and assessment tools for breakthrough pain

CHAPTER 3 R&D APPROACH
Classification of pipeline products
Majority of pipeline products are reformulations of existing opioids
Oral transmucosal opioids
Oral inhaled opioids
Intranasal opioids
Subcutaneous opioids
Transdermal opioids
Clinical trial design in breakthrough pain
Actiq clinical trials set the standard
Actiq pivotal trial overview
Clinical trial endpoints in breakthrough pain
Primary endpoints: the Brief Pain Inventory is often used to assess pain in cancer patients
Secondary endpoints: economic and quality-of-life measures are important

CHAPTER 4 BREAKTHROUGH PAIN PIPELINE ANALYSIS
Pipeline overview
The success of Actiq and established efficacy make fentanyl a popular target
Key companies involved in the breakthrough pain pipeline
Cephalon: leading the way in breakthrough pain
Strong CNS focus is good for market growth
Follow-on drug strategy can offset generic incursion
Drug delivery expertise provides positive long term outlook
Leverage oncology resource to reach out to key treatment decision makers
Strategies for success
Broaden customer base with key additional indications
Back pain
Postoperative pain
Neuropathic pain
Osteoarthritis
Refractory migraine

CHAPTER 5 LATE-STAGE DRUG ANALYSIS & FORECASTS
Overview
Late stage pipeline summary
Definition of current comparator therapy
Comparison of key compounds
Comparative forecasts
Fentora
Profile
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
Forecasts to 2016
Datamonitor drug assessment summary
Rapinyl
Profile
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
Forecasts to 2016
Datamonitor drug assessment summary
BEMA Fentanyl
Profile
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
Forecasts to 2016
Datamonitor drug assessment summary
Intranasal morphine gluconate, Nastech
Profile
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
Forecasts to 2016
Datamonitor drug assessment summary
Rylomine (intranasal morphine)
Profile
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
Forecasts to 2016
Datamonitor drug assessment summary
PMI-150 (intranasal ketamine)
Profile
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
Forecasts to 2016
Datamonitor drug assessment summary
Fentanyl Taifun (oral inhaled fentanyl)
Profile
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
Forecasts to 2016
Datamonitor drug assessment summary
AeroLEF (oral inhaled fentanyl)
Profile
Drug overview
Clinical trial data
Patient potential
Marketing factors
Satisfaction of unmet needs
Forecasts to 2016
Datamonitor drug assessment summary
Other drugs
Titragesia (transdermal fentanyl patch)
Pain pen (subcutaneous hydromorphone injection)
TPM-01 (transdermal morphine cream)
AD-923 (sublingual fentanyl)
Nasalfent (intranasal fentanyl)

BIBLIOGRAPHY
Journal articles and conference abstracts
Websites


APPENDIX A
Contributing experts
Sales forecasts
Competitive positioning analysis of pipeline breakthrough pain drugs
Methodology
Datamonitor forecast methodology and assumptions
Product forecasts
Estimation of launch dates
Patient expiry and generic assumptions
Definition of a standard unit

APPENDIX B
About Datamonitor
About Datamonitor Healthcare
Datamonitor Healthcare's therapy area capabilities
About the CNS analysis team
Disclaimer

List of Tables
Table 1: Prevalence of breakthrough pain across the seven major markets, 2006
Table 2: Estimation of the breakthrough pain market across the seven major markets, 2005
Table 3: Characteristics of immediate-release opioids useful for breakthrough pain
Table 4: Primary opioid-related adverse events for 130 patients initially enrolled in the trial of Actiq for cancer-related breakthrough pain
Table 5: Characteristics of patients enrolled in the Farrar et al. (1998) Actiq trial
Table 6: Number of R&D projects in each class split by mode of delivery, 2006
Table 7: Clinical R&D pipeline for breakthrough pain drugs, 2006
Table 8: Cephalon's inline and pipeline pain product range, 2006
Table 9: Key products in late-stage R&D pipeline for breakthrough pain, 2006
Table 10: Primary opioid-related adverse events for 130 patients initially enrolled in the trial of Actiq for cancer-related breakthrough pain
Table 11: Pharmacokinetic parameters in adult subjects receiving the various doses of Actiq
Table 12: Fentora product claims on www.fentora.com
Table 13: Key approval and launch dates impacting Fentora's revenue forecast, 2006-2016
Table 14: Key approval and launch dates impacting Rapinyl's revenue forecast, 2006-2016
Table 15: BEMA technology product claims taken from BioDelivery Sciences's website
Table 16: Key approval and launch dates impacting BEMA Fentanyl revenue forecast, 2006-2016
Table 17: Key approval and launch dates impacting intranasal morphine gluconate revenue forecast, 2006-2016
Table 18: Key approval and launch dates impacting Rylomine revenue forecast, 2006-2016
Table 19: Key approval and launch dates impacting PMI-150 revenue forecast, 2006-2016
Table 20: Key approval and launch dates impacting Fentanyl Taifun revenue forecast, 2006-2016
Table 21: Key approval and launch dates impacting AeroLEF revenue forecast, 2006-2016
Table 22: Datamonitor's forecast sales of pipeline breakthrough pain drugs and the total breakthrough pain market across the seven major markets ($m), 2006-2016
Table 23: Summary of commercial and research/clinical attractiveness of late-stage drugs for breakthrough pain
Table 24: Estimation of launch dates by phase of development
Table 25: Estimated generic discounts by country, 2006*
Table 26: Estimates of brand erosion by following patent expiry by country


List of Figures
Figure 1: Datamonitor's breakthrough pain forecast market across the seven major markets, 2006-2016
Figure 2: Datamonitor breakthrough pain drug assessment summary, 2006-2016
Figure 3: The different types of breakthrough pain
Figure 4: The current versus ideal approach to breakthrough pain treatment
Figure 5: Onset of action versus duration of action of opioid formulations
Figure 6: Actiq study design
Figure 7: Breakthrough pain drug pipeline by development phase and formulation, 2006
Figure 8: Breakdown of the breakthrough pain pipeline by formulation, 2006
Figure 9: Breakdown of the pipeline by molecule, 2006
Figure 10: Difference in pain intensity between Actiq and placebo (ITT analysis)
Figure 11: Pain relief of Actiq versus placebo (ITT analysis)
Figure 12: Datamonitor's comparative forecast of sales for key products across the seven major markets ($m), 2006-2016
Figure 13: Pain intensity difference of Fentora versus placebo over time
Figure 14: Comparison of pain intensity difference scores of Actiq versus Fentora
Figure 15: Datamonitor's forecast of sales for Fentora across the seven major markets ($m), 2006-2016
Figure 16: Datamonitor's competitive positioning analysis for Fentora, 2006-2016
Figure 17: Datamonitor's forecast of sales for Rapinyl across the seven major markets ($m), 2006-2016
Figure 18: Datamonitor's competitive positioning analysis for Rapinyl, 2006-2016
Figure 19: Datamonitor's forecast of sales for BEMA Fentanyl across the seven major markets ($m), 2006-2016
Figure 20: Datamonitor's competitive positioning analysis for BEMA Fentanyl, 2006-2016
Figure 21: Datamonitor's forecast of sales for Intranasal morphine gluconate across the seven major markets ($m), 2006-2016
Figure 22: Datamonitor's competitive positioning analysis for Intranasal morphine gluconate, 2006-2016
Figure 23: Datamonitor's forecast of sales for Rylomine across the seven major markets ($m), 2006-2016
Figure 24: Datamonitor's competitive positioning analysis for Rylomine, 2006-2016
Figure 25: PMI-150 study design
Figure 26: Datamonitor's forecast of sales for PMI-150 across the seven major markets ($m), 2006-2016
Figure 27: Datamonitor's competitive positioning analysis for PMI-150, 2006-2016
Figure 28: Datamonitor's forecast of sales for Fentanyl Taifun across the seven major markets ($m), 2006-2016
Figure 29: Datamonitor's competitive positioning analysis for Fentanyl Taifun, 2006-2016
Figure 30: Datamonitor's forecast of sales for AeroLEF across the seven major markets ($m), 2006-2016
Figure 31: Datamonitor's competitive positioning analysis for AeroLEF, 2006-2016

Abstract

Introduction

In spite of generic Actiq competition, Cephalon’s reign of the breakthrough pain market will be secured in the short-term with sales of its follow-on brand Fentora. From 2008, however, a number of fast-acting analgesics will enter the arena and battle for market share; this and other growth drivers will see the market more than double from 2005 to reach an estimated $2.5 billion in 2016.

Scope
  • Discussion and quantification of the patient potential and market size of breakthrough pain in both malignant and non-malignant diseases
  • Assessment of the unmet clinical needs in breakthrough pain as validated by interviewed international opinion leaders
  • Detailed overview and assessment of key drugs in Phase II and above clinical development, including Fentora, Rapinyl, and BEMA Fentanyl
  • Ten-year sales forecasts to 2016 for key pipeline products
Highlights

Relatively high unmet clinical need, additional patient groups, the launch of new products, and no further key patent expiries within the next ten years will see the breakthrough pain market more than double from 2005 to reach $2.5 billion in 2016.

As well as for oral transmucosal fentanyl products, opportunities also exist for non-oral analgesics. Intranasal and inhaled technology may provide convenient and fast acting analgesia and are potentially suitable for self-administration in the lucrative outpatient setting.

A key growth strategy will be to gain initial approval for cancer breakthrough pain and then drive sales in additional indications through off-label use or regulatory approval. Key non-malignant applications for fast acting analgesics include breakthrough pain in post-operative pain, chronic low back, and osteoarthritic pain.

Reasons to Purchase
  • Explore the strategies that have made Cephalon the market leading company in breakthrough pain
  • Examine the potential for intranasal and inhaled analgesics and what other factors companies are using to differentiate their products
  • Analyze the competitive environment at the time of product launch and identify lucrative gaps in the market


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