Pipeline Insight: Osteoporosis - Intermittent dosing drives market growth

Published by: Datamonitor

Published: Mar. 30, 2007 - 231 Pages

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the osteoporosis market

Key metrics

Datamonitor Pipeline Assessment Summary

CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS

Pipeline overview

Traditional, well-stocked pipeline

Growing PTH class hints at upcoming innovation

Reformulation as a substitute for innovation

Osteoporosis drug development not limited to big pharma

Key companies involved in the osteoporosis pipeline

Merck & Co.: coping with change

Merck's line expands, but the patent is wide open

Limited hope in the pipeline

Novartis: an old player with new strategies

Osteoporosis indication a key driver in Zometa growth

New classes and patent expiration represent threats

GlaxoSmithKline: A newcomer with a long-term approach

Boniva as a learning curve

Pipeline hints at future success

Key R&D company strategies

Optimizing administration

Yearly dosing has potential as the next stage in intermittent dosing

Options in delivery mode maintain whole brand sales

The addition of mineral supplements: calcium and vitamin D

Additional dose calcium satisfies physicians' demands

Combining vitamin D aids Merck's key brand's lifecycle

Genericization: if you can not beat them, join them

CHAPTER 3 OSTEOPOROSIS - MARKET POTENTIAL

Definition of osteoporosis

Etiology of osteoporosis

Osteoporosis classification: primary and secondary

Pathology and complications

Development of osteoporosis drugs

Segmentation of osteoporosis

Severity

Gender: osteoporosis in men

Niche populations

Glucocorticoid-induced osteoporosis

Paget's disease

CNS disorder-related fracture risk

Ethnic diversity

Prostate cancer

Premature menopause

HIV

Anorexia nervosa

Epidemiology of osteoporosis

Methodological difficulties in assessing prevalence

Prevalence of osteoporosis and osteopenia in postmenopausal women

Overview of the prevalence of osteoporosis and osteopenia in postmenopausal women

US

Japan

France

Germany

Italy

Spain

UK

Prevalence of osteoporosis and osteopenia in men

Introduction

Overview of the prevalence of osteoporosis/osteopenia in men

US

Japan

France

Germany

Italy

Spain

UK

Osteoporotic fractures, their implications and minor risk groups

Introduction

Limitations of fracture prevalence data

Overview of fracture prevalence

US

Japan

France

Germany

Italy

Spain

UK

Epidemiological trends

Unmet needs in osteoporosis

Unmet clinical needs

Need for improved compliance

Need for efficacy at least equivalent to Fosamax and Actonel

Need for surrogate endpoint efficacy

Need for efficacy at the hip

Unmet environmental needs

Need for increased patient identification, treatment rates and use of appropriate treatments in each patient

Need for primary prevention in osteoporosis - preventing the first fracture reduces the future fracture burden

Need for greater recognition of secondary causes of osteoporosis

Need for greater recognition of male osteoporosis and causes of secondary osteoporosis in men for screening or case-finding purposes

CHAPTER 4 R&D APPROACH

Classification of pipeline products

Bisphosphonates

Mechanism of action

Class breakdown

The gold standard therapy: Fosamax

Bisphosphonates threatened by genericization

Pipeline bisphosphonates

SERMs

Mechanism of action

Pipeline SERMs

Calcitonins

Mechanism of action

Pipeline calcitonins

Parathyroid hormone (PTH) and analogues

Mechanism of action

Pipeline PTH

Dual action bone agents (strontium ranelate)

Mechanism of action

Pipeline DABAs

Hormone replacement therapy (HRT)

Mechanism of action

Class breakdown

Pipeline hormonal therapies

Vitamin D

Mechanism of action

Pipeline vitamin D

Other mechanisms of action

Monoclonal antibodies

Cathepsin K inhibitors

Clinical trial design in osteoporosis

Clinical trial guidelines

Pre-clinical planning: use of animal models

Prevention and treatment: the implications for endpoint selection

Trial design and study population

Osteoporosis trial design and execution: can anything replace fracture data?

Problems with definitions: a need for greater consistency

Large-scale trials: can surrogate endpoints ever predict fracture risk?

The ethics of placebo-controlled trials: is there a realistic alternative?

Recruiting the right study population

Clinical trial endpoints in osteoporosis

Fracture rate

Significance of fracture rate as an endpoint

Considerations with fracture endpoints

Changes in BMD

Significance of BMD as an endpoint

Limitations of BMD as a clinical trial endpoint

Biochemical markers of bone turnover

How useful are bone markers?

Limitations in the use of bone-specific markers

Surrogate endpoints: predicting fracture risk

Changes in bone microarchitecture

Problems associated with microarchitecture assessment

CHAPTER 5 BISPHOSPHONATE LATE-STAGE DRUG ANALYSIS AND FORECASTS

Comparative forecasts

Comparative Datamonitor drug assessment summaries

Overview for bisphosphonates

Definition of current comparator therapy - Fosamax

Clinical trial data

Aclasta/Reclast (zoledronate/zoledronic acid)

Drug profile

Clinical trial data

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

Bisponal/ONO-5920 (minodronic acid hydrate)

Drug profile

Clinical trial data

Patient potential

Market potential

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

MER-103 (alendronate sodium)

Drug profile

Clinical trial data

Patient potential

Market potential

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

Other drugs in the bisphosphonate class

Nerixia (neridronic acid)

Abiogen's expertise may offset a halting development

CHAPTER 6 SERMS LATE-STAGE DRUG ANALYSIS AND FORECASTS

Overview for SERMs

Definition of current comparator therapy - Evista

Bazedoxifene

Drug profile

Clinical trial data for the treatment of osteoporosis

Clinical trial data for the prevention of osteoporosis

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

Other drugs in the SERM class

Arzoxifene (LY353381)

Lilly's Evista follow on?

PSK-3471

CHAPTER 7 CALCITONIN LATE-STAGE DRUG ANALYSIS AND FORECASTS

Overview for calcitonins

Definition of current comparator therapy - Miacalcin

Clinical trial data

BN-002

Drug profile

Clinical trial data

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

CHAPTER 8 PTH LATE-STAGE DRUG ANALYSIS AND FORECASTS

Comparative forecasts

Comparative Datamonitor drug assessment summaries

Overview of PTH

Definition of current comparator therapy - Forteo

hPTH (1-34)

Drug profile

Clinical trial data

Patient potential

Marketing factors

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

Ostabolin-C

Drug profile

Clinical trials

Patient potential

Marketing potential

Satisfaction of unmet need

Forecasts to 2016

Datamonitor drug assessment summary

Other drugs in the PTH class

MBRI-93.02 (hPTH)

Unhampered development will allay looming class competition

CHAPTER 9 OTHER DRUGS LATE-STAGE ANALYSIS AND FORECASTS

Comparative forecasts

Comparative Datamonitor drug assessment summaries

Overview of 'other drugs'

Definition of current comparator therapy

Denosumab (AMG-162)

Drug profile

Clinical trial data

Patient potential

Marketing potential

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

ED-71

Drug profile

Clinical trial data

Patient potential

Marketing potential

Satisfaction of unmet needs

Forecasts to 2016

Datamonitor drug assessment summary

Other drugs in the class

MK-0822

Merck diversifies to cathepsin K inhibitors in the event of falling bisphosphonate sales

NBS-101

Clinical and commercial doubt surrounds DABA

SHT-546

CHAPTER 10 INNOVATIVE EARLY-STAGE PROJECTS

Key Phase I compounds in osteoporosis

ACE-011

Potential to pioneer the provision of anti-resorptive and anabolic activity

Changing the face of osteoporosis treatment

Acceleron should optimize interest in ACE-011

2MD

A high risk strategy for Pfizer

Early results indicate a potent anabolic agent

ED-71's progress represents a useful guide

Raloxifene (extended release)

A reformulation to rival Evista

Proprietary technology improves bioavailability

External influences on SERM commercialization must be considered

BIBLIOGRAPHY

Journal papers and conference abstracts

Websites

APPENDIX A

Methodology

Datamonitor forecast methodology

Market sizing

Estimated 2006 sales revenue

Osteoporosis specific sales calculations

Product forecasts

Estimation of launch dates

Definition of a standard unit

Japanese market data

Patient expiry and generic assumptions

Datamonitor drug assessment summary

Contributing experts

Report methodology

APPENDIX B

About Datamonitor

About Datamonitor Healthcare

Datamonitor Healthcare's therapy area capabilities

About the Women's Health analysis team

Disclaimer

List of Tables

Table 1: Forecast key pipeline products for osteoporosis in the seven major markets ($), 2006-2016

Table 2: R&D pipeline in osteoporosis, 2007

Table 3: Causes of secondary (Type III) osteoporosis

Table 4: World Health Organization classification of osteoporotic bone loss

Table 5: Epidemiology overview of osteoporosis

Table 6: Prevalence of osteopenia and osteoporosis in postmenopausal women across the seven major markets, 2007

Table 7: Prevalence of osteopenia and osteoporosis in men over 50 in the seven major markets, 2007

Table 8: Prevalence of vertebral fractures in men and women over 50 in the seven major markets, 2007

Table 9: UN projected population aged 50 years and over in 2017

Table 10: Summary of therapeutic classes in osteoporosis, by ATC code in alphabetical order

Table 11: Overview of currently marketed bisphosphonates indicated for use in osteoporosis treatment and prevention, 2007

Table 12: Overview of currently marketed SERM indicated for use in osteoporosis treatment and prevention, 2007

Table 13: Overview of currently marketed calcitonins indicated for use in osteoporosis treatment and prevention, 2007

Table 14: Overview of currently marketed PTH drugs indicated for use in osteoporosis treatment and prevention, 2007

Table 15: Overview of currently marketed DABA products indicated for use in osteoporosis treatment and prevention, 2007

Table 16: Quantitative measures used for clinical efficacy endpoints in osteoporosis

Table 17: Summary of the biochemical markers of bone resorption and formation used to measure rate of bone turnover

Table 18: Late-stage bisphosphonates in development for osteoporosis

Table 19: Fosamax: key facts

Table 20: Defining the gold standard: key clinical trial results for Fosamax

Table 21: Novartis's HORIZON trial design, 2003

Table 22: Key events, approval and launch dates impacting Aclasta revenue forecasts for osteoporosis in the seven major markets, 2007-2016

Table 23: Key events, approval and launch dates impacting Bisponal revenue forecasts for osteoporosis in the seven major markets, 2007-2016

Table 24: Key events, approval and launch dates impacting MER-103 revenue forecasts for osteoporosis in the seven major markets, 2007-2016

Table 25: Late-stage SERMs in development for osteoporosis

Table 26: Evista key facts

Table 27: Key events, approval and launch dates impacting bazedoxifene revenue forecasts for osteoporosis in the seven major markets, 2007-2016

Table 28: Late-stage calcitonins in development for osteoporosis

Table 29: Miacalcin: key facts

Table 30: Forthcoming trials for BN-002

Table 31: Key events, approval and launch dates impacting BN-002 revenue forecasts for osteoporosis in the seven major markets, 2007-2016

Table 32: Late-stage PTH in development for osteoporosis

Table 33: Forteo: key facts

Table 34: Key events, approval and launch dates impacting hPTH revenue forecasts for osteoporosis in the seven major markets, 2007-2016

Table 35: Key events, approval and launch dates impacting Ostabolin-C revenue forecasts for osteoporosis in the seven major markets, 2007-2016

Table 36: Other late-stage drugs in development for osteoporosis

Table 37: Key events, approval and launch dates impacting Denosumab revenue forecasts for osteoporosis in the seven major markets, 2007-2016

Table 38: Key events, approval and launch dates impacting ED-71 revenue forecasts for osteoporosis in the seven major markets, 2007-2016

Table 39: Drugs in Phase I and preclinical development for osteoporosis, 2007

Table 40: Summary of therapeutic classes in osteoporosis, by ATC code in alphabetical order

Table 41: Estimation of launch dates by phase of development

Table 42: Estimated generic discounts by country, 2006*

Table 43: Estimates of brand erosion by following patent expiry by country

Table 44: Weightings of research and clinical factors used for pipeline drug assessment

Table 45: Weightings of commercial factors used for pipeline drug assessment

List of Figures

Figure 1: Datamonitor's osteoporosis drug assessment summary for the seven major markets, 2007-2016

Figure 2: Osteoporosis pipeline breakdown by development phase, 2007

Figure 3: The osteoporosis pipeline by phase and class of drug, 2007

Figure 4: Osteoporosis drugs and their overlap into other indications

Figure 5: Unmet clinical needs in osteoporosis, 2007

Figure 6: Unmet environmental needs in osteoporosis, 2007

Figure 7: Schematic showing steps of vitamin D activation

Figure 8: Datamonitor's comparative forecast of sales for the bisphosphonates across the seven major markets ($m), 2007-2016e

Figure 9: Datamonitor's competitive positioning analysis for Aclasta, MER-103 and Bisponal in the seven major markets, 2007-2016

Figure 10: Datamonitor's forecast of sales for Aclasta across the seven major markets ($m), 2007-2016

Figure 11: Datamonitor's competitive positioning analysis for Aclasta in the seven major markets, 2007-2016

Figure 12: Datamonitor's forecast of sales for Bisponal across the seven major markets ($m), 2007-2016

Figure 13: Datamonitor's competitive positioning analysis for Bisponal in the seven major markets, 2007-2016

Figure 14: Datamonitor's forecast of sales for MER-103 across the seven major markets ($m), 2007-2016

Figure 15: Datamonitor's competitive positioning analysis for MER-103 in the seven major markets, 2007-2016

Figure 16: Datamonitor's forecast of sales for bazedoxifene across the seven major markets ($m), 2007-2016

Figure 17: Datamonitor's competitive positioning analysis for bazedoxifene in the seven major markets, 2007-2016

Figure 18: Datamonitor's forecast of sales for BN-002 across the seven major markets ($m), 2007-2016

Figure 19: Datamonitor's competitive positioning analysis for BN-002 in the seven major markets, 2007-2016

Figure 20: Datamonitor's comparative forecast of sales for PTH across the seven major markets ($m), 2007-2016

Figure 21: Datamonitor's competitive positioning analysis for Ostabolin-C and hPTH in the seven major markets, 2007-2016

Figure 22: Datamonitor's forecast of sales for hPTH across the seven major markets ($m), 2007-2016

Figure 23: Datamonitor's competitive positioning analysis for hPTh in the seven major markets, 2007-2016

Figure 24: Datamonitor's forecast of sales for Ostabolin-C across the seven major markets ($m), 2007-2016

Figure 25: Datamonitor's competitive positioning analysis for Ostabolin-C in the seven major markets, 2007-2016

Figure 26: Datamonitor's comparative forecast of sales for 'other drugs' across the seven major markets ($m), 2007-2016

Figure 27: Datamonitor's competitive positioning analysis for Denosumab and ED-71 in the seven major markets, 2007-2016

Figure 28: Datamonitor's forecast of sales for Denosumab across the seven major markets ($m), 2007-2016

Figure 29: Datamonitor's competitive positioning analysis for Denosumab in the seven major markets, 2007-2016

Figure 30: Datamonitor's forecast of sales for ED-71 across the seven major markets ($m), 2007-2016

Figure 31: Datamonitor's competitive positioning analysis for ED-71 in the seven major markets, 2007-2016

Abstract

Introduction

The long-standing unmet need of the osteoporosis market has been for improved adherence to treatment. Two pipeline products, Amgen's Denosumab and Novartis' Aclasta (zoledronate), have answered this demand with intermittent dosing schedules and consequently are expected to generate blockbuster revenues. This will rejuvenate the market which is otherwise stalling under multiple patent expiries.

Scope

Analysis of patient potential, unmet needs and clinical trial design in osteoporosis Overview of drugs in late- and early-stage clinical development; with analysis of key companies involved in the R&D pipeline Detailed profiles of key compounds in development for use in osteoporosis, with forecasts of drug revenues to 2016 Review of the key strategies adopted by current market players

Highlights

Despite the genericization of the market leader Fosamax and patent expiries on other key brands, pipeline products are still viable. Datamonitor expects pipeline products to swell the total market value 4.4% between 2007 and 2016 to $10.9 billion. Products that offer intermittent dosing schedules are highly desirable in the osteoporosis market and can generate blockbuster revenues. Such therapies answer the demand from patients and physicians for more convenient delivery mechanisms that increase compliance and ultimately improve treatment outcome. Although bisphosphonates are the mainstay of osteoporosis treatment, there is potential for new and innovative products to gain market share. Those that suit niche populations, such as Amgen's ED-71 which finds favor as a vitamin D analogue in Japan, will be able to fight generic competition.

Reasons to Purchase

Understand clinical and environmental unmet needs in the osteoporosis market based on key opinion leader comments Benchmark key late-stage pipeline products against the current market leader and class comparator Assess the global (US, Japan, five major EU) sales forecasts of key late-stage pipeline drugs; and examine their clinical and commercial potential

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