Pipeline Insight: Osteoporosis - The Science of Compliance

Published by: Datamonitor

Published: Oct. 25, 2005 - 259 Pages

Table of Contents

About the Women's Health pharmaceutical analysis team

Scope of the analysis

Datamonitor insight into the disease osteoporosis market

Key metrics

Datamonitor Pipeline Assessment Summary

Key conclusions regarding top-line view of pipeline

A diverse pipeline ready to burst

PTH therapies and reformulations throughout the pipeline

Key companies involved in the osteoporosis pipeline

Pfizer - market entry setback as Oporia stumbles at FDA

What were the reasons for rejection and what are Pfizer's options?

Potential strategic options and impact on Oporia's launch date estimates and future revenues

Novartis

Missing the bone-formation boat?

Patent expiration could leave new indications at risk. Are dosing reformulations enough to protect them?

GlaxoSmithKline - A newcomer with a long-term approach

Chugai - a major player in Japan

Merck - managing the Fosamax lifecycle

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

Missing long-term investment opportunities

Definition of osteoporosis

Etiology of osteoporosis

Osteoporosis classification: primary and secondary

Pathology and complications

Drug targets in osteoporosis

Development of osteoporosis drugs

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

Segmentation of osteoporosis

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

Niche populations

Glucocorticoid-induced osteoporosis

Anorexia nervosa

HIV

CNS disorder-related bone loss

Paget's disease

Ethnic diversity

Premature menopause

Unmet needs in osteoporosis

Unmet clinical needs

Need for improved compliance

Need for efficacy at the hip - BMD and fractures

Need for efficacy at the spine - equivalent to Fosamax and Actonel in fractures and BMD

Need for additional bone-forming agents - alternative formulations, better safety profile, efficacy at the hip

Need for surrogate endpoint efficacy - suppression of resorption and maintenance or up-regulation of formation

Unmet environmental needs

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

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

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

Classification of pipeline products

Bisphosphonates

Mechanism of action

Class breakdown

The gold standard therapy: Fosamax

SERMs

Mechanism of action

Calcitonins

Mechanism of action

Parathyroid hormone (PTH) and analogues

Mechanism of action

Hormone therapy

Mechanism of action

Class breakdown

Vitamin D

Mechanism of action

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

Overview for the bisphosphonates

Pipeline summary

Definition of current comparator therapy - Fosamax

Clinical trial data

Fosamax Plus D (alendronate and cholecalciferol)

Drug overview

Pipeline attractiveness

Forecast

Boniva (ibandronate)

Drug overview

Clinical trial data

Patient potential

Marketing factors

Satisfaction of unmet needs

Pipeline attractiveness

Forecasts

Aclasta (zoledronate)

Drug overview

Clinical trial data

Patient potential

Marketing factors

Satisfaction of unmet needs

Pipeline attractiveness

Forecasts

Comparison of key compounds in the bisphosphonate class

Overview for the SERMs

Pipeline summary

Definition of current comparator therapy - Evista

Comparative analysis

Oporia (lasofoxifene)

Drug overview

Clinical trial data

Ongoing late-stage clinical trials

Patient potential

Marketing factors, ambitious plans for simultaneous global launch

Satisfaction of unmet needs

Pipeline attractiveness

Forecasts

Bazedoxifene

Drug overview

Clinical trial data

Bazedoxifene and Premarin

Patient potential

Marketing factors, overcoming negative hormone therapy perceptions

Satisfaction of unmet needs

Pipeline attractiveness

Forecasts

Comparison of key compounds in the SERM class

Overview for PTH class

Pipeline summary

Definition of current comparator therapy - Forteo

Comparative analysis

Preos/Preotact (rhPTH 1-84)

Drug overview

Clinical trial data

Patient potential

Marketing factors

Satisfaction of unmet needs

Pipeline attractiveness

Forecasts to 2015

Other PTH drugs in development

Asahi Kasei Pharma - teriparatide/PTH (1-34)

Comparison of key compounds in the PTH class

Overview of the calcitonins

Pipeline overview

Definition of current comparator therapy - Miacalcin

Clinical trial data

Comparative analysis

Fortical

Drug overview

Clinical trial data

Patient and marketing potential

Satisfaction of unmet needs

Pipeline attractiveness

Forecasts

Pipeline Overview

Definition of current comparator therapy

Comparative analysis

Protelos (strontium ranelate)

Drug overview

Clinical trial data

Patient potential

Marketing factors

Satisfaction of clinical unmet needs

Pipeline attractiveness

Forecasts

Denusomab (AMG-162)

Drug overview

Clinical trial data

Patient and marketing potential

Satisfaction of unmet needs

Pipeline attractiveness

Forecasts

ED-71

Drug Overview

Clinical trial data

Patient and marketing potential

Satisfaction of unmet needs

Pipeline attractiveness

Forecasts

Comparison of key compounds in the 'Others' class

Key Preclinical compounds in osteoporosis

Src kinase inhibitors

Vitronectin receptor antagonists

GSK - SB 273005

Long-acting proteins

Human Genome Sciences

Methodology

Datamonitor forecast methodology

Datamonitor drug assessment summary

Bibliography

Epidemiology

United States

Japan

France

Germany

Italy

Spain

UK

General

Clinical trial data

Report methodology

About Datamonitor

About Datamonitor Healthcare

Datamonitor Healthcare's therapy area capabilities

About the cardiovascular analysis team

Disclaimer

List of Tables

Table 1: Global forecast for top five pipeline drugs and total osteoporosis market ($m), 2005-15

Table 2: Summary of commercial and research/clinical attractiveness of top five late-phase drugs for osteoporosis

Table 3: R&D pipeline in osteoporosis, 2005

Table 4: Number of key osteoporosis drugs by class and development phase, 2005

Table 5: Summary of PTH therapies in development for osteoporosis

Table 6: Causes of secondary (Type III) osteoporosis

Table 7: World Health Organization classification of osteoporotic bone loss

Table 8: Epidemiology overview of osteoporosis

Table 9: Prevalence of osteopenia and osteoporosis in postmenopausal women across the seven major markets, 2005

Table 10: Prevalence of osteopenia and osteoporosis in men over 50 in the seven major markets, 2005

Table 11: Prevalence of vertebral fractures in men and women over 50 in the seven major markets, 2005

Table 12: Summary of therapeutic classes in osteoporosis, by ATC code in alphabetical order

Table 13: Regional patent expiration of currently-marketed osteoporosis drugs

Table 14: Overview of currently-marketed bisphosphonates indicated for use in osteoporosis treatment and prevention

Table 15: Overview of currently-marketed SERMs indicated for use in osteoporosis treatment and prevention

Table 16: Overview of currently-marketed calcitonins indicated for use in osteoporosis treatment

Table 17: Overview of currently marketed PTH drugs indicated for use in osteoporosis treatment

Table 18: Quantitative measures used for clinical efficacy endpoints in osteoporosis

Table 19: Summary of the biochemical markers of bone resorption and formation used to measure rate of bone turnover

Table 20: Summary of bisphosphonate products in late-stage development for osteoporosis

Table 21: Fosamax: Key facts

Table 22: Defining the gold standard: key clinical trial results for Fosamax

Table 23: Summary of products within the Fosamax brand

Table 24: Dose ranging study results for 20mg and placebo with ibandronate, % change from baseline

Table 25: Summary of Phase II trials of ibandronate in postmenopausal osteoporosis

Table 26: Results at 2 and 3 years in study comparing 3-monthly i.v. ibandronate, and daily oral alfacalcidol, % BMD relative to baseline, 2003

Table 27: Factors affecting forecast revenues of Boniva (oral and IV), 2005-15

Table 28: Novartis's HORIZON trial design, 2003

Table 29: Factors affecting forecast revenues of Aclasta, 2008-15

Table 30: Global sales forecasts for bisphosphonates, 2005-15

Table 31: SERMs late-stage pipeline summary

Table 32: Evista: key facts

Table 33: Percentage change in bone turnover markers with lasofoxifene after six months

Table 34: Mean percentage change from baseline at 24 months

Table 35: Factors affecting forecast revenues of Oporia, 2008-15

Table 36: Factors affecting forecast revenues of bazedoxifene and bazedoxifene/Premarin, 2008-15

Table 37: Global sales forecasts for SERMs, 2007-15

Table 38: Summary of PTH drugs in late-stage development for osteoporosis

Table 39: Forteo: key facts

Table 40: Results of PATH trial (%), 2003

Table 41: Factors affecting forecast revenues of Preos/Preotact, 2008-15

Table 42: Overview of the calcitonins in late-stage development for the prevention or treatment of osteoporosis

Table 43: Miacalcin: key facts

Table 44: Factors affecting forecast revenues of Fortical, 2008-15

Table 45: Overview of 'Other' drugs in late-stage development for the prevention and treatment of osteoporosis, 2005

Table 46: Study population, design and endpoints.

Table 47: PREVOS change in BMD results, percent from baseline

Table 48: STRATOS mean annual change in BMD, percent from baseline

Table 49: Factors affecting forecast revenues of Protelos, 2008-15

Table 50: Factors affecting forecast revenues of ED-71, 2008-15

Table 51: Global sales forecasts for 'Other' drugs, 2005-15

Table 52: Drugs in development for osteoporosis, 2005

List of Figures

Figure 1: Datamonitor osteoporosis drug assessment summary

Figure 2: Osteoporosis pipeline breakdown by development phase shows heavily pregnant late-stage pipeline

Figure 3: Pipeline overview of osteoporosis drugs

Figure 4: Pfizer's possible actions in response to FDA "not approvable" letter on Oporia for osteoporosis prevention

Figure 5: US Oporia forecast comparing Datamonitor's potential sales estimates before and after FDA gave its not approvable verdict

Figure 6: Forecast of Fosamax brand, generic and total molecule sales in the US, 2004-15

Figure 7: Schematic of key current and pipeline drugs, their targets and their effects on bone formation and resorption

Figure 8: Osteoporosis drugs and their overlap into other indications

Figure 9: Prevalence of osteopenia and osteoporosis in women over 50 years across the seven major markets, 2005

Figure 10: Prevalence of osteopenia and osteoporosis in men over 50 in the seven major markets, 2005

Figure 11: Prevalence of vertebral fractures in men and women over 50 across the seven major markets, 2005

Figure 12: Unmet clinical needs in osteoporosis

Figure 13: Schematic showing steps of vitamin D activation

Figure 14: Pipeline attractiveness of Fosamax Plus D/Fosavance in osteoporosis

Figure 15: Osteoporosis sales forecast for Fosamax Plus D in osteoporosis to 2015

Figure 16: SWOT analysis of Boniva for osteoporosis

Figure 17: Assessment of Boniva key performance indicators

Figure 18: Pipeline attractiveness of Boniva in osteoporosis

Figure 19: Global sales forecast for Boniva (oral and IV) in osteoporosis to 2015

Figure 20: SWOT analysis of Aclasta for osteoporosis

Figure 21: Assessment of Aclasta key performance indicators

Figure 22: Pipeline attractiveness of Aclasta in osteoporosis

Figure 23: Global sales forecast for Aclasta in osteoporosis to 2015

Figure 24: Datamonitor's drug assessment summary for the late-stage pipeline bisphosphonate therapies

Figure 25: Global sales forecasts for bisphosphonates, 2005-15

Figure 26: SWOT analysis of Oporia in osteoporosis

Figure 27: Assessment of Oporia key performance indicators

Figure 28: Pipeline attractiveness of Oporia for osteoporosis

Figure 29: Global sales forecast for Oporia in osteoporosis to 2015

Figure 30: SWOT analysis of bazedoxifene in osteoporosis

Figure 31: Assessment of bazedoxifene key performance indicators

Figure 32: Pipeline attractiveness of bazedoxifene and bazedoxifene plus Premarin for osteoporosis

Figure 33: Global sales forecast for bazedoxifene and bazedoxifene/Premarin in osteoporosis to 2015

Figure 34: Datamonitor's drug assessment summary for the late-stage pipeline SERM therapies

Figure 35: Global sales forecasts for SERMs, 2007-15

Figure 36: SWOT analysis of Preos in osteoporosis

Figure 37: Assessment of Preos key performance indicators

Figure 38: Pipeline attractiveness of Preos for osteoporosis

Figure 39: Global sales forecast for Preos/Preotact in osteoporosis to 2015

Figure 40: Datamonitor's drug assessment summary for the late-stage pipeline PTH therapies

Figure 41: SWOT analysis of Fortical in osteoporosis

Figure 42: Assessment of Fortical key performance indicators

Figure 43: Pipeline attractiveness of Fortical for osteoporosis

Figure 44: Global sales forecast for Fortical in osteoporosis to 2015

Figure 45: SWOT analysis of Protelos in osteoporosis

Figure 46: Assessment of Protelos key performance indicators

Figure 47: Pipeline attractiveness of Protelos for osteoporosis

Figure 48: Global sales forecast for Protelos in osteoporosis to 2015

Figure 49: SWOT analysis of Denosumab in osteoporosis

Figure 50: Assessment of Denosumab key performance indicators

Figure 51: Pipeline attractiveness of Denosumab in osteoporosis

Figure 52: Global sales forecast for Denosumab in osteoporosis to 2015

Figure 53: SWOT analysis of ED-71 in osteoporosis

Figure 54: Assessment of ED-71 key performance indicators

Figure 55: Pipeline attractiveness of ED-71 for osteoporosis

Figure 56: Global sales forecast for ED-71 in osteoporosis to 2015

Figure 57: Datamonitor's drug assessment summary for the late-stage pipeline 'Other' therapies

Figure 58: Global sales forecasts for 'Other' drugs, 2005-15

Abstract

About MarketResearch.com
MarketResearch.com is an online aggregator selling over 250,000 market research reports, company profiles and country profiles from over 650 research firms. Our reports will provide you with the critical business and competitive intelligence you need for strategic planning and marketing research. Coverage includes the US, UK, Europe, Asia and global markets.