Pipeline Insight: Osteoarthritis â The Wait for a ... - Datamonitor

A Datamonitor report 

Pipeline Insight: Osteoarthritis – 

The Wait for a DMOAD Continues 

Published: Nov-06 

Product Code: DMHC2237 

Providing you with: 

• Detailed pipeline analysis of the key 

osteoarthritis products in development, plus 

indication-specific drug sales forecasts to 

2015 

• Competitive drug analysis of the latephase 

osteoarthritis pipeline, based on 

clinical and commercial attractiveness 

Use this report to... 

Explore the potential of COX-2s such as 

Novartis' Prexige and Merck's Arcoxia in the 

osteoarthritis indication 

• Overview of patient potential and unmet 

needs in osteoarthritis across the US, 5EU 

and Japanese markets 

• Identification of licensing opportunities 

based on company portfolios and market 

needs 

www.datamonitor.com/healthcare

Pipeline Insight: Osteoarthritis – The Wait for a DMOAD Continues 

DMHC2237 

Introduction 

Osteoarthritis (OA) is characterized by the progressive destruction of articular 

joints and is a major cause of pain in Western populations. Osteoarthritis is the 

most common form of arthritis and severely impacts the physical function and 

day-to-day quality of life of an individual. It also impacts heavily on the economy 

and it is believed to cost the US alone an estimated $60 billion per year. 

Whilst OA is not life-threatening, the WHO estimates that 80% of OA sufferers have limitations 

in movement, and 25 per cent cannot perform the major activities of daily life. The current OA 

pipeline is dominated by disease-modifying OA drugs (DMOADs). However, success of 

DMOADs has been limited and the majority of DMOADs remain in early-stage development. At 

the moment late-stage pipeline remains focused on COX-2s, NSAIDs, analgesics and 

corticosteroids, which only treat the symptoms of OA. 

Key findings and highlights 

• The key unmet need in osteoarthritis is disease modification. The early-phase pipeline is 

dominated by disease-modifying OA drugs (DMOADs), clearly indicating the future direction 

of the market. With the first DMOAD to market likely to reach blockbuster status, companies 

should strengthen their R&D potential by focusing efforts on DMOAD research. 

• The issue of cardiovascular safety remains at the forefront of the COX-2 and traditional 

NSAID classes. As evidenced by Prexige (lumiracoxib) and Arcoxia (etoricoxib), 

appropriately designed, large-scale safety studies will be crucial if any COX-2s are to be 

approved by the FDA and EMEA. Prexige and Arcoxia remain in pre-registration in the US. 

• Over the next ten years a number of COX-2 inhibitors as well as NSAIDs and 

corticosteroids, some with novel mechanisms of action and reportedly improved side effect 

profiles, will enter the market. Success will depend on effective but restrained marketing, 

product differentiation and strategic out-licensing arrangements. 

Reasons to buy 

• Explore the potential of COX-2s such as Novartis' Prexige and Merck's Arcoxia in the 

osteoarthritis indication 

• Quantify the future size of and market potential for novel treatments in the osteoarthritis 

indication 

• Identify who the key players in the osteoarthritis market will be as well as understanding 

gaps in the market for potential products 

For more information... 

Contact Joanna Chertkow, 21C Analysis Team 

tel: +44 20 7675 7293 fax: +44 20 7675 7016 email: hcmarketing@datamonitor.com

www.datamonitor.com/healthcare 

Sample pages from the report 

“...I think at the moment in clinical practice where most clinicians would not prescribe 

selective COX-2 inhibitors in people with established CV risk, I think they would 

consider them in people who are at increased risk of GI problems...” 

Key Opinion Leader, Pipeline Insight: Osteoarthritis – The Wait for a DMOAD Continues


DMHC2237 

Table of contents 

ABOUT DATAMONITOR HEALTHCARE 

• About the CNS, Arthritis and Pain pharmaceutical 

analysis team 

EXECUTIVE SUMMARY 

• Scope of the analysis 

• Datamonitor insight into the osteoarthritis market 

- Summary 

• Key metrics 

• Datamonitor pipeline assessment summary 

PATIENT POTENTIAL 

• Definition of osteoarthritis 

• Segmentation of osteoarthritis 

- Primary (idiopathic) osteoarthritis 

- Secondary osteoarthritis 

• Epidemiology of osteoarthritis 

- Country calculations 

• Unmet need in OA 

- Disease modification is the key unmet need in OA 

- OA drugs require a reduced side effect profile 

- Quality of life and patient education should be 

addressed for all treatments 

- OA awareness and perception in society requires 

improvement 

- Emerging imaging and biomarker research will 

impact both on diagnosis and trial endpoints 

R&D APPROACH 

• Classification of marketed and pipeline OA drugs 

- Non-steroidal anti-inflammatory drugs (NSAID) 

- Disease modifiers (DM) 

- Analgesics 

- Corticosteroids (CS) 

- Hyaluronic acids (HA) 

- Nutriceuticals 

• Clinical trial design in osteoarthritis 

- Comparator Drugs 

• Clinical trial endpoints in OA 

- Pain scale endpoints 

- Disease modification endpoints 

- Other endpoints 

OSTEOARTHRITIS PIPELINE ANALYSIS 

• Pipeline overview 

- Pre-registration 

- Phase III 

- Phase II 

• Key companies involved in the osteoarthritis 

pipeline 

- Pfizer dominates the OA market with Celebrex, but 

will it be first to market with a DMOAD? 

- NicOx expects naproxcinod to compete with COX- 

2 inhibitors 

- Overview of strategies for success 

NSAID LATE-STAGE DRUG ANALYSIS AND 

FORECASTS 

• Overview for NSAIDs 

- Pipeline summary 

• Definition of current NSAID comparator therapy 

• Lumiracoxib 

- Drug overview 

- Clinical trial data 

- Patient potential 

- Marketing factors 

- Satisfaction of unmet needs 

- Forecasts to 2015 

• Etoricoxib 







• Naproxcinod (AZD3582) 







• Licofelone 







IDEA-033 











• GW-406381 







• LAS-34475 







• Other late stage NSAIDs 

- Efipladib 

- PN 100 

- SFPP 

• Late-stage development compounds recently 

discontinued 

- Tilmacoxib 

- AZD-9056 

DISEASE MODIFIER LATE-STAGE DRUG ANALYSIS 

• Overview for disease modifiers 

• Definition of current comparator therapy 

• ChondroCelect 

- Overview 

• Salmon Calcitonin 



• Doxycycline 



• Other disease modifiers 

- Anakinra 

- Adalimumab 

- SD-6010 

- CP-544439 

- AZD-8955 

- CPA-926 

• Late-stage development compounds recently 

discontinued 

- Pralnacasan 

- AMG-108 

- S-3536 

- ONO-4817 

- ICE Inhibitors 

- AD-729 

ANALGESICS LATE-STAGE DRUG ANALYSIS AND 

FORECASTS 

• Overview for analgesics 

- Pipeline summary 

• Current comparator therapy: Acetaminophen 

• Zucapsaicin 







• Other analgesic drugs 

- AT-1022 

- RN-624 

- Bicifadine 

- MK-0686 

- Icatibant 

CORTICOSTEROID LATE-STAGE DRUG ANALYSIS 

AND FORECASTS 

• Overview for corticosteroids 

• Definition of current comparator therapy 

• CRx-102 







INNOVATIVE EARLY-STAGE PROJECTS 

• Overview for innovative early-stage projects 

- Phase I 

- Preclinical 

• MMP inhibitors 

- MMP-1 and MMP-13 are key targets for future OA 

therapies 

- Most early-stage DMOADs are directed against 

MMPs but side effects are an issue 

• Tumor necrosis factor and Interleukin-1 

- TNF-alpha and IL-1 antagonists offer promise but 

problems such as short half life remain an issue 

• Cathepsin K inhibitors 

- Cathepsin K inhibitors are being developed by 

GSK and Medivir 

• Bone modulators 

- Preventing the loss of bone in OA could slow or 

stop disease progression 

• c-fms inhibitors 

- GSK is looking to treat OA by inhibiting 

inflammatory cells 





DMHC2237 

• Botox 

- Intra-articular Botox injections might provide pain 

relief in OA but unwanted effects on surrounding 

muscle might become evident 

• NFKappaB modulators and IKK beta inhibitors 

- Therapies targeting gene transcription raise 

concerns over potential side effects 

• Key research impacts on osteoarthritis 

APPENDIX A 

APPENDIX B 

TABLES 

Table 1: Estimated adult OA populations in the seven 

major markets, by age group, 2006 (000s) 

Table 2: OA sufferers who present with the disease in 

specific parts of the body (%): US, Japan and 

5EU markets, 2003 

Table 3: US OA patient population by age group and 

gender, 2006 (000s) 

Table 4: Breakdown of arthritis population from NHIS 

survey and estimated OA percentages, 2003 

Table 5: Adult OA population in five major EU countries, 

by age and gender, 2006 (000s) 

Table 6: Combined sample of northern England studies, 

radiographic knee OA by age and gender 

Table 7: Estimated symptomatic knee OA prevalence: 

UK adults 

Table 8: Spanish EPISER study showing breakdown of 

hand and knee OA by age group, 2001 

Table 9: Adult OA population (000s) in Japan, by age 

and gender, 2006 

Table 10: GAIT study response rates by treatment group 

and pain level, 2005, % 

Table 11: Baseline Lequesne and WOMAC, with 6-month 

ITT changes and % of OARSI-A responders in 

the GUIDE study 

Table 12: Biomarkers in OA 

Table 13: Pipeline drugs in pre-registration development 

for OA, 2006 

Table 14: Pipeline drugs in Phase III development for OA, 

2006 

Table 15: Pipeline drugs in Phase II development for OA, 

2006 

Table 16: Number of key OA therapies by class and 

phase of development, 2006 

Table 17: Pipeline OA therapies by mode of delivery, 

2006 

Table 18: NicOx R&D pipeline, 2006 

Table 19: Key NSAIDs in late-stage R&D pipeline for OA, 

2006 

Table 20: Aleve's key facts, 2006 

Table 21: Lumiracoxib TARGET study: summarized GI 

safety results 

Table 22: Lumiracoxib TARGET study: summarized CV 

safety results, 

Table 23: Lumiracoxib vs celecoxib: WOMAC total score. 

Table 24: Lumiracoxib vs celecoxib: VAS total score. 

Table 25: Factors having an impact on Prexige's sales 

revenue across the seven major markets, 

2006-15 

Table 26: Cost per standard unit for COX-2s in the UK 

Table 27: Factors having an impact on Arcoxia's revenue 

2006-15 

Table 28: Difference between groups in the change in 

WOMAC pain subscale score (mm) from 

baseline to the mean of weeks 4 and 6. 

Table 29: Factors having an impact on naproxcinod's 

revenue from launch-2015 

Table 30: Change from baseline in liver enzyme levels at 

week 12 for licofelone and celecoxib 

Table 31: Factors having an impact on licofelone's 


Table 32: Factors impacting IDEA-033's revenue from 

launch-2015 

Table 33: GW-406381 vs celecoxib: Effect on systolic 

blood pressure 

Table 34: Factors having an impact on GW-406381's 


Table 35: LAS-34475: OARSI criteria results, EULAR 

2003 

Table 36: Factors having an impact on LAS-34475's 


Table 37: Discontinued R&D projects in NSAIDs, 2003-06 

Table 38: Key disease modifiers in late-stage R&D 

pipeline for OA, 2006 

Table 39: Results of a Phase II efficacy trial for oral 

salmon calcitonin 

Table 40: Results of doxycycline vs placebo on JSN 

Table 41: Discontinued R&D projects in DMOADs, 

2003-06 

Table 42: Key analgesics in late-stage R&D pipeline for 

OA, 2006 

Table 43: Factors having an impact on zucapsaicin's 


Table 44: RN-624: Results of Phase I study 

Table 45: Key products in late-stage R&D pipeline for 

corticosteroids, 2006 

Table 46: CRx-102: Phase II clinical trial results, 2006 

Table 47: Factors having an impact on CRx-102's 


Table 48: Phase I and preclinical molecular targets for 

disease modifying therapies, 2006 

Table 49: Pipeline drugs in Phase I development for OA, 

2006 





Table 50: Pipeline drugs in preclinical development for 

OA, 2006 

Table 51: Datamonitor's definition of OA market by ICD10 

code 

Table 52: Datamonitor's forecast OA revenues of pipeline 

drugs across the seven major markets ($m) 

Table 53: Calculation of the $/SU of Celebrex and 

Arcoxia for Japan based on average historic 

sales in Pacific Rim from 2002 - 2005 

FIGURES 

Figure 1: The OA market, 2006-2015 

Figure 2: Comparative sales revenue for key OA pipeline 

products in the seven major markets, US$, m, 

2006-2015 

Figure 3: Drug OA drug assessment summary 

Figure 4: Adult (15+) OA population in the seven major 

markets, 2006 

Figure 5: Adult OA population, five major EU countries, 

by age group, 2006 

Figure 6: Key unmet needs in OA, 2006 

Figure 7: Number of key OA therapies by class and 

phase of development, 2006 

Figure 8: Pfizer's therapeutic focus, 2005 

Figure 9: Total vs OA-specific historical sales of Celebrex 

in the US 

Figure 10: Total historic sales and OA-specific sales of 

Bayer's Aleve in the US, 2002 - 2005 

Figure 11: Datamonitor's competitive positioning analysis 

of Prexige for OA, 2006 

Figure 12: Comparison of IC50s of NSAIDs and COX-2 

inhibitor 

Figure 13: Datamonitor's forecast of OA sales for Prexige 

across the seven major markets (US$m), 

2006- 2015 


of Arcoxia for OA, 2006 

Figure 15: Datamonitor's forecast of OA sales for Arcoxia 


2006- 2015 


of naproxcinod for OA, 2006 

Figure 17: Datamonitor's forecast of OA sales for 

naproxcinod across the seven major markets 

(US$m), 2006-2015 


of licofelone for OA, 2006 


licofelone across the seven major markets 

(US$m), 2006-2015 


of IDEA-033 for OA, 2006 


IDEA-033 across the seven major markets 

(US$m), 2006-2015 

Figure 22: GW-406381: Phase II study design 

Figure 23: GW-406381: Improvement in WOMAC 

subscore 


of GW-406381 for OA, 2006 


GW-406381 across the seven major markets 

(US$m), 2006-2015 


of LAS-34475 for OA, 2006 


LAS-34475 across the seven major markets 

(US$m), 2006-2015 


of zucapsaicin for OA, 2006 


zucapsaicin across the seven major markets 

(US$m), 2006-2015 

Figure 30: CRx-102: Primary endpoint results for Phase II 

study 


of CRx-102 for OA, 2006 

Figure 32: Datamonitor's forecast of OA sales for CRx-102 


2006-2015 

“...The first goal in research right now is to find a treatment that 

could modify disease...” 

Key Opinion Leader, Pipeline Insight: Osteoarthritis – The Wait for a DMOAD Continues


DMHC2237 

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