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[Report]
Pipeline Insight: Osteoarthritis - The Wait for a DMOAD Continues
Published: 2006/11
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Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the CNS, Arthritis and Pain pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the osteoarthritis market
- Key metrics
- Datamonitor pipeline assessment summary
- CHAPTER 2 PATIENT POTENTIAL
- Definition of osteoarthritis
- Segmentation of osteoarthritis
- Primary (idiopathic) osteoarthritis
- Secondary osteoarthritis
- Epidemiology of osteoarthritis
- Country calculations
- OA affects 11% of the adult US population
- OA will be a growing problem as the elderly European population
increases
- OA of the knee affects 70% of the Japanese OA population
- 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
- CHAPTER 3 R&D APPROACH
- Classification of marketed and pipeline OA drugs
- Non-steroidal anti-inflammatory drugs (NSAID)
- Disease modifiers (DM)
- DMOADs
- Growth factors and hormones
- Cell therapy and gene therapy
- Analgesics
- Corticosteroids (CS)
- Hyaluronic acids (HA)
- Nutriceuticals
- Clinical trial design in osteoarthritis
- Comparator Drugs
- The choice of comparator drug is vital to ensure OA trial reliability
- The FDA requires the use of naproxen as the comparator drug in
long-term safety studies in OA
- Clinical trial endpoints in OA
- Pain scale endpoints
- Western Ontario and McMaster Osteoarthritis (WOMAC) Index remains
the most widely used clinical trial endpoint
- Australian/Canadian (AUSCAN) Index is used specifically in clinical
trials of hand OA
- Lequesne's Algofunctional Indices
- OARSI/OMERACT Response Criteria aim to improve responder criteria in
clinical trials but needs better validation
- Disease modification endpoints
- Radiography remains the most widely used endpoint in DMOAD trials
but accuracy is questionable
- Magnetic Resonance Imaging is a powerful but costly tool for
monitoring disease progression in articular joints
- Biomarkers are still under investigation and require further
validation
- Other endpoints
- Anti-Platelet Trialists' Collaboration (APTC) is a useful endpoint
to assess the CV risk of COX-2s
- CHAPTER 4 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?
- Celebrex is the market leading COX-2 inhibitor and has achieved
blockbuster status
- Pfizer has two DMOAD candidates in Phase II development
- Pfizer buys Rinat Neuroscience to extend neuroscience research and
in doing so acquires a product candidate for OA
- NicOx expects naproxcinod to compete with COX-2 inhibitors
- NicOx has developed clear strategies for success
- Overview of strategies for success
- CHAPTER 5 NSAID LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview for NSAIDs
- Definition of current NSAID comparator therapy
- Lumiracoxib
- Drug overview
- Clinical trial data
- Patient potential
- Prexige will be an attractive treatment option for OA, and has been
shown to be as safe as ibuprofen and naproxen
- Marketing factors
- Novartis is in a good position to market Prexige with strong safety
data and significant market experience
- Satisfaction of unmet needs
- The FDA has concluded that Prexige carries only a moderate CV risk,
similar to Pfizer's Celebrex
- Forecasts to 2015
- Etoricoxib
- Drug overview
- Clinical trial data
- Patient potential
- Merck is enrolling unprecedented numbers of OA patients on the MEDAL
trial to investigate the CV safety of Arcoxia
- Arcoxia has a limited patient potential, however, there is a
possibility that a niche market for Arcoxia exists in patients who found
relief from Vioxx
- Marketing factors
- It would be inadvisable for Merck to market Arcoxia in a similar
fashion as seen previously with Vioxx
- Satisfaction of unmet needs
- Arcoxia carries a high cardiac risk and the EMEA recommends that
Arcoxia be contra-indicated in patients with hypertension
- Forecasts to 2015
- Naproxcinod (AZD3582)
- Drug overview
- Clinical trial data
- Patient potential
- Naproxcinod will gain from the anxieties that surround the COX-2s
- Marketing factors
- NicOx needs to secure a marketing partner for naproxcinod
- Satisfaction of unmet needs
- Naproxcinod has an improved safety profile over other NSAIDs and
COX-2s
- Naproxcinod may have a niche market in OA patients with hypertension
and increased CV risk
- Forecasts to 2015
- Licofelone
- Drug overview
- Clinical trial data
- Patient potential
- Licofelone has similar efficacy to NSAIDs and COX-2s but its
long-term safety still needs to be assessed
- Marketing factors
- EuroAlliance need to secure a new global marketing agreement to
ensure the success of licofelone
- Satisfaction of unmet needs
- Hepatic tolerability could help differentiate Licofelone from
Celebrex
- Forecasts to 2015
- IDEA-033
- Drug overview
- Clinical trial data
- Patient potential
- Topical IDEA-033 could be a safe and effective alternative to oral
NSAIDs and COX-2s
- Marketing factors
- Idea Therapeutics lacks experience of the OA market and requires a
marketing partner
- Satisfaction of unmet needs
- IDEA-033 has a reduced potential for side effects because of low
systemic concentrations of ketoprofen
- Forecasts to 2015
- GW-406381
- Drug overview
- Clinical trial data
- Patient potential
- As measured by WOMAC subscore, GW-406381 is more effective than
Celebrex at improving pain in OA
- Marketing factors
- GW-406381 has a similar effect on blood pressure as Celebrex
- Satisfaction of unmet needs
- The commercial attractiveness of GW-406381 will be significantly
reduced because it will have fourth to market status
- Forecasts to 2015
- LAS-34475
- Drug overview
- Clinical trial data
- Patient potential
- The patient potential for LAS-34475 will not be as great as the
potential seen with previous COX-2 inhibitors
- Marketing factors
- LAS-34475 will benefit from Almirall's previous experience of the OA
market
- Satisfaction of unmet needs
- LAS-34475 requires a long-term safety study
- Fifth to market status will damage LAS-34475's commercial
attractiveness
- Forecasts to 2015
- Other late stage NSAIDs
- Efipladib
- Phospholipase inhibitors are not specific and would be more
interesting in truly inflammatory arthritis
- PN 100
- Combination therapies, such as PN 100, ensure patient compliance
- SFPP
- Mitsubishi Pharmaceuticals pulls out of SFPP development
- Late-stage development compounds recently discontinued
- CHAPTER 6 DISEASE MODIFIER LATE-STAGE DRUG ANALYSIS
- Overview for disease modifiers
- Definition of current comparator therapy
- ChondroCelect
- Overview
- ChondroCelect is a cell therapy for the treatment of cartilage
damage in OA
- ChondroCelect began the TiGenix Phase III clinical trial (TIGACT-01)
in 2005
- Salmon Calcitonin
- Drug overview
- Salmon calcitonin could prevent the enhanced turnover of bone that
is associated with OA progression but osteoporosis appears to be the
primary indication
- Salmon calcitonin has a good safety profile and is not carcinogenic
- Clinical trial data
- Doxycycline
- Drug overview
- Clinical trial data
- Other disease modifiers
- Anakinra
- Anakinra improves WOMAC pain subscore but the improvement is not
statistically significant
- Adalimumab
- Pilot studies at Universities are underway for Humira in OA
- SD-6010
- Pfizer sees iNOS as a potential therapeutic target
- CP-544439
- Pfizer's CP-544439 specifically targets MMP-13
- AZD-8955
- CPA-926
- Late-stage development compounds recently discontinued
- Pralnacasan
- AMG-108
- S-3536
- ONO-4817
- ICE Inhibitors
- AD-729
- CHAPTER 7 ANALGESICS LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview for analgesics
- Current comparator therapy: Acetaminophen
- Zucapsaicin
- Drug overview
- Clinical trial data
- Patient potential
- Zucapsaicin will be limited to OA patients who do not tolerate or
whose pain is not controlled by NSAIDs or COX-2s
- Marketing factors
- Winston Laboratories does not have experience in the OA market and
requires a partner for zucapsaicin
- Satisfaction of unmet needs
- The future long-term safety trial for zucapsaicin will help clarify
a reduced side effect profile
- Forecasts to 2015
- Other analgesic drugs
- AT-1022
- AT-1022 is a hydromorphone patch that has been specifically designed
to provide sustained levels of analgesia
- RN-624
- RN-624 is a first in class biologic therapy for the treatment of the
pain associated with OA
- Clinical trial data
- Bicifadine
- With sustained release bicifadine, OA patients will experience less
frequent daily dosing and an increased tolerability of the drug
- Clinical trial data
- MK-0686
- Merck has not disclosed the mode of action of MK-0686
- Icatibant
- Icatibant is a selective bradykinin B2 receptor antagonist
- CHAPTER 8 CORTICOSTEROID LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview for corticosteroids
- Definition of current comparator therapy
- CRx-102
- Drug overview
- Clinical trial data
- Patient potential
- CRx-102 will have a greater patient potential than the gold standard
corticosteroid prednisolone
- Marketing factors
- CombinatoRx has collaborations and agreements with pharmaceutical
companies for some of its product candidates but requires a partner for
CRx-102
- Satisfaction of unmet needs
- CRx-102 is a well tolerated drug, which has a reduced side effect
profile
- Forecasts to 2015
- CHAPTER 9 INNOVATIVE EARLY-STAGE PROJECTS
- Overview for innovative early-stage projects
- 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
- 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
- Methodology
- Datamonitor forecast methodology
- ICD10 code definition of OA indication
- Product forecasts
- Definition of a standard unit
- Contributing experts
- Bibliography
- Websites
- Datamonitor reports
- Report methodology
- APPENDIX B
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's therapy area capabilities
- About the CNS, Arthritis and Pain analysis team
- Disclaimer
- List of 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 revenue from
launch-2015
- 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 revenue from
launch-2015
- Table 35: LAS-34475: OARSI criteria results, EULAR 2003
- Table 36: Factors having an impact on LAS-34475's revenue from
launch-2015
- 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 revenue from
launch-2015
- 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 revenue from
launch-2015
- 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 $/SU of Celebrex and Arcoxia for Japan
based on average historic sales in Pacific Rim from 2002 - 2005
- List of Figures
- Figure 1: The OA market, 2006-2015
- Figure 2: Comparative sales revenue for key OA pipeline products in
the seven major markets, US$, 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$m), 2006-2015
- Figure 14: Datamonitor's competitive positioning analysis of Arcoxia
for OA, 2006
- Figure 15: Datamonitor's forecast of OA sales for Arcoxia across the
seven major markets (US$m), 2006-2015
- Figure 16: Datamonitor's competitive positioning analysis of
naproxcinod for OA, 2006
- Figure 17: Datamonitor's forecast of OA sales for naproxcinod across
the seven major markets (US$m), 2006-2015
- Figure 18: Datamonitor's competitive positioning analysis of
licofelone for OA, 2006
- Figure 19: Datamonitor's forecast of OA sales for licofelone across
the seven major markets (US$m), 2006-2015
- Figure 20: Datamonitor's competitive positioning analysis of IDEA-033
for OA, 2006
- Figure 21: Datamonitor's forecast of OA sales for IDEA-033 across the
seven major markets (US$m), 2006-2015
- Figure 22: GW-406381: Phase II study design
- Figure 23: GW-406381: Improvement in WOMAC subscore
- Figure 24: Datamonitor's competitive positioning analysis of GW-406381
for OA, 2006
- Figure 25: Datamonitor's forecast of OA sales for GW-406381 across the
seven major markets (US$m), 2006-2015
- Figure 26: Datamonitor's competitive positioning analysis of LAS-34475
for OA, 2006
- Figure 27: Datamonitor's forecast of OA sales for LAS-34475 across the
seven major markets (US$m), 2006-2015
- Figure 28: Datamonitor's competitive positioning analysis of
zucapsaicin for OA, 2006
- Figure 29: Datamonitor's forecast of OA sales for zucapsaicin across
the seven major markets (US$m), 2006-2015
- Figure 30: CRx-102: Primary endpoint results for Phase II study
- Figure 31: Datamonitor's competitive positioning analysis of CRx-102
for OA, 2006
- Figure 32: Datamonitor's forecast of OA sales for CRx-102 across the
seven major markets (US$m), 2006-2015
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[Report]
Pipeline Insight: Osteoarthritis - The Wait for a DMOAD Continues
Published: 2006/11
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Published by : Datamonitor  |
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Product Code : DC47033 |
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