Pipeline Insight: Osteoporosis - Bone building drugs become the heart of the pipeline

Introduction

Osteoporosis continues to be an attractive therapy area for large pharmaceutical companies due to its high prevalence rate and unmet need. Across the seven major markets, sales for osteoporosis drugs grew with a compound annual growth rate (CAGR) of 2.0% from 2005 to $6.9 billion in 2009. Nonetheless, several promising pipeline drugs will help the market resume growth.

Scope

-Patient potential analysis across the seven major markets and BRIC nations (Brazil, Russia, India, and China).

-Review of the key clinical and environmental unmet needs supported by insight from key opinion leaders across the US, Europe and Japan.

-Analysis of target product profile for an osteoporosis drug.

-R&D pipeline analysis with detailed profiles and forecasts of key agents, including Amgen’s Prolia (denosumab) and Merck’s odanacatib.

Highlights

Osteoporosis prevalence is expected to increase due to the general aging population. By 2020, the total male and female osteoporosis population is forecast to increase by 16.0% from 168 million in 2010 to reach 188 million patients across the seven major markets.

Despite some long-term safety and cost concerns, Prolia will become the osteoporosis market leader by 2019, but will not achieve blockbuster sales. Moreover, its position will be threatened should odanacatib show a superior clinical profile.

Over the forecast period, three new anabolic drugs are due to launch. These will have to compete on cost, efficacy and safety with the class leader Forteo (teriparatide, Eli Lilly). While these drugs will address some unmet needs, early clinical data suggests that more potent drugs such Amgen’s antisclerostin may dominate the market in the future.

Reasons to Purchase

-Understand patient population dynamics

-Gain insight into shortcomings of current osteoporosis treatment and to what extent pipeline drugs will address these unmet clinical needs.

-Identify licensing opportunities based on company portfolio and market needs.

Overview
Catalyst
Summary
Executive Summary
Strategic scoping and focus
Datamonitor insight into the disease market
Related reports
Upcoming related reports

1. Pipeline Overview and Dynamics
Key findings
Pipeline overview
Clinical pipeline
Comparative forecasts: Prolia to become market leader by 2019
Datamonitor pipeline assessment summary: anabolic treatments are the most clinically attractive products
Key companies involved in the osteoporosis pipeline
Osteoporosis drug development not limited to Big Pharma
Novartis remains a key market player
Key R&D company strategies
Pipeline developers focus on reformulations to address route of administration unmet needs
Anabolic treatments become a priority in the market
Indication expansions increase the market potential of osteoporosis drugs
2. Disease Overview - Market Potential
Key findings
Definition of osteoporosis
Definition of osteoporosis
Etiology
Symptoms
Diagnosis and treatment rates
Under-diagnosis is a major problem in osteoporosis
World Health Organization fracture risk assessment tool
Treatment rates have been increasing but are still low
Patient segmentation
Disease severity
Gender
Epidemiology
Seven major markets
Female osteoporosis
Male osteoporosis
BRIC countries
Brazil: hip fracture prevalence is higher in men than women
Russia: over 85% of hip fractures occur in women over 60 years of age
India: Indian women experience osteoporotic fractures 10-20 years earlier than Caucasian women
China: over 76 million Chinese women will experience a hip fracture in 2010
Rest of the world
Current treatment options
Bisphosphonates
Selective estrogen receptor modulators
Parathyroid hormones
Calcitonins
Dual acting bone agents
Vitamin D and analogs
Calcium
Current gold standard and comparator therapies
Fosamax (alendronate; Merck & Co)
Clinical trial data for Fosamax
Individual class comparators
Current market overview
Market definition for this report
Growth in the seven major markets slows down
Bisphosphonates remain the largest class despite generic penetration
Fosamax generic launch results in market decline
Future outlook: despite growing pressure from generics, launch of pipeline drugs will offset decline up to 2019
Unmet need in osteoporosis
Need for improved anabolic therapies
Efficacy at the hip
Increased compliance
Companies should focus on increasing awareness of the treatments available to increase compliance
Better side-effect profile and safety
Long-term safety of bisphosphonate use is questioned
Efficacy for spine fractures
Target product profile versus current level of attainment
3. R&D Approach
Key findings
Clinical trial design in osteoporosis
Preclinical trials
Two different animal species testing is required by the FDA and EMA
Preclinical trial design should reflect the clinical indication
Clinical trial design
The FDA and EMA have different patient inclusion requirements for osteoporosis trials
Clinical endpoints
Future developments in osteoporosis clinical trials
4. Pipeline Analysis & Forecasts: Bisphosphonates
Key findings
Overview for pipeline bisphosphonates
Pipeline summary
Comparative forecasts
EX101 (alendronate; EffRx)
Drug overview
Drug profile
SWOT analysis
Datamonitor drug assessment score card for EX101
Clinical attractiveness
Satisfaction of unmet needs
EX101 shows reduced gastric side effects compared to gold standard
Commercial attractiveness
EX101 can clearly differentiate itself in a competitive bisphosphonate market, but effervescent formulations can be unpopular with patients
Nycomed's market experience will help boost EX101's sales
US partner still needed
Forecasts to 2019
Almerol (MER-103, alendronate; Merrion)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for Almerol
Clinical attractiveness
Satisfaction of unmet needs
Almerol 6mg weekly shows bioequivalence to Fosamax
Commercial attractiveness
Almerol will face strong competition upon launch
Merrion requires a marketing partner to launch the drug
Forecasts to 2019
5. Pipeline Analysis & Forecasts: Selective Estrogen Receptor Modulators
Key findings
Overview for pipeline selective estrogen receptor modulators
Pipeline summary
Forecast summary
Aprela (bazedoxifene with conjugated estrogens; Pfizer)
Drug overview
Drug profile
Clinical trial data
Ongoing clinical trials
SWOT analysis
Datamonitor drug assessment score card for Aprela
Clinical attractiveness
Satisfaction of unmet needs
Aprela targets menopausal women differentiating it from its competition
Efficacy data will boost Aprela's clinical potential
Aprela's safety remains an issue
Commercial attractiveness
Further delays reduces overall commercial attractiveness
Bazedoxifene approval in the EU paves the way for Aprela in this region
Aprela will be mainly prescribed by gynecologists
Forecasts to 2019
Late-stage development compounds recently discontinued
Eli Lilly terminates development of arzoxifene
6. Pipeline Analysis & Forecasts: Parathyroid Hormones and Analogs
Key findings
Overview for pipeline parathyroid hormones and analog drugs
Pipeline summary
Comparative forecasts
ZT-031 (hPTH1-31; Zelos Therapeutics)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for ZT-031
Clinical attractiveness
Satisfaction of unmet needs
Faster onset of action provides differentiation from competition
Subcutaneous formulation is not favorable
Commercial attractiveness
Partnering is required to access the market
Pricing strategy will be critical to exploit full market potential
Forecasts to 2019
ZP-PTH (hPTH1-34; Zosano Pharma)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for ZP-PTH
Clinical attractiveness
Satisfaction of unmet needs
ZP-PTH is a patient-friendly drug
Increased hip efficacy provides clinical differentiator
Commercial attractiveness
Big Pharma is required to reach full drug potential
505b2 regulatory strategy can reduce developmental costs
Forecasts to 2019
BA058 (parathyroid hormone peptide fragment; Radius)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for BA058
Clinical attractiveness
Satisfaction of unmet needs
Phase II studies suggest good drug efficacy
Commercial attractiveness
Radius will benefit from Novartis deal should option go ahead
Forecasts to 2019
Other drugs in parathyroid hormone and analog class
ViaDerm-hPTH (parathyroid hormone peptide fragment; TransPharma/Eli Lilly)
CaPTHymone (parathyroid hormone analog; Bone Medical)
7. Pipeline Analysis & Forecasts: Calcitonins
Key finding
Overview for pipeline calcitonin drugs
Pipeline summary
Comparative forecasts
SMC021 (salmon calcitonin; Novartis)
Drug overview
Drug profile
Clinical trial data
Ongoing clinical trials
SWOT analysis
Datamonitor drug assessment score card for SMC021
Clinical attractiveness
Satisfaction of unmet needs
SMC021's oral formulation remains favorable
Commercial attractiveness
Sales for calcitonins have been declining
Novartis market experience
Forecasts to 2019
Capsitonin (BN-002; Bone Medical)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for Capsitonin
Clinical attractiveness
Satisfaction of unmet needs
Clinical attractiveness
Oral formulation is an improvement over current modes of administration
Commercial attractiveness
Bone Medical will seek a marketing partner to launch the product
Competition from oral calcitonins will be high at the time of launch
Forecasts to 2019
8. Pipeline Analysis & Forecasts: Dual Acting Bone Modulators
Key finding
Overview for pipeline dual acting bone agents
Pipeline summary
Forecast summary
NBS101 (Strontium malonate; Osteologix)
Drug overview
Drug profile
Clinical trial data
SWOT analysis
Datamonitor drug assessment score card for NBS101
Clinical attractiveness
Satisfaction of unmet needs
Phase II data suggest better efficacy than Protelos
NBS101 oral formulation is an improvement over Protelos
Commercial attractiveness
NBS101 can target patients who stop alendronate treatment
US launch and partnering deals will boost the drug potential
Forecasts to 2019
9. Pipeline Analysis & Forecasts: Other Drugs
Key findings
Overview for other pipeline drugs
Pipeline summary
Comparative forecasts
Prolia (denosumab; Amgen)
Drug overview
Drug profile
Clinical trial data
Clinical trial 1
SWOT analysis
Datamonitor drug assessment score card for Prolia
Clinical attractiveness
Satisfaction of unmet needs
Prolia shows similar efficacy to alendronate
Serious skin disorder risk limits patient potential despite robust efficacy
Long-term safety remains a concern
Commercial attractiveness
Price to remain competitive without destroying the monoclonal antibody market
FDA panel restricts Prolia's patient potential
Prolia is recommended for approval in the EU
GlaxoSmithKline deal maximizes Prolia's potential in tough European market
Possible label extension for cancer indications boosts revenue potential
Forecasts to 2019
Odanacatib (MK0822; Merck & Co)
Drug overview
Drug profile
Clinical trial data
Ongoing clinical trials
SWOT analysis
Datamonitor drug assessment score card for odanacatib
Clinical attractiveness
Satisfaction of unmet needs
Novel target provides potential superior efficacy
Odanacatib shows continued efficacy after 3 years of treatment
Commercial attractiveness
Odanacatib's commercial potential will be driven by Merck & Co's market experience
By the time odanacatib launches the osteoporosis market will be extremely competitive
Forecasts to 2019
Eldecalcitol (ED-71; Chugai/Taisho)
Drug overview
Drug profile
Clinical trial data
Clinical trial 1
SWOT analysis
Datamonitor drug assessment score card for eldecalcitol
Clinical attractiveness
Satisfaction of unmet needs
Eldecalcitol met all Phase III endpoints and showed higher efficacy than Alfarol
Commercial attractiveness
Commercial potential limited by Japan launch only
Forecasts to 2019
Other drugs in other classes
MK5442 (Merck & Co)
Drug overview
Ongoing clinical trials
Sclerostin (AMG785; Amgen)
Drug overview
Ongoing clinical trials
2MD/DP001 (vitamin D analog; Deltanoid Pharma)
Drug overview
Clinical trial data
San134 (Glucagon-like peptide 2; Sanos Bioscience)
ACE-011 (activin inhibitor; Acceleron Pharma)
Late-stage development compounds recently discontinued
Ronacaleret fails to increase BMD and causes a mild primary hyperparathyroidism
10. Innovative Early-Stage Approaches
Key findings
New targets for anabolic treatments
Wnt signaling pathway therapeutic potential
Bone morphogenetic protein in osteoporosis
Insulin-like growth factor I
The future of treatment in osteoporosis
Combination therapies
Bibliography
Journals
Websites
Datamonitor reports
Conferences
APPENDIX
Data definitions, limitations and assumptions
Standard units
Country group definitions
Rest of European Union
Middle East and North Africa (MENA)
Rest of World
Derivation of sales forecasts and pricing trends
Indication-specific sales calculations
Caveats to using Prescribing insight
New product launches and expiries
Forecast methodology
Product forecasts
Contributing experts
Conferences attended
About Datamonitor
About Datamonitor Healthcare
About the Disease analysis team
Datamonitor consulting
Disclaimer

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