Alzheimer's Disease: Markets, Pipeline and Opportunities 2009

Table of Contents

1. Alzheimer' s Disease

• 1.1 Alzheimer' s Disease
• 1.2 Statistics and Costs
• 1.3 Histopathology
• 1.4 Amyloid Beta (Aβ)
• 1.5 Tau Proteins and Neurofibrillary Tangles
• 1.6 Cholinergic Hypothesis
• 1.7 Diagnosis
• 1.8 Cognitive Tests
• 1.9 Treatment

2. Alzheimer' s Disease Statistics

• 2.1 Background
• 2.2 Dementia - Global Population
• 2.3 Global Incidence
• 2.4 Global New Cases
• 2.5 Global Prevalence
• 2.6 Estimated Global Prevalence in 2020
• 2.7 Developed and Developing Countries
• 2.8 Global Trends
• 2.9 Dementia and AD
• 2.10 John Hopkins University Study
• 2.11 Disease Costs

3. The Global Drug Market

• 3.1 The Global Drug Market

4. Donepezil Hydrochloride (AriceptR)

• 4.1 Donepezil hydrochloride (AriceptR)
• 4.2 Global Sales
• 4.3 Global Sales - Eisai
• 4.4 Japan Sales - Eisai
• 4.5 US Sales - Eisai
• 4.6 Regional Sales - Eisai
• 4.7 Global Sales - Pfizer

5. Memantine AxuraR NamendaR EbixaR

• 5.1 Memantine

6. Rivastigmine Tartrate (ExelonR)

• 6.1 Rivastigmine Tartrate

7. Piracetam NootropilR

• 7.1 Piracetam

8. Galantamine (RazadyneR)

• 8.1 Galantamine Hydrobromide

9. Global and Regional Sales

• 9.1 Overview

10. Other Marketed Therapeutic Agents

• 10.1 Background
• 10.2 Colostrinin
• 10.3 Cerebrolysin
• 10.4 Nicergoline

11. Drug Repurposing in Alzheimer' s Disease

• 11.1 Background

12. Drug Pipeline - Phases I-III

• 12.1 Background
• 12.2 Phase III
• 12.3 Phase II
• 12.4 Phase I

13. Discussion

• 13.1 Overview
• 13.2 Markets
• 13.3 Drug Pipeline
• 13.4 Conclusions

References

Figures

• Figure 1.1 Diagram indicating the two cleavage positions of APP (by β- and γ-secretases), generating Aβ
• Figure 2.1 The global population (millions) of individuals e" 60.
• Figure 2.2 The global incidence of dementia (Number of Individuals/1000) in 2001.
• Figure 2.3 Global new cases of dementia (Number of Individuals/1000) in 2001.
• Figure 2.4 The global prevalence of dementia in 2001
• Figure 2.5 The estimated prevalence of dementia in 2020
• Figure 2.6 The estimated prevalence of dementia in 2040
• Figure 2.7 The prevalence of dementia in developed and developing countries in 2001 and estimates of prevalence in 2020 and 2040.
• Figure 2.8 Estimate of changes (% change) in the prevalence of dementia between 2001 and 2020.
• Figure 2.9 Estimate of changes (% change) in the prevalence of dementia between 2001 and 2040.
• Figure 3.1. The global sales (US$, millions) of AD drugs from 1999-2008. These figures reflect the sales of the five major anti-AD drugs namely donepezil (AriceptR, Eisai), memantine (AxuraR/NamendaR/EbixaR,Merz), rivastigmine (ExelonR, Novartis), galantamine (RazadyneR, J&J) and piracetam (NootropilR,UCB). Sales in 2008 of the drugs donepezil and memantine were estimated, based on a 10% increase in their respective 2007 sales figures.
• Figure 3.2. The annual change (%) in the global sales of anti-Alzheimer' s disease drugs from 1999-2008. These figures reflect the sales of the five major anti-Alzheimer' s disease drugs namely donepezil (AriceptR, Eisai), memantine (AxuraR/NamendaR/EbixaR,Merz), rivastigmine (ExelonR, Novartis), galantamine (RazadyneR, J&J) and piracetam (NootropilR,UCB). Sales in 2008 of the drugs donepezil and memantine were estimated, based on a 10% increase in their global 2007 sales figures.
• Figure 3.3 The global sales histogram (US$, Millions) for 2008 of the anti-Alzheimer' s disease donepezil (AriceptR, Eisai), memantine (AxuraR/NamendaR/EbixaR,Merz), rivastigmine (ExelonR, Novartis), galantamine (RazadyneR, J&J) and piracetam (NootropilR,UCB). Sales for 2008 for the drugs donepezil and memantine were estimated, based on a 10% increase in Eisai and Merz global 2007 sales figures.
• Figure 3.4 The global sales pie chart (US$, Millions) for 2008 of the anti-Alzheimer' s disease drugs donepezil (AriceptR, Eisai), memantine (AxuraR/NamendaR/EbixaR,Merz), rivastigmine (ExelonR, Novartis), galantamine (RazadyneR, J&J) and piracetam (NootropilR,UCB). Sales for 2008 for the drugs donepezil and memantine were estimated, based on a 10% increase in Eisai and Merz global 2007 sales figures.
• Figure 3.5 The global sales histogram (US$, Millions) for 2007 of the anti-Alzheimer' s disease drugs donepezil (AriceptR, Eisai), memantine (AxuraR/NamendaR/EbixaR,Merz), rivastigmine (ExelonR, Novartis), galantamine (RazadyneR, J&J) and piracetam (NootropilR,UCB).
• Figure 3.6 The global sales pie chart (US$, Millions) for 2007 of the anti-Alzheimer' s disease drugs donepezil (AriceptR, Eisai), memantine (AxuraR/NamendaR/EbixaR,Merz), rivastigmine (ExelonR, Novartis), galantamine (RazadyneR, J&J) and piracetam (NootropilR,UCB).
• Figure 4.1 Global sales (US$, millions) of AriceptR (donepezil hydrochloride) by Eisai and Pfizer (under licence to Eisai) from 1999 to 2008. Eisai' s own sales for 2008 for the drugs were not available at the time of publication of this reports and have been estimated based on a 10% increase of the company' s global 2007 AriceptR sales figures.
• Figure 4.2 The annual growth (as % change) in the global sales of AriceptR (donepezil hydrochloride) by Eisai and Pfizer (under licence to Eisai) from 1999 to 2008. Eisai' s own sales for 2008 for the drugs were not available at the time of publication of this reports and have been estimated based on a 10% increase of the company' s global 2007 AriceptR sales figures.
• Figure 4.3 Global sales (US$, millions) of AriceptR (donepezil hydrochloride) by Eisai from 1999 to 2008. Sales for 2008 for the drugs were not available at the time of publication of this reports and have been estimated based on a 10% increase in their global 2007 AriceptR sales figures.
• Figure 4.4 The annual change (as % change) in the global sales of AriceptR (donepezil hydrochloride) by Eisai from 1999 to 2008. Sales for 2008 for the drugs were not available at the time of publication of this reports and have been estimated based on a 10% increase in their global 2007 AriceptR sales figures.
• Figure 4.5 Sales (US$, millions) of AriceptR (donepezil hydrochloride) in Japan by Eisai from 1999 to 2008. Sales for 2008 for the drugs were not available at the time of publication of this reports and have been estimated based on a 10% increase Eisai' s/Pfizer' s global 2007 AriceptR sales figures.
• Figure 4.6 The annual change (as % change) in the sales of AriceptR (donepezil hydrochloride) in Japan by Eisai from 1999 to 2008. Sales for 2008 for the drugs were not available at the time of publication of this reports and have been estimated based on a 10% increase Eisai' s/Pfizer' s global 2007 AriceptR sales figures.
• Figure 4.7 US Sales (US$, millions) of AriceptR (donepezil hydrochloride) by Eisai from 1999 to 2008. Sales for 2008 for the drugs were not available at the time of publication of this reports and have been estimated based on a 10% increase in their 2007 AriceptR sales figures.
• Figure 4.8 The annual change (as % change) in the sales of AriceptR (donepezil hydrochloride) in the US by Eisai from 2003 to 2008. Sales for 2008 for the drugs were not available at the time of publication of this reports and have been estimated based on a 10% increase in their 2007 AriceptR sales figures.
• Figure 4.9 Global and regional sales (US$, millions) of AriceptR (donepezil hydrochloride) by Eisai from 2002 to 2008. Sales for 2008 for the drugs were not available at the time of publication of this reports and have been estimated based on a 10% increase in their 2007 AriceptR sales figures.
• Figure 4.10 2007 relative direct sales (US$, millions) of AriceptR by Eisai in the US, Japan, Europe and Asia (excluding Japan).
• Figure 4.11 The annual global change in the sales of AriceptR (donepezil hydrochloride) by Pfizer from 2003 to 2008. Source: Biopharm Reports.
• Figure 4.12 The annual change (as % change) in the sales of AriceptR (donepezil hydrochloride) in the Pfizer from 2004 to 2008.
• Figure 5.1 Global sales (US$, millions) of AxuraR NamendaR EbixaR (memantine) by Merz and licensees from 2003/4 to 2007/8. Sales for 2008/9 for the drugs were not available at the time of publication of this reports and have been estimated based on a 10% increase Merz' and its licensees 2007 sales figures.
• Figure 5.2 The annual change (as % change) in the global sales of AxuraR NamendaR EbixaR (memantine) by Merz and its licensees from 2004/5 to 2008/9. Sales for 2008/9 for the drugs were not available at the time of publication of this reports and have been estimated based on a 10% increase in Merz' 2007 sales figures.
• Figure 5.3 Annual US sales (US$, millions) of AxuraR NamendaR EbixaR (memantine) by Merz and licensees from 2003/4 to 2007/8. Sales for 2008/9 for the drugs were not available at the time of publication of this reports and have been estimated based on a 10% increase Merz' and its licensees 2007 sales figures.
• Figure 5.4 The annual change (as % change) in the US sales of AxuraR NamendaR EbixaR (memantine) by Merz and its licensees from 2004/5 to 2008/9. Sales for 2008/9 for the drugs were not available at the time of publication of this reports and have been estimated based on a 10% increase in Merz' 2007 sales figures.
• Figure 5.5 Regional sales (US$, millions) of AxuraR NamendaR EbixaR (memantine) by Merz and licensees from 2003/4 to 2006/7.
• Figure 6.1 Global sales (US$, millions) of ExelonR (rivastigmine tartrate) by Novartis from 2000 to 2008.
• Figure 6.2 The annual change in the global sales of ExelonR by Novartis from 2001 to 2008.
• Figure 6.3 US sales (US$, millions) of ExelonR (rivastigmine tartrate) by Novartis from 2001 to 2008.
• Figure 6.4 The annual change in the US sales of ExelonR by Novartis from 2002 to 2008.
• Figure 7.1. The global sales (US$, millions) of NootropilR (piracetam) by UCB from 2000 to 2008
• Figure 7.2 The annual change (as % change) in the global sales of NootropilR by BMS from 2001 to 2008.
• Figure 7.3. The sales (US$, millions) of NootropilR (piracetam) by UCB from 2005 to 2008 (Europe and Worldwide)
• Figure 9.1 US sales of donepezil, memantine, Rivastigmine and galantamine in 2007.
• Figure 9.2 US sales of donepezil, memantine, rivastigmine and galantamine in 2008.
• Figure 9.3 US sales of AD drugs from 2001 - 2008. Sales of Eisai' s Aricept in 2008
• have been estimated based on a 10% increase on the company' s sales figures of 2007.
• Figure 9.4 US sales of AD drugs from 2004 - 2008, as % Change. Sales of Eisai' s Aricept in 2008 have been estimated based on a 10% increase on the company' s sales figures of 2007.
• Figure 12.1. Alzheimer' s disease - drug candidates in the development pipeline, Phase I - III
• Figure 12.2 Phase III Alzheimer' s disease drug categories. SA: Single Agent (a single candidate molecule that has not been approved other indications). SOAD: Single Other Approved Drug (a single drug that has already been approved for another indication). Nutr Suppl: Nutritional Supplement MOAD: Multiple Other Approved Drugs (multiple drugs that have already been approved for other indication).
• Figure 12.3 Phase III Alzheimer' s disease drug categories. SA: Single Agent (a single candidate molecule that has not been approved other indications). SOAD: Single Other Approved Drug (a single drug that has already been approved for another indication). Nutr Suppl: Nutritional Supplement MOAD: Multiple Other Approved Drugs (multiple drugs that have already been approved for other indication).
• Figure 12.4 Phase II Alzheimer' s disease drug categories. SA: Single Agent single candidate molecule that has not been approved other indications). SOAD: Single Other Approved Drug (a single drug that has already been approved for another indication). Nutr Suppl: Nutritional Supplement MOAD: Multiple Other Approved Drugs (multiple drugs that have already been approved for other indication).
• Figure 12.5 Phase II Alzheimer' s disease drug categories. SA: Single Agent single candidate molecule that has not been approved other indications). SOAD: Single Other Approved Drug (a single drug that has already been approved for another indication). Nutr Suppl: Nutritional Supplement MOAD: Multiple Other Approved Drugs (multiple drugs that have already been approved for other indication).
• Figure 12.6 Phase I Alzheimer' s disease drug categories. SA: Single Agent single candidate molecule that has not been approved other indications). SOAD: Single Other Approved Drug (a single drug that has already been approved for another indication). Nutr Suppl: Nutritional Supplement MOAD: Multiple Other Approved Drugs (multiple drugs that have already been approved for other indication).
• Figure 12.7 Phase I Alzheimer' s disease drug categories. SA: Single Agent single candidate molecule that has not been approved other indications). SOAD: Single Other Approved Drug (a single drug that has already been approved for another indication). Nutr Suppl: Nutritional Supplement MOAD: Multiple Other Approved Drugs (multiple drugs that have already been approved for other indication).
• Figure 13.1. The global sales of AD drugs from 1999-2008. These figures reflect the sales of the five major anti-Alzheimer' s disease drugs namely donepezil (AriceptR, Eisai), memantine (AxuraR/NamendaR/EbixaR,Merz), rivastigmine (ExelonR, Novartis), galantamine (RazadyneR, J&J) and piracetam (NootropilR,UCB). Sales in 2008 of the drugs donepezil and memantine were estimated, based on a 10% increase in Eisai' s and Merz' global 2007 sales figures.
• Figure 13.2. The annual change in the global sales of anti-Alzheimer' s disease drugs from 1999-2008. These figures reflect the sales of the five major anti-Alzheimer' s disease drugs namely donepezil (AriceptR, Eisai), memantine (AxuraR/NamendaR/EbixaR,Merz), rivastigmine (ExelonR, Novartis), galantamine (RazadyneR, J&J) and piracetam (NootropilR,UCB). Sales in 2008 of the drugs donepezil and memantine were estimated, based on a 10% increase in Eisai' s and Merz' global 2007 sales figures.
• Figure 13.3 The global sales histogram (US$, Millions) for 2008 of the anti-Alzheimer' s disease donepezil (AriceptR, Eisai), memantine (AxuraR/NamendaR/EbixaR,Merz), rivastigmine (ExelonR, Novartis), galantamine (RazadyneR, J&J) and piracetam (NootropilR,UCB).
• Figure 13.4. Alzheimer' s disease - drug candidates in the development pipeline, Phase I - 3

Tables

• Table 3.1 The global sales (US$, millions) 2004-2008 of the anti-Alzheimer' s drugs donepezil (AriceptR, Eisai), memantine (AxuraR/NamendaR/EbixaR,Merz), rivastigmine (ExelonR, Novartis), galantamine (RazadyneR, J&J) and piracetam (NootropilR,UCB) and colostrinin (colostrinin"!, Regen Therapeutics). * Sales for 2008 for the drugs donepezil and memantine were estimated, based on a 10% increase in Eisai and Merz global 2007 sales figures.
• Table 9.1 Global and regional sales of the AD drugs donepezil, memantine, rivastigmine, Piracetam, galantamine and colostrinin. *= Sales by Eisai **= sales by Pfizer
• Table 11.1 Number of drug drugs studies relating to potential repurposing and others which may treat some of symptoms of AD
• Table 11.2a Phase III studies relating to potential repurposing and others linked to the treatment of some of the symptoms of AD
• Table 12.2 Phase II Alzheimer' s disease drug categories. SA: Single Agent (a single candidate molecule that has not been approved other indications). SOAD: Single Other Approved Drug (a single drug that has already been approved for another indication). Nutr Suppl: Nutritional Supplement MOAD: Multiple Other Approved Drugs (multiple drugs that have already been approved for other indication).
• Table 12.3 Phase I Alzheimer' s disease drug categories. SA: Single Agent (a single candidate molecule that has not been approved other indications). SOAD: Single Other Approved Drug (a single drug that has already been approved for another indication). Nutr Suppl: Nutritional Supplement MOAD: Multiple Other Approved Drugs (multiple drugs that have already been approved for other indication).
• Table 13.1 Phase III Alzheimer' s disease drug categories. SA: Single Agent (a single candidate molecule that has not been approved other indications). SOAD: Single Other Approved Drug (a single drug that has already been approved for another indication). Nutr Suppl: Nutritional Supplement MOAD: Multiple Other Approved Drugs (multiple drugs that have already been approved for other indication).