Custom Intelligence. Alzheimer s Disease Landscape Summary

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1 Custom Intelligence Alzheimer s Disease Landscape Summary Prepared August 21

2 Alzheimer s Disease Landscape: Executive Summary Current standard of care in Alzheimer s Disease (AD) consists of symptomatic treatment with no true disease modifying drugs yet available. Acetyl cholinesterase inhibitors (AChEIs) are the first-line treatment for mild to moderate AD. Because all approved AChEIs are similar in terms of efficacy, treatment choices are based on tolerability, convenience, reimbursement status, and preference. Donepezil [Aricept ; Eisai/Pfizer] is generally preferred. The NMDA receptor antagonist memantine is frequently prescribed in combination with an AChEI, and is the standard of care for moderate to severe AD. Increasingly, memantine plus an AChEI is also becoming the standard of care in mild to moderate AD (despite demonstrating limited clinical efficacy in this population) because of memantine s benign side effect profile and distinct mechanism of action. Namenda (memantine) worldwide sales are expected be approximately $2.2 billion this year. The standard endpoint for AD clinical trial is the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), a battery of cognitive tests that was the basis for approval of Aricept and Namenda. Pfizer, Johnson & Johnson, and Élan s bapineuzumab failed phase III trials July 212. The phase III EXPEDITION I&II trials of Lilly s similar anti-aβ antibody solanezumab also failed to meet their primary endpoints. However, solanezumab plus symptomatic therapy could still potentially have a big impact on the future market if it is launched as forecast in 21. Secretase and tau inhibitors are the other major mechanisms of action currently being explored as disease modifying agents in AD. 2 References: Adis Clinical Trials Insight, Adis Research & Development Insight, 21 Alzheimer s Disease Facts and Figures, Alzheimer s & Disease, Volume 9, Issue 2

3 Alzheimer s Disease Landscape: Executive Summary (cont.) Baxter s Gammagard and other intravenous immunoglobulin (IVIg) preparations could also potentially fill the gap between AchE Inhibitors and true disease modifying targeted drugs. For potential disease modifying agents, more sensitive instruments are also being explored, as ADAS-cog requires significant cognitive impairment to register a score different from normal. One example is the neuropsychological test battery (NTB). Biomarkers including CSF Aβ, CSF tau, and imaging results from PET and MRI scans are also being discussed as phase II endpoints. The greatest unmet need is early, accurate and prompt diagnosis. Improved diagnostic tools including biomarkers that enable earlier, more-accurate diagnosis would significantly increase the diagnosed patient pool and lead to broader treatment of AD, particularly if a disease-modifying therapy became available. A therapy that truly alters the course of AD is also a significant unmet need, but failures of potentially disease-modifying therapies in the last five years have tempered the optimism of many experts. Nonetheless, these drugs are likely the biggest opportunity in drug development, but development costs, in terms of time, dollars, and risk, are high. Symptomatic drugs have a real opportunity, as evidenced by the success of Aricept and Namenda, but as these drugs are replaced by low-cost generics, the bar is high for cost effective symptomatic therapies. Experts call for therapies that provide greater slowing of functional decline in AD and thus delay the need for nursing home placement. Of particular interest are not only therapies that provide benefits in cognitive improvement over existing therapies, but also therapies specifically developed for AD patients that target the neuropsychological symptoms associated with the disease. References: Adis Clinical Trials Insight, Adis Research & Development Insight, 21 Alzheimer s Disease Facts and Figures, Alzheimer s & Disease, Volume 9, Issue 2

4 21 Global Development Programs by (active) 21 Global Clinical Trials by (ongoing) I I/II 122 II II/III 1 2 III IV 8 No Data All Active Development Programs by Country

5 Top 1 MOAs and development companies (late stage developmental & launched drugs) (Current landscape) Top 1 MOAs and development companies (early stage developmental & preclinical drugs) (Predictor of future landscape) Tau protein inhibitors -HT antagonists PET enhancers APP secretase modulators Histamine H antagonists Alpha-synuclein inhibitors -HT antagonists AChe inhibitors 8 NMDA antagonists APP secretase inhibitors 12 Antioxidants Tau protein inhibitors 1 Undefined BACE1 protein inhibitors 18 Immunostimulants Immunostimulants 19 AChe inhibitors 1 Undefined Aβ inhibitors Aβ inhibitors Pfizer AbbVie GlaxoSmithKline NIH (USA) Abbott Laboratories AC Immune AstraZeneca Elan Corporation Eli Lilly 12 1 Merck & Co AstraZeneca Pfizer Bristol-Myers Squibb Roche Wyeth GlaxoSmithKline Takeda University of California at Irvine Abbott Laboratories Roche

6 Revenue (USD Millions) Credit Suisse Global Revenue Forecasts in AD: Memantine Donepezil Rivastigmine Galantamine Solanezumab ABT 12 BAN 21 Crenezumab Gantenerumab Lu AE 8 Ispronicline ORM 121 SB 2 E 2212 AZD 21 E 29 ASP AZD 1 CAD 1 RG 1 SAR 89 Vanutide cridificar Last updated: March 21. Forecasts not available for all compounds.

7 Detailed Chapters & Analyses Available on Request Paradigm Evolution in Alzheimer s Disease Future Key Data Presentations Key 21 Alzheimer s Disease Meetings Alzheimer s Disease Disease Overview Alzheimer s Disease Disease Management Current Market for Alzheimer s Disease Pharmacotherapeutics Future Treatments & Emerging Trends Competitive Landscape: Overview of Key Compounds in Development Revenue Forecasts and Expected Launch Dates SWOT Analyses of Key Compounds Key Clinical Trial Analysis Institutions/Companies with significant activity in Alzheimer s Disease Key Clinical Publications Current Treatment Guidelines by Region Comprehensive Monitoring and Tracking of Key Alzheimer's Disease Compounds and Companies Detailed charts of global developmental and clinical trial activity (see attached appendices) Licensing Opportunities in Alzheimer s Disease

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