RELEASED JULY 2019 2019 ALZHEIMER’S DRUG PIPELINE THE ...

RELEASED JULY 2019

2019 ALZHEIMER'S DRUG PIPELINE2

THE CURRENT STATE OF ALZHEIMER'S DRUG DEVELOPMENT

PHASE 3 FACTS 2019

Percent Change from 2018

PHASE 2 FACTS 2019

Percent Change from 2018

Number of Drugs: 26

-16%

Commercial Launch:

22 drugs could reach the market in the next ve years

-12%

Number of Symptomatic Drugs: 9

-25%

Number of Disease Modifying Drugs: 17

-11%

Prevention Trials: 6 drugs are in prevention trials

-14%

Mechanism of Action:

7 drugs classi ed as Amyloid

-30%

12 drugs classi ed as Neurotransmission

-14%

Number of Drugs: 72

06%

Commercial Launch:

7 drugs could reach the market in the next ve years

-13%

Number of Symptomatic Drugs: 13

00%

Number of Disease Modifying Drugs: 59

07%

Prevention Trials: 2 drugs are in prevention trials

00%

Mechanism of Action:

5 drugs classi ed as Neuronal + Synaptic Growth

67%

12 drugs classi ed as Tau

09%

A Breakdown by Mechanism of Action

INFLAMMATION 1 DRUG

TAU 1 DRUG

ANTIMICROBIAL

1 DRUG

OTHER

4 DRUGS

4% 4% 15% 4%

27%

NEURONAL + SYNAPTIC GROWTH

5 DRUGS INFLAMMATION

2 DRUGS

TAU 12 DRUGS

STEM CELL 3 DRUGS

ENDOCRINE 1 DRUG

ANTIMICROBIAL 2 DRUGS

7% 3%

4% 1 3% 22%

OTHER 16 DRUGS

2361 Drugs in Phase 3

46%

NEUROTRANSMISSION 12 DRUGS

AMYLOID 7 DRUGS

17% 3% 4%

BLOOD + VASCULAR 2 DRUGS

INSULIN + GLUCOSE 3 DRUGS

72 Drugs

in Phase 2

18%

18%

NEUROTRANSMISSION

AMYLOID

13 DRUGS

13 DRUGS

Symptomatic vs. Disease-Modifying

A Disease-Modifying drug is one that attempts to alter the underlying pathobiology of Alzheimer's disease and is being tested with biomarkers.

A Symptomatic drug is one that attempts to lessen the symptomology often associated with Alzheimer's disease, such as agitation, aggression, and insomnia.

Methodology

This analysis was constructed through extensive research and interviews, including interviews with company executives about publicly available information, SEC lings, company reports, presentations at medical conferences, and media coverage. Additionally, academic research experts and select RA2 members provided input and review of the analysis. However, the responsibility for the content of this report belongs solely to UsAgainstAlzheimer's, the convener of RA2, and not to any other organization or individual. Information presented in this analysis includes Alzheimer's drugs that are in Phase 2 and Phase 3. This information is subject to change given the nature of clinical trials and drug development. Our intention is to provide regular updates on the status of drug development in Alzheimer's, and we welcome input and corrections. Contact: dholzapfel@

Prevention Trials

Prevention trials are all trials conducted on pre-symptomatic participants, including those who are healthy and cognitively normal.

THE CURRENT STATE OF ALZHEIMER'S DRUG DEVELOPMENT

2

PHASE 3 Alzheimer's Drugs and Estimated Commercial Launch Dates

Sodium Oligo-mannurarate

Shanghai Greenvalley Pharmaceutical Co.

Zolpidem

Brasilia University Hospital

Zoplicone

Brasilia University Hospital

AXS-05

Axsome Therapeutics, Inc.

Docosahexaenoic acid

University of Southern California; Alzheimer's Association

Masitinib

AB Science

AVP-786

Avanir Pharmaceuticals

Donepezil Transdermal Patch

Icure Pharmaceutical Inc.

Troriluzole

Biohaven Pharmaceuticals, Inc.

Octohydroaminoacridine Succinate

Shanghai Mental Health Center

Methylphenidate

National Institute on Aging; Johns Hopkins Bloomberg School of Public Health

ALZT-OP1

AZTherapies

TRx0237

TauRx Therapeutics

Brexpiprazole

Otsuka Pharmaceuticals

Guanfacine

Imperial College London

ANAVEX 2-734

Anavex Life Sciences Corp.

Icosapent Ethyl

VA Of ce of Research and Development; University of Wisconsin, Madison

Solanezumab

Eli Lilly

Escitalopram

JHSPH Center for Clinical Trials; National Institute on Aging

AGB101

AgeneBio, Inc.; National Institute on Aging

COR388 HCl

Cortexyme Inc.

Gantenerumab

Roche / Genentech (In-licensed from Morphosys)

E2609

Eisai Co., Ltd. and Biogen

BAN2401

Eisai Co., Ltd. and Biogen

CAD106

Novartis Pharmaceuticals

CNP520

Novartis Pharmaceuticals

2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027

KEY Estimated Trial Completion

Estimated Regulatory Filing

Estimated Commercial Launch Date

MOA Amyloid

Blood + Vascular

Stem Cell

Inflammation

Insulin + Glucose

Neurotransmission

Neuronal + Synaptic Growth

Other

Tau

Endocrine Antimicrobial

THE CURRENT STATE OF ALZHEIMER'S DRUG DEVELOPMENT

3

PHASE 2 Alzheimer's Drugs and Estimated Commercial Launch Dates

ANAVEX 2-73

Anavex Life Sciences Corp.

Piromelatine

Neurim Pharmaceuticals Ltd

SUVN-502

Suven Life Sciences Ltd

Levetiracetam

University of Minnesota, University of Oxford; Medical College Of Wisconsin; Beth Israel Deaconess Medical Center

DHP1401

Daehwa Pharmaceutical Co., Ltd

MLC901

National University Hospital, Singapore

Lithium

New York State Psychiatric Institute, National Institute on Aging

Lemborexant

Eisai

E2609

Biogen, Eisai Co., Ltd.

MP-101

Mediti Pharma Inc.

PTI-125

Pain Therapeutics

BAN2401

Biogen, Eisai Co., Ltd.

NA-831

NeuroActiva, Inc; The Florey Institute of Neuroscience and Mental Health

Valaciclovir

Ume? University; New York State Psychiatric Institute

Insulin Glulisine

Health Partners Institute

AADvac1

AXON Neuroscience SE

GV1001

GemVax & Kael

Lupron

New York University School of Medicine

Neurostem

Medipost Co Ltd.

Bryostatin 1

Neurotrope Bioscience, Inc.

VX-745

EIP Pharma, LLC

L-Serine

Dartmouth-Hitchcock Medical Center

AstroStem

Nature Cell Co. Ltd.

Perindopril

Sunnybrook Health Sciences Centre

2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029

KEY Estimated Trial Completion

Estimated Regulatory Filing

Estimated Commercial Launch Date

MOA

Amyloid

Blood + Vascular

Stem Cell

Inflammation

Insulin + Glucose

Neurotransmission

Neuronal + Synaptic Growth

Other

Tau

Endocrine Antimicrobial

THE CURRENT STATE OF ALZHEIMER'S DRUG DEVELOPMENT / Phase 2 Alzheimer's Drugs and Estimated Commercial Launch Dates 4

Telmisartan

Sunnybrook Health Sciences Centre

LM11A-31-BHS

PharmatrophiX Inc.; National Institute on Aging

UCMSCs

South China Research Center for Stem Cell and Regenerative Medicine

S-Equol

University of Kansas Medical Center; Ausio Pharmaceuticals

BI 425809

Boehringer Ingelheim

BAC

Charsire Biotechnology Corp.; A2 Healthcare Taiwan Corporation

Benfotiamine

Burke Medical Research Institute

GRF6019

Alkahest, Inc.

Liraglutide

Imperial College London

Curcumin

VA Of ce of Research and Development; Verdure Sciences

DAOI

Chang Gung Memorial Hospital

Posiphen

QR Pharma Inc.

GB301

GMP BIO Co., LTD.

Nilotinib

Georgetown University

IONIS-MAPTRx

Ionis Pharmaceuticals, Inc.

CERE-110

Sangamo Therapeutics

MMFS-205-SR

Neurocentria, Inc; Ohio State University

ALZ-8015

Alzheon

Sargramostim

Genzyme, Sano , University of Colorado Denver

Allogeneic Human Mesenchymal Stem Cells

Stemedica Cell Technologies, Inc.

BPN14770

Tetra Discovery Partners

Nicotinamide

University of California, Irvine

RO7105705

Roche / Genentech (In-licensed from AC Immune)

Deferiprone

Neuroscience Trials Australia

2018 2018

2019 2019

2020 2020

2021 2022 2021 2022

2023 2024 2023 2024

2025 2026 2025 2026

2027 2027

2028 2029 2028 2029

KEY Estimated Trial Completion

Estimated Regulatory Filing

Estimated Commercial Launch Date

MOA

Amyloid

Blood + Vascular

Stem Cell

Inflammation

Insulin + Glucose

Neurotransmission

Neuronal + Synaptic Growth

Other

Tau

Endocrine Antimicrobial

THE CURRENT STATE OF ALZHEIMER'S DRUG DEVELOPMENT / Phase 2 Alzheimer's Drugs and Estimated Commercial Launch Dates 5

RPh201

Regenera Pharma Ltd

AD-35

Zhejiang Hisun Pharmaceutical Co. Ltd.

CT1812

Cognition Therapeutics

AMX0035

Amylyx Pharmaceuticals Inc.

Meganatural-Az Grapeseed Extract

Icahn School of Medicine at Mount Sinai; National Center for Complementary and Integrative Health

AR1001

AriBio Co., Ltd.

Montelukast VersaFilm

IntelGenx Corp.

Riluzole

Sano , Rockefeller University, Icahn School of Medicine at Mount Sinai

Dronabinol

Johns Hopkins University; McLean Hospital

ORY-2001

Oryzon Genomics S.A.

ABvac40

Araclon Biotech S.L.

Rifaximin

Duke University/Valeant Pharmaceuticals International, Inc.

UB 311

United Neuroscience

Prazosin

Alzheimer's Disease Cooperative Study, National Institute on Aging

BIIB092

Biogen

Thiethylperazine

Immungenetics AG

Candesartan

Emory University

LY3002813

Eli Lilly and Company

LY3303560

Eli Lilly and Company

Crenezumab

Roche / Genentech (In-licensed from AC Immune)

APH-1105

Aphios

Dapagli ozin

University of Kansas Medical Center

Methylthioninium Chloride

The University of Texas Health Science Center at San Antonio

ABBV-8E12

AbbVie

2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030

KEY Estimated Trial Completion

Estimated Regulatory Filing

Estimated Commercial Launch Date

MOA Amyloid

Blood + Vascular

Stem Cell

Inflammation

Insulin + Glucose

Neurotransmission

Neuronal + Synaptic Growth

Other

Tau

Endocrine Antimicrobial

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