1 US Investigator Meeting DIAS-4, Chicago, July 2011

DIAS 4 USA Investigators’ meeting

Introduction: Lundbeck

July 15-16, 2011Chicago, IL

Bob AndersUS Clinical Lead

Lundbeck Inc. Deerfield, IL

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Lundbeck in Brief - Worldwide

We are a global pharmaceutical company specializing in central nervous system disorders

Founded by Hans Lundbeck in 1915

An integrated company with core competencies in research, development, production, marketing and sales

Marketed pharmaceuticals to treat Alzheimer’s disease, depression, anxiety, Parkinson’s disease and schizophrenia

Headquarters in Copenhagen, Denmark

Approximately 5,300 employees in 54 countries

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Lundbeck: Dedicated to Innovation

Our strengths Research has been the foundation of Lundbeck activities

for more than 50 years Known worldwide for our pioneering work Multidisciplinary, empowered project teams In-house expertise in CNS State-of-the-art technologies Extensive international collaboration

Our focus Stroke, depression, anxiety, psychosis, neurodegenerative disorders and

epilepsy

Our investments Lundbeck invested 23% of total revenue in R&D in 2009

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Compound Indication Activity Phase I Phase II Phase IIIRegulatory

filing

ClobazamLennox-Gastaut syndrome

GABA enhancer 2011

I.V. Carb Epilepsy Sodium channel blocker 2012

Desmoteplase Stroke Plasminogen activator 2012

Lu AA24493Stroke/neuronal damage

Tissue protective cytokine 2012+

Lu 02-750 Parkinson’s disease Dopaminergic agent 2012+

Lu AE04621 Parkinson’s disease Dopaminergic agent 2012+

PIPELINE: NEUROLOGY

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DEDICATED TO INNOVATION

Compound Indication Activity Phase I Phase II Phase IIIRegulatory

filing

Serdolect® US Schizophrenia Dopamine/serotonin

Nalmefene Alcohol dependenceSpecific opioid receptor antagonist

2011

Lu AA21004 Depression + GAD5HT3, 5HT7 antagonist, 5HT1a agonist and 5HT enhancer

2012

Lu AA24530 Depression Multiple targets 1) 2012+

Zicronapine Psychosis Monoaminergic 2012+

Lu AE58054 PsychosisSelective 5-HT6 antagonist

2012+

Lu AA39959 2) Psychosis/bipolar Ion channel modulator 2012+

1) In pre-clinical studies, Lu AA24530 has demonstrated activities as a monoamine enhancer with reuptake inhibition at monoamine transporters, and antagonist activity at 5-HT3 and 5-HT2c receptors

2) Clinical trials currently on hold

PIPELINE: PSYCHIATRY

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Research and development facilities Production facilities Sales

Headquarters

Global Presence

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Who we are: Lundbeck IncChicago area-> Deerfield, IL

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Who we are: Copenhagen, Denmark (Valby) -> Lu HQ

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DIAS 4 US General Responsibilitiesfor Study Management and Collaboration

CRAs Clinical Coordinating Center (CCC) and

Regional Hubs

Lu Inc/ H Luc

Operational- first level of contact Site Recruitment/ facilitating enrollment/ peer support

Operational and coordination overview

Pre-trial Visits (PTVs), site initiation visits (SIVs), close out visits (COVs) Ongoing monitoring visits Handle queries from sites as initial contact Manage shipment of lab supplies initially, re-order done by sites. Send IMP notifications upon RGL approval Review RAVE data entry, answer questionsReview source documentsPerform RAVE training

Recruit potential sites Initial site screening Stimulate recruitment Address study issues from sites with Sponsor including issues related to inclusion/ exclusion criteria, study design, visit structure, etc. Track enrollment activity (weekly) Review site issues to minimize turnover and encourage commitment Discuss screening efforts and strategy within centersHold monthly teleconferences, web conferences with site staff

Contract finalizations Grant Payment – set up and finalization Manage other supplies Track enrollment activity (real time) Handle queries on inclusion/exclusion criteria Safety (manage SAE reporting)Conduct periodic visits, discuss study challenges with site staff

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DIAS 4 US Study Team

Yasir Al-Rawi Sr Specialist, Desmoteplase expert

physician

Bob Anders US coordination

Thomas Breuer International Study Manager

Lidiya Flaksman Clinical Program Manager

Ebru Karakoc Specialist, Clinical Research Physician

Rich McVey Clinical Program Manager

Krishna Talluri Director, Medical Affairs

Thomas Truelsen Senior Specialist

Dipali Patel Clinical Trial Associate

Christina Giannoulis-Kolodziej Clinical Trial Associate

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DIAS 4 USRegional CRAs

CRA manager- Denise Redding

Michael Burke: Mid-Atlantic/ Midwest

Karen Dumka: Northeast

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DIAS 4 USRegional CRAs, cont.

Elisa Dauphinee: Southeast

Susan Pickell: Northeast/Mid-Atlantic

Audrey Sumner: Southeast

Gloria Gambit- West

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UIC Dept of Neurology US DIAS CCC Members

1. Philip B. Gorelick, MD MPH FACP (director)2. Dilip Pandey, M.D. (co-director)3. Rebecca Grysiewicz, DO (local site PI)4. Maureen Hilllmann, RN (nurse manager)5. Yvonne Harris, MPA (administrator)6. Vidas Simkus (internet support manager)

CCC= Clinical Coordinating Center

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Region Hub Directors- CCC

Midwest- Phil Gorelick, Dilip Pandey, UICSouthwest- David Hess, Med College GAMid-Atlantic- Max Hammer, UPMC, PANortheast- Lee Schwamm, MGH, BostonSouthwest – Timothy Ingall, Mayo, AZWest- Greg Albers, Stanford, CA

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DIAS-4

VERY IMPORTANT TRIALOur goals are common: Enhance patient recruitmentRight patient selectionTimely evaluations and imagingTimely randomizationTimely TMP and observationsTimely follow upWe will work together to reach our goals

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DIAS-4

We will work together to reach our goals

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OUR JOURNEY

We want to improve the quality of life for those suffering

from psychiatric and neurological disorders