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Aging is a Significant Risk Factor For a Variety of Diseases

Aging is a Significant Risk Factor For a Variety of Diseases

Youth

TherapiesAging Process

Hair Loss

Neurodegeneration

Cancer

Osteoporosis

Type 2 Diabetes

Sarcopenia

Atherosclerosis

CV Disease

Old Age

Adapted from: Nature: Reviews Drug Discovery, June 24, 2005, “Ageing and Metabolism: Drug Discovery Opportunities” Curtis, et al

Elixir is developing and commercializing drugs to treat

and prevent metabolic disease, prevent age-related diseases…

extending the quality and length of human life

Adapted from Nature: Reviews Drug Discovery, June 24, 2005, “Ageing and Metabolism: Drug Discovery Opportunities” Curtis, et al

Genetic pathways that control lifespan

Life-span extendingTarget intervention Insulin/IGF-1 Insulin and IGF-1 downregulate InsR and IGF-1R downregulate IRS downregulate PI3K downregulate PTEN downregulate PDK downregulate AKT downregulate FOXO downregulate GHR downregulate GHRHR downregulateSir2 Sir2 orthologuesupregulateAMPK AMPK upregulate TSC upregulate TOR upregulate S6K upregulateHeat-shock proteins HSF upregulate HSP70 upregulate Small HSPs upregulateOther INDY/NaCT downregulate P66shc downregulate JNK upregulate

*

Elixir: Drug discovery against a host of Age-related DiseasesElixir: Drug discovery against a host of Age-related Diseases

Youth

TherapiesAging Process

Hair Loss

Neurodegeneration

Cancer

Osteoporosis

Type 2 Diabetes

Sarcopenia

Atherosclerosis

CV Disease

Old Age

First product out of the Science of AgingFirst product out of the Science of Aging

EX-1350 Ghrelin antagonist

• Aging: Daf2 – INSr – IGF1R

• One of the most exciting targets in metabolic disease– Multi-billion dollar product opportunity

• Most advanced oral (small molecule) program in industry

• Multiple potent, bio-available proprietary antagonists

• Development partnership by year-end

• IND filing 2008

• Life extension animal experiment on-going

• Initial indications: Diabetes and obesity

(*BMI 30, or ~ 30 lbs overweight for 5’4” person)Obesity Trends* Among U.S. Adults: 1985 * BMI ≥30, or ~ 30 lbs overweight for 5’ 4” woman

Large & Growing Market of Metabolic DiseaseLarge & Growing Market of Metabolic Disease

Source: Behavioral Risk Factor Surveillance System, CDC.

10%–14%<10%No Data

(*BMI 30, or ~ 30 lbs overweight for 5’4” person)

Source: Behavioral Risk Factor Surveillance System, CDC.

Obesity Trends* Among U.S. Adults: 1995 * BMI ≥30, or ~ 30 lbs overweight for 5’ 4” woman

Large & Growing Market of Metabolic DiseaseLarge & Growing Market of Metabolic Disease

15%–19%10%–14%<10%No Data

(*BMI 30, or ~ 30 lbs overweight for 5’4” person)

Source: Behavioral Risk Factor Surveillance System, CDC.

Obesity Trends* Among U.S. Adults: 2000 * BMI ≥30, or ~ 30 lbs overweight for 5’ 4” woman

Large & Growing Market of Metabolic DiseaseLarge & Growing Market of Metabolic Disease

20%–24%15%–19%10%–14%<10%No Data

(*BMI 30, or ~ 30 lbs overweight for 5’4” person)

≥25%20%–24%15%–19%10%–14%<10%No Data

Source: Behavioral Risk Factor Surveillance System, CDC.

Obesity Trends* Among U.S. Adults: 2004 * BMI ≥30, or ~ 30 lbs overweight for 5’ 4” woman

Large & Growing Market of Metabolic DiseaseLarge & Growing Market of Metabolic Disease

Slowrate of aging

Preventother agerelated diseases

Enormous Market PotentialEnormous Market Potential

Preventmetabolicdisease

Treatdiabetes & obesity

Leveraging Elixir biology & pharmacology expertiseLeveraging Elixir biology & pharmacology expertise

EX-1314 Ghrelin agonist

• In-licensed from BMS 4/05

• Orally-active, small molecule

• Several indications/markets – cancer cachexia ($600 MM opportunity)

– gastroparesis ($1.5 B opportunity)

• 2007 IND filing/initiation of Phase 1

• 4-5 year clinical development timeline

Agonist

EX1314Pre-clinical/IND

Phase 1

Phase 2

Phase 3

Antagonist

EX1350Pre-clinical/IND

IND/Phase 1

Phase 2

Phase 3

Development timeline for ghrelin programsDevelopment timeline for ghrelin programs

2006 2007 2008 2009 2010 2011

Elixir TodayElixir Today

• Science of aging metabolic disease

• Large & growing markets

• Maturing pipeline of high-value programs– Validating Pharma collaboration

• Business Strategy– Supplement pipeline with later-stage asset in metabolic disease

– Build a modest revenue stream to fund research & development

– Build development & commercial capabilities in metabolic disease

April 2006: In-license of late-stage type 2 diabetes product Revenue generation Funding for discovery & development Path to profitability

Elixir Pipeline Elixir Pipeline

Drug Discovery

Development Programs

SIRT

INDY

AMPK

Commercialization

Metfast Glufast

Ghrelin

agonist

Ghrelin

antagonist

A Late-stage Type 2 Diabetes ProductA Late-stage Type 2 Diabetes Product

Glufast (mitiglinide)• Established diabetes class with two competitors

• Solid pre-clinical and clinical data package

– 5 phase III trials (3 EU) 1,500 patients

– Japan Approved

2005 Meglitinide Market:$300 MM

+10% vs. ’04 *

* 2005 IMS data

• Safe and effective as 1st line or in combination with metformin

• Best in Class

• Mechanism: Management of post-meal glucose surges – Upside:

Growing recognition of need to manage post-meal glucose surges

Glufast “Best in Class” ProfileGlufast “Best in Class” Profile

Glufast Prandin Starlix

Efficacy + + -

Safety + - +

Glufast Commercialization StrategyGlufast Commercialization Strategy

Elixir will launch a specialty sales force at approval

• Competitive promotion declining

– Big enough to be interesting to us… but not for big pharma

• Small number of key prescribers

– 8,000 MD’s (50% of all class prescriptions)

– Sales force of 50 sales representatives

– Deploy in key metro areas for maximum targeting efficiency

• Quickly convert current Prandin/Starlix prescribers

• NB: Starlix 1st year sales: $43 MM

– KOL pre-launch for combination product (Metfast)

Metfast: An Even Larger Market Opportunity A “Super-Metformin ”Metfast: An Even Larger Market Opportunity A “Super-Metformin ”

Metfast (b.i.d. metformin + Glufast fixed combination)

• Patients on metformin easily transitioned to Metfast

– Same convenience/benefits of metformin plus

• coverage of FPG + PPG additional HbA1c reduction

• reducing risks of cardiovascular disease

• Rapid development plan (one 6-month treatment trial)

• New intellectual property

• Significant primary care sales opportunity- Glucovance (fixed-combination) analogy

Metfast: Significant Sales OpportunityMetfast: Significant Sales Opportunity

million

Source IMS 2001-2003

$0

$100

$200

$300

$400

$500

Sales

2001 2002 2003

Year

Glucovance$M

Physician Target AudiencePhysician Target Audience

Glufast OpportunityPrescriber target

Metfast Opportunity

Non-prescribers of meglitinides

Primary care marketing partner

Metfast Commercialization StrategyMetfast Commercialization Strategy

Marketing partner with large primary care sales force

– Existing primary care sales force

• Three 500 sales rep teams

– Strong managed care presence

– Partnership structure

• Significant upfront/approval signing payment

• Very competitive market for high-value primary care products

• Profit share

2006 2007 2008 2009

Elixir’s Near-term Diabetes Franchise TimelineElixir’s Near-term Diabetes Franchise Timeline

Glufast

Final Phase 3 trial

File NDA

Launch “best in class”

Metfast

Phase 3 trial

File NDA

Partner launch

If no additional Phase 3 required by FDA

Revenue Generation Accelerated With Glufast / MetfastRevenue Generation Accelerated With Glufast / Metfast

Revenue

Ghrelin AgonistGhrelin Antagonist

Modest Burn

Cash Flow Positive

Blockbuster

Revenue

2007 2008 2009 2010 2012 2013 20152011 2014

Glufast/Metfast

Executive TeamExecutive Team

William Heiden, Chief Executive Officer20 years of drug commercialization & development experience

Peter DiStefano, Ph.D., Chief Scientific Officer 20 years of drug discovery & development experience

Alan Watson, Ph.D., Chief Business Officer20 years of drug discovery, development, IP, and bus dev

Bard Geesaman, M.D., Ph.D., VP Medical 10 years of research and entrepreneurial ventures

Karen Roberts, VP Finance 20 years of public and private company finance and admin

2006 2007 2008 2009

MilestonesMilestones

Elixir Glufast pre-NDA meeting with FDA IPOGlufast/Metfast

Phase III trialNDA Filing/ApprovalCommercial Launch

Ghrelin Antagonist - 1350Big Pharma PartnershipIND/Phase I trial

Phase II trials Ghrelin Agonist - 1314

IND/Phase I trialPhase II trial

SIRT1 in metabolism/aging Medicinal chemistry screen Pre-clinical development IND

Enormous Potential of Elixir’s Scientific PlatformEnormous Potential of Elixir’s Scientific Platform

Type 2diabetes

Cardiovascular disease

ObesityCancer

Youth

Old Age

Elixir’s Novel Approach:Therapeutic Intervention

at the core of theDiseases of Aging

This presentation is confidential and the intellectual property of Elixir Pharmaceuticals, Inc.

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www.elixirpharm.com