company highlights drug delivery market

28
• Company Highlights • Drug Delivery Market • Business Strategy • Scientific Expertise • Technology Platforms • Intellectual Property • Product Pipeline • Competition • Management • Use of Proceeds • Summary Agenda

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Page 1: Company Highlights Drug Delivery Market

• Company Highlights• Drug Delivery Market• Business Strategy • Scientific Expertise• Technology Platforms• Intellectual Property• Product Pipeline• Competition• Management• Use of Proceeds• Summary

AgendaAgenda

Page 2: Company Highlights Drug Delivery Market

DisclaimerDisclaimer

The presentation of this information may contain forward looking statements that are based on current expectations, forecasts and assumptions that include risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties include, but are not limited to pricing, competition, dependency on new product development, reliance on major customers, customer demand for our products and services, control of costs and expenses, general industry and market conditions and growth rates, and general domestic and international economic conditions including interest rate and currency exchange rate fluctuations.

For a further list and description of such risks and uncertainties, see the reports filed by IntelGenx Technologies Corp. with SEDAR.

While the information herein is collected and compiled with care, neither IntelGenx Technologies Corp. nor any of its affiliated companies represents, warrants or guarantees the accuracy or the completeness of the information. The information is presented solely for educational purposes, and is not to be considered as either legal or accounting advice.

Page 3: Company Highlights Drug Delivery Market

• Operating in high growth, oral controlled release drug delivery

space

• Focused on developing improved versions of existing drugs, and

other novel products

• Product candidates address large markets with unmet needs Osteoarthritis – USD 10B + Acute Pain – USD 10B + Depression – USD 15B + Smoking Cessation – USD 1B +

• Strategic partnerships in place for key development programs

• 25 years experience in pharmaceutical product development

• Broad IP coverage – three issued patents, five applications

currently pending (three US, two PCT)

Company OverviewCompany Overview

Page 4: Company Highlights Drug Delivery Market

• Established in 2003 as Canadian Corporation

• Incorporated as IntelGenx Technologies, Corp. (Delaware) in

2006

• 3,500 sqft R&D facility in St-Laurent, Quebec

• 8 Employees

• 16,457,489 common shares outstanding

•17,317,180 shares fully diluted

•5,116,489 shares floating

Corporate ProfileCorporate Profile

Page 5: Company Highlights Drug Delivery Market

Oral CROral CR60%60%

Implant 10%

Inhalation27%

Transdermal 8%

All Other2%

Global DDS sales in 2005: US$52 bn

US Drug Delivery MarketUS Drug Delivery Market

“Drug delivery market dominated by oral delivery systems”

Source: IMS America - Drug delivery based products

Page 6: Company Highlights Drug Delivery Market

Drug Delivery MarketDrug Delivery Market

Drug delivery market set to double to $96mm by 2010

• Products involving drug delivery growing at more than twice the rate of regular pharmaceutical products

• DD viewed by brand companies as effective tool to manage brand life cycle

• DD technology improves brand product

Page 7: Company Highlights Drug Delivery Market

Drug Delivery MarketDrug Delivery Market

Key drivers for DDS growth:

• Fewer novel drugs being approved by FDA (45-50 in late ’90s vs. 30-31 from 2003 to 2005)

• Significant decrease of development risk (90% probability of success)

• Producing better drugs than the original novel drug leads to increased patient compliance

Multiple doses cause spikes in drug plasma levels, adverse side effects

FDA Novel Drug Approvals

0

10

20

30

40

50

60

1995 1997 1999 2001 2003 2005

# o

f N

AS

Lau

nch

ed

Biotech NAS Non-Biotech NAS

Source: Pharmaceutical Research and Manufactures of America (PhRMA)

Page 8: Company Highlights Drug Delivery Market

Drug Delivery MarketDrug Delivery Market

Partnering deals involving DDS are increasing due to:

• DDS being viewed by brand companies as effective tool for brand life cycle management

• Lower risk and lower development costs compared to NCE’s

Page 9: Company Highlights Drug Delivery Market

Business ModelBusiness Model

Main Strategic Focus Leverage platform technologies to improve existing products

• Create life cycle management opportunities - 505(b)(2)• Novel controlled release formulations – “Super Generics”

Creating new business opportunities

• Leverage platform technologies to access new markets - PNV• Specialty products

Page 10: Company Highlights Drug Delivery Market

Revenue ModelRevenue Model

Mitigate upfront development risk

• Develop projects to “proof of concept” stage, then• Seek partner to fund remaining development

Maximize revenue

• Receive up front payments and ongoing research and development fees

• Receive milestone payments and sales royalties

• Receive manufacturing royalties via strategic partnership with approved manufacturer

Page 11: Company Highlights Drug Delivery Market

Building ValueBuilding Value

Growth Strategy

•Continue growing pipeline of partnered products

•Source new opportunities from partners and in-house initiatives

•Internally fund blockbuster potential, 505(b)(2) opportunities beyond proof of concept stage and out-license at premium terms

Page 12: Company Highlights Drug Delivery Market

Horst G. Zerbe, Ph.D.

• Founder and Co-inventor of over 30 patents in drug delivery related technologies

• Held key R&D positions in drug delivery at LTS Lohmann Therapy Systems, 3M Pharmaceuticals, Schwarz Pharma

• Instrumental in development of oral once-a-day ISMN, Theophyllin, transdermal Estradiol and Nitroglycerin, breath films

• One of Canada’s foremost experts in transdermal drug delivery technologies

• Published numerous scientific papers

Key Scientific ExpertiseKey Scientific Expertise

Page 13: Company Highlights Drug Delivery Market

Trilayer Tablet OverviewTrilayer Tablet Overview

• Superior alternative to osmotic pump delivery systems

• High drug loading capacity (important for once-daily

formulations)

• Ability to co-release drug combinations with different release

rates

• Suitable for large number of actives

• Highly versatile, broad range of delivery profiles

• Manufacturing cost savings of 50% compared to other oral

delivery technologies

• Reduces IP litigation risks

Trilayer Tablet

Advantages

Page 14: Company Highlights Drug Delivery Market

IntelGenx Trilayer Tablets: Controlled erosion as an efficient tool to achieve zero-order drug release

Release MechanismRelease Mechanism

0

20

40

60

80

100

120

0 5 10 15 20

time (hrs)

dru

g re

leas

e (%

)

core

trilayer tablet

Page 15: Company Highlights Drug Delivery Market

In Vitro DissolutionIn Vitro Dissolution

In Vitro release profile of Metoprolol Succinate from IntelGenx trilayer tablets compared to Toprol XL® tablets

0

20

40

60

80

100

0 6 12 18 24 30

Time (hrs)

Drug

rel

ease

(%)

Reference

INT Trilayer

Page 16: Company Highlights Drug Delivery Market

In Vivo PerformanceIn Vivo Performance

0

20

40

60

80

0 6 12 18 24 30

Time [h]

Con

c. [

nMol

/l]

Reference

Trilayer

Plasma concentrations of Metoprolol Succinate after administration of IntelGenx trilayer tablets compared to Toprol XL tablets (single dose,

fasted, n=6)

Page 17: Company Highlights Drug Delivery Market

Quick Release Wafer OverviewQuick Release Wafer Overview

Advantages

• Instant delivery / onset of action

• Avoids first-pass effect

• Ability to swallow is not required

• FDA approved for pharmaceutical products

• Increases patient compliance

• Adjustable flavours and textures

Quick Release Wafer

Page 18: Company Highlights Drug Delivery Market

Quick Release WaferQuick Release Wafer

Comparison of Cmax ( ) and Tmax ( ) after oral and buccal administration of Isosorbide Dinitrate

Tablet

Wafer

0

2

4

6

8

10

12

14

5 10 15 30 45 60 90 120

Time (min)

Con

c (n

g/m

l)

Page 19: Company Highlights Drug Delivery Market

Intellectual PropertyIntellectual Property

Patent/Application No. Title Date submitted / issued

US 6,231,957 Rapidly Disintegrating Flavor Wafer for Flavor Enrichment

05/ 2001

US 6,660,292 Rapidly Disintegrating Film for Precooked Foods

12/ 2003

US 7,132,113 Flavored Film 11/ 2006

US Provisional Appl.

60/755,280

Multilayer Tablet 12/ 2005

US Appl.

11/635,361

Multi-Vitamin And Mineral Supplement 12/ 2005

PCT/CA2006/000613, US 11/403,362

Delayed Release Pharmaceutical Oral Dosage Form And Method Of Making Same

04/ 2006

Page 20: Company Highlights Drug Delivery Market

Product PipelineProduct PipelinePipeline Status

INT005 Osteoarthritis

INT003 Smoking Cessation

INT004 Antidepressant

INT001 Antihypertensive

INT006 PNV

INT0010 Pain Management

INT002 Antihypertensive

INT007 Erectile Dysfunction

PreclinicalDevelopment

PilotBE Study

Mfg.Scale-Up

PivotalBE Study

RegulatorySubmission

Page 21: Company Highlights Drug Delivery Market

Pipeline StatusPipeline Status

2009Formulation development ongoing

Internal Project

1.95 bnErectileDysfunction

Quick Release Wafer

INT007/06

2009Formulation development completed

Internal Project

35 bnHypertensionTrilayer Tablet

INT002/04

2009Formulation development ongoing

Yes22.5 bnPain management

SL TabletINT0010/06

2007Formulation development completed

Yes800 million (US only)

PregnancyDry-coated Tablet

INT006/05

2008Mfg scale-up ongoingNo35 bnHypertensionMultilayerTabletINT001/04

2008Formulation development completed

Yes15 bnDepressionMonolayerTabletINT004/06

2009

Formulation development completed, Phase I ongoing

Yes> 1 bnSmoking Cessation

MonolayerTabletINT003/05

2009Formulation development completed

No12 bnOsteoarthritisMultilayerTablet

INT005/05

Expected Commercialization

Current StatusPartner05 Global SalesIndicationPlatformProject Code

Page 22: Company Highlights Drug Delivery Market

PipelinePipeline

Active Drug Indication Platform Reference

Loperamide IBS Wafer Imodium

Nicotine Nicotine Replacement Wafer Nicorette

DHE Migraine Wafer D.H.E. 45

THC Pain Management Wafer Dronabinol

Zolmitryptan Migraine Wafer Zomig

Diclofenac / Famotidine Osteoarthritis Trilayer Tablet -

Other Pipeline Candidates

Page 23: Company Highlights Drug Delivery Market

Competitive EnvironmentCompetitive Environment

Competitive Positioning

High

Commercial

Rating

Low

Low High

Technological Rating

Elan

Alza

Eurand

Intelgenx

AndrX Skypharma

Biovail

Penwest

Labopharm

Mistral

Page 24: Company Highlights Drug Delivery Market

Public MarketPublic Market

Comparables

Company Symbol Comment

Elite Pharmaceuticals ELI 2.10 41 Oral CR

Labopharm DDS.TO 7.11 404 Contramid (modified starch)

Emisphere EMIS 5.82 137 P/ P delivery via chemical binding

SCOLR Pharma Inc. DDD 4.50 171 CDT Dual Polymer Platform

Penwest PPCO 18.35 422 Bilayer tablets / hydrogel matrix

Cipher DND 3.30 79 LIDOSE, MPCRC

NexMed NEXM 0.94 63 Transdermal Delivery

Depomed DEPO 3.46 140 Bilayer tablets

Novadel Pharma Inc. NVD 1.65 82 Inhalation Technology

Price Market Cap ($MM)

Page 25: Company Highlights Drug Delivery Market

Management TeamManagement Team

Horst G. Zerbe, Ph.D., President and CEO, Prior to founding IntelGenx, he served as the president of Smartrix Technologies Inc. in Montreal, and as Vice President of R&D at LTS Lohmann Therapy Systems in West Caldwell, NJ. He holds over 40 patents in drug delivery related fields and has published numerous scientific papers in recognized journals.

Joel Cohen, CFA, CFO, has extensive experience in biotechnology financings and in financial analysis. He is a former investment banker at Canaccord Capital, where he specialized in biotechnology financings. He has worked on numerous IPOs, private and public financings for various companies.

Nadine Paiement, M.Sc., Manager, Pharmaceutical R&D, holds a M.Sc. degree in Polymer Chemistry from Sherbrooke University, and is co-inventor of IntelGenx’ trilayer technology.

Page 26: Company Highlights Drug Delivery Market

Board of DirectorsBoard of Directors

Horst G. Zerbe, Ph.D., CEO, IntelGenx Corp.

Joel Cohen, CFA, CFO, IntelGenx Corp.

J. Bernard Boudreau Sr. VP, PharmEng Inc. Prior to joining the pharmaceutical industry, Mr. Boudreau served as the Minister of Finance and Minister of Health of the provincial government of Nova Scotia.

David Coffin-Beach, Ph.D., President, ATP Solutions, Inc. As the former President and CEO of TorPharm and Associate Director at Schering Plough, Dr. Coffin-Beach brings a wealth of experience in the pharmaceutical industry to the table.

Reiza Rayman, M.D., M.Sc., Principal Investigator, Robotic Tele-surgery and Hybrid Cardiac Surgery. Dr. Rayman is one of the pioneers of robotic open-heart surgery. He is currently completing his Ph.D. in Medical Biophysics.

Page 27: Company Highlights Drug Delivery Market

Building the FutureBuilding the Future

Upcoming Milestones for next 18 months:

• Launch INT006 on US market• Submit NDA for INT004• Complete pivotal biostudy for INT005• Prepare pilot biobatch for INT0010• Complete second round of financing

Page 28: Company Highlights Drug Delivery Market

Delivering ValueDelivering Value

Investment Highlights

• Unique, proprietary drug delivery platform technologies

• Strong IP portfolio – 3 US patents issued, 5 applications pending

• Broad product pipeline

• Addressing multi-billion dollar markets

• Strategic R&D and commercial partnerships in place

• Strong management and key scientific expertise

• Near-term revenue expectations