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Agenda

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25 years experience in pharmaceutical product development ... DD viewed by brand companies as effective tool to manage brand life cycle ... – PowerPoint PPT presentation

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Title: Agenda


1
Agenda
  • Company Highlights
  • Drug Delivery Market
  • Business Strategy
  • Scientific Expertise
  • Technology Platforms
  • Intellectual Property
  • Product Pipeline
  • Competition
  • Management
  • Use of Proceeds
  • Summary

2
Disclaimer
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.

3
Company Overview
  • 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)

4
Corporate Profile
  • Established in 2003 as Canadian Corporation
  • Incorporated as IntelGenx Technologies, Corp.
    (Delaware) in 2006
  • 3,500 sqft RD facility in St-Laurent, Quebec
  • 8 Employees
  • 16,457,489 common shares outstanding
  • 17,317,180 shares fully diluted
  • 5,116,489 shares floating

5
US Drug Delivery Market
Drug delivery market dominated by oral delivery
systems
Global DDS sales in 2005 US52 bn
Source IMS America - Drug delivery based
products
6
Drug 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

7
Drug 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
60
50
40
30
of NAS Launched
20
10
0
1995
1997
1999
2001
2003
2005
Biotech NAS
Non-Biotech NAS
Source Pharmaceutical Research and Manufactures
of America (PhRMA)
8
Drug 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 NCEs

9
Business 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

10
Revenue 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

11
Building 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

12
Key Scientific Expertise
  • Horst G. Zerbe, Ph.D.
  • Founder and Co-inventor of over 30 patents in
    drug delivery related technologies
  • Held key RD 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 Canadas foremost experts in transdermal
    drug delivery technologies
  • Published numerous scientific papers

13
Trilayer Tablet Overview
Trilayer Tablet
Advantages
  • 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

14
Release Mechanism
IntelGenx Trilayer Tablets Controlled erosion
as an efficient tool to achieve zero-order drug
release
15
In Vitro Dissolution
In Vitro release profile of Metoprolol Succinate
from IntelGenx trilayer tablets compared to
Toprol XL tablets
16
In Vivo Performance
Plasma concentrations of Metoprolol Succinate
after administration of IntelGenx trilayer
tablets compared to Toprol XL tablets (single
dose, fasted, n6)
17
Quick Release Wafer Overview
Quick Release Wafer
  • 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

18
Quick Release Wafer
Comparison of Cmax ( ) and Tmax ( ) after
oral and buccal administration of Isosorbide
Dinitrate
19
Intellectual Property
20
Product Pipeline
Pipeline Status
Preclinical Development
Pilot BE Study
Mfg. Scale-Up
Pivotal BE Study
Regulatory Submission
INT005 Osteoarthritis INT003 Smoking
Cessation INT004 Antidepressant INT001
Antihypertensive INT006 PNV INT0010 Pain
Management INT002 Antihypertensive INT007
Erectile Dysfunction
21
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22
Pipeline
Other Pipeline Candidates
23
Competitive Environment
Competitive Positioning
24
Public Market
Comparables
25
Management 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 RD 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 RD,
holds a M.Sc. degree in Polymer Chemistry from
Sherbrooke University, and is co-inventor of
IntelGenx trilayer technology.
26
Board 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.
27
Building 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

28
Delivering 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 RD and commercial partnerships in
    place
  • Strong management and key scientific expertise
  • Near-term revenue expectations
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