Transcript Document

Agenda
•
•
•
•
•
•
•
•
•
•
•
Company Highlights
Drug Delivery Market
Business Strategy
Scientific Expertise
Technology Platforms
Intellectual Property
Product Pipeline
Competition
Management
Use of Proceeds
Summary
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.
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)
Corporate Profile
• 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
US Drug Delivery Market
“Drug delivery market dominated by oral delivery systems”
All Other Transdermal
8%
2%
Implant
10%
Oral CR
60%
Inhalation
27%
Global DDS sales in 2005: US$52 bn
Source: IMS America - Drug delivery based products
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
Drug Delivery Market
FDA Novel Drug Approvals
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
60
50
# of NAS Launched
•
40
30
20
10
0
1995
1997
Biotech NAS
1999
2001
2003
Non-Biotech NAS
 Multiple doses cause spikes in drug
plasma levels, adverse side effects
Source: Pharmaceutical Research and Manufactures of America (PhRMA)
2005
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 NCE’s
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
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
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
Key Scientific Expertise
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
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
Release Mechanism
IntelGenx Trilayer Tablets:
Controlled erosion as an efficient tool to achieve zero-order drug release
120
drug release (%)
100
80
60
40
core
trilayer tablet
20
0
0
5
10
time (hrs)
15
20
In Vitro Dissolution
In Vitro release profile of Metoprolol Succinate from IntelGenx trilayer
tablets compared to Toprol XL® tablets
100
Drug release (%)
80
60
Reference
40
INT Trilayer
20
0
0
6
12
18
Time (hrs)
24
30
In Vivo Performance
Plasma concentrations of Metoprolol Succinate after administration of IntelGenx
trilayer tablets compared to Toprol XL tablets (single dose, fasted, n=6)
80
Reference
Conc. [nMol/l]
60
Trilayer
40
20
0
0
6
12
18
Time [h]
24
30
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
Quick Release Wafer
Comparison of Cmax (
) and Tmax ( ) after oral and
buccal administration of Isosorbide Dinitrate
14
Conc (ng/ml)
12
10
8
W afer
6
4
2
Tablet
0
5
10
15
30
45
Time (min)
60
90
120
Intellectual 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.
Multilayer Tablet
12/2005
Multi-Vitamin And Mineral Supplement
12/2005
Delayed Release Pharmaceutical Oral Dosage
Form And Method Of Making Same
04/2006
60/755,280
US Appl.
11/635,361
PCT/CA2006/000613,
US 11/403,362
Product Pipeline
Pipeline Status
Preclinical
Development
INT005 Osteoarthritis
INT003 Smoking Cessation
INT004 Antidepressant
INT001 Antihypertensive
INT006 PNV
INT0010 Pain Management
INT002 Antihypertensive
INT007 Erectile Dysfunction
Pilot
BE Study
Mfg.
Scale-Up
Pivotal
BE Study
Regulatory
Submission
Pipeline Status
Project Code
INT005/05
Platform
Multilayer
Tablet
Indication
Osteoarthritis
05 Global Sales
12 bn
Partner
Current Status
Expected
Commercialization
No
Formulation
development
completed
2009
2009
Smoking
Cessation
> 1 bn
Yes
Formulation
development
completed, Phase I
ongoing
INT003/05
Monolayer
Tablet
INT004/06
Monolayer
Tablet
Depression
15 bn
Yes
Formulation
development
completed
2008
INT001/04
Multilayer
Tablet
Hypertension
35 bn
No
Mfg scale-up ongoing
2008
Pregnancy
800 million (US
only)
Yes
Formulation
development
completed
2007
Pain
management
22.5 bn
Yes
Formulation
development
ongoing
2009
Hypertension
35 bn
Internal
Project
Formulation
development
completed
2009
Erectile
Dysfunction
1.95 bn
Internal
Project
Formulation
development
ongoing
2009
INT006/05
INT0010/06
INT002/04
INT007/06
Dry-coated
Tablet
SL Tablet
Trilayer Tablet
Quick Release
Wafer
Pipeline
Other Pipeline Candidates
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
-
Competitive Environment
Competitive Positioning
Alza
Biovail
High
Elan
Skypharma
AndrX
Labopharm
Commercial
Intelgenx
Rating
Penwest
Eurand
Mistral
Low
Low
High
Technological Rating
Public Market
Comparables
Company
Symbol
Price
Comment
Market Cap ($MM)
Oral CR
ELI
2.10
41
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
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
NVD
1.65
82
Elite Pharmaceuticals
Penwest
Novadel Pharma Inc.
Bilayer tablets
Inhalation Technology
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 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.
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. CoffinBeach 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.
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
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 R&D and commercial partnerships in place
• Strong management and key scientific expertise
• Near-term revenue expectations