Company Highlights Drug Delivery Market
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Transcript of Company Highlights Drug Delivery Market
![Page 1: Company Highlights Drug Delivery Market](https://reader035.fdocuments.us/reader035/viewer/2022062418/554c2958b4c905191f8b4a51/html5/thumbnails/1.jpg)
• Company Highlights• Drug Delivery Market• Business Strategy • Scientific Expertise• Technology Platforms• Intellectual Property• Product Pipeline• Competition• Management• Use of Proceeds• Summary
AgendaAgenda
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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.
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• 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
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• 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
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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
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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
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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)
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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
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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
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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
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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
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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
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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
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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
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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
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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)
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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
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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)
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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
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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
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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
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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
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Competitive EnvironmentCompetitive Environment
Competitive Positioning
High
Commercial
Rating
Low
Low High
Technological Rating
Elan
Alza
Eurand
Intelgenx
AndrX Skypharma
Biovail
Penwest
Labopharm
Mistral
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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)
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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.
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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.
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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
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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