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Company Highlights Drug Delivery Market

Company Highlights Drug Delivery Market






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    Company Highlights Drug Delivery Market Company Highlights Drug Delivery Market Presentation Transcript

    • 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.
      • 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 Overview
      • 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 Profile
    • Global DDS sales in 2005: US$52 bn US Drug Delivery Market “ Drug delivery market dominated by oral delivery systems” Source: IMS America - Drug delivery based products Oral CR 60% Implant 10% Inhalation 27% Transdermal 8% All Other 2%
    • 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
      • 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 # of NAS Launched Biotech NAS Non-Biotech NAS Source: Pharmaceutical Research and Manufactures of America (PhRMA)
    • 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 p artner 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
      • 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 Expertise
    • Trilayer 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
    • IntelGenx Trilayer Tablets: Controlled erosion as an efficient tool to achieve zero-order drug release Release Mechanism
    • In Vitro Dissolution In Vitro release profile of Metoprolol Succinate from IntelGenx trilayer tablets compared to Toprol XL® tablets
    • In Vivo Performance Plasma concentrations of Metoprolol Succinate after administration of IntelGenx trilayer tablets compared to Toprol XL tablets (single dose, fasted, n=6)
    • Quick 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
    • Quick Release Wafer Comparison of C max ( ) and T max ( ) after oral and buccal administration of Isosorbide Dinitrate
    • Intellectual Property
    • Product Pipeline Pipeline Status INT005 Osteoarthritis INT003 Smoking Cessation INT004 Antidepressant INT001 Antihypertensive INT006 PNV INT0010 Pain Management INT002 Antihypertensive INT007 Erectile Dysfunction Preclin ical Development Pilot BE Study Mfg. Scale-Up Pivotal BE Study Regulatory Submission
    • Pipeline Other Pipeline Candidates
    • Competitive Environment Competitive Positioning
    • Public Market Comparables
    • 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. 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.
    • 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