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The material and comments in this presentation is The material and comments in this presentation is
confidential, proprietary and privileged, including confidential, proprietary and privileged, including copyright. Statements made in this presentation copyright. Statements made in this presentation are based on information available to VDDI, and are based on information available to VDDI, and are presented in the good faith belief as to their are presented in the good faith belief as to their
accuracy, but VDDI does not warrant their accuracy, but VDDI does not warrant their accuracy.accuracy.
AgendaAgenda Remarks and AssumptionsRemarks and Assumptions Business ModelBusiness Model Company OverviewCompany Overview Products in Development Products in Development
• Medical PeptidesMedical Peptides• NADs InhibitorsNADs Inhibitors• GP IIb/IIIa InhibitorGP IIb/IIIa Inhibitor
Next StepsNext Steps Closing CommentsClosing Comments
VDDI’s Global GoalVDDI’s Global Goal To increase knowledge and To increase knowledge and
commercial value in novel drug commercial value in novel drug development for life-threatening development for life-threatening indications in the areas of indications in the areas of cardiovascular and infectious cardiovascular and infectious diseases by:diseases by:
Using the in-licensing model to fill gapsUsing the in-licensing model to fill gaps Increasing the depth in our portfolioIncreasing the depth in our portfolio Out-licensing to maximize the value of Out-licensing to maximize the value of
A Knowledge-driven Global A Knowledge-driven Global EconomyEconomy
Pharmaceutical companies – playing the role Pharmaceutical companies – playing the role of of change agentschange agents -- must prepare for the -- must prepare for the
future and adopt and support technology – future and adopt and support technology – biopharmaceuticals, ICT and biopharmaceuticals, ICT and
nanotechnology. They must see nanotechnology. They must see themselves as active partners, rather than themselves as active partners, rather than passive benefactors, with the stakeholders passive benefactors, with the stakeholders they support. If they don’t, they will get a they support. If they don’t, they will get a
lot poorer.*lot poorer.** * Jianming Li, National Cancer Institute, Washington, DC; William Halal, The George Washington Jianming Li, National Cancer Institute, Washington, DC; William Halal, The George Washington
University, Washington, DCUniversity, Washington, DC
A 21A 21stst Century Approach Century Approach VDDI’s focus is in VDDI’s focus is in
targeted drugs targeted drugs (cardiovascular (cardiovascular and infectious and infectious disease) with disease) with effective effective treatments aimed treatments aimed at smaller sets of at smaller sets of patients.patients.
The Economic RealitiesThe Economic Realities Industry losing control of pricingIndustry losing control of pricing Generic drugs Generic drugs Third-party payers – governments & Third-party payers – governments &
managed care – are demanding more managed care – are demanding more value with less expenditures value with less expenditures
A trend emerging to shift a fraction A trend emerging to shift a fraction of drug cost to patients (USA) which, of drug cost to patients (USA) which, generates a political will to confront generates a political will to confront local/national lobbylocal/national lobby
This Decade – 2002-2007…This Decade – 2002-2007… Patents will expire on 35 drugs with Patents will expire on 35 drugs with
global sales of more than $73 billion.global sales of more than $73 billion.But…But… Only 14 potential blockerbusters are Only 14 potential blockerbusters are
likely to be approved and launched likely to be approved and launched during this period.during this period.
Source: Datamonitor, London & Fortune Biotech, David Stipp, May 27, 2003
The “Bottom-up” SystemThe “Bottom-up” SystemA "bottom-up" entrepreneurial system A "bottom-up" entrepreneurial system
exhibits many of the characteristics exhibits many of the characteristics associated with organic life: associated with organic life:
• Organic systems provide large numbers of Organic systems provide large numbers of small, redundant units to ensure the survival of small, redundant units to ensure the survival of the larger whole.the larger whole.
• An An organic business modelorganic business model allows companies allows companies the freedom to innovate, while competitive the freedom to innovate, while competitive forces select the most successful ideas for forces select the most successful ideas for development & commercialization of development & commercialization of biopharmaceutical products. biopharmaceutical products.
MissionMission ProfitProfit Profit, but also Profit, but also science & science &
societysociety11 Jianming Li, National Cancer Institute, Washington, DC; William Halal, The George Washington University, Washington, DC Jianming Li, National Cancer Institute, Washington, DC; William Halal, The George Washington University, Washington, DC
Adopting this business model allows Adopting this business model allows VDDI to:VDDI to:• Put more resources into things that add Put more resources into things that add
value, andvalue, and• Better manage risk associated with Better manage risk associated with
biopharmaceutical developmentbiopharmaceutical development
Company OverviewCompany Overview• Founded September 1999Founded September 1999• Headquartered Brentwood, TN USA: support offices in Headquartered Brentwood, TN USA: support offices in
Ann Arbor, Bangkok, Dublin, CT, and FL Ann Arbor, Bangkok, Dublin, CT, and FL (administrative & (administrative & scientific)scientific)
• Experienced Management Team Experienced Management Team • Represents the Represents the entrepreneurialentrepreneurial model to drive success model to drive success• Aggressive in-licensing and outsourcing modelAggressive in-licensing and outsourcing model• Values new approaches and collaborationsValues new approaches and collaborations
Company: Company: VDDI PharmaceuticalsVDDI Pharmaceuticals Products:Products: Antibiotics, Medical Peptides, Antibiotics, Medical Peptides,
CardiovascularCardiovascular Markets:Markets: Global Global Customers (current):Customers (current): Regulatory agencies Regulatory agencies
& & U.S. Government U.S. Government Capital Requirements: Capital Requirements: $5 M$5 M Business Model: Business Model: In licensing, technology In licensing, technology
partnerships, and outsourcing modelpartnerships, and outsourcing model Exit: Exit: Marketing Partners, IPO (Q4,2004)Marketing Partners, IPO (Q4,2004)
ManagementManagement R. Stephen PorterR. Stephen Porter, Pharm D, Chairman, CEO and President, Pharm D, Chairman, CEO and President
• Therapeutic Antibodies; American CyanamidTherapeutic Antibodies; American Cyanamid Steve SensoliSteve Sensoli, MBA, Chief Business Officer, MBA, Chief Business Officer
• SmithKline; Johnson and Johnson; FDA consultantSmithKline; Johnson and Johnson; FDA consultant Kristen FlahartyKristen Flaharty, Pharm D. - Sr. VP Regulatory Affairs, Pharm D. - Sr. VP Regulatory Affairs
Desmond FitzgeraldDesmond Fitzgerald, PhD, MB, BAO, BCH , PhD, MB, BAO, BCH • Royal College of Surgeons, Dept of Clinical Royal College of Surgeons, Dept of Clinical
Pharmacology; Adjunct Prof. Of Medicine Univ. of Pharmacology; Adjunct Prof. Of Medicine Univ. of PennsylvaniaPennsylvania
James TchengJames Tcheng, MD, MD• Associate Professor of Medicine - Duke Clinical Research Associate Professor of Medicine - Duke Clinical Research
Institute & University Health SystemInstitute & University Health System• Practicing Cardiologist; over 2500 angioplastiesPracticing Cardiologist; over 2500 angioplasties
VDDI’s IP PortfolioVDDI’s IP PortfolioVDDI focuses on:VDDI focuses on: Intellectual Intellectual
Propperty (IP) Propperty (IP) where general where general proof-of-principle proof-of-principle has already been has already been established, andestablished, and
IP’s that are novel IP’s that are novel or dominant.or dominant.
Strategic AdvantagesStrategic Advantages High Quality, Fast Track DevelopmentHigh Quality, Fast Track Development
• Lean OperationLean Operation• InnovationInnovation• ““Best of Breed” global partners/collaboratorsBest of Breed” global partners/collaborators• Pharmacology expertisePharmacology expertise• Building a Global Building a Global KMKM (knowledge management) model (knowledge management) model
for for Clinical, Regulatory, and Product Development Clinical, Regulatory, and Product Development ExpertiseExpertise
Narrow Indication: Broad Application CompoundsNarrow Indication: Broad Application Compounds• Seek fast track approvalSeek fast track approval
VDDI is in the innovation–based VDDI is in the innovation–based biopharmaceutical business. Our biopharmaceutical business. Our success (as well as our partners) success (as well as our partners) involves cultivating a small number involves cultivating a small number of skilled scientists, business of skilled scientists, business executives, and organizations and executives, and organizations and managing these ongoing networks of managing these ongoing networks of biopharmaceutical partners to biopharmaceutical partners to achieve a “win-win” situation. achieve a “win-win” situation.
But remember…But remember… Profitability comes down to:Profitability comes down to:
• Good scienceGood science• Quality high-impact decisionsQuality high-impact decisions• Good risk managementGood risk management
Because..Because..““Ultimately the value of a drug comes Ultimately the value of a drug comes
down to the degree of patient benefit down to the degree of patient benefit it offers – not the number of people it offers – not the number of people it’s prescribed for.”it’s prescribed for.”
Arthur Levinson, CEO, GenentechArthur Levinson, CEO, Genentech
library of novel compounds with massive library of novel compounds with massive diversitydiversity
Reverse Reverse magaininsmagainins, , indolicidinsindolicidins and and cecropinscecropins of particular interestof particular interest
Reversal of improved peptides; reduce Reversal of improved peptides; reduce hemolytic potential and protease degradationhemolytic potential and protease degradation• Increases duration of action, lowers Increases duration of action, lowers Cost of Cost of
synthetasesynthetase (NADs) inhibitors (NADs) inhibitors Enzyme that plays an essential role Enzyme that plays an essential role
in oxidation-reduction reactions in in oxidation-reduction reactions in bacteriabacteria
NADs inhibitor can stop growth and NADs inhibitor can stop growth and be used as a prophylaxis against be used as a prophylaxis against infectioninfection
Novel class of small molecules, simple 4-Novel class of small molecules, simple 4-step synthesis = “low cost of goods”step synthesis = “low cost of goods”
Fast Track, Orphan designation, & Fast Track, Orphan designation, & nontraditional accelerated development nontraditional accelerated development (US FDA)(US FDA)
Narrow indication/broad applicationNarrow indication/broad application Segmented biologic spectrum (Gram +) of Segmented biologic spectrum (Gram +) of
activityactivity Three distinct and large market potentialsThree distinct and large market potentials Intellectual property secureIntellectual property secure
Current Lead ProductCurrent Lead Product Phase III cardiovascular drugPhase III cardiovascular drug
• Pharmacia donation to Western Michigan University with Pharmacia donation to Western Michigan University with exclusive licenseexclusive license for a for a GP IIb/IIIaGP IIb/IIIa antagonist antagonist
Cardiovascular Product…. The Cardiovascular Product…. The MarketMarket
Annual worldwide market for product is Annual worldwide market for product is estimated to exceed $ 1 billionestimated to exceed $ 1 billion
Worldwide license for the technology with Worldwide license for the technology with estate of estate of 161 patents 161 patents (99 issued- 19 US)(99 issued- 19 US)
Acute Coronary SyndromesAcute Coronary Syndromes (ACSs)-- (ACSs)-- research data indicates that research data indicates that oraloral GP IIb/IIIa GP IIb/IIIa inhibitor therapy merits a prominent role inhibitor therapy merits a prominent role in the initial management of patients with in the initial management of patients with ACSs. ACSs.
coronary stent and coronary stent and angioplastyangioplasty
Next Steps….Next Steps…. Establish a presence through collaboration Establish a presence through collaboration
and marketing partners in Asia-Pacific. and marketing partners in Asia-Pacific. Start funneling technology into strategic Start funneling technology into strategic
partnerships, while keeping intellectual partnerships, while keeping intellectual property and value they create.property and value they create.
Find a smart way to get Asia-Pacific’s Find a smart way to get Asia-Pacific’s smart money and people involved.smart money and people involved.
Establish global collaborative research to Establish global collaborative research to create sustainable value and pipelines.create sustainable value and pipelines.
The 21The 21stst Century Scenario Century Scenario As traditional Big
Pharma’s structural and resource advantages decay and more products and services enter the global competitive arena, strategies and collaborations formed around knowledge can change the game and open up new paths of profitability.