Investment Vp Business Development Cv - PowerPoint

							VDDI Pharmaceuticals
     Trilithon Pharma, Ltd.
     and AmphiBiotics, Ltd.




R. Stephen Porter, Pharm.D.
            FCP, MRCP

     Chairman, President, CEO


      www.virtualdrugdevelopment.com




                                       1
 Company: VDDI Pharmaceuticals (1999)
 Products: ID, CV
 Markets: Global
 Business Model: Global, Virtual,
  Opportunistic, In licensing and
  Outsourcing model
 Capitalization: Equity $3M; DoD $8M
 Capital Requirements: $5M/($20M)
 Liquidity Events Marketing Partners,
  Acquisition, IPO

                                         2
     Business Model: Strategic
                    Advantages
 VDDI acquires, develops, and commercializes specialty
  pharmaceutical products discovered by Universities,
  pharmaceutical and biotechnology companies
 High Quality, Fast Track Development
 Lean Operation, widely distributed by design
 “Best of Breed” Global partners/collaborators
 Extensive Pharmacology, Clinical, Regulatory and Product
  Development Expertise
 An organic business model
 Narrow Indication - Broad application



                                                             3
Business Model: Revenue

 Government contracts
 Out-licensing Agreements:
  – Up-front payments
  – Development Milestones
  – Royalties
 Strategic partnership
  payments
 Product Sales
                              4
     Core competency matched with
          strategic outsourcing
                                Product Life Cycle

               RESEARCH         DEVELOPMENT SALES &
                                            MARKETING


Products   Academic
             Labs
                                                  Partners

     Pharma                     VDDI                          Revenue
               Biotechs                                 CSO

                      CRO               Drug
                                       supply

                                            CRO
                            FDA


              C       C     C     C

              Consultant Services                                       5
       VDDI Management
   R. Stephen Porter, Pharm D., Chairman, CEO and President
    – Therapeutic Antibodies; American Cyanamid
   Steve Sensoli, MBA – Chief Business Officer
    – GeneWorks, Glyderm

   Kristen Flaharty, Pharm D. - Sr. VP Regulatory Affairs
    – SmithKline, KKF Consulting
   John Ferkany, PhD, MBA - VP Preclinical Development
    – Oread, Oceanix, Nova
   Sam Yenne, PhD, MBA – VP Project Development
    – Paradigm Genetics, Rhone-Poulenc
   Mark Fisher, Ph.D. - VP Manufacturing
    – SmithKline; Johnson and Johnson; FDA consultant
   Robert Dunne, MBA, General Manager, Trilithon Pharma,
    Ltd.
    – Elan Corp. Tosara Products, Ltd., Bioglan Pharma Plc., and
      Pharmaceed Consultants Ltd.
                                                                   6
   VDDI Pharmaceuticals
    Board of Directors
 R. Stephen Porter, 53 Chairman
 Douglas C. Altenbern, 63, Director.
  Former CEO, Endata, Inc.
 Matthew A. Gonda, Ph.D., 52,
  Director. CEO, Transmolecular, Inc.
 Steve Sensoli, 42, Director. President
  and COO, GeneWorks, LLC



                                           7
     Anti-Infective Programs:
         Medical Peptides
 Exclusive license from University of
  Ulster and Queen’s University
  – extended library of potential drug
    candidates
 Enabling Technology ( Interlink
  Bio)
  – “Rev-4” produces stability and
    extended duration
 Pre-clinical animal studies
                                         8
Past Limitations of Peptides
 Peptide instability – protease
  degradation
   – Reduced t 1/2 in host
   – Degradation by pathogens
   – Degradation during biological
     production
 Hemolytic activity
   – Limited to topical applications
 Cost of Goods
   – Chemical synthesis vs. biological
     production                          9
         Cationic Peptides
-Mode of Action different from current antibiotics




                                                     10
              Anti-Infective:
             NADs Technology
 Exclusive license from UAB –and a partner
  contractor
 Novel class of small molecules, simple 4-step
  synthesis = Low COG
 DARPA, NIH and DoD funding
 Fast track, orphan designation, & accelerated
  development
 Preclinical Development animal
   – iterative chemistry
 No competition in IP; broad estate
   – Recent issued patents in Antibacterial and
     fungal
                                              11
      Novel      Inhibitors of Nicotinamide Adenine
              Dinucleotide Synthetase (NADS)
                                            NH2
                                                                                                             O
                                        N             N
                                                                                                                 OH
                                                                     O        O
                                            N        N
   NADS novel enzyme target
                                                                                                     +
                                                          O        O P O P O                     N
                                                                                             O                           Nicotinicacid Adenine Dinucleotide
                                                                     OH  OH

   Critical for spore germination in               HO       OH
                                                                                        HO       OH

    anthrax                                                                           PPi
                                                                                             Mg2+
                                                                                                                                             H2N

                                                                                                                                                       N
                                                NH2                                                                                    N

   Prokaryotes enzyme v.different
                                                                                  ATP
                                                                                                                 O       O
                                            N             N                                                                              N         N
                                                                                                                         P           O

    from Eukaryotes (selectivity)
                                                                                                                     O     O
                                                                         O        O                                      OH
                                                N        N
                                                                                                         +
                                                              O     O P O P O                        N
                                                                                                                                   OH OH
    micromolar inhibitors
                                                                                                 O
                                                    HO
                                                                      OH  OH

                                                                                                                                  :NH3
                                                              OH

    active in-vitro on                                                                     HO
                                                                             :NH3 - glutamine
                                                                                                     OH



      B anthracis, S. Aureus,                   NH2
                                                                                                                 O

      MRSA, B. Subtilis,
                                            N             N
                                                                                                                     NH2
                                                                         O        O
                                                N        N

      VREF
                                                                                                         +
                                                              O     O P O P O                        N
                                                                                                 O                   Nicotinamide Adenine Dinucleotide
                                                                      OH  OH
                                                                                                                     (NAD)

    mic = 0.4-0.8 mg/ml                              HO       OH
                                                                                            HO       OH




                                                                                                                                                              12
Anti-infective Programs
 Anti-anthrax Program
  – DoD, NIH, Bioshield
     “Peace dividend”
 Anti-microbial Program
  – Emerging resistant
    infections
 Anti-fungal Program
  – Candida, Aspergillus

                           13
Aggregate Sales Potential
   Indication                  Estimated peak Sales
 Anthrax                       $350 M US Military &
                                 HSD
 Gram positive                   $500 M Foreign
                                 nations
  bacterial
  infections (S. aureus,        $1 B Worldwide
  MRSA, vancomycin resistant
  strains, VREF

 Fungal infections             $500 M worldwide



                                                        14
Cardiovascular Products




                          15
          Current and Future therapeutic Scenario's


           Venous                              Arterial
Chronic




                                  Exanta®          Plavix®

                                                             Aspirin

                            Warfarin                          Ticlid®
Acute




                                              IV Fibans

                                 AngioMax®
                            LMWH                          PO Fibans
                                   Arixtra®
                             UHF
                                                                        16
   Adapted from Morgan Stanley
           Xemilofiban
 Late stage GPIIb/IIIa Inhibitor
 (Fiban)
 Unmet Medical Need
 161 Patents (99 issued- 19 US)
  – FTO and competitive analysis

 Development Program to be
 Completed and Product to Market in
 2-3 years
                                      17
 Why have IV and Oral GP IIb/IIIa
   inhibitors underperformed?
 Improper dose; low Platelet Inhibition
  and escape
 Improper timing; need upstream
 Too expensive (IV)
 Inconsistent concomitant therapy,
  thienopyridines, Heparin (LMWH), ASA
 Poor patient selection: too broad
  (Troponin I levels, Diabetics)
 Improper duration 12 -48 hr vs. 6
  months
 50 K patients and $2 Billion on PO
  development
                                           18
     Why Xemilofiban?
 Class effect (if IV then PO)
   – LD with maintenance 48 hrs
   – Need arterial passivation

 PK/PD (Short t½)
 Low Cost of Goods (small molecule)
 Pharmacoeconomics (Reduced daily
  total care cost)
 No drug interactions (Plavix® Lipitor®)



                                            19
Pharmacoeconomics
 Value proposition
           Comparative costs
            for IV drugs $550-
            650 for Integrilin®,
            $700 for
            Aggrastat® and
            $1,800 ReoPro®
            (70kg)
           Xemilofiban
             – $200/day X 2
           Coated Stents
            $3200/stent

                                   20
        Fiban Summary
 Target indications:
  –upstream dosing for PCI with
    Stent placement
  –Non coronary Stents (Carotid,
    Renal)
  –Pre hospital AMI
 Unmet Medical Need :” bang for
  buck”
 Follow on Products Heads of
  Agreement with Ube Industries
                                   21
  Aggregate Sales Potential
        Oral Fibans
  Indication         Estimated peak Sales
 PCI Stent           $200 M EU $300 M
                      US and ROW

                      $100M
 Non-Cardiovas.
  – Carotid, Renal
    Stents

                      $1 B Worldwide
 AMI



                                        22
   Business Proposals
 Debt and Equity
  Investments
 Joint Development Ventures
   –Upfronts and milestones
  and Royalty
 M&A

                               23
    Creative Investment
  Strategies/Opportunities
 Equity US VDDI $5 Million
  (Possibly Staged $5/20)
 Equity Trilithon Pharma, Ltd.
  (Dublin) ($1 Million) €2.5M
 Equity AmphiBiotics, Ltd. (Ulster,
  Belfast) ($1 Million) $1.5M



                                       24
     Partnering Strategy
Critical care focus of VDDI's CV
and ID cpds.,
  –Not attractive to big players in the
  Pharma
Mid-size players will give priority
to our compounds
  –regional in the US, Europe and Asia.
Government Partnering
  –Bioshield, DoD

                                          25
           Use of Proceeds
 Forward integration of ID and CV
  development subsidiaries (VIPCO)
 Close on Irish Investments (Government
  and Private equity term sheets)
 Expand indications for NADs and Medical
  peptide programs for emerging infections



                                             26
   Financial Highlights
                                ($000s)

                       Actual                           Projected
Year            2001       2002     2003      2004       2005       2006       2007



Revenue          11        1,884    7,082     32,725     87,096     125,778    136,044




Expenses        992        3,401    -11,022   -20,746    -31,336    -113,888   -121,124

Profit before
   Tax          -981       -1,517   -3,940    11,979     55,760     11,890     14,920

Additional
                 11        1,884    5,000
   Capital*




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