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VDDI Pharmaceuticals Trilithon Pharma, Ltd. and AmphiBiotics, Ltd. R. Stephen Porter, Pharm.D. FCP, MRCP Chairman, President, CEO www.virtualdrugdevelopment.com. Company: VDDI Pharmaceuticals (1999) Products: ID, CV Markets: Global
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VDDI PharmaceuticalsTrilithon Pharma, Ltd.and AmphiBiotics, Ltd. R. Stephen Porter, Pharm.D. FCP, MRCP Chairman, President, CEO www.virtualdrugdevelopment.com
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
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
Business Model:Revenue • Government contracts • Out-licensing Agreements: • Up-front payments • Development Milestones • Royalties • Strategic partnership payments • Product Sales
Academic Labs Partners VDDI SALES & MARKETING RESEARCH DEVELOPMENT Biotechs CSO CRO Drug supply CRO FDA C C C C Core competency matched with strategic outsourcing Product Life Cycle Products Revenue Pharma Consultant Services
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.
VDDI PharmaceuticalsBoard 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
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
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
Cationic Peptides • Mode of Action different from current antibiotics
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
Novel Inhibitors of Nicotinamide Adenine Dinucleotide Synthetase (NADS) • NADS novel enzyme target • Critical for spore germination in anthrax • Prokaryotes enzyme v.different from Eukaryotes (selectivity) • micromolar inhibitors • active in-vitro on B anthracis, S. Aureus, MRSA, B. Subtilis, VREF mic = 0.4-0.8 mg/ml
Anti-infective Programs • Anti-anthrax Program • DoD, NIH, Bioshield • “Peace dividend” • Anti-microbial Program • Emerging resistant infections • Anti-fungal Program • Candida, Aspergillus
Anthrax Gram positive bacterial infections (S. aureus, MRSA, vancomycin resistant strains, VREF Fungal infections $350 M US Military & HSD $500 M Foreign nations $1 B Worldwide $500 M worldwide Aggregate Sales Potential Indication Estimated peak Sales
Current and Future therapeutic Scenario's Venous Arterial Chronic Plavix® Exanta® Aspirin Ticlid® Warfarin Acute IV Fibans AngioMax® PO Fibans LMWH Arixtra® UHF 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
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 concomitanttherapy, 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
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®)
PharmacoeconomicsValue 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
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
PCI Stent Non-Cardiovas. Carotid, Renal Stents AMI $200 M EU $300 M US and ROW $100M $1 B Worldwide Aggregate Sales PotentialOral Fibans Estimated peak Sales Indication
Business Proposals • Debt and Equity Investments • Joint Development Ventures • Upfronts and milestones and Royalty • M&A
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
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
Use of Proceeds • Forward integration of ID and CV development subsidiaries (VIPCO) • Close on Irish Investments (Government and Private equity term sheets) • Expandindications for NADs and Medical peptide programs for emerging infections
Financial Highlights ($000s)