"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* 27