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Oral biologic drugs like oral Insulin

Oral biologic drugs like oral Insulin. Market Situation. Opportunity. Biologic drugs are growing at a rapid 16% annually Most biologics (like Insulin) must be injected Easy to administer biologic drugs – Oral Delivery. Unmet Need. Spark Biotech’s Solution. Market for lead drugs.

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Oral biologic drugs like oral Insulin

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  1. Oral biologic drugs like oral Insulin

  2. MarketSituation Opportunity • Biologic drugs are growing at a rapid 16% annually • Most biologics (like Insulin) must be injected • Easy to administer biologic drugs – Oral Delivery Unmet Need Spark Biotech’s Solution

  3. Market for lead drugs • Therapeutic Protein and biologics market estimated at $50 Billion by 2010* • Insulin • Global sales forecast in the diabetes market for Insulin is ~$10.3 B in 2008 with a CAGR of 16.2%1 • Human Growth Hormone • In 2001 worldwide Human Growth Hormone (hGH) sales were ~1.5 B with a CAGR of 8%2 * Source: ”Therapeutic Proteins: Strategic Market Analysis and Forecasts to 2010”, DataMonitor Report #:DMHC1803 1 Source: ”Drugs of Tomorrow 2001: Diabetes”, DataMonitor Report #:DMHC1738 2 Source: ”Human Growth Hormone – Delivery Technology Driving Market Growth”, DataMonitor Report #:BFHC0519

  4. Management Team

  5. Paracellular Transcellular Transcytosis M-Cells on Peyer’s patches Insulin Sparkulin™ - Oral delivery WHERE the body needs it • Nanospheres and Microspheres • Unmodified drug molecule Encapsulation • Natural polymer based microspheres and nanoparticles • Mechanism of action • Carrier device containing nano/microspheres • Physiologically natural delivery path • Liver targeted

  6. Oral reformulation of Biologic drugs Studies - In vitro- In vivo models Spark Platforms- Gelatin- Chitosan- Alginate- Protenoid (P)- Protenoid (A)- PCL-PEG Drugs Studied- Insulin- BSA- pDNA- Vaccines- Anti-cancer drugs- Contraceptive Spark’s Technology • Customizable for … • Range of molecular sizes • Release characteristics • Dosage • Targeting • Stimuli sensitive

  7. Making Insulin Therapy Effective Today’s Insulin Therapy Sparkulin™ Therapy High Glucose (Hyperglycemia) High Glucose (Hyperglycemia) 160 mg/dL Blood Glucose 70 mg/dL Low Glucose (Hypoglycemia) Low Glucose (Hypoglycemia) Time Time

  8. Normal Glucose Levels Insulin Release Enzymatic Reaction Swelling Sparkulin™ - On Demand Insulin ReleaseWHEN the body needs it Glucose Diffusion Unmodified Insulin Glucose Enzymes

  9. Development Status • Six different oral biologic delivery technologies studied in-vitro and in-vivo • In-vitro and animal studies performed for oral delivery of insulin 3 0 0 2 5 0 2 0 0 Blood Clucose Level (mgs Glucose/100ml Blood) 1 5 0 1 0 0 5 0 0 0 4 8 1 2 1 6 2 0 2 4 2 8 3 2 T i m e ( H o u r s )

  10. Development Status • Patent pending and other patents in process • Proof of concept human study of oral delivery carrier conducted • Partnership discussions with Bharat Biotech – Oral Heparin and in early discussions with Genentech, J&J, Eli Lilly, Takeda, and Novo Nordisk • Completing pre-clinical in-vitro and rat model study of glucose-sensitive, on-demand oral Insulin - Sparkulin™ • R&D collaboration with Argonne National Laboratory for nano/microsphere characterization (SEM & TEM) SEM – Scanning Electron Microscopy, TEM – Tunneling Electron Microscopy

  11. Sparkulin™ { OtherDrugs Spark Biotech Partnering OralEPO OralhGH Spark’s Business Model • Initial clinical development and commercialization for sales in India • Partnership with large Bio-Pharma company for clinical development and sales in US • Value Propositions Competitive advantage Product lifecycle management Market expansion Pricing power

  12. $ 5M $ 5M $ 7.5M $ 15M $ 20M Royalty Pre-Clinical Phase I Phase II Phase III NDA USA - hGH 2006 2009 2010 2011 2012 2007 2008 2013 Pre-Clinical Phase I Phase II Phase III NDA USA - Insulin $ 20M $ 25M $ 45M Royalty CMD CMD CMD CMD CMD CMD CMD CMD CMD CMD CMD CMD CMD NBE NBE NBE NBE NBE NBE NBE NBE NBE NBE NBE NBE NBE NBE CommercialMarketedDrug NBE NBE NewBiologicEntity Development Milestones India - InsulinPre-clinical and Clinical2006 - 2008 FDA – Food and Drug Administration of USA IND – Investigational New Drug Application NDA – New Drug Application for marketing drug

  13. Investment Strategy • Several rounds of funding to support pipeline development Seed/ Series A $4.9 M (2006) Series B $15 M (2008) Series C $25 M (2009) Exit >$300 MValuation (2010) • Seed/Series A – Use of proceeds • Complete pre-clinical studies and file IND of Sparkulin™ with USFDA • Complete Phase I and II Clinical development of Sparkulin™ in India • Business Development • 16x return at exit for Seed/Series A investors in 4-5 years

  14. Cash Flow and Profit & Loss • Revenues grow significantly upon sales of Sparkulin™ in the USA • Cash flow and balance remains positive

  15. Spark Biotech – Success Factors • Large and growing market - Build up opportunities • Risk reduced path to commercialization • Established Biologics • Unmodified drug molecule and FDA approved polymers used • Speed to market – Fast development and commercialization in India, which contributes to speed of development in the USA • Broad applicability of technology and flexibility • Business model reduces burn rate • Depth of experience

  16. Orally delivered biologic drugs - Sparkulin™ Orally delivering Insulin where and when the body needs it

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