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Napo Pharmaceuticals, Inc. Slide 0 Development and commercialization of proprietary branded pharmaceuticals to global marketplace through local partnerships.

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Presentation on theme: "Napo Pharmaceuticals, Inc. Slide 0 Development and commercialization of proprietary branded pharmaceuticals to global marketplace through local partnerships."— Presentation transcript:

1 Napo Pharmaceuticals, Inc. Slide 0 Development and commercialization of proprietary branded pharmaceuticals to global marketplace through local partnerships –Late stage, first in class, gastro-intestinal product, crofelemer –Strong safety database leveraged by four clinical indications: -CRO-HIV, final Phase 3 under SPA agreement, fast-track o Complete H2, 2009 o Interim release, Q2, 2009 o “ADVENT” trial o US Launch end 2010 - CRO-IBS, Phase 2, fast-track - CRO-ID, Phase 2 o Indian filing and approval, mid-2010; royalty stream - CRO-PED, Phase 1 Proprietary pipeline depth in same mechanistic class Napo Pharmaceuticals, Corporate Introduction

2 Napo Pharmaceuticals, Inc. Slide 1 What is Crofelemer? Novel, pure, patented anti-secretory agent, sustainably harvested from rain forest –IP coverage until 2017; patent restoration on top of that; supply barriers to entry Clinical studies completed in ~1,800 patients  No drug related adverse events Competitive advantages of mechanism of action Crofelemer (250mg) clinical trial supply

3 Napo Pharmaceuticals, Inc. Slide 2 Crofelemer: From Plant to Molecule Sustainably harvested from rain forest targeted for “fair-trade” product, sequesters CO2 - Robert F. Kennedy, Jr., Environmental advisor

4 Napo Pharmaceuticals, Inc. Slide 3 Glenmark (Listed on the Bombay Stock Exchange and the National Stock Exchange) –Dedicated crofelemer manufacturing facility on FDA approved campus –Low-cost/large-scale manufacturing Also licensee for emerging economies (AIDS diarrhea, infectious diarrhea, pediatric) –Target Indian regulatory filing H2, ’09 –Ascending to 14% royalties to Napo –Glenmark projects over $500 million sales ($80 mm for just CRO-HIV in India) $1.0 million equity investment and western 1% royalty aligns IP incentives API supply agreement directly with Salix for western territories Similar terms with AsiaPharma in greater China Glenmark Pharmaceuticals Provides Low-Cost GMP Manufacturing In India

5 Western partner– Salix Pharmaceuticals, Inc. Specialty pharmaceutical company focused on the gastroenterology market in North America In-license, development, marketing, contract manufacturing Specialty salesforce to high-prescribing gastroenterologists 2008 sales of $174 mm; earnings of -$0.90/share Market cap: ~$500 mm (SLXP) Napo Pharmaceuticals, Inc. Slide 4

6 Two simultaneous clinical “shots on goal” for 2010 CRO-HIV/Salix; CRO-ID/ Glenmark Each paid for completely by respective partner –Including low-cost / large-scale manufacturing Each indication provides “back-up” to other partner Each indication provides indication extension for other partner Third clinical shot on goal in 2011 with the initiation of CRO-PED Napo Pharmaceuticals, Inc. Slide 5

7 Napo Pharmaceuticals, Inc. Slide 6 Stakeholders involvement and empowerment -Acceleration of FDA approved pediatric product - Company commitment to “disaster” and resource-constrained access - Return based on lucrative western market - Secured by crofelemer asset Royalty-based financing

8 Background: Diarrhea among children 2.5 Million children <5yrs die each year from diarrhea (WHO) 2.5M 100 million disability-adjusted life years of morbidity At least double this estimate if long-term effects are considered Increasing morbidity (cognitive and physical), despite decreasing mortality 100 million disability-adjusted life years of morbidity At least double this estimate if long-term effects are considered Increasing morbidity (cognitive and physical), despite decreasing mortality 100M Chronic diarrhea particularly affects HIV patients, even with Rx - Affects treatment efficacy, treatment compliance, quality of life 3 million children in Sub-Saharan Africa have HIV “All my pediatric HIV +ve patients who die, die from diarrhea.” -Nurse at Tygerburg Hospital, S. Africa Chronic diarrhea particularly affects HIV patients, even with Rx - Affects treatment efficacy, treatment compliance, quality of life 3 million children in Sub-Saharan Africa have HIV “All my pediatric HIV +ve patients who die, die from diarrhea.” -Nurse at Tygerburg Hospital, S. Africa HIV

9 Napo Pharmaceuticals, Inc. Slide 8 Provide CRO-PED to NGO’s (i.e. DRI) - Medicine at cost - Target worst affected geographic areas Accelerated develop pediatric formulation of crofelemer (CRO-PED) for - HIV-associated diarrhea - Acute diarrheal diseases Use of proceeds and Mission of B corp Sustainably harvest Croton lechleri Fair trade Benefit sharing Dr. Carl Niamatali, physician working in the Amazon area: …”[crofelemer] is the number one medicine I use for diarrhea… It has a better profile than other drugs…”

10 Napo Pharmaceuticals, Inc. Slide 9 a CGI Global Health Program Corporate Structure & Financing B- Corporation CAP: Wholly owned subsidiary B- Corporation CAP: Wholly owned subsidiary Investment (secured by Product IP) ROI: 0.5% royalty on Napo sales/$1.0 MM investment for 5x investment+ Convertible Debt @ $2.0/share conversion CGI: Clinton Global Initiative Investor Napo Pharmaceuticals -Develop CRO-HIV -Oversee CRO-PED Napo Pharmaceuticals -Develop CRO-HIV -Oversee CRO-PED Reimbursement for dev. activities Pediatric product rights, equity for convertible debt, royalty Donor Return on investment (ROI)

11 Napo Pharmaceuticals, Inc. Slide 10 Napo Pharmaceuticals, Inc. Slide 10 Industry of the Future- Diseases with no borders 50% of disease today is water-bourne disease. 1/3 rd of the world's population is now subject to water scarcity 7. By 2025, an estimated 2.8 billion of us will live in areas with increasingly scarce water resources. 8 “Impure water and diarrhea are weapons of mass destruction” Gerald Martone, Director of Emergency Relief, International Rescue Committee, in commenting about the devastation in West Sudan Image: © Pierre Holtz | UNICEF


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