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Corporate Presentation

Corporate Presentation. therapies. Therapies. Type 2 Diabetes. Hair Loss. Sarcopenia. Neurodegeneration. Atherosclerosis. Cancer. CV Disease. Osteoporosis. Aging is a Significant Risk Factor For a Variety of Diseases. Youth. Aging Process. Old Age.

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Corporate Presentation

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  1. Corporate Presentation

  2. therapies Therapies Type 2 Diabetes Hair Loss Sarcopenia Neurodegeneration Atherosclerosis Cancer CV Disease Osteoporosis Aging is a Significant Risk Factor For a Variety of Diseases Youth Aging Process Old Age Adapted from: Nature: Reviews Drug Discovery, June 24, 2005, “Ageing and Metabolism: Drug Discovery Opportunities” Curtis, et al

  3. Elixir is developing and commercializing drugs to treat and prevent metabolic disease, prevent age-related diseases… extending the quality and length of human life

  4. * Genetic pathways that control lifespan Life-span extending Target intervention Insulin/IGF-1 Insulin and IGF-1 downregulate InsR and IGF-1R downregulate IRS downregulate PI3K downregulate PTEN downregulate PDK downregulate AKT downregulate FOXO downregulate GHR downregulate GHRHR downregulate Sir2 Sir2 orthologues upregulate AMPK AMPK upregulate TSC upregulate TOR upregulate S6K upregulate Heat-shock proteins HSF upregulate HSP70 upregulate Small HSPs upregulate Other INDY/NaCT downregulate P66shc downregulate JNK upregulate Elixir: Drug discovery against a host of Age-related Diseases Youth Therapies Aging Process Old Age Type 2 Diabetes Hair Loss Sarcopenia Neurodegeneration Atherosclerosis Cancer CV Disease Osteoporosis Adapted from Nature: Reviews Drug Discovery, June 24, 2005, “Ageing and Metabolism: Drug Discovery Opportunities” Curtis, et al

  5. First product out of the Science of Aging EX-1350 Ghrelin antagonist • Aging: Daf2 – INSr – IGF1R • One of the most exciting targets in metabolic disease • Multi-billion dollar product opportunity • Most advanced oral (small molecule) program in industry • Multiple potent, bio-available proprietary antagonists • Development partnership by year-end • IND filing 2008 • Life extension animal experiment on-going • Initial indications: Diabetes and obesity

  6. Large & Growing Market of Metabolic Disease Obesity Trends* Among U.S. Adults: 1985 * BMI ≥30, or ~ 30 lbs overweight for 5’ 4” woman (*BMI 30, or ~ 30 lbs overweight for 5’4” person) 10%–14% <10% No Data Source: Behavioral Risk Factor Surveillance System, CDC.

  7. Large & Growing Market of Metabolic Disease Obesity Trends* Among U.S. Adults: 1995 * BMI ≥30, or ~ 30 lbs overweight for 5’ 4” woman (*BMI 30, or ~ 30 lbs overweight for 5’4” person) 15%–19% 10%–14% <10% No Data Source: Behavioral Risk Factor Surveillance System, CDC.

  8. Large & Growing Market of Metabolic Disease Obesity Trends* Among U.S. Adults: 2000 * BMI ≥30, or ~ 30 lbs overweight for 5’ 4” woman (*BMI 30, or ~ 30 lbs overweight for 5’4” person) 20%–24% 15%–19% 10%–14% <10% No Data Source: Behavioral Risk Factor Surveillance System, CDC.

  9. Large & Growing Market of Metabolic Disease Obesity Trends* Among U.S. Adults: 2004 * BMI ≥30, or ~ 30 lbs overweight for 5’ 4” woman (*BMI 30, or ~ 30 lbs overweight for 5’4” person) ≥25% 20%–24% 15%–19% 10%–14% <10% No Data Source: Behavioral Risk Factor Surveillance System, CDC.

  10. Treat diabetes & obesity Prevent other age related diseases Prevent metabolic disease Slow rate of aging Enormous Market Potential

  11. Leveraging Elixir biology & pharmacology expertise EX-1314 Ghrelin agonist • In-licensed from BMS 4/05 • Orally-active, small molecule • Several indications/markets • cancer cachexia ($600 MM opportunity) • gastroparesis ($1.5 B opportunity) • 2007 IND filing/initiation of Phase 1 • 4-5 year clinical development timeline

  12. Development timeline for ghrelin programs Agonist EX1314Pre-clinical/IND Phase 1 Phase 2Phase 3 Antagonist EX1350 Pre-clinical/IND IND/Phase 1Phase 2 Phase 3 2009 2010 2011 2006 2007 2008

  13. Elixir Today • Science of aging  metabolic disease • Large & growing markets • Maturing pipeline of high-value programs • Validating Pharma collaboration • Business Strategy • Supplement pipeline with later-stage asset in metabolic disease • Build a modest revenue stream to fund research & development • Build development & commercial capabilities in metabolic disease • April 2006: In-license of late-stage type 2 diabetes product • Revenue generation • Funding for discovery & development • Path to profitability

  14. Commercialization Glufast Metfast Elixir Pipeline Development Programs Ghrelin agonist Ghrelin antagonist Drug Discovery SIRT INDY AMPK

  15. A Late-stage Type 2 Diabetes Product Glufast (mitiglinide) • Established diabetes class with two competitors • Solid pre-clinical and clinical data package • 5 phase III trials (3 EU) 1,500 patients • Japan Approved 2005 Meglitinide Market: $300 MM +10% vs. ’04 * * 2005 IMS data

  16. Glufast “Best in Class” Profile • Safe and effective as 1st line or in combination with metformin • Best in Class • Mechanism: Management of post-meal glucose surges • Upside: Growing recognition of need to manage post-meal glucose surges

  17. Glufast Commercialization Strategy Elixir will launch a specialty sales force at approval • Competitive promotion declining • Big enough to be interesting to us… but not for big pharma • Small number of key prescribers • 8,000 MD’s (50% of all class prescriptions) • Sales force of 50 sales representatives • Deploy in key metro areas for maximum targeting efficiency • Quickly convert current Prandin/Starlix prescribers • NB: Starlix 1st year sales: $43 MM • KOL pre-launch for combination product (Metfast)

  18. Metfast (b.i.d. metformin + Glufast fixed combination) Patients on metformin easily transitioned to Metfast Same convenience/benefits of metformin plus coverage of FPG + PPG additional HbA1c reduction reducing risks of cardiovascular disease Rapid development plan (one 6-month treatment trial) New intellectual property Significant primary care sales opportunity Glucovance (fixed-combination) analogy Metfast: An Even Larger Market Opportunity A “Super-Metformin ”

  19. Metfast: Significant Sales Opportunity million $M Glucovance Source IMS 2001-2003

  20. Glufast Opportunity Prescriber target Metfast Opportunity Non-prescribers of meglitinides Physician Target Audience Primary care marketing partner

  21. Metfast Commercialization Strategy Marketing partner with large primary care sales force • Existing primary care sales force • Three 500 sales rep teams • Strong managed care presence • Partnership structure • Significant upfront/approval signing payment • Very competitive market for high-value primary care products • Profit share

  22. Glufast Final Phase 3 trial File NDA Launch “best in class” Metfast Phase 3 trial File NDA Partner launch 2009 2006 2007 2008 If no additional Phase 3 required by FDA Elixir’s Near-term Diabetes Franchise Timeline

  23. Glufast/Metfast Revenue Generation Accelerated With Glufast / Metfast Blockbuster Revenue Ghrelin Agonist Ghrelin Antagonist R e v e n u e Cash Flow Positive Modest Burn 2007 2008 2009 2010 2011 2012 2013 2014 2015

  24. Executive Team William Heiden, Chief Executive Officer20 years of drug commercialization & development experience Peter DiStefano, Ph.D., Chief Scientific Officer 20 years of drug discovery & development experience Alan Watson, Ph.D., Chief Business Officer20 years of drug discovery, development, IP, and bus dev Bard Geesaman, M.D., Ph.D., VP Medical 10 years of research and entrepreneurial ventures Karen Roberts, VP Finance 20 years of public and private company finance and admin

  25. Milestones 2007 2008 2009 2006 Elixir Glufast pre-NDA meeting with FDA IPO Glufast/Metfast Phase III trial NDA Filing/Approval Commercial Launch Ghrelin Antagonist - 1350 Big Pharma Partnership IND/Phase I trial Phase II trials Ghrelin Agonist - 1314 IND/Phase I trial Phase II trial SIRT1 in metabolism/aging Medicinal chemistry screen Pre-clinical development IND

  26. Elixir’s Novel Approach: Therapeutic Intervention at the core of the Diseases of Aging Enormous Potential of Elixir’s Scientific Platform Cancer Obesity Type 2 diabetes Cardiovascular disease Old Age Youth

  27. Corporate Presentation www.elixirpharm.com

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