09 CeoMeeting- Session 4- Artisan


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Session 4: Health & Wellness

Title: The Changing Face Of Healthcare: Where Are The Opportunities?

Dr Jeff Wager, Artisan Pharma

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09 CeoMeeting- Session 4- Artisan

  1. 1. CEO’s Life Sciences Conference “Innovation Without Borders” Sheraton Imperial Hotel, Kuala Lumpur, Malaysia October 6 th and 7 th 2009 Non-Confidential
  2. 2. Executive Summary of Artisan & ART 123 <ul><li>HQ in Waltham, MA, USA (just outside Boston) </li></ul><ul><li>Joint venture between Asahi Kasei Pharma (AKP) and a strategic syndicate of Japanese, Singaporean, American and European investors: </li></ul><ul><ul><li>JAFCO, Bio One Capital, NGN Capital, New Leaf, Quintiles/Novaquest </li></ul></ul><ul><li>First-in-class MOA therapy for treatment of DIC; strong KOL support as highly differentiated therapy </li></ul><ul><li>No competitive products in development </li></ul><ul><li>Approved in Japan for treatment of DIC in mid-2008 at ~$5800 per course of therapy </li></ul><ul><li>Immediate sales in emerging markets possible leveraging ICH-5 compliant, CTD-formatted Japanese approval dossier </li></ul><ul><li>In P2b/3 development for DIC in sepsis at >150 sites in 17 countries, including emerging markets of Malaysia, Singapore, India, Thailand, Australia & New Zealand & Argentina </li></ul><ul><li>$39 million Series A financing completed mid-2006 </li></ul><ul><li>~$45 million Series B underway: </li></ul><ul><ul><li>~$20 million committed by current investors and AKP </li></ul></ul><ul><ul><li>Final closing targeted for 4Q09 to complete Phase 2b/3 trial </li></ul></ul><ul><li>Financial exit expected in ~ 1H2011 following completion of P2b/3 trial </li></ul>
  3. 3. ART 123 for the Treatment of DIC <ul><li>Recomodulin® Infusion </li></ul><ul><li>Broadly indicated in Japan for the treatment of DIC </li></ul><ul><li>Lyophilized </li></ul><ul><li>Licensed to Artisan worldwide ex-Japan, China, Taiwan, Korea </li></ul>
  4. 4. DIC & ART 123 <ul><li>ART 123 indicated broadly in Japan for treatment of DIC of any cause: infection/sepsis, hematologic malignancy, obstetric complications, toxin syndromes, etc. </li></ul><ul><li>Particularly significant strategic marketing and development opportunity in DIC in sepsis </li></ul><ul><li>Sepsis: </li></ul><ul><ul><li>hyper-inflammatory response to a known or suspected infection </li></ul></ul><ul><ul><li>0.25% incidence worldwide except for Nordic regions (slightly lower) </li></ul></ul><ul><ul><li>20-50% mortality rate depending on severity </li></ul></ul><ul><ul><li>Only approved therapy (Xigris®) struggling with sales and regulatory actions </li></ul></ul><ul><li>Disseminated intravascular coagulation (DIC) </li></ul><ul><ul><li>Key pathophysiologic mechanism of sepsis </li></ul></ul><ul><ul><li>Involves widespread coagulation </li></ul></ul><ul><ul><li>Development of DIC doubles the risk of death due to sepsis (Source: Levi, M. N Engl J Med 1999;341:586-592) </li></ul></ul><ul><ul><li>DIC result of coagulation AND pro-inflammatory cytokine activation </li></ul></ul><ul><li>ART 123 restores homeostasis to coagulation & inflammatory pathways if, when and as needed </li></ul>
  5. 5. Summary of Clinical Experience with ART-123 (as of Sep 30, 2009) Study Region Sponsor Indication # of subjects Phase 1 Japan Asahi Kasei Pharma (AKP) - 20 Early Phase 2 Disseminated intravascular coagulation (DIC) 12 Late Phase 2 90 Phase 3 116 Post marketing surveillance 1,243 Phase 2b (ongoing) World-wide Artisan DIC in sepsis 541 Phase 1 USA AKP - 55 Phase 2 USA/Canada Deep vein thrombosis (DVT) 312 Total 2,389
  6. 6. Global Thought-Leaders in Critical Care, DIC/Sepsis and Thrombomodulin Support ART 123 Professor of Emergency and Critical Care Medicine, lead investigator of ART 123 Japanese 3 study Keio University Tokyo, Japan Prof. Naoki Aikawa, M.D., DMSc, F.A.C.S. Ex-Medical Director for Lilly in charge of Xigris; ex-Vice President of Novo Nordisk, Inc. Chief Scientific Officer Sangart, Inc. Howard Levy, MD Extensive research on pathophysiology of thrombotic and cardiovascular disorders and their pharmacologic management Loyola University Med. Center Chicago, IL Jawad Fareed, Ph.D. Extensive research in thromboembolism and hematology McMaster University Hamilton, Ontario Mark A. Crowther M.D., M.Sc., F.R.C.P.C. Research on the regulation of blood clotting with a special emphasis on the role of blood vessel proteins, including thrombomodulin, in controlling clot formation Oklahoma Med. Res. Found. Oklahoma City, OK Charles T. Esmon, Ph.D. Leading clinician and researcher in cardiovascular disease and critical care medicine Cooper University Camden, NJ Joseph E. Parrillo, M.D. Author of Xigris NEJM publication and author of Xigris cost-effectiveness paper University of Brussels Belgium Jean-Louis Vincent, M.D., Ph.D. Author of retrospective analysis of Xigris for DIC and NEJM DIC review; experimental and clinical studies on the interaction of infection/inflammation and hemostasis University of Amsterdam Netherlands Marcel Levi, M.D., Ph.D. Xigris external consultant; lead author of Xigris NEJM publication; author of Xigris cost-effectiveness paper; extensive research in sepsis and pulmonary disease Vanderbilt University Nashville, TN Gordon Bernard, M.D. Relevant Background Location Member
  7. 7. The Artisan Proposition for Malaysia <ul><li>Establishment of Artisan Pharma (Malaysia) Sdn Bhd (“APM”) </li></ul><ul><li>APM Mission: to implement vertical operations throughout Asia Pacific headquartered in Malaysia: </li></ul><ul><ul><li>Bulk ART 123 manufacturing through Alpha Biologics Sdn Bhd </li></ul></ul><ul><ul><li>Fill-finish ART 123 manufacturing through CCM Pharmaceuticals Bhd </li></ul></ul><ul><ul><li>Clinical development of ART 123 in Malaysia </li></ul></ul><ul><ul><li>Marketing, sales and distribution of ART 123 in Malaysia and other Asia Pacific countries </li></ul></ul>
  8. 8. Estimated DIC in Sepsis Patients in Asia Pacific Nations Licensed to Artisan
  9. 9. Benefits to Malaysia <ul><li>Innovative biologic product wholly manufactured and sold in SE Asia </li></ul><ul><li>Near-term (12-18 months) product revenue-generating company </li></ul><ul><li>Brings Artisan relationships with major Japanese pharma company (Asahi) and top-tier group of investors to Malaysia </li></ul><ul><li>Job creation: </li></ul><ul><ul><li>Manufacturing </li></ul></ul><ul><ul><li>Clinical development </li></ul></ul><ul><ul><li>Marketing and sales </li></ul></ul><ul><ul><li>General & administrative </li></ul></ul><ul><li>Skills training: manufacturing, clinical development, marketing and sales, administrative </li></ul><ul><li>Generation of tax revenue </li></ul>