Access Pharmaceuticals (ACCP)


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OneMedForum New York 2010 - Company Presentation. Access Pharmaceuticals, Inc., a emerging biopharmaceutical company that focuses on adding value to exciting product concepts in research by advancing those products through clinical development.

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Access Pharmaceuticals (ACCP)

  1. 1. OneMedForum New York – Emerging Company Conference<br />The Roosevelt Hotel – June 30, 2010<br />Investor Presentation<br />June 2010<br /><br />
  2. 2. This presentation contains certain statements that may be forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including statements relating to the product portfolio and pipeline and clinical programs of the combined company, the market opportunities for MuGard™, the sales of, market opportunities for and planned studies of ProLindac™, the market opportunities for Thiarabine and the Cobalamin programs, and the combined company’s goals and objectives. These statements are subject to numerous risks and uncertainties, including but not limited to the risks detailed in Access's Annual Report on Form 10-KSB for the year ended December 31, 2009, and other reports filed by the companies with the Securities and Exchange Commission.<br />These materials are not an offer to sell securities and are not soliciting an offer to buy securities. <br />For Additional Access Pharmaceuticals Information, Go to the Following <br />Publicly Available Resources:<br /><br />at AccessPharma<br /> at Access Pharmaceuticals<br />2<br />Safe Harbor Statement<br />
  3. 3. <ul><li>Two Drug Delivery Platforms – Proprietary drug delivery platforms creates multiple product opportunities; mitigates single product/technology exposure.
  4. 4. Deep Late Stage Products – Access has late-stage products, including FDA-approved MuGard, and ProLindac and Thiarabine (through multiple Phase II trials).
  5. 5. Partnering Strategy – Access has completed eight partnerships or collaborations in the past 24 months: upfront payments, royalties, research costs, clinical costs.
  6. 6. Experienced Team –Experienced chemists, pre-clinical and manufacturing experts, clinical development personnel, and business development and finance personnel.
  7. 7. Focus on Shareholder Value – Management and board members are significant shareholders, focused on increasing shareholder value.</li></ul>3<br />Corporate Overview & Highlights<br />Access Pharmaceuticals, Inc.(ACCP.OB) – a drug delivery company with late-stage products for cancer, diabetes and hormone replacement. Several products are based on Access’ proprietary drug delivery platform technologies.<br />
  8. 8. 4<br />Multiple Platforms Drives Opportunity<br />Two proprietary, drug-delivery platform technologies enable product development across multiple biotechnology sub-sectors: Cancer, Diabetes, Hormone, Fertility, etc..<br />
  9. 9. 5<br />MuGard –FDA-approved cancer supportive care product<br />
  10. 10. MuGard™ - Treating A Significant Health Issue<br />Oral Mucositis:Significant Medical Issue – Often Unrecognized, Undiagnosed and Undertreated<br />6<br />
  11. 11. <ul><li>>$1 Billion Addressable Market: Target all cancer patients; 1.5 million US cancer patients annually (incidence). Roughly 90% of patients on radiation (43% severe); and 40% of patients receiving chemotherapy
  12. 12. MuGard Stands Alone:Only FDA-approved product that instructs pre-treatment; Safe to swallow
  13. 13. Multiple Marketing Partners: Partners signed for EU, Switzerland, Norway, Iceland, China, Korea; US manufacturing completed – launch activities commencing
  14. 14. Royalties: 20%, scaling to 25%</li></ul>7<br />MuGard™ - Oral Mucositis (OM)<br />European Launch Underway; North American / Far East Launch Soon<br />Royalties Start This Year<br />
  15. 15. MuGard’s Industry Leading Label<br />Indications: indicated for the management of pain and relief of pain…<br />Directions for use: Gargle and spit out.<br />Indications: dryness or dry mouth associated with various conditions<br />Directions for use: Swish and spit out. <br />Indications: “Magic Mouthwash" prepared by pharmacists and used to treat mouth sores (oral mucositis) <br />Directions for use: Gargle and spit out<br />Indications: MuGard is indicated for the management of oral mucositis/ stomatitis<br />Directions for use: <br />… rinse may be expelled or swallowed … safe to swallow …<br />…recommended that patients purchase MuGard™prior to the commencement of cancer therapy ..<br />MuGard is recommended for preventative use<br />MuGard can be swallowed to coat lesions in throat<br />8<br />
  16. 16. MuGard - US Commercial Launch Activities<br /><ul><li>Manufacturing of MuGard (Accupac) – product manufactured and ready to ship
  17. 17. Key opinion leader collaboration (Dr. Stephen Sonis) – Oral Mucositis expert
  18. 18. MuGard Centers-of-Excellence Program – targeting large oncology networks to build awareness and clinical experience with MuGard
  19. 19. Work with reimbursement consultants – filed reimbursement coding application and discussions are ongoing with major third-party payers
  20. 20. Key Clinical Data – presented last week at MASCC and ongoing throughout the year; supports prevention, treatment, pain relieve, ease-of-use
  21. 21. Secure additional distribution channels
  22. 22. Long-term stability for full commercial availability – on schedule for late July
  23. 23. Additional MuGard partnerships</li></ul>9<br />ACCP Remains On-track for Full-Scale North American MuGard Launch<br />
  24. 24. 10<br />Cobalamin– oral drug delivery platform <br />to enhance absorption of large molecules <br />
  25. 25. 11<br />1<br />2<br />3<br />4<br />Cobalamin Oral Drug Delivery Platform<br />Using The Body’s Own Vitamin B-12 Absorption System<br />To Enable and Enhance Delivery of Drugs Through Gut Wall<br />The “Trojan Horse” Delivery Vehicle<br />The nanoparticle coated<br />with Cobalamin (red)<br />binds to intrinsic factor (1),<br />which in turn binds to its<br />cell surface receptor (2).<br />The nanoparticle is <br />transported across the<br />cell (3), crosses the gut<br />wall and enters the <br />bloodstream (4).<br />Nanopolymer “payload” can be<br />Insulin, growth hormone, EPO, etc.<br />
  26. 26. 12<br />Significant Oral Bioavailability<br />Multiple Collaborations Driving Enhanced Data Set;<br />Planning Initiation of Phase I Human Trial in Cobalamin Oral Insulin<br /><ul><li>Cobalamin Oral Insulin– Access has achieved unprecedented levels of oral bioavailability of insulin in two animal models ( >80% of that achieved by injection).
  27. 27. Two Ongoing Collaborations– Oral insulin provided to two collaborators that have confirmed high levels of oral bioavailability with Cobalamin oral insulin
  28. 28. Cobalamin Human Growth Hormone– Demonstrated high oral bioavailability and a 25% improvement in weight gain in standard animal model
  29. 29. Multiple Applications– Ongoing discussions with multiple potential partners looking at exploiting Cobalamin oral drug delivery for insulin, HGH, fertility drugs, proteins, etc.
  30. 30. Patent Life-cycle Management Tool –protect patent (IP) position through cobalamin formulation of existing drugs, resulting in new IP
  31. 31. Phase I Human Trial– Moving Cobalamin oral insulin into a proof-of-concept Phase 1 study in man
  32. 32. sRNAi– Adaptation of Cobalamin system to provide delivery vector for sRNAi therapeutics being evaluated; partnering and collaboration discussions ongoing</li></li></ul><li>13<br />ProLindac– Phase II cancer drug for solid tumors<br />
  33. 33. 14<br />ProLindac™ <br />Positioning ProLindac™ as a Replacement for Sanofi-Aventis’ Eloxatin<br />Represents a $3+ Billion Market Opportunity<br /><ul><li>ProLindacTM – Access designed a second generation DACH platinum using our proprietary nano-polymer expertise.
  34. 34. Eloxatin®
  35. 35. FDA approved (2001) for front-line metastatic colorectal cancer
  36. 36. 2008 $2.5+ billion projected sales globally
  37. 37. Significant neurotoxicity
  38. 38. Partnering On-going– Partnered with Aosaikang Med Group (ASK) in China and JCOM in Korea. Partners paid upfront, committed to run 3 clinical trials that ACCP controls, and royalties.</li></ul>DACH Platinum (same active in Eloxatin) is inactive while attached to polymer background<br />Chelator releases platinum compound in low pH environment; e.g. tumor<br />
  39. 39. <ul><li>Monotherapy in relapsed, platinum-sensitive patients
  40. 40. 36 patients enrolled in six centers in France; final follow-up ongoing
  41. 41. Heavily treated patients (at least 3, up to 7, previous regimens)
  42. 42. Exploring two dosing schedules (once/two weeks and once/three weeks)
  43. 43. Safety – ProLindac Exhibited Very Benign Safety Profile
  44. 44. Patients tolerating drug well through multiple cycles (up to 10 or more)
  45. 45. No Eloxatin-like neurotox; no nephrotox; no hematotoxicity; no worse emesis
  46. 46. Efficacy and Activity – ProLindac “Outperforms” Current Best Care
  47. 47. At highest doses, 66.7% ProLindac patients responded; Activity levels superior to oxali or carbo in monotherapy in similar but healthier patient populations (approx 20%)
  48. 48. Next Steps
  49. 49. Combination trials: Partners ASK and JCOM paying for three Access-designed and managed Phase 2/3 trials: ProLindac plus taxol in recurrent ovarian and ProLindac plus Lilly’s Gemzar in liver and pancreatic cancer; additional combination studies possible in other tumor types
  50. 50. Partnering discussions ongoing</li></ul>15<br />ProLindac™ Phase II Trial – Relapsed Ovarian<br />Final Study Results – Safe and Active DACH Platinum Drug<br />
  51. 51. 16<br />Thiarabine– Phase II cancer drug <br />for Leukemias and Lymphomas<br />
  52. 52. 17<br />Thiarabine – A Novel Nucleoside Analogue<br />Significant Clinical Data Available – Ready for Phase II Trials<br /><ul><li>New Nucleoside Analogue – Same class as other clinically successful FDA approved nucleoside analogues such as fludarabine and cladrabine; Clofarabine was approved after a single 44 patient study.
  53. 53. Significant Data/Information Known – Drug was well tolerated and active in two Phase 2 clinical trials in advanced solid tumors. Significant clinical pharmacology and dose scheduling information known.
  54. 54. MD Anderson Cancer Center – Principal investigator is Hagop Kantarjian, M.D., Head of Leukemia Dept. at MD Anderson(same team of experts that have successfully led to approved nucleoside analogues in leukemias and lymphomas).
  55. 55. Clinical Plan – Pre-clinical and clinical studies indicate strong potential in leukaemia or lymphoma. Based upon clinical data, ACCP is finalizing trial designs and protocols in AML, ALL, and B-cell lymphomas.</li></li></ul><li><ul><li>SpePharm, B.V. –MuGard marketing partner in European Union; rolling launch of MuGard ongoing in UK, Germany, Italy, Nordic countries, Greece; anticipated launches in France, Benelux, Spain and throughout EU continues.
  56. 56. Aosaikang Medicinal Group (ASK)–Rights to ProLindac in greater China; provides second source manufacturing; obligated to pay for two controlled combination studies
  57. 57. JCOM Ltd – Rights to ProLindac in Korea; obligated to pay for one pivotal controlled combination study.
  58. 58. JCOM Ltd–Rights to MuGard in Korea; securing regulatory approval and preparing commercial launch in 2010
  59. 59. RHEI Pharma: – Rights to MuGard in greater China; securing regulatory approval, and seeking source of supply; preparing for commercial launch
  60. 60. US Large Pharma – Sponsored research agreement evaluating cobalamin oral drug delivery platform (insulin and human growth hormone)
  61. 61. US and European Biotechnology Company –Material transfer agreement and collaboration agreement; evaluating cobalamin oral insulin in animal models </li></ul>18<br />Active Partnering Strategy For Drug Programs<br />Active Business Development Effort; Securing Partnerships and<br />Collaborations to Enhance Value and Share Costs<br />
  62. 62. Jeffrey B. Davis, Chief Executive Officer:President, SCO Financial Group LLC; Sr. VP and CFO of a healthcare technology company; VP, Corporate Finance, at Deutsche Morgan Grenfell; Senior marketing and product management positions at AT&T Bell Laboratories; Marketing and Product Manager at Philips Medical Systems North America. MBA, The Wharton School, University of Pennsylvania; BS Biomedical Engineering, Boston University. <br />Esteban Cvitkovic, M.D., Vice Chairman, Senior Director, Clinical Oncology R&D: Board-certified oncologist with over 30 years experience in oncology therapeutics, including clinical research, clinical pharmacology, design of single-agent and combination regimens, and optimization of clinical efficacy; played a fundamental role in the registration strategy and post-registration development of cisplatin and oxaliplatin; held staff and academic appointments at Memorial Sloan Kettering Cancer Center (NY), Columbia Presbyterian (NY), Hospital St. Louis (Paris), Instituto Mario Negri (Milan) and InstitutGustaveRoussy (Villejuif).<br />Frank Jacobucci, Vice President Sales & Marketing: Over 20 years experience in sales management, including senior sales executive positions at oncology focused companies including MGI Pharma, Genetics Institute, Wyeth Oncology, Aventis, Precision Therapeutics and CRC Oncology Services. <br />David P. Nowotnik, Ph.D., Senior Vice President Research and Development:Senior Director, Product Development, Guilford Pharmaceuticals, Inc.; Group Leader, Bristol-Myers Squibb. Section Leader, Amersham International. Research Chemist, Tate and Lyle and Aspro-Nicholas. PhD, Organic Chemistry, University of London. <br />Stephen B. Thompson, Vice President and CFO: Controller and Administration Manager, API; Controller, Robert E. Woolley, Inc., a hotel real estate company; Controller, OKC Limited Partnership, an oil and gas company. Accounting and finance, Santa Fe International Corporation. <br />Phillip Wise, Vice President Business Development and Strategy: VP, Commercial and Business Development and CFO, Enhance Pharmaceuticals; VP, Commercial and Business Development, Ardent Pharmaceuticals; Director of Managed Care Marketing & Director of New Product Planning, GlaxoWellcome; MBA, University of Virginia; BS, Industrial and Systems Engineering, Georgia Institute of Technology.<br />19<br />Experienced Management Team<br />
  63. 63. Board of Directors<br />Strong Board of Directors with Relevant Experience<br /><ul><li>Steven H. Rouhandeh, ChairmanSteve Rouhandeh is a Chief Investment Officer of SCO Capital Partners, L.P., a New York based life sciences fund.  Steve also is a founder of SCO Financial Group LLC, a highly successful value-oriented healthcare group with 11-year track record in sector (advisory, research, banking and investing). Steve possesses a diverse background in financial services that includes experience in asset management, corporate finance, investment banking and law.
  64. 64. Esteban Cvitkovic, M.D., Vice Chairman – see Management
  65. 65. Mark Ahn, Ph.D.Dr. Ahn is currently Professor and Chair of the Science & Technology Entrepreneurship Faculties of Commerce & Administration and Science at the Victoria University of Wellington, in Wellington, New Zealand. Previously, Dr. Ahn was President and CEO of Hana Biosciences, Inc., and earlier, Vice President Hematology at Genentech, Inc. where he was responsible for Rituxan. Prior to that, Dr. Ahn held senior positions at Bristol-Myers Squibb, Amgen and FMC Corporation.
  66. 66. Mark AlvinoMark Alvino is a Managing Director at Griffin Securities, a leading provider of corporate finance advisory and brokerage services to the life sciences industry. Prior to that, Mark was a Managing Director for SCO Securities, and additionally held several senior management positions within the investment banking and investor relations industries
  67. 67. Stephen B. Howell, M.D.Dr. Howell is Professor of Medicine, University of California at San Diego, and has extensive experience in platinum therapeutics. Dr. Howell is also a Director of Clinical Investigation and Development Therapeutics Program, UCSD Cancer Center, and has previously received the Milken Foundation prize for contributions to cancer chemotherapy.
  68. 68. Jeffrey B. Davis, Chief Executive Officer – see Management</li></ul>20<br />
  69. 69. <ul><li>Ticker: ACCP (OTCBB)
  70. 70. Applying to Nasdaq and NYSE-AMEX exchanges
  71. 71. Capital Structure</li></ul> Common shares outstanding 15.4 million shares<br /> Common under preferred shares 9.9 million shares<br />Total common shares 25.3 million shares<br /><ul><li>Debt: $5.5 million note due end 2011, convertible at $27.50 per share.
  72. 72. Cash Burn: Roughly $4 million annually. With current cash on balance sheet and expected upfront and milestone payments, Access has sufficient cash into 2011.
  73. 73. High Quality Institutional Investors: Includes SCO Capital Partners, Oracle Partners, Ramius, CSFB, Schroeder’s Bank</li></ul>21<br />Financial Overview<br />
  74. 74. Milestones / News Flow – 2010 and forward<br />Significant News Flow Anticipated in 2010 / 2011<br /><ul><li>Achieve scale-up manufacturing of MuGard (Accupac)
  75. 75. MuGard approval in Korea
  76. 76. bioRASI collaboration (Cobalamin first-in-man trial)
  77. 77. Key opinion leader collaboration (Dr. Stephen Sonis)
  78. 78. North American / Far East launches of MuGard
  79. 79. Additional MuGard clinical data, ongoing and at MASCC
  80. 80. Additional MuGard partnerships
  81. 81. Cobalamin preclinical data; additional partnerships and collaborations
  82. 82. Launch Phase 1 Cobalamin oral insulin trial
  83. 83. Initiate ProLindac combination Phase 2 trial; data available
  84. 84. Seek global or regional partnerships for ProLindac (discussions ongoing)
  85. 85. Secure additional investment banking research analyst coverage</li></ul>22<br />
  86. 86. <ul><li>Cobalamin Oral Drug Delivery Platform – multiple long term opportunities (oral insulin, oral HGH, fertility drugs,etc.); multiple collaborations ongoing; launch Phase 1 human trial in oral insulin
  87. 87. Late Stage Oncology Pipeline: Proprietary technology has created portfolio of new products for large markets
  88. 88. One FDA-Approved product, MuGard – North American launch; intro in Europe underway; Asia next; >$1 billion opportunity
  89. 89. One Phase 2/3-ready cancer drug, ProLindac – New form of proven drug, takes direct aim at Sanofi’s $2.5 billion Eloxatin franchise
  90. 90. One Phase 2-ready cancer drug, Thiarabine – superior version of clinically and commercially successful nucleoside analogue
  91. 91. Commercial Strategy: Multi-local development and marketing partners to shift risk and share costs, while retaining very attractive revenue/royalty rights.
  92. 92. Value Visibility: Seek “re-listing” on national exchange; actively present company to the investment community.</li></ul>23<br />Conclusions – Investment Highlights<br />ACCP – An Undervalued Investment Opportunity<br />