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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 …

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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  • 1. OneMedForum New York – Emerging Company Conference
    The Roosevelt Hotel – June 30, 2010
    Investor Presentation
    June 2010
  • 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.
    These materials are not an offer to sell securities and are not soliciting an offer to buy securities. 
    For Additional Access Pharmaceuticals Information, Go to the Following
    Publicly Available Resources:
    at AccessPharma
    at Access Pharmaceuticals
    Safe Harbor Statement
  • 3.
    • Two Drug Delivery Platforms – Proprietary drug delivery platforms creates multiple product opportunities; mitigates single product/technology exposure.
    • 4. Deep Late Stage Products – Access has late-stage products, including FDA-approved MuGard, and ProLindac and Thiarabine (through multiple Phase II trials).
    • 5. Partnering Strategy – Access has completed eight partnerships or collaborations in the past 24 months: upfront payments, royalties, research costs, clinical costs.
    • 6. Experienced Team –Experienced chemists, pre-clinical and manufacturing experts, clinical development personnel, and business development and finance personnel.
    • 7. Focus on Shareholder Value – Management and board members are significant shareholders, focused on increasing shareholder value.
    Corporate Overview & Highlights
    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.
  • 8. 4
    Multiple Platforms Drives Opportunity
    Two proprietary, drug-delivery platform technologies enable product development across multiple biotechnology sub-sectors: Cancer, Diabetes, Hormone, Fertility, etc..
  • 9. 5
    MuGard –FDA-approved cancer supportive care product
  • 10. MuGard™ - Treating A Significant Health Issue
    Oral Mucositis:Significant Medical Issue – Often Unrecognized, Undiagnosed and Undertreated
  • 11.
    • >$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. MuGard Stands Alone:Only FDA-approved product that instructs pre-treatment; Safe to swallow
    • 13. Multiple Marketing Partners: Partners signed for EU, Switzerland, Norway, Iceland, China, Korea; US manufacturing completed – launch activities commencing
    • 14. Royalties: 20%, scaling to 25%
    MuGard™ - Oral Mucositis (OM)
    European Launch Underway; North American / Far East Launch Soon
    Royalties Start This Year
  • 15. MuGard’s Industry Leading Label
    Indications: indicated for the management of pain and relief of pain…
    Directions for use: Gargle and spit out.
    Indications: dryness or dry mouth associated with various conditions
    Directions for use: Swish and spit out.
    Indications: “Magic Mouthwash" prepared by pharmacists and used to treat mouth sores (oral mucositis)
    Directions for use: Gargle and spit out
    Indications: MuGard is indicated for the management of oral mucositis/ stomatitis
    Directions for use:
    … rinse may be expelled or swallowed … safe to swallow …
    …recommended that patients purchase MuGard™prior to the commencement of cancer therapy ..
    MuGard is recommended for preventative use
    MuGard can be swallowed to coat lesions in throat
  • 16. MuGard - US Commercial Launch Activities
    • Manufacturing of MuGard (Accupac) – product manufactured and ready to ship
    • 17. Key opinion leader collaboration (Dr. Stephen Sonis) – Oral Mucositis expert
    • 18. MuGard Centers-of-Excellence Program – targeting large oncology networks to build awareness and clinical experience with MuGard
    • 19. Work with reimbursement consultants – filed reimbursement coding application and discussions are ongoing with major third-party payers
    • 20. Key Clinical Data – presented last week at MASCC and ongoing throughout the year; supports prevention, treatment, pain relieve, ease-of-use
    • 21. Secure additional distribution channels
    • 22. Long-term stability for full commercial availability – on schedule for late July
    • 23. Additional MuGard partnerships
    ACCP Remains On-track for Full-Scale North American MuGard Launch
  • 24. 10
    Cobalamin– oral drug delivery platform
    to enhance absorption of large molecules
  • 25. 11
    Cobalamin Oral Drug Delivery Platform
    Using The Body’s Own Vitamin B-12 Absorption System
    To Enable and Enhance Delivery of Drugs Through Gut Wall
    The “Trojan Horse” Delivery Vehicle
    The nanoparticle coated
    with Cobalamin (red)
    binds to intrinsic factor (1),
    which in turn binds to its
    cell surface receptor (2).
    The nanoparticle is
    transported across the
    cell (3), crosses the gut
    wall and enters the
    bloodstream (4).
    Nanopolymer “payload” can be
    Insulin, growth hormone, EPO, etc.
  • 26. 12
    Significant Oral Bioavailability
    Multiple Collaborations Driving Enhanced Data Set;
    Planning Initiation of Phase I Human Trial in Cobalamin Oral Insulin
    • Cobalamin Oral Insulin– Access has achieved unprecedented levels of oral bioavailability of insulin in two animal models ( >80% of that achieved by injection).
    • 27. Two Ongoing Collaborations– Oral insulin provided to two collaborators that have confirmed high levels of oral bioavailability with Cobalamin oral insulin
    • 28. Cobalamin Human Growth Hormone– Demonstrated high oral bioavailability and a 25% improvement in weight gain in standard animal model
    • 29. Multiple Applications– Ongoing discussions with multiple potential partners looking at exploiting Cobalamin oral drug delivery for insulin, HGH, fertility drugs, proteins, etc.
    • 30. Patent Life-cycle Management Tool –protect patent (IP) position through cobalamin formulation of existing drugs, resulting in new IP
    • 31. Phase I Human Trial– Moving Cobalamin oral insulin into a proof-of-concept Phase 1 study in man
    • 32. sRNAi– Adaptation of Cobalamin system to provide delivery vector for sRNAi therapeutics being evaluated; partnering and collaboration discussions ongoing
  • 13
    ProLindac– Phase II cancer drug for solid tumors
  • 33. 14
    Positioning ProLindac™ as a Replacement for Sanofi-Aventis’ Eloxatin
    Represents a $3+ Billion Market Opportunity
    • ProLindacTM – Access designed a second generation DACH platinum using our proprietary nano-polymer expertise.
    • 34. Eloxatin®
    • 35. FDA approved (2001) for front-line metastatic colorectal cancer
    • 36. 2008 $2.5+ billion projected sales globally
    • 37. Significant neurotoxicity
    • 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.
    DACH Platinum (same active in Eloxatin) is inactive while attached to polymer background
    Chelator releases platinum compound in low pH environment; e.g. tumor
  • 39.
    • Monotherapy in relapsed, platinum-sensitive patients
    • 40. 36 patients enrolled in six centers in France; final follow-up ongoing
    • 41. Heavily treated patients (at least 3, up to 7, previous regimens)
    • 42. Exploring two dosing schedules (once/two weeks and once/three weeks)
    • 43. Safety – ProLindac Exhibited Very Benign Safety Profile
    • 44. Patients tolerating drug well through multiple cycles (up to 10 or more)
    • 45. No Eloxatin-like neurotox; no nephrotox; no hematotoxicity; no worse emesis
    • 46. Efficacy and Activity – ProLindac “Outperforms” Current Best Care
    • 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. Next Steps
    • 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. Partnering discussions ongoing
    ProLindac™ Phase II Trial – Relapsed Ovarian
    Final Study Results – Safe and Active DACH Platinum Drug
  • 51. 16
    Thiarabine– Phase II cancer drug
    for Leukemias and Lymphomas
  • 52. 17
    Thiarabine – A Novel Nucleoside Analogue
    Significant Clinical Data Available – Ready for Phase II Trials
    • 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. 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. 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. 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.
    • 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. Aosaikang Medicinal Group (ASK)–Rights to ProLindac in greater China; provides second source manufacturing; obligated to pay for two controlled combination studies
    • 57. JCOM Ltd – Rights to ProLindac in Korea; obligated to pay for one pivotal controlled combination study.
    • 58. JCOM Ltd–Rights to MuGard in Korea; securing regulatory approval and preparing commercial launch in 2010
    • 59. RHEI Pharma: – Rights to MuGard in greater China; securing regulatory approval, and seeking source of supply; preparing for commercial launch
    • 60. US Large Pharma – Sponsored research agreement evaluating cobalamin oral drug delivery platform (insulin and human growth hormone)
    • 61. US and European Biotechnology Company –Material transfer agreement and collaboration agreement; evaluating cobalamin oral insulin in animal models
    Active Partnering Strategy For Drug Programs
    Active Business Development Effort; Securing Partnerships and
    Collaborations to Enhance Value and Share Costs
  • 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.
    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).
    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.
    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.
    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.
    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.
    Experienced Management Team
  • 63. Board of Directors
    Strong Board of Directors with Relevant Experience
    • 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. Esteban Cvitkovic, M.D., Vice Chairman – see Management
    • 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. 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. 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. Jeffrey B. Davis, Chief Executive Officer – see Management
  • 69.
    • Ticker: ACCP (OTCBB)
    • 70. Applying to Nasdaq and NYSE-AMEX exchanges
    • 71. Capital Structure
    Common shares outstanding 15.4 million shares
    Common under preferred shares 9.9 million shares
    Total common shares 25.3 million shares
    • Debt: $5.5 million note due end 2011, convertible at $27.50 per share.
    • 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. High Quality Institutional Investors: Includes SCO Capital Partners, Oracle Partners, Ramius, CSFB, Schroeder’s Bank
    Financial Overview
  • 74. Milestones / News Flow – 2010 and forward
    Significant News Flow Anticipated in 2010 / 2011
    • Achieve scale-up manufacturing of MuGard (Accupac)
    • 75. MuGard approval in Korea
    • 76. bioRASI collaboration (Cobalamin first-in-man trial)
    • 77. Key opinion leader collaboration (Dr. Stephen Sonis)
    • 78. North American / Far East launches of MuGard
    • 79. Additional MuGard clinical data, ongoing and at MASCC
    • 80. Additional MuGard partnerships
    • 81. Cobalamin preclinical data; additional partnerships and collaborations
    • 82. Launch Phase 1 Cobalamin oral insulin trial
    • 83. Initiate ProLindac combination Phase 2 trial; data available
    • 84. Seek global or regional partnerships for ProLindac (discussions ongoing)
    • 85. Secure additional investment banking research analyst coverage
  • 86.
    • 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. Late Stage Oncology Pipeline: Proprietary technology has created portfolio of new products for large markets
    • 88. One FDA-Approved product, MuGard – North American launch; intro in Europe underway; Asia next; >$1 billion opportunity
    • 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. One Phase 2-ready cancer drug, Thiarabine – superior version of clinically and commercially successful nucleoside analogue
    • 91. Commercial Strategy: Multi-local development and marketing partners to shift risk and share costs, while retaining very attractive revenue/royalty rights.
    • 92. Value Visibility: Seek “re-listing” on national exchange; actively present company to the investment community.
    Conclusions – Investment Highlights
    ACCP – An Undervalued Investment Opportunity