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.
Digital & Social Marketing for Medical Devices
Access Pharmaceuticals (ACCP)
1. OneMedForum New York – Emerging Company Conference The Roosevelt Hotel – June 30, 2010 Investor Presentation June 2010 www.accesspharma.com
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: www.AccessPharma.com at AccessPharma at Access Pharmaceuticals 2 Safe Harbor Statement
3.
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.3 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..
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%7 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 8
24. 10 Cobalamin– oral drug delivery platform to enhance absorption of large molecules
25. 11 1 2 3 4 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.
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
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
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%)
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 ongoing15 ProLindac™ Phase II Trial – Relapsed Ovarian Final Study Results – Safe and Active DACH Platinum Drug
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.
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 18 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. 19 Experienced Management Team
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.
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 Bank21 Financial Overview
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.23 Conclusions – Investment Highlights ACCP – An Undervalued Investment Opportunity