Access Pharmaceuticals Presentation - Spring 2011
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Access Pharmaceuticals Presentation - Spring 2011



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 ...

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.



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Access Pharmaceuticals Presentation - Spring 2011 Presentation Transcript

  • 1. Drug Delivery Company – Two Robust Platform Technologies Rich Product Pipeline – Active Partnering Strategy Investor Presentation Spring 2011
  • 2. Safe Harbor Statement 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 Accesss 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 2
  • 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.   CobOral and CobaCyte Drug Delivery Platforms – Proprietary drug delivery platforms creates multiple product opportunities; mitigates single product/technology exposure.   Late Stage Product Pipeline – Access has received FDA marketing clearance for oral mucositis product MuGard; ProLindac and Thiarabine have completed Phase 2 trials.   Partnering Strategy – Access has completed eight partnerships or collaborations in the past 24 months: upfront payments, royalties, research costs, clinical costs.   Experienced Team – Experienced chemists, pre-clinical and manufacturing experts, clinical development personnel, and business development and finance personnel.   Focus on Shareholder Value – Management and board members are significant shareholders, focused on increasing shareholder value. 3
  • 4. Multiple Platforms Drives Opportunity Two proprietary, drug-delivery platform technologies enable product development across multiple biotechnology sub-sectors: Cancer, Diabetes, Hormone, Fertility, etc.. Pre- Product Oncology clinical IND Phase 1 Phase 2 Phase 3 Potential Commercially MuGard ™ Launched >$1B ProLindac™ ~ $3 B Thiarabine™ >$600 M CobOral / CobaCyte – Drug Delivery Cobalamin Oral Insulin Moving toward Proof of Concept in Man Study >$1B Human Growth Hormone >$1B GLP-1; Other Injectables >$1B 4
  • 5. MuGard – Commercially launched in late 2010 5
  • 6. MuGard™ - Treating A Significant Health Issue Significant Medical Issue – Often Unrecognized, Undiagnosed and Undertreated Well being Pain Problems with eating, drinking, speaking and swallowing Weight loss Impairment of quality of life e.g. mood Infection Reduces infection barrier Compromised Reduced dosage treatment Breaks or delays in therapy affecting treatment outcomes Economic Prolonged hospital stays impact Increased use of resources e.g. feeding tube placement 6
  • 7. MuGard™ - Oral Mucositis (OM) Large Unmet Medical Need – Commercially Launching in US, Europe and Far East  >$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.  MuGard Stands Alone: Only oral mucositis product that instructs pre-treatment; Safe to swallow on label.  US Commercial Launch: US manufacturing completed – launch activities underway.  Multiple Marketing Partners: Partners signed for EU, Switzerland, Norway, Iceland, China, Korea.  Royalties: 20%, scaling to 25% 7
  • 8. MuGard’s Industry Leading LabelIndications: dryness or Indications: indicated Indications: “Magic Indications: MuGarddry mouth associated for the management of mouthwash" prepared is indicated for thewith various conditions pain and relief of by pharmacists and management of oral pain… used to treat mouth mucositis/ stomatitisDirections for use: sores (oral mucositis)Swish and spit out. Directions for use: Directions for use: Gargle and spit out. Directions for use: … rinse may be Gargle and spit out expelled or swallowed … safe to swallow … MuGard is recommended for preventative use …recommended that MuGard can be swallowed to coat lesions in throat patients purchase MuGard™ prior to the commencement of cancer therapy .. 8
  • 9. MuGard: US Distribution Strategy   Oncology Network Sampling Program   MuGard Centers-of Excellence   Broad-scale sampling program to top oncology networks to educate and promote the benefit MuGard provides patients   BioScrip (Nasdaq: BIOS) Specialty Distribution Partner   Nationwide distribution platform with extensive physician network   Live “stand-alone” retail pharmacies in over 30 top metro areas   75,000 square-foot mail distribution facility in Columbus, Ohio   Various order and delivery options for patient   Judicator of claims – handles insurance claims process   iMedicor and Direct Medical Solutions   Non-personal online marketing capability   Direct Medical Solutions - direct sales reps   Supports other distribution channels 9
  • 10. MuGard: US Commercial Launch Activities ACCP Remains On-track for Full-Scale North American MuGard Launch   Achieved scale-up manufacturing of MuGard (Accupac) – product manufactured and shipped to specialty distributor   Key opinion leader collaboration (Dr. Stephen Sonis) – Oral Mucositis expert   Launch sampling program – targeting large oncology networks to build awareness and clinical experience with MuGard   Work with reimbursement consultants – filed reimbursement coding application and discussions are ongoing with major third-party payers   Additional MuGard clinical data, ongoing and at MASCC   Secure Additional Distribution Channels – Ongoing   Long-term Stability for full commercial availability   Additional MuGard partnerships 10
  • 11. Cobalamin – oral drug delivery platform to enhance absorption of large molecules 11
  • 12. CobOral / CobaCyte Drug Delivery Platforms Using The Body’s Own Vitamin B-12 Absorption System To Enable and Enhance Delivery of Drugs The “Trojan Horse” Delivery Vehicle 1 2 The nanoparticle coated with Cobalamin (red) binds to intrinsic factor (1), which in turn binds to its cell surface receptor (2). 3 4 The nanoparticle is Nanopolymer “payload” can be transported across theInsulin, growth hormone, EPO, etc. cell (3), crosses the gut wall and enters the bloodstream (4). 12
  • 13. CobOral Oral Insulin Program Cobalamin Enhanced Nanopolymers – Enabling Oral Insulin Multiple CobOral Formulation Agreements In Place  CobOral technology makes “active drug” look like Vitamin B-12; achieved significant levels of oral bioavailability with insulin and HGH  Studies conducted on numerous products including Insulin, LHRH, EPO, Interferon, G-CSF  Seeking co-development partner in diabetes field  Potential for use in wide variety of disease states where vitamin intake is up regulated, including cancer, rheumatoid arthritis, Crohn’s, autoimmune disorders Clinically Relevant Glucose Lowering Effect in Diabetic Rat Model 13
  • 14. Significant Oral Bioavailability Multiple Collaborations Driving Enhanced Data Set; Planning Initiation of Phase 1 Human Trial in Cobalamin Oral Insulin   CobOral Oral Insulin – Access has achieved unprecedented levels of oral bioavailability of insulin in two animal models ( >80% of that achieved by injection).   Multiple Ongoing Collaborations – Oral insulin provided to collaborators that have confirmed high levels of oral bioavailability; new collaborations ongoing   CobOral Human Growth Hormone – Demonstrated high oral bioavailability and a 25% improvement in weight gain in standard animal model   Multiple Applications – Ongoing discussions with multiple potential partners looking at exploiting CobOral/CobaCyte oral drug delivery for insulin, HGH, fertility drugs, proteins, etc.   Patent Life-cycle Management Tool –protect patent (IP) position through cobalamin formulation of existing drugs, resulting in new IP   sRNAi – Adaptation of Cobalamin system to provide delivery vector for sRNAi therapeutics being evaluated; partnering and collaboration discussions ongoing 14
  • 15. ProLindac – Phase II cancer drug for solid tumors 15
  • 16. ProLindac™ Positioning ProLindac™ as a Replacement for Sanofi-Aventis’ Eloxatin Represents a $3+ Billion Market Opportunity   ProLindacTM – Access designed a second DACH Platinum (same active in Eloxatin) is generation DACH platinum using our inactive while attached to polymer proprietary nano-polymer expertise. background   Eloxatin® •  FDA approved (2001) for front-line metastatic colorectal cancer •  2008 $2.5+ billion projected sales globally •  Significant neurotoxicity   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 Chelator releases platinum compound in low pH controls, and royalties. environment; e.g. tumor 16
  • 17. ProLindac™ Phase II Trial – Relapsed Ovarian Final Study Results – Safe and Active DACH Platinum Drug   Monotherapy in relapsed, platinum-sensitive patients •  36 patients enrolled in six centers in France; final follow-up ongoing •  Heavily treated patients (at least 3, up to 7, previous regimens) •  Exploring two dosing schedules (once/two weeks and once/three weeks)   Safety – ProLindac Exhibited Very Benign Safety Profile •  Patients tolerating drug well through multiple cycles (up to 10 or more) •  No Eloxatin-like neurotox; no nephrotox; no hematotoxicity; no worse emesis   Efficacy and Activity – ProLindac “Outperforms” Current Best Care •  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%)   Next Steps •  First combination trial launched: ProLindac plus taxol in recurrent ovarian; partners planning additional combination trials (ProLindac plus Lilly’s Gemzar in liver and pancreatic cancer) •  Partnering discussions ongoing 17
  • 18. Thiarabine – Phase II cancer drug for Leukemias and Lymphomas 18
  • 19. Thiarabine – A Novel Nucleoside Analogue Significant Clinical Data Available – Initiated Phase I/II study at MD Anderson Cancer Center   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.   Significant Data/Information Known – Drug was well tolerated and active in two previously conducted Phase II clinical trials in advanced solid tumors. Significant clinical pharmacology and dose scheduling information known.   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).   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. 19
  • 20. Active Partnering Strategy For Drug Programs Active Business Development Effort; Securing Partnerships and Collaborations to Enhance Value and Share Costs   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.   Aosaikang Medicinal Group (ASK) – Rights to ProLindac in greater China; provides second source manufacturing; obligated to pay for two controlled combination studies   JCOM Ltd – Rights to ProLindac in Korea; obligated to pay for one pivotal controlled combination study.   JCOM Ltd – Rights to MuGard in Korea; secured MuGard marketing approval and preparing commercial launch in 2010   RHEI Pharma: – Rights to MuGard in greater China; securing regulatory approval, and seeking source of supply; preparing for commercial launch   US Large Pharma – Multiple sponsored formulation agreements evaluating cobalamin oral drug delivery platform (various large molecules, insulin, GLP, HGH)   US and European Biotechnology Company – Material transfer agreement and collaboration agreement 20
  • 21. Experienced Management Team   Jeffrey B. Davis, Chief Executive Officer President, SCO Financial Group LLC; Senior Vice President and Chief Financial Officer of a healthcare technology company; Vice President, 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 Dr. Cvitkovic is a board-certified oncologist with more than 30 years experience in oncology therapeutics, including clinical research, clinical pharmacology, design of single-agent and combination regimens, and optimization of clinical efficacy. Dr. Cvitkovic played a fundamental role in the registration strategy and post-registration development of cisplatin and oxaliplatin. Dr. Cvitkovic has held staff and academic appointments at Memorial Sloan Kettering Cancer Center (NY), Columbia Presbyterian (NY), Hospital St. Louis (Paris), Instituto Mario Negri (Milan) and Institut Gustave Roussy (Villejuif).   Frank Jacobucci, Vice President Sales & Marketing Mr. Jacobucci has 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 Chief Financial Officer, Enhance Pharmaceuticals; VP, Commercial and Business Development, Ardent Pharmaceuticals; Director of Managed Care Marketing & Director of New Product Planning, Glaxo Wellcome; MBA, University of Virginia; BS, Industrial and Systems Engineering, Georgia Institute of Technology. 21
  • 22. Board of Directors Strong Board of Directors with Relevant Experience   Steven H. Rouhandeh, Chairman Steve 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.   Esteban Cvitkovic, M.D., Vice Chairman – see Management   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.   Mark Alvino Mark 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   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.   Jeffrey B. Davis, Chief Executive Officer – see Management 22
  • 23. Financial Overview   Ticker: ACCP (OTCBB)   Capital Structure Common shares outstanding 19.2 million shares Common under preferred shares 11.7 million shares Total common shares 30.9 million shares   Debt: $5.5 million note due end 2011, convertible at $27.50 per share.   Cash Burn: Roughly $4 million annually. With current cash on balance sheet and expected upfront and milestone payments, Access has sufficient cash into 2012.   High Quality Institutional Investors: Includes SCO Capital Partners, Oracle Partners, CSFB, Schroeder’s Bank 23
  • 24. Milestones / News Flow – 2011 and forward Significant News Flow Anticipated in 2011 and 2012   Global roll-out of MuGard for oral mucositis   Initiate dose-escalating trial for Thiarabine   Initiate ProLindac combination Phase 2 trial   Multiple CobaOral / CobaCyte formulation agreements   Far East launches of MuGard   Additional MuGard co-promotion / partnerships   CobOral / CobaCyte collaborations and data   ProLindac and Thiarabine clinical data   Seek global or regional partnerships for ProLindac, Thiarabine, and Cobalamin programs 24
  • 25. Conclusions – Investment Highlights ACCP – An Undervalued Investment Opportunity   CobaOral / CobaCyte Drug Delivery Platforms – multiple long term opportunities (oral insulin, oral HGH, fertility drugs,etc.); multiple collaborations ongoing; launch Phase I human trial in oral insulin   Late Stage Oncology Pipeline: Proprietary technology has created portfolio of new products for large markets •  One FDA-Approved product, MuGard – North American launch; intro in Europe underway; Asia next; >$1 billion opportunity •  One Phase 2/3-ready cancer drug, ProLindac – New form of proven drug, takes direct aim at Sanofi’s $2.5 billion Eloxatin franchise •  One Phase 2-ready cancer drug, Thiarabine – superior version of clinically and commercially successful nucleoside analogue   Commercial Strategy: Multi-local development and marketing partners to shift risk and share costs, while retaining very attractive revenue/royalty rights.   Value Visibility: Seek “re-listing” on national exchange; actively present company to the investment community. 25