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Oncology Focused Specialty Pharmaceutical Company Rich Product Pipeline – Active Partnering Strategy. Safe Harbor Statement.
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Oncology Focused Specialty Pharmaceutical Company Rich Product Pipeline – Active Partnering Strategy
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 Access's Annual Report on Form 10-KSB for the year ended December 31, 2008, 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.
Corporate Strategy & Highlights • Pipeline & Platforms: Deep pipeline of late stage products (including FDA approved MuGard, for the treatment of oral mucositis) mitigates single product/technology exposure. • Partnering Strategy:Access has completed six partnerships in the past 18 months: upfront payments, royalties, 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. Late Stage Oncology Pipeline; Emphasis on Strategic Partnering; Focus on Building Shareholder Value
MuGard™ -Oral Mucositis (OM) • >$1 Billion Addressable Market: Target all cancer patients; 1,500,000 US cancer patients annually (incidence). Roughly 90% of patients on radiation (43% severe); and 40% of patients receiving chemotherapy • MuGard Stands Alone: Only FDA approved product that instructs pre-treatment and treatment; Safe to swallow • Multiple Marketing Partners: Partners signed for EU, Switzerland, Norway, Iceland, China, Korea; US – contract salesforce 1Q 2010; partners to come • Royalties: 20%, scaling to 25% US Launch 1Q 2010; European Launch Underway Royalties Start This Year
MuGard™ -OM As Significant Health Issue Significant Medical Issue – Often Unrecognized, Undiagnosed and Undertreated • Schattner MD. Oral mucositis is often underrecognized and undertreated. Highlights of the 13th Annual Conference National Comprehensive Cancer Network. March 2008. Elsevier. • Signs & Symptons: Redness or rash, ulceration, pain (sometimes severe), inability to chew, speak or swallow • Patient Risk Affected By: Area, dose and timing of radiation treatment; type, intensity and combinations of chemotherapy; prior therapies and prior episodes of OM; incidence/severity unpredictable 6
MuGard™ -Preventing OM Oral Mucositis Has Profound Impact on Patient Health “…patients with OM [oral mucositis] are fourfold more likely to have unplanned breaks in radiation therapy and more than three timesas likely to be hospitalized…”1 International guidelines recommend preventive strategies2 “Use of a preventive oral care regimen should be part of routine supportive care along with a therapeutic oral care regimen if mucositis develops”2 • Vera-Llonch, M., G. Oster, et al. (2006). "Oral mucositis in patients undergoing radiation treatment for head and neck carcinoma." Cancer 106(2): 329-36 • Keefe, D. M., M. M. Schubert, et al. (2007). "Updated clinical practice guidelines for the prevention and treatment of mucositis." Cancer 109(5): 820-31. 7
MuGard™ -Early Results Very Positive Post Approval Marketing Assessment Studies Showing Significant Efficacy • UK, Germany, Italy Seeding Studies: Providing over 1200 patients with MuGard; clinicians provide feedback and assessments • Prophylactic Use: Used prior to radiation and/or chemotherapy treatment • Early results: Very positive feedback from clinicians, nurses, patients and SpePharm; data to be collected, analyzed, presented in 2010 • Roll Out: Launched in UK, Germany, Italy, Greece and Norway; France, Benelux and Spain throughout 2009/2010 8
MuGard’ 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 MuGardTM prior to the commencement of cancer therapy .. MuGard is recommended for preventative use MuGard can be swallowed to coat lesions in throat 9
MuGard™ -Market Dynamics / US Launch Access Preparing for 1Q 2010 US MuGard Launch Market / Patient Dynamics • Few good treatment options and no prophylactic; OM underdiagnosed (unlike emesis) • Incidence / Severity is unpredictable among patients; should treat all (larger market) • Interruption of chemo or radiation treatment affects patient care and doctor revenue US Market Launch • Launch product being manufactured – Accupac • Hybrid direct / contract sales force • Target key opinion leaders – radiation (H/N); large oncology networks • Secure 3rd party payor/Medicare reimbursement • Seeking co-promotion arrangements with oncology/onc. supportive care companies • Leverage ongoing market assessment data from European partner, SpePharm 10
ProLindac™ Market Opportunity • Eloxatin® • FDA approved (2001) for front-line metastatic colorectal cancer • 2008 $2.5+ billion projected sales globally • Significant cumulative neurotoxicity • Losing patent protection globally • ProLindacTM – Access designed a second generation DACH platinum using our proprietary nano-polymer expertise. • Partnering On-going: Partnered with Aosaikang Med Group (ASK) in China and JCOM in Korea. Partners paid upfronts, committed to run 3 clinical trials that ACCP controls, and royalties. Positioning ProLindac as a Replacement for Sanofi-Aventis’ Eloxatin Represents a $3+ Billion Market Opportunity
ProLindac™ - More Platinum, More Safely Unique Design Enables Delivery of More Platinum, with Fewer Side Effects; DACH Platinum (same active in Eloxatin) is inactive while attached to polymer background Represents “equi-toxic” doses of ProLindac and Eloxatin Chelator releases platinum compound in low pH environment; e.g. tumor • New PK/PD studies shows ProLindac simulates “4-day continuous infusion”, • contributing to increased activity and enhanced safety profile
ProLindac™ - Phase 1/2 Trial • All Late-Stage Solid Tumors – dose ranging (60 mg Pt/m2 to 1240 mg Pt/m2) once weekly for 3 weeks • Primary Endpoints – maximum tolerated dose and safety • Safety (n=26) • Dose limiting toxicity: neutropenia • No unanticipated AEs (adverse events) • No acute neurotoxicity (important as compared to Eloxatin) • Efficacy (n=16 evaluable patients) • 2 PR (melanoma, ovarian) • 1 PR biomarker (ovarian) • 4 SD (esophageal, melanoma, thyroid, cervical) Initial European Phase 1/2 Clinical Trial Suggests Efficacy With Improved Safety Profile Significant Drug Activity and Benign Toxicity Profile Warrants Further Development
ProLindac™ Phase 2 Trial – Relapsed Ovarian • Monotherapy in relapsed, platinum-sensitive patients • 28 patients enrolled in six centers in France; final follow-up ongoing • Heavily treated patients (at least 3, up to 6, 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 9 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 • 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 • Partnering discussions ongoing Final Study Results – Safe and Active DACH Platinum Drug
Thiarabine – A Novel Nucleoside Analogue • 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 Phase 2 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 leukemia or lymphoma. Based upon clinical data, ACCP is finalizing trial designs and protocols in AML, ALL, and B-cell lymphomas. Significant Clinical Data Available – Ready for Phase 2 Trials
1 2 3 4 Cobalamin-coated Nanopolymer 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.
Cobalamin-coated Nanopolymer Platform Cobalamin Enhanced Nanopolymers – Enabling Oral Insulin Sponsored Research Partnerships Ongoing Clinically Relevant Glucose Lowering Effect in Diabetic Rat Model 17 • Uses Cobalamin (VB12 analogs) to take advantage of the body’s natural receptor-based transport system • Recently announced two MTA collaborative agreements • Studies conducted on numerous products including Insulin, LHRH, EPO, Interferon, G-CSF • Achieved significant levels of oral bioavailability with insulin and HGH • Potential for use in wide variety of disease states where vitamin intake is up regulated, including cancer, rheumatoid arthritis, Crohn’s, autoimmune disorders
Management • Jeffrey B. Davis, Chief Executive OfficerPresident, 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&DDr. 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 DevelopmentSenior 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 CFOController 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 StrategyVP, 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. Experienced Management Team
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. • 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 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 • 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 TherapeuticsProgram, UCSD Cancer Center, and has previously received the Milken Foundation prize for contributions to cancer chemotherapy. • David Luci, CPA, Esq.David Luci has extensive experience in accounting and legal in the biotechnology sector, and previously held the position of Executive Vice President, Chief Financial Officer and General Counsel of Bioenvision, Inc. David Luci is currently General Counsel and Director of Investor Relations for MacroChem Corporation. 19
Financial Overview • Ticker: ACCP (OTCBB) • Applying to Nasdaq and NYSE-AMEX exchanges • Capital Structure Common shares outstanding 13.1 million shares Common under preferred shares 9.9 million shares Total common shares 23.0 million shares • Debt: $5.5 million note due end 2011, convertible at $27.50 per share. • Cash Burn: Roughly $3 million annually. With current cash on balance sheet and expected upfront and milestone payments, Access has sufficient cash into 2010. • High Quality Institutional Investors: Includes SCO Capital Partners, Oracle Partners, CSFB, UBS, Schroeder’s Bank
Milestones / News Flow – 2010 and forward Significant News Flow Anticipated in 2009 and 2010 • Secure MuGard partnership in Europe (SpePharm BV) and China (RHEI Pharma) • Secured ProLindac & MuGard Partnership in Korea (JCOM) • Secured ProLindac Partnership in China (ASK – Aosaikang Med Group) • Signed 2 Cobalamin collaborative agreements • Issued Final Study Report on Phase 2 Recurrent Ovarian Cancer Trial • Achieved GMP manufacturing scale-up of ProLindac • European commercial launch of MuGard (UK, Germany, Italy, Norway, Sweden) • US launch of MuGard; Asian launch of MuGard • Ongoing data from European Marketing Assessment Study (UK, Germany, Italy). • Seek global or regional partnerships for ProLindac (discussions ongoing) • Initiate additional ProLindac Phase 2 combination trials globally • Re-List Access on a national exchange • Secure additional investment banking research analyst coverage 21
Conclusions – Investment Highlights • Late Stage Oncology Pipeline: Proprietary technology has created portfolio of new products for large markets • One FDA-Approved product, MuGard – US launch in early 2010; 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 • Vitamin B-12 oral delivery platform – multiple long term opportunities (oral insulin, oral HGH, etc.); multiple collaborations ongoing • 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. ACCP – An Undervalued Investment Opportunity