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Oncology Focused Specialty Pharmaceutical Company Rich Product Pipeline – Active Partnering Strategy

Access Pharmaceuticals, Inc. Investor Presentation

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Page 1: Access Pharmaceuticals, Inc. Investor Presentation

Oncology Focused Specialty Pharmaceutical CompanyRich Product Pipeline – Active Partnering Strategy

Oncology Focused Specialty Pharmaceutical CompanyRich Product Pipeline – Active Partnering Strategy

Page 2: Access Pharmaceuticals, Inc. Investor Presentation

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 effectiveness and use of phenylbutyrate as a therapy, market opportunities for and planned studies of phenylbutyrate, the use of and development plans for Angiolix, Alchemix and Prodrax, 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, 2007, 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. 

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Safe Harbor Statement

Page 3: Access Pharmaceuticals, Inc. Investor Presentation

Pipeline & Platforms: Deep pipeline of late stage products (including FDA approved MuGard) enables multiple “opportunities to win” and mitigates single product failure risks or disappointments.

Partnering Strategy: Access seeks development and marketing partners to drive permanent value creation among multiple large product opportunities. Access has completed six partnerships in the past 18 months.

Experienced Team: Access has built a management team that includes experienced chemists, pre-clinical and manufacturing experts, clinical development personnel, and business development and finance personnel.

Acquisitions and In-licensing: Acquire and in-license products and technologies; opportunistically seek undervalued company acquisitions (such as Somanta and MacroChem) to build out asset base and drive value. Access has acquired two public companies in the past 18 months.

Focus on Shareholder Value: Actively promote company and stock in the investment community. Management and board members are significant shareholders, focused on increasing shareholder value.

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Corporate Strategy & Highlights

Late Stage Oncology Pipeline; Emphasis on StrategicPartnering; Focus on Building Shareholder Value

Page 4: Access Pharmaceuticals, Inc. Investor Presentation

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            ProductOncology Pipeline Pre-clinical IND Phase 1 Phase 2 Phase 3 Potential             

MuGard ™ FDA Approved ~ $350 M

ProLindac™            ~ $3 B             

Thiarabine  >$600 M

Angiolix mAb           >$1 B

Other preclinical   Includes Prodrax and phenylbutyrate > $500 M

VB-12 Oral Delivery   Developing under partnership arrangements (insulin, HGH)

Non-core Dermatology Assets Being Partnered/Sold

Pexiganan ~ $500 M

EcoNail           >$100 M

Late Stage Oncology Pipeline

Page 5: Access Pharmaceuticals, Inc. Investor Presentation

Addressable Market: Debilitating side effect of

radiation and chemo; >$1 billion est. in US alone

MuGard: a muco-adhesive nanopolymer solution;

acts as barrier function

European Partner: Partnered with SpePharm in EU,

Switzerland, Norway and Iceland – launching now

US & Far East Partners: Partnered with Milestone

Biosciences (US), RHEI Pharma (China) in China,

and JCOM/DongA (Korea); launching mid-2009

Royalties of 20%, scaling to 25%

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MuGard™ - FDA Approved Treatment

MuGard Demostrates Efficacy VersusHistorical Control (standard of care)

MuGard Demostrates Efficacy VersusHistorical Control (standard of care)

Product Launch Ongoing; Royalties Expected in 2009Product Launch Ongoing; Royalties Expected in 2009

Page 6: Access Pharmaceuticals, Inc. Investor Presentation

Oxaliplatin (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.

Pre-clinical models: At least as active as, and superior or markedly superior to, Eloxatin in multiple pre-clinical tumor models.

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ProLindac™ Market Opportunity

Positioning ProLindac as a Replacement for Sanofi-Aventis’ EloxatinRepresents a $3+ Billion Market Opportunity

Positioning ProLindac as a Replacement for Sanofi-Aventis’ EloxatinRepresents a $3+ Billion Market Opportunity

Tumor Model Efficacy vs. Eloxatin

M5076 sarcoma (Pt-resistant)

Markedly Superior

B16 melanoma Markedly Superior

2008 ovarian xenograft Markedly Superior

Colo-26 colon Superior

HT-29 colon xenograft Superior

HCT-116 colon xenograft Superior

L1210 leukemia Superior

0157 Hybridoma Superior

M5076 sarcoma Similar

Lewis lung Similar

P815 Mastocytoma Similar

Page 7: Access Pharmaceuticals, Inc. Investor Presentation

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0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30

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Oxaliplatin 5 mg Pt/kg q1w x 3

ProLindac 75 mg Pt/kg q1w x 3

ProLindac™ - More Platinum, More Safely

Unique design enables more platinum delivery, with fewer side effects

Unique design enables more platinum delivery, with fewer side effects

Represents “equi-toxic” dosesof ProLindac and Eloxatin

Represents “equi-toxic” dosesof ProLindac and Eloxatin

DACH Platinum (same active in Eloxatin) is inactive while attached to polymer background

Chelator releases platinum compound in low pH environment; e.g. tumor

Page 8: Access Pharmaceuticals, Inc. Investor Presentation

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)

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ProLindac™ - Phase 1/2 Trial

Initial European Phase 1/2 Clinical Trial Suggests EfficacyWith Improved Safety Profile

Initial European Phase 1/2 Clinical Trial Suggests EfficacyWith Improved Safety Profile

Significant Drug Activity and Benign Toxicity ProfileWarrants Further Development

Page 9: Access Pharmaceuticals, Inc. Investor Presentation

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 q2w and q3w dosing schedules

Safety – ProLindac Exhibited Very Benign Safety Profile• Patients tolerating drug well through multiple cycles (up to 9 or more)• No Oxaliplatin-like neurotox; no nephrotox; no hematotoxicity; no worse emesis

Efficacy and Activity – ProLindac Exhibited Strong Activity• At highest dose intensity, 6 of 9 patients responded (2 off study for non-drug reasons);

activity levels superior to oxali or carbo in monotherapy in similar patient populations• New PK/PD studies shows ProLindac simulates “4-day continuous infusion”,

contributing to increased activity and enhanced safety profile Next Steps

• Combination trials: initiating two combo trials – recurrent ovarian in combo with taxol and pancreatic in combo with gemcitabine; additional combination studies possible in other tumor types (prostate with taxotere, etc.)

• Partnering discussions ongoing

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ProLindac™ Phase 2 Trial – Relapsed Ovarian

Final Study Results – Safe and Active DACH Platinum DrugFinal Study Results – Safe and Active DACH Platinum Drug

Page 10: Access Pharmaceuticals, Inc. Investor Presentation

New Nucleoside Analogue – Successor molecule in same class as other FDA approved (clinically and commercially

successful) nucleoside analogues such as fludarabine and cladrabine. Known class of drug – clofarabine was

approved on fewer than 50 patients.

Significant Data/Information Known – Thiarabine has been in two Phase 2 clinical trials in advanced solid tumors (rather

than hematological malignancies) at high doses. Significant clinical pharmacology and dose scheduling information known.

Drug well tolerated.

MD Anderson Cancer Center – ACCP is working with Dr. Hagop Kantarjian, Head of Leukemia Dept. at MD Anderson in

Houston to develop Thiarabine (same team of experts that have successfully led to approved nuceloside 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, B-cell lymphoma, cutaneous T-cell lymphoma and other

indications.

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Thiarabine – A Novel Nucleoside Analogue

Significant Clinical Data Available – Ready for Phase 2 TrialsSignificant Clinical Data Available – Ready for Phase 2 Trials

Page 11: Access Pharmaceuticals, Inc. Investor Presentation

“Hot” Area – Big pharma aggressively seeking new monoclonal antibody (mAb) therapies

following successes of Avastin, Erbitux, Herceptin, Rituxan and others.

New Target – Angiolix has a proprietary target, lactadherin, a potent stimulator of the

vasculature needed to supply blood to tumors (angiogenesis).

Preclinical Studies – Evaluating Angiolix alone, in combination with chemotherapy, and

head-to-head against Avastin in two solid tumor types (at Imperial College London). Results

indicate Angiolix has anti-tumor activity alone, and in combination with chemotherapy.

Mechanism of Action – Angiolix inhibits angiogenesis and induces apoptosis through the

integrin pathway. Additionally, unlike Avastin, Angiolix has anti-proliferative activity by

itself (dual MOA).

Partnering – Angiolix is in pre-clinical development. Access is actively seeking

development partners for this novel mAb.

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Angiolix – On the heels of Avastin

Monoclonal Antibody Therapy – Unique Target, LactadherinMonoclonal Antibody Therapy – Unique Target, Lactadherin

Page 12: Access Pharmaceuticals, Inc. Investor Presentation

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Cobalamin-coated Nanopolymer Platform

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3

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The nanoparticle coatedwith Cobalamin (red)binds to intrinsic factor (1),which in turn binds to itscell surface receptor (2).

The nanoparticle coatedwith Cobalamin (red)binds to intrinsic factor (1),which in turn binds to itscell surface receptor (2).

The nanoparticle is transported across thecell (3), crosses the gutwall and enters the bloodstream (4).

The nanoparticle is transported across thecell (3), crosses the gutwall and enters the bloodstream (4).

Using The Body’s Own Vitamin Absorption SystemTo Enable and Enhance Delivery of Drugs Through Gut Wall

The “Trojan Horse” Delivery Vehicle

Using The Body’s Own Vitamin Absorption SystemTo Enable and Enhance Delivery of Drugs Through Gut Wall

The “Trojan Horse” Delivery Vehicle

Nanopolymer “payload” can beInsulin, growth hormone, EPO, etc.

Nanopolymer “payload” can beInsulin, growth hormone, EPO, etc.

Page 13: Access Pharmaceuticals, Inc. Investor Presentation

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Uses Cobalamin (VB12 analogs) to take advantage of the body’s natural receptor-based transport system

Can be used to increase either systemic or cellular uptake of known chemical entities

Can amplify uptake 103– 106 times Studies conducted on numerous

products including Insulin, LHRH, EPO, Interferon, G-CSF

Potential for use in wide variety of disease states where vitamin intake is up regulated, including cancer, rheumatoid arthritis, Crohn’s, autoimmune disorders

Cobalamin-coated Nanopolymer Platform

Cobalamin Enhanced Nanopolymers – Enabling Oral InsulinSponsored Research Partnerships Ongoing

Cobalamin Enhanced Nanopolymers – Enabling Oral InsulinSponsored Research Partnerships Ongoing

Clinically Relevant Glucose LoweringEffect in Diabetic Rat Model

Clinically Relevant Glucose LoweringEffect in Diabetic Rat Model

Page 14: Access Pharmaceuticals, Inc. Investor Presentation

Pexiganan – Novel, topical antibiotic for the treatment of diabetic foot ulcers. NCE, peptide, novel mechanism of

action – broad spectrum (effective against gram positive, incl. MRSA, gram negative, aerobic/anaerobic

organisms. Safety and efficacy profile well established.

Market – Diabetes large and growing market. Treatment usually with oral antibiotics (not approved indications),

not very effective due to neuropathy. Clinicians desire topical.

Studies – Two Phase 3 trials completed (>700 patients). Comparable efficacy vs. oral ofloxacin (well tolerated,

no SAEs). Low potential for resistance; no cross-resistance with known antibiotics; no known contraindications.

Plan of Action – Meet with FDA regarding outstanding clinical concerns and manufacturing concerns. Seek

regulatory pathway, approvals – here and abroad.

Partnering – Access is actively seeking development partners for Pexiganan.

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Pexiganan – Novel Topical Antibiotic

Large & Growing Markets; Late Stage Product; Actively Seeking Partners

Large & Growing Markets; Late Stage Product; Actively Seeking Partners

Page 15: Access Pharmaceuticals, Inc. Investor Presentation

EcoNail – Proprietary lacquer formulation of econazole (generic anti-fungal) and SEPA for the

treatment of nail fungus or onychomycosis.

Market – Effects roughly 10% of population globally (roughly 30 million in US). Novartis’

Lamisal (oral, systemic) does US sales of $500 million – suffers from systemic side effects

(requires liver function tests). J&J’s Sporanox does $120 million. Only lacquer (non-oral) is

Sanofi’s Penlac (~$100 million) with low efficacy.

Studies – Phase 2 completed. Well-tolerated, especially relative to two lacquers in

development. Evidence of clinical improvement of onychomycosis with negative cultures.

Partnering – Access is actively seeking development partners for EcoNail.

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EcoNail™ – Onychomycosis

Phase 2 Trial Completed – Seeking Development Partner Phase 2 Trial Completed – Seeking Development Partner

Page 16: Access Pharmaceuticals, Inc. Investor Presentation

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).

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.

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Management

Experienced Management TeamExperienced Management Team

Page 17: Access Pharmaceuticals, Inc. Investor Presentation

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. 

Marc 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.

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Board of Directors

Strong Board of Directors with Relevant ExperienceStrong Board of Directors with Relevant Experience

Page 18: Access Pharmaceuticals, Inc. Investor Presentation

Ticker: ACCP (OTCBB)

Applying to Nasdaq and AMEX exchanges

Capital Structure

Common shares outstanding 11.3 million shares

Common under preferred shares 10.6 million shares

Total common shares 21.9 million shares

Warrants (approx 8 million) all out of the money

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 2010.

High Quality Institutional Investor Group: Includes SCO Capital Partners, Oracle Partners,

CSFB, UBS, Schroeder’s Bank

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Financial Overview

Page 19: Access Pharmaceuticals, Inc. Investor Presentation

Secure MuGard partnership in Europe (SpePharm BV) and China (RHEI Pharma)

Complete Somanta & MacroChem acquisitions

Secured ProLindac & MuGard Partnership in Korea (JCOM)

Secured ProLindac Partnership in China (ASK)

Seek global or regional partnerships for ProLindac (discussions ongoing)

Seek additional Cobalamin trial programs and/or partners, globally

Seek Pexiganan partnerships or sale of asset

Final report on Phase 2 ovarian trial in Europe

Initiate additional ProLindac Phase 2 combination trials globally

Re-List Access on a national exchange

Secure additional investment banking research analyst coverage

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Milestones – 2009 and forward

Significant News Flow Anticipated in 2009Significant News Flow Anticipated in 2009

Page 20: Access Pharmaceuticals, Inc. Investor Presentation

Late Stage Oncology Pipeline: Access leverages its proprietary technology platforms to generate NCEs (new chemical entities) targeting large markets.

• ProLindac – Novel DACH platinum addresses $3 billion market opportunity

• Cobalamin Oral Delivery Platform – multiple large drug opportunities

• MuGard – validates nanopolymer chemistry expertise

Experienced Team: Access has built a management team and consultant group of experienced chemists, pre-clinical and manufacturing experts, clinical development personnel, and business development and finance personnel.

Partnering Strategy: Seeks global development and marketing partners to drive permanent value creation among multiple large product opportunities.

Acquisitions and In-licensing: Acquire and in-license products and technologies; opportunistically seek company acquisitions (such as Somanta and MacroChem) to build out asset base and drive value.

Value creation: Seek “re-listing” on national exchange; actively promote company and stock in the investment community.

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Conclusions – Investment Highlights

ACCP – An Undervalued Investment OpportunityACCP – An Undervalued Investment Opportunity

Page 21: Access Pharmaceuticals, Inc. Investor Presentation