Corporate Fact Sheet OTC: ACCP
Corporate Offices 2600 Stemmons Freeway, Suite 176 Dallas, TX 75207-2107 Tel: (214) 905-5100 Fax: (214) 905-5101 http://www.accesspharma.com
Nanotechnology Meets Biotechnology Company Overview Access Pharmaceuticals, Inc. (ACCP.OB) is an emerging pharmaceutical company focused on the development and commercialization of proprietary products for the treatment and supportive care of cancer patients. Access has one approved product, two products in Phase 2 development, and five preclinical development programs. The Access Pharmaceuticals, Inc. (ACCP.OB) is an pharmaceutical on the and Company’s approved product is MuGard™ foremerging the management of oral company mucositis focused (a common anddevelopment debilitating side commercialization of proprietary products for themarketing treatmentauthorization and supportivehas care of cancer patients. Company’s effect of many cancer therapies) for which been allowed by theThe FDA. Access’ products include MuGard™ for the management oral is mucositis (a common debilitating side patients, effect of many TM, a polymer-linked ProLindac platinum cancerofdrug in Phase 2 clinicaland testing in cancer as is TM, a polymercancer therapies) for which marketing authorization has been allowed by the FDA, and ProLindac Phenylbutyrate, a pleotropic agent which current evidence suggests acts as both an HDAC inhibitor and a linked platinumagent. cancerThe drug in Phase preclinical II clinical testing of cancer patients. The Company has advanced drug differentiating Company’s development programs include Angiolix, aalso humanized monoclonal delivery technologies including Cobalamin™-mediated targeted delivery and oral drug delivery. antibody which acts as an anti-angiogenesis factor and is potentially targeted to a number tumor types, including breast and ovarian; Prodrax, a non-toxic prodrug which is activated in the hypoxic zones of solid tumors to kill • tumor MuGard™ cells; Alchemix, a chemotherapeutic agent that combines two modes of action to overcome drug resistance, In the area of supportive care the for company’s cancer patients, Access has drug received marketing allowance for MuGard™ in the TM oral and oral insulin, which utilizes Cobalamin delivery technology. United States from the Food and Drug Administration. MuGard™ is indicated for the management of mucositis • MuGard™ which is an ulceration of the oral cavity. Mucositis is a common and debilitating side effect of many cancer In the area of supportive care for cancer patients, Access has received marketing in the treatments. The addressable worldwide market for mucositis is estimated to be inallowance excess offor $1MuGard™ billion annually. United States from the Food and Drug Administration. MuGard™ provides a protective coating to the mucosal surfaces in the mouth. A clinical study has shown MuGard™ the management of and mucositis MuGard™ toisbeindicated effective for in lowering the incidence severity of mucositis. which is an ulceration of the oral cavity. Mucositis is a common and debilitating side effect of many cancer • ProLindac™ treatments. The lead addressable worldwideProLindac market for TM, mucositis The company’s drug candidate, is currently in a Phase II trial In Europe in ovarian cancer is estimated to be in excess of $1 billion annually. MuGard™ prodrugs to enhance the delivery of a platinum patients. ProLindac™ applies the principles of nanoparticulate provides a protective coating tomodels the mucosal surfaces in thenormal tissue from the cytotoxic platinum while in drug to tumors. In preclinical ProLindac™ protects mouth. A clinical study has shown MuGard™ to be effective circulation and enhances uptake of drug to tumors, whereinthe platinum is released by virtue of a pH-sensitive lowering the incidence and severity of mucositis. linker. Platinum-based drugs are among the largest classes of chemotherapeutic compounds. The drug used in ProLindac™ is DACH platinum, which is also the active moiety of oxaliplatin (Eloxatin; Sanofi – Aventis), a drug for • ProLindac™ cancer patients which has annual sales of $2+ billion worldwide. The company’s lead drug candidate, ProLindacTM, is currently in a Phase 2 trial In Europe in ovarian cancer patients. • Phenylbutyrate TM, is currently ProLindac™ applies the candidate, principles of nanoparticulate prodrugs to enhance theEurope delivery of a platinum The company’s lead drug ProLindac in a Phase II trial In in ovarian cancer drug to tumors. In preclinical models ProLindac™ protects normal tissue from the cytotoxic platinum while in circulation patients. ProLindac™ applies the principles of nanoparticulate prodrugs to enhance the delivery of a platinum drug to and enhances uptake of drug to tumors, where the platinum is released by virtue of a pH-sensitive linker. tumors. In preclinical models ProLindac™ protects normal tissue from the cytotoxic platinum while in circulation and Platinum-based drugsto are among thethelargest classes of chemotherapeutic compounds. The drug used in enhances uptake of drug tumors, where platinum is released by virtue of a pH-sensitive linker. Platinum-based ProLindac™ DACH platinum, is also the activecompounds. moiety of oxaliplatin (Eloxatin; Sanofi–Aventis), a platidrug for drugs are amongisthe largest classeswhich of chemotherapeutic The drug used in ProLindac™ is DACH cancer which hasmoiety annualofsales of $2+(Eloxatin; billion worldwide. num, whichpatients is also the active oxaliplatin Sanofi – Aventis), a drug for cancer patients which has annual sales of $2+ billion worldwide • Cobalamin™ - Coated Nanoparticles The company also has Cobalamin™ technologies in early-stage development. These technologies are based upon the use of Cobalamin™–coated nanoparticles, for enhanced targeting of drugs to sites of disease (utilizing the increased demand for cobalamin that occurs at disease sites, such as cancer). The company also has extensive intellectual property surrounding the use of this technology for oral drug delivery including oral delivery of insulin. While oral delivery is by far the preferred route of administration for most drugs, this route is not available to many existing and/or promising therapeutic compounds because of their physical and chemical properties. Cobalamin™-coated nanoparticles provide an opportunity for oral delivery of such compounds by utilizing the body’s natural uptake mechanisms.
February, 2008
Select Financial Data: Share Price (2/1/08): Shares Outstanding:
$2.80 17.3 million (includes cs and ps)
52-Week Price Range: Market Cap:
$2.10-10.66 $48 million
NanoPolymer Platform Technology Access leverages its proprietary NanoPolymer technology platforms to generate NCEs (new chemical entities) with enhanced drug effectiveness while decreasing side effects. Nanoparticulate delivery systems can be used to (1) enhance drug absorption, (2) facilitate sustained targeted delivery, (3) enable oral bioavailability of previously injectable drugs, and (4) mediate side effects.
Recent Company Announcements • Jan 29, 2008: Access Pharmaceuticals Announces $2.7 Million New Equity • Jan 14, 2008: Access Licenses MuGard™ to RHEI Pharmaceuticals, a Leading Specialty Pharmaceutical Company for Distribution in China and Certain Other Southeast Asian Countries • Jan 07, 2008: Access Pharmaceuticals Closes Acquisition of Somanta Pharmaceuticals
Investment Highlights • Focus on Oncology
Access’ Product Pipeline Chart
• MuGard™ market allowance received for potential $1 billion cancer supportive care market
MuGardTM ProLindacTM
• ProLindacTM has a positive profile compared to oxaliplatin, a $2+ billion product
Ovarian Cancer Colorectal/Other
• Experienced management team
Oral Insulin/hGH Angiolix
• Product portfolio breadth
Prodrax Alchemix
• Numerous strategies to create
• Strong IP position
shareholder value
Phenylbutyrate Glioblastoma
Partnered
Management Team Jeffrey B. Davis, Chairman and Chief Executive Officer SCO Financial Group LLC
Esteban Cvitkovic, M.D., Vice Chairman (Europe), Senior Director, Clinical Oncology R&D Founder, Cvitkovic & Associates Consultants (now owned by AAIOncology)
David P. Nowotnik, Ph.D., Senior Vice President R&D Sr. Dir. Prod Dev, Guilford ¤ Bristol-Myers Squibb ¤ Amersham International
Phillip Wise, V.P. Business Development & Strategy VP, Com and Bus Dev & CFO, Enhance Pharmaceuticals ¤ Glaxo Wellcome
Stephen B. Thompson, Vice President, CFO Controller, Robert E. Woolley Inc. ¤ OKC Limited Partnership ¤ Sante Fe
• •
Multiple product opportunities Broad technology base
For more Information: Investor Relations: Donald C. Weinberger Wolfe Axelrod Weinberger LLC (212) 370370-4500 Michael Wachs, CEOcast, Inc. (212) 732732-4300 This fact sheet includes historical information and forward-looking actions that Access anticipates, based on certain assumptions. Actual results could be different from projections, and Access assumes no obligation to update this information. The risks associated with the Company are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2006 and other reports filed by the Company with the Securities