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Transcript
Changing the Course of Cancer Therapy AltaRex (TSE:AXO) In Registration A Prospectus has been filed with the Ontario Securities Commission for a public offering of Common Shares Safe Harbor Statement This presentation contains forward-looking statements that involve risks and uncertainties, which may cause actual results to differ materially from the statements made. For this purpose, any statements that are contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words “believes”, “anticipates”, “plans”, “intends”, “expects” and similar expressions are intended to identify forward-looking statements. Such risks and uncertainties include, but are not limited to, the need for capital, changing market conditions, completion of clinical trials, patient enrollment rates, uncertainty of preclinical trial results, the establishment of manufacturing processes and new corporate alliances, the timely development, regulatory approval and market acceptance of the Company’s products, litigation, proprietary rights, patent protection and other risks detailed from time-to-time in the Company’s filings with the United States Securities and Exchange Commission and Canadian securities authorities. A L T A R E X AltaRex Business Model Focus exclusively on antibodies Utilize the Company’s AIT® assay platform to accelerate clinical candidate selection Focus initially on cancer, subsequently on infectious and autoimmune diseases Realize value through partnerships and/or JVs (or by directly marketing in North American niche markets) A L T A R E X Monoclonal Antibodies Nine U.S. regulatory approvals in the last 5 years First year Rituxan® & Herceptin® >$150MM; both set new standards – Reasons for success include a relative lack of toxicity 1999 therapeutic antibody market @ $1.3 billion 3500 3000 2500 Sales (MM$) 2000 1500 1000 500 0 1994 1995 1996 1997 1998 1999 2000 2001 2002 Monoclonal Antibody Sales Hambrecht & Quist Industry Report 1999 Year A L T A R E X Partnering Strategy Think globally, act locally Niche markets: four AIT® cancer antibodies; ROFO for new cancer antibodies Partner makes equity investment in AltaRex at a premium to market price Identify and consummate joint ventures with established and “local” marketing/sales organizations with biotech success A L T A R E X Partnering Strategy Think globally, act locally AltaRex conducts global development program including manufacturing For North America and Northern Europe: - JV for OvaRex™ (like niche markets) or - Multiple cancer antibodies, share 50:50 worldwide development costs A L T A R E X Partnering Strategy Think globally, act locally “Local” development or pan-European development conducted and paid for by “local” partners on pro-rata basis “Local” registration and pricing support “Local” sales and marketing efforts by partner Net operating profits split 50:50 upon commercialization A L T A R E X Partnering Strategy Worldwide OvaRex™ sales potential - U.S. $800MM+ (Company estimate) North America Germany France Italy Japan Scandinavia Spain, Portugal U.K. Greece, Balkans Australia/New Zealand Benelux Korea Israel ROW Global Sales (%) 63% 10% 5% 4% 4% 3% 3% 3% 2% 1% <1% <1% <1% <1% 100% A L T A R E X AltaRex Elucidates OvaRex™ Mechanism of Action at Scientific Conferences American Society of Hematology - New Orleans (Dec.) Society of Gynecological Oncologists - San Diego (Feb.) American Association for Cancer Research - San Francisco (April) Immunology 2000 - Seattle (May) American Society of Clinical Oncology (May) Future Trends in Therapeutic Antibodies - London (June) A L T A R E X Immunity and Cancer Immune system potent guardian Usually able to control early-stage tumors Late-stage tumors “inactivate” the immune system by: – Shedding “self ” tumor antigens generating tolerance (not recognized as foreign) and immunosuppression – Secreting inhibitory cytokines A L T A R E X How Can OvaRex™ MAb Augment Cancer Immunity? Low dose stimulation of immune system with foreign molecule (mouse protein) that binds tumor antigen Transportation of the antigen to antigen presenting cells (enhanced in presence of HAMA) Enhanced antigen processing and activation of T and B cells Activation of co-stimulating cytokines Removal of immune suppressive tumor antigens A L T A R E X OvaRex™ MAb Summary Targets TAA CA125 over-expressed >80% of late-stage ovarian cancer patients Ovarian cancer devastating (few symptoms; late diagnosis; high mortality) OvaRex™ data from relapsed patents (target indication) evidence efficacy and safety in phase II trials Double-blind placebo-controlled or controlled trials ongoing in “watchful waiting” (target indication); Fast Track obtained Registration plans for North America & Europe (including bridging to state-of-the-art manufacturing) A L T A R E X AIT® Pipeline One antibody, multiple tumors…one tumor, multiple antigens DISCOVERY PRECLINICAL PHASE I OvaRex™ Ovarian AR54 Ovarian BrevaRex™ Multiple myeloma GivaRex™ GI ProstaRex™ Prostate Antiviral/Autoimmune Multiple Opportunities A L T A R E X PHASE II/III In Summary AIT® Technology platform: Novel and safe therapeutic approach Multiple targets for cancer immunotherapy Potent method to induce tumor killing Product pipeline established Discovery assay system for future opportunities OvaRex™ in late-stage clinical development with near-term commercial potential A L T A R E X