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Immunity for Life TM Biotec Pharmacon– Dream or reality? AksjeNorge-dagen Tromsø 22. april 2009 Lars Viksmoen Adm.dir. The company Biotec Pharmacon background Started in animal health in 1990, with particulate betaglucans to stimulate weight gain in fish farms Immune modulating hypothesis generated by chance Established a wealth of data and proof of concept Divested Animal Health for NOK 37.5 million in 2008 Retained Consumer Health and Marine Biochemicals Established pharmaceutical operation in 2000, with the development of soluble beta glucan (SBG) 3 Biotec Pharmacon overview Pharmaceuticals Ulcers and Wounds Immunotherapy of Cancer Non-pharmaceuticals Consumer Health Marine Biochemicals Beta 1,3/1,6 glucan Focus: - Pharmaceutical R&D - Commercial non-pharma production, marketing and sales 4 Listed on Oslo Stock Exchange Market Capitalization of ~NOK 390 million Per 17 April 2009 Ownership 24.6 million shares 10 largest hold 57.8% Per 21 January 2009 Shareholder PARO AS VERDANE PRIVATE EQUITY AS VERDIPAPIRFOND ODIN NORGE LUDWIG MACK AS SUNDT AS HARTVIG WENNBERG AS NORDEA BANK DENMARK AS GUNNAR RØRSTAD OSLO PENSJONSFORSIKRING AS NORGESINVESTOR PROTO AS SUM 10 LARGEST Percent 14.74% 9.32% 8.24% 7.47% 4.15% 3.63% 3.33% 2.56% 2.20% 2.20% 57.84% 5 The product Pharmaceutical concept SBG stimulates the immune system SBG (Soluble Beta Glucan) a unique, highly bioactive, soluble beta-1,3/1,6-glucan from cell walls of yeast alien to the human body How it works: stimulates the innate immune system enhances the efficacy of the adaptive immune system addresses a range of diseases 7 The macrophage The central effector cell in innate immunity Mechanisms of action SBG binds to receptors on macrophages – normalising their function SBG Dectin-1 “Human β-glucan receptor” CR3 (CD11b/CD18)-receptor A B C Toll like receptor 2/6 9 Clinical programs Clinical development phases Phase Purpose/Question Pre-clinical Safety and pharmacology Phase I Is it safe? Phase II Does it work? Phase III How well does it work? 11 Pipeline PC Phase I II III Filing Diab. foot ulcer Oral mucositis Cancer IBD 12 Diabetic foot ulcer Proof of Concept – clinical phase II SBG in diabetic foot ulcers SBG Control 14 Phase III – diabetic foot ulcer Two pivotal studies 2008 Clinical phase Q1 Q2 Q3 2010 2009 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase III, Nottingham, UK Phase III, Europe/Eastern Europe Both phase III studies fully enrolled (assuming no increase in sample size) Endpoints Primary: Proportion of patients with target ulcers than heal within 8 weeks Secondary: Proportion of patients with target ulcers than heal within 12 weeks Time to healing of target ulcers Percent change in target ulcer area Recurrence of healed targets ulcers within 12 weeks after healing Target filing for marketing authorisation in Europe by mid-2010 15 Addressing major unmet medical needs Sizeable market*: 250+ million adult diabetics, growing at ~2.5% p.a. Serious condition*: 15-25% of diabetics with foot ulcer require amputation 1 in 6 diabetics develop an ulcer at some stage 85% of diabetics’ leg amputations are preceded by ulcers 70% of all leg amputations in diabetic patients People with diabetes are 25x more likely to amputate a leg Therapy: No standard drug treatment, only hygiene/general wound care SBG approach: SBG reactivates skin immune cells and enhances the body’s own wound healing capabilities Source, International Diabetes Federation 16 Diabetic foot ulcers Milestone schedule 2007 Established phase III programs (2 studies) 2009 Study results FDA Guidance Meeting Enter partnership(s)? 2010 Filing for marketing authorisation in Europe 2011 Launch 17 Oral mucositis Proof of Concept – clinical phase II SBG for prevention and treatment of oral mucositis Patients developing severe Oral Mucositis (%) 70 Placebo 60 50 SBG 40 30 20 10 0 1 Source: Sook Bin Woo, eMedicine, Chemotherapy-induced Oral Mucositis 15 21 23 30 Duration of therapy (days) 36 40 n=36 19 Oral Mucositis – Clinical Program Clinical phase 2008 Q1 Q2 Q3 2009 Q4 Q1 Q2 Q3 2010 Q4 Q1 Q2 Q3 Q4 Phase III, Europe Phase III, Eastern Europe 2nd study put on hold awaiting results from the 1st study Patient enrolment well advanced in European phase III study 130 patients at ~20 centres in three European countries Initially slow patient inclusion, now enrolled > 2/3 of planned patients Interim analysis scheduled after 80 evaluable patient, with results in Q3’09 Second phase III study has been put on hold Awaiting results from the first phase III study Decision lowers 2009 R&D costs by NOK 20-25 million Filing for market authorisation depending on results from first study 20 Addressing major unmet medical needs Sizeable market: Incidence ~ 400-600.000 per year (OECD) Serious condition: Severe impact on ability to complete cancer therapy Therapy: No standard drug treatment, only hygiene and/or symptomatic care SBG approach: SBG reactivates mucosal immune cells and enhances the body’s own wound healing capabilities 21 Oral Mucositis Milestone schedule 2008 Established phase III program (2 studies) 2009 Postponement 2nd phase III study Interim analysis 1st phase III study Completion of patient inclusion 1st phase III study? 2010 Filing for marketing authorisation in Europe, alt. start 2nd phase III study? Enter partnership(s) 22 Immune therapy of cancer Proof of concept in cancer SBG and monoclonal antibodies (mAb) Significant (p<0.05) effect of mAb+SBG versus mAb alone mAB alone Methodology: Inoculation of mice with human neuroblastoma cancer cells, leading to development of tumors Treatment with the mAb 3F8 in active and control group SBG in addition to mAb (3F8) in the active group Primary end point: Tumor size (% increase) mAB + SBG 24 Proof of Concept – clinical phase Ib/IIa SBG + mAb for cancer therapy Open label study with SBG+3F8 in children with neuroblastoma Well tolerated even at very high dosage levels Promising efficacy data; objective response in ~40% of the patients Full results awaited in first half 2009 Marked decrease in neuroblastoma disease burden Before After 123I-MIBG scan of patient treated with one cycle of 3F8+SBG (80mg/kg/day) * 3F8 is a monoclonal antibody (mAb) 25 Immunotherapy of cancer Clinical phase 2007 Q1 Q2 Q3 2008 Q4 Q1 Q2 Q3 2009 Q4 Q1 Q2 Q3 Q4 Phase I/II, Sloan Kettering Phase I/II, Rikshospitalet Phase I/II, Ullevål Neuroblastoma: Completed enrolment, strong safety data Non-Hodgkins’ lymphoma: Completed enrolment, strong safety data Breast cancer: 10/12 patients included Awaiting final data to decide on further progress Actively seeking partners to further develop the portfolio 26 Partnering opportunities Focusing on attractive market areas Ulcers & Wounds and Cancer Disease aspects: Addressing unresolved medical problems Addressing major disease areas - diabetes and cancer Competitive aspects: No well established therapies Few new product candidates in development Commercial aspects: Innovative products - attractive pricing Underdeveloped market - high growth potential Hospital products – less costly market access 28 Partnering opportunities Open for commercial partnering opportunities for SBG Global or regional Open for partnering opportunities for all disease indications Diabetic foot ulcer Oral mucositis Immunotherapy of cancer Partner search in progress 29 Summary Summary Product (SBG) that works Established Proof of Concept in three indications; diabetic foot ulcer, oral mucositis, and immunotherapy of cancer Addressing serious unresolved medical problems with high unmet medical needs in major market segments Well advanced clinical program Phase III results for diabetic foot ulcer by end 2009 Phase III oral mucositis interim analysis Q3’09 Initiated partnering discussions Open to commercial partnerships for all indications in all markets 31 Summary: Milestone schedule 1st half 2009 Complete enrollment in phase III diabetic ulcer studies Decision on next step in cancer program Seek FDA Guidance Meeting 2nd half 2009 Results from phase III studies for diabetic foot ulcer Interim analysis for 1st oral mucositis phase III study Enter partnership deal ? Mid-2010 Enter partnership deal ? File for marketing authorisations in Europe for diabetic foot ulcer, to be followed by oral mucositis 32 Thank You For Your Attention 33 Appendix Financial status Net cash position of NOK 124 million at YE 2008 Sufficient cash through to filing for diabetic ulcer phase III Balance Sheet composition 31 December 2008 Current assets Current Liabilities Liabilities Cash Cash Non-current assets Noncurrent Equity Equity 35 Management and Board of Directors Management Board of Directors Lars Viksmoen - CEO Svein Mathisen (Chairman) Jørn Lunde - CFO Jan Gunnar Hartvig Rolf Engstad – CSO Ingrid Alfheim Sven Rohmann – VP Business Development Kari Stenersen Britt Olaussen – VP Clinical Development Kari Skinnemoen – VP Regulatory Affairs Ingrid Wiik Arne Handeland Morten Eide (Employee rep.) Steinar Børresen – VP Manufacturing Arvid Vangen – VP Finance & Adm Arvid Lindberg – Managing Director ICH Please refer to www.biotec.no for more information 36 Addressing major unmet medical needs Diabetic foot ulcers Oral mucositis Immunotherapy of cancer Sizeable markets: 3.5 million diabetics develop foot ulcers annually ~400-600,000 incidents annually in the OECD Fastest growing segment of pharma industry Serious conditions: US: ~100,000 amputations p.a. Severe impact on cancer therapy The last resort of cancer therapy Therapies: No standard drug treatment No standard drug treatment mAb + adjuvants: a new standard? Documented effects: SBG reactivates skin immune cells, enhances the body’s own wound healing capabilities SBG stimulates mucosal immune cells, enhancing the body’s own wound healing capabilities SBG enhances the immune system’s effectiveness in killing cancer cells 37