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Immunity for Life TM
Lars ViksmoenAdm.dir.
Biotec Pharmacon–Dream or reality?
AksjeNorge-dagenTromsø 22. april 2009
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
Focus: - Pharmaceutical R&D- Commercial non-pharma production, marketing and sales
4
Pharmaceuticals Non-pharmaceuticals
Ulcers and Wounds
Immunotherapy of Cancer Consumer Health
Marine Biochemicals
Beta 1,3/1,6 glucan
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
5
Shareholder PercentPARO AS 14.74%VERDANE PRIVATE EQUITY AS 9.32%VERDIPAPIRFOND ODIN NORGE 8.24%LUDWIG MACK AS 7.47%SUNDT AS 4.15%HARTVIG WENNBERG AS 3.63%NORDEA BANK DENMARK AS 3.33%GUNNAR RØRSTAD 2.56%OSLO PENSJONSFORSIKRING AS 2.20%NORGESINVESTOR PROTO AS 2.20%SUM 10 LARGEST 57.84%
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Pharmaceutical conceptSBG 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
Mechanisms of actionSBG binds to receptors on macrophages –normalising their function
9
CR3 (CD11b/CD18)-receptor
SBG
Toll like receptor 2/6
AB
C
Dectin-1“Human β-glucan receptor”
Clinical development phases
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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?
Phase III – diabetic foot ulcerTwo pivotal studies
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:
Target filing for marketing authorisation in Europe by mid-201015
Proportion of patients with target ulcers than heal within 12 weeksTime to healing of target ulcersPercent change in target ulcer areaRecurrence of healed targets ulcers within 12 weeks after healing
Clinical phase 2008 2009 2010
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase III, Nottingham, UK Phase III, Europe/Eastern Europe
Addressing major unmet medical needs
250+ million adult diabetics, growing at ~2.5% p.a.
1 in 6 diabetics develop an ulcer at some stage
15-25% of diabetics with foot ulcer require amputation
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
No standard drug treatment, only hygiene/general wound care
SBG reactivates skin immune cells and enhances the body’s own wound healing capabilities
Sizeable market*:
Serious condition*:
Therapy:
SBG approach:
16Source, International Diabetes Federation
Diabetic foot ulcers Milestone schedule
2007
2009
2010
2011
Established phase III programs (2 studies)
Study results FDA Guidance Meeting Enter partnership(s)?
Filing for marketing authorisation in Europe
Launch
17
Proof of Concept – clinical phase IISBG for prevention and treatment of oral mucositis
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0
10
20
30
40
50
60
70
1 15 21 23 30 36 40
SBG
Placebo
Patients developing severe Oral Mucositis (%)
Duration of therapy (days) n=36Source: Sook Bin Woo, eMedicine, Chemotherapy-induced Oral Mucositis
20
Oral Mucositis – Clinical Program
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
Clinical phase 2008 2009 2010
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase III, Europe Phase III, Eastern Europe 2nd study put on hold awaiting results from the 1st study
Addressing major unmet medical needs
Incidence ~ 400-600.000 per year (OECD)
Severe impact on ability to complete cancer therapy
No standard drug treatment, only hygiene and/or symptomatic care
SBG reactivates mucosal immune cells and enhances the body’s own wound healing capabilities
Sizeable market:
Serious condition:
Therapy:
SBG approach:
21
Oral Mucositis Milestone schedule
2008
2009
2010
Established phase III program (2 studies)
Postponement 2nd phase III study Interim analysis 1st phase III study Completion of patient inclusion 1st phase III study?
Filing for marketing authorisation in Europe, alt. start 2nd phase III study?
Enter partnership(s)
22
Proof of concept in cancerSBG and monoclonal antibodies (mAb)
Significant (p<0.05) effect of mAb+SBG versus 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)
24
mAB alone
mAB + SBG
Proof of Concept – clinical phase Ib/IIaSBG + 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
25
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)
Immunotherapy of cancer
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 portfolio26
Clinical phase 2007 2008 2009
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase I/II, Sloan Kettering Phase I/II, Rikshospitalet Phase I/II, Ullevål
Focusing on attractive market areasUlcers & 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 progress29
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
markets31
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
Results from phase III studies for diabetic foot ulcer
Interim analysis for 1st oral mucositis phase III study
Enter partnership deal ?
Enter partnership deal ?
File for marketing authorisations in Europe for diabetic foot ulcer, to be followed by oral mucositis
2nd half 2009
Mid-2010
32
Financial status
Net cash position of NOK 124 million at YE 2008
Sufficient cash through to filing for diabetic ulcer phase III
35
EquityNon-current assets
Current assets
Cash
Liabilities
Balance Sheet composition 31 December 2008
Current
Cash
Non-current Equity
Liabilities
Management and Board of Directors
Management Lars Viksmoen - CEO
Jørn Lunde - CFO
Rolf Engstad – CSO
Sven Rohmann – VP Business Development
Britt Olaussen – VP Clinical Development
Kari Skinnemoen – VP Regulatory Affairs
Steinar Børresen – VP Manufacturing
Arvid Vangen – VP Finance & Adm
Arvid Lindberg – Managing Director ICH
Board of Directors Svein Mathisen (Chairman)
Jan Gunnar Hartvig
Ingrid Alfheim
Kari Stenersen
Ingrid Wiik
Arne Handeland
Morten Eide (Employee rep.)
Please refer to www.biotec.no for more information 36
Addressing major unmet medical needs
3.5 million diabetics develop foot ulcers annually
US: ~100,000 amputations p.a.
No standard drug treatment
SBG reactivates skin immune cells, enhances the body’s own wound healing capabilities
~400-600,000 incidents annually in the OECD
Severe impact on cancer therapy
No standard drug treatment
SBG stimulates mucosal immune cells, enhancing the body’s own wound healing capabilities
Fastest growing segment of pharma industry
The last resort of cancer therapy
mAb + adjuvants: a new standard?
SBG enhances the immune system’s effectiveness in killing cancer cells
Sizeable markets:
Serious conditions:
Therapies:
Documented effects:
37
Diabetic foot ulcers Oral mucositis Immunotherapy of cancer