Immunity for Life TM

Lars ViksmoenAdm.dir.

Biotec Pharmacon–Dream or reality?

AksjeNorge-dagenTromsø 22. april 2009

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)

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Biotec Pharmacon overview

Focus: - Pharmaceutical R&D- Commercial non-pharma production, marketing and sales

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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

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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%

The product

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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

The macrophageThe central effector cell in innate immunity

Mechanisms of actionSBG binds to receptors on macrophages –normalising their function

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CR3 (CD11b/CD18)-receptor

SBG

Toll like receptor 2/6

AB

C

Dectin-1“Human β-glucan receptor”

Clinical programs

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?

Pipeline

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PC Phase I II III Filing

Diab. foot ulcer

Oral mucositis

Cancer

IBD

Diabetic foot ulcer

Proof of Concept – clinical phase IISBG in diabetic foot ulcers

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SBG

Control

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

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Oral mucositis

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

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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:

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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)

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Immune therapy of cancer

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)

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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

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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

Partnering opportunities

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

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

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Thank You For Your Attention

Appendix

Financial status

Net cash position of NOK 124 million at YE 2008

Sufficient cash through to filing for diabetic ulcer phase III

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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:

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Diabetic foot ulcers Oral mucositis Immunotherapy of cancer