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Immunity for Life TM Sven Rohmann VP Business Development SBG in Cancer and Oral Mucositis

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Immunity for Life TM

Sven Rohmann

VP Business Development

SBG in Cancer and Oral Mucositis

Disclaimer

This Presentation includes and is based, inter alia, on forward-looking information and statements that aresubject to risks and uncertainties that could cause actual results to differ. These statements and thisPresentation are based on current expectations, estimates and projections, which generally are identifiable bystatements containing words such as ”expects”, ”believes”, ”estimates” or similar expressions. Important factorsthat could cause actual results to differ materially from those expectations include, among others, generaleconomic and industry conditions in markets which are expected to be major markets for Biotec PharmaconASA’s products, as well as risks and uncertainties related to product development, regulatory approvals,commercial partnerships, the outcome of intellectual property rights litigation and the competitive situation.

Although Biotec Pharmacon ASA believes that its expectations and the Presentation are based upon reasonableassumptions, it can give no assurance that those expectations will be achieved or that the actual results will beas set out in the Presentation. Biotec Pharmacon ASA is making no representation or warranty, expressed orimplied, as to the accuracy, reliability or completeness of the Presentation, and neither Biotec Pharmacon ASAnor any of its directors, officers or employees will have any liability to you or any other persons resulting fromyour use of the information contained herein.

This presentation was prepared for the European Cancer Cluster Partnering Meeting in Toulouse, on September3rd and 4th 2009, and the information contained within will not be updated in this presentation. The followingslides should be read and considered in connection with other information provided by the company.

No shares of Biotec Pharmacon are being offered in connection with this presentation and no such shares havebeen registered under the U.S. Securities Act of 1933, as amended (the "Act"), and such shares may not beoffered or sold in the United States absent registration or an applicable exemption from the registrationrequirements of the Act.

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Biotec Pharmacon – Company facts

Market Cap of ~NOK 520m per

20 August 2009

Started in animal health in

1990, with particulate beta

glucans against infectious

diseases in fish

Established pharmaceutical

operation in 2000, with the

development of soluble beta

glucan (SBG)

Consumer Health and Marine

Biochemicals Businesses are

further assets.3

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Biotec Pharmacon(OSE ticker "Biotec")

Biotec Pharmacon Oslo Børs, Pharma&Biotech

Pharmaceutical conceptSBG regulates the innate immune system

SBG (Soluble Beta Glucan)

a unique/proprietary, highly

bioactive, soluble beta-1,3/1,6-

glucan

from cell walls of yeast

alien to the human body

How it works:

SBG has regulating and

normalizing effect on

macrophages and other

immune-competent cells.

enhances the efficacy of the

adaptive immune system4

Mechanisms of action: CellsSBG simultaneously branches into receptors

on e.g. macrophages

5

CR3 (CD11b/CD18)-receptor SBG

Toll like receptor 2/6

AB

C

Dectin-1

“Human b-glucan receptor”

Mechanism of actionb-Glucan binding of Dectin-1 receptor results in activation of

macrophages

6

Naive macrophage

CR

Target cell

=Tumor antigen

mAb C3b

LIMITED ACTION

C3b

Target cell

mAb

(1-n)= beta-glucan

ACTION

Cytokine

production

Acute inflam.

Phagocytosis

Expression of

co-factors

FcR

MacrophageDectin-1

FcR

CR

SBG

Mechanism of actionb-Glucan binding of complement receptor 3 results in iC3b-

mediated activation of granulocytes

7

granulocyte

CD11bCD18

granulocyte

Target cell

=Tumor antigen

mAb iC3b

NO ACTION

iC3b

Target cell

mAb

(1-n)= beta-glucan

ACTION

Phagocytosis

Respiratory burst

Cytotoxicity

FcR

CD18

Cytokines

from activated MØ

FcRCD11b

+ SBG

SBG - Clinical development portfolio

8

Preclinical Phase I Phase II Phase III NDA

Diabetic ulcers

Oral mucositis

Immunotherapy of

cancer

IBD

<< SBG

Preclinical Efficacy of SBG Mucosa Defects

9

*P<0.05, **P<0.01, ***P<0.001, 2-way ANOVA

SBG protects against DSS-induced colitis, and

has effect on epithelial proliferation and

intestinal restitution

Sandvik et al. 2008 submitted

<< SBG

Clinical Proof of Concept

phase II: Oral Mucositis

36 patients, single center, randomized, parallel group study to assess the

safety and efficacy of SBG on oral mucositis in head and neck cancer

patients receiving radiation therapy, with or without chemotherapy 10

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

<< SBG

Clinical phase 2008 2009 2010

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Phase III, Europe Phase III, Eastern Europe 2

nd study put on hold awaiting results from the 1

st study

Pivotal Trial - Phase IIIOral Mucositis

11

Patient population

• Number of patients; n=130

• 129 patients enrolled

• No changes made after sample size

reassessment

Primary endpoint

• Incidence of OM CTCgrade 3/4 at any time of

commencement of radiotherapy up to 5 days

after radiotherapy ceases.

Secondary endpoints

• Time from commencement of Radiotherapy to

onset of OM CTC grad 3/4 ;

• Duration of OM CTC grade 3/4

• Overall incidence of OM CTC grade 2, 3 and 4

Blue area = periods of patient inclusion, black areas = periods of study completion and reporting

Eligible for orphan drug designation in Europe.

<< SBG

MoA – Synergy with mAbsCancer

12

Synergy of p.o. barley beta-

glucan and antibodies against

tumor associated antigen in nude

micea) Melanoma xenografts in nude mice

b) Epidermoid carcinoma xenografts

c) Human breast carcinoma xenografts

c) Herceptin

b) anti-EGF-R

a) anti-GD3

Additional Finding:

Subcutaneous Daudi lymphoma was

significantly suppresses when rituximab

was administered with oral BG (not shown)

+ SBG

Cheung N-K et al. Cancer Immunol Immunother (2002) 51:557-564

Preclinical Proof of ConceptCancer

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)

13

mAB alone

mAB + SBG

+ SBG

Clinical phase 2008 2009 2010

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Phase I/II, Sloan Kettering

Patient populations• First study; n=45

• Patient enrolment completed

Primary endpoint

• Assess the clinical toxicity of SBG in combination

with anti-GD2 antibody 3F8 in stage 4 juvenile

neuroblastoma patients.

Secondary endpoints• Assess the biologic effects of SBG in combination

with anti-CD2 antibody 3F8

Blue area = periods of patient inclusion, black areas = periods of study completion and reporting

Clinical Proof of Concept –

Phase Ib/IIa

Before After

123I-MIBG scan of patient treated with one cycle

of 3F8+SBG (80mg/kg/day)

Marked decrease in neuroblastoma

disease burden

+ SBG

Clinical phase 2007 2008 2009

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Ullevål: SBG+Herceptin for breast cancer

Rikshospitalet: SBG+Rituximab for non-Hodgkin’s lymphoma

Patient populations• Study 1; n=10, Study 2; n=12

• Patient enrolment completed in both studies

Primary endpoint

• Study 1: Assess the safety of oral SBG in

combination with Herceptin given to breast cancer

patients undergoing standard chemo- and antibody

treatment.

• Study 2: Assess the safety of oral SBG in

combination with MabThera (Rituximab) given to

non-Hodgkin’s lymphoma patients undergoing

standard chemo- and antibody treatment.

Secondary endpoints• Both studies: Assess the anti-tumor response of the

combination treatment

Safety – Clinical Phase I/II

15

Blue area = periods of patient inclusion, black areas = periods of study completion and reporting

+ SBG

Partnering opportunities

In partnering discussions with both global and

regional partners

Presently all partnering possibilities open,

including:

Commercial partnering opportunities for

SBG for Oral mucositis

R&D Collaborations on the use of SBG

together with mAbs

R&D Collaborations on the use of SBG

together with cancer vaccines

16

+ SBG

<< SBG

Summary

SBG works

Established Proof of Concept on the beneficial effects of SBG

in supportive care in cancer (OM);

Established clinical data suggesting a potentially important

role of SBG in cancer treatment when combined with

antibodies.

Advanced clinical program in Europe and USA

Ongoing partnering discussions

Open to commercial and R&D partnerships on treatment of

oral mucositis and cancer.

17

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Contact:

Sven Rohmann, MD, PhD

Mobile: +41 79 577 8895

E-mail: [email protected]

Biotec Pharmacon ASA,

Strandgata 3

N-9008 Tromso, Norway,

or

Biotec Pharmacon ASA,

Drammensveien 149

N-0277 Oslo, Norway

www.biotec.no

Appendix

Financials and Management

21

Financial Highlights

Q2 09 Q2 08 H1 09 H1 08 2008 Q1 09

Revenue 11.4 14.3 23.7 26.2 51.7 12.3

EBITDA, non-pharma 0.2 -1.1 -0.6 -3.8 -5.6 -0.8

EBITDA, pharma R&D -20.1 -10.0 -36.0 -21.0 -72.0 -15.9

EBITDA, unallocated -0.9 -3.5 -1.1 -5.1 -10.3 -0.2

EBITDA, total -20.8 -14.6 -37.7 -29.9 -87.9 -16.9

EBIT -21.6 -15.4 -39.2 -31.5 -91.3 -17.6

Net financials 1.0 2.0 2.5 3.9 8.3 1.5

Profit before tax, continued operations -20.6 -13.4 -37.8 -27.7 -83.0 -16.1

Net profit, continued operations -20.6 -13.4 -36.8 -27.7 -78.8 -16.1

Net profit, discontinued operations - 1.0 - 0.7 26.6 -

Net result for the period -20.6 -12.3 -36.8 -26.9 -52.2 -16.1

22

Consolidated Balance Sheet Condensed figures

(NOK ’000) 30.06.09 31.12.08

Non-current assets 47 719 47 818

Cash and cash eq. 79 782 124 589

Other current assets 18 044 15 349

Total current assets 97 826 139 938

Assets 145 545 187 757

Equity 123 152 159 264

Liabilities 22 393 28 493

Equity & Liabilities 145 545 187 757

Equity Ratio 85% 85%

0

20

40

60

80

100

120

140

160

180

200

NOKm

Equity

Liabilities

Non-

current

Current

31/12/0830/06/09

Balance Sheet composition

Cash

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

Immunocorp Consumer Health

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

23

Further Pharmaceutical

concept Data

25

Mechanism of actionSBG on cellular level

TLR2

Dectin

SBG

Clathrin

Dependent

Caveolin-1

regulated

Golgi

Syk kinasePI3K

Akt

GSK3b

Dectin

degradation IL-13, IL-17, MCP-1

GM-CSF

TLR2 SBG

Dectin

Protein

synthesis

, Prx I

In-vitro resultsSBG stimulates cytokine production in macrophages

SBG in a mice

study shows

strong effect on

TNF-alpha

A close to linear

increase in cytokine

production (TNF-

alpha) in peritoneal

macrophages with

increasing dose of

SBG

26

Zykova 2005

0

10

20

30

40

50

60

70

80

0 0.1 0.2 0.5 1 5

TN

F-a

(p

g/m

l)

Concentration of stimulant (mg/ml)

SBG

Placebo

In-vitro resultsSBG stimulates cytokine production in whole blood

SBG in a human

study shows an

effect on TNF-a,

IL-6, IL-8, IL-10

and TF production

The concentration of

cytokines peak at

different timepoints.

SBG induced the

production of large

amounts IL-8 and TF

27

Toxicology/safety in animalsSBG in in-vitro and in-vivo animal studies

Very favourable toxicity

No potential clinical hazard identified for proposed

human use, for either topical or oral administration

28

No potential found for mutagenicity or genotoxicity

Minimal lethal dose could not be found in toxicity studies in

rodents or non-rodents

NOEL dose of 200 mg/kg/day after oral administration for 28

days in rats, 300mg/kg/day in dogs

Demonstrated good local tolerance after topical application

Proof of Concept – Clinical phase IISBG in treatment of diabetic foot ulcers

29

SBG

Control

Patient

populations

• First study; n=120, second study; n=130

• Patient enrolment completed

• No changes made after interim analyses

Primary

endpoint

• Proportion of patients with target ulcers that

heal within 8 weeks

Secondary

endpoints

• Time to healing of target ulcers

• % change in target ulcer area

• Recurrence within 12 weeks after healing

• Patient well-being and satisfaction (first study)

• Proportion that heals within 12 weeks (second

study)

Phase III – diabetic foot ulcerTwo pivotal studies

30

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

Blue area = periods of patient inclusion, black areas = periods of study completion and reporting

First study

Second study

Diabetic foot ulcers Milestone schedule

31

YTD

• Completed patient inclusion in 1st phase III study

• Performed interim study in 2nd phase III study

• Completed patient inclusion in 2nd phase III study

Q3 2009• Completion of treatment and follow-up programs

• Data collection and analysis

Q4 2009 • Final results expected to be ready from both studies

July-2010• Filing for market approval in Europe, in a decentralized

process with UK as reference member state