immunity for life tm - biotec.no · market cap of ~nok 526m ... oral mucositis immunotherapy of...
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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 5th Swiss-Scandinavian Bio-Business Seminar, on 1 October, 2009, andthe information contained within will not be updated in this presentation. The following slides should be read andconsidered 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 background
Started in animal health in 1990, with particulate
betaglucans against infectious diseases in fish
Based on need for other anti-infectious agents than antibiotics
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
Pharmaceutical R&D
Commercial non-pharma production, marketing and sales
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Pharmaceuticals Non-pharmaceuticals
Ulcers and
Wounds
Immunotherapy
of CancerConsumer Health
Marine
Biochemicals
Beta 1,3/1,6 glucan
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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
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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
Oslo Stock Exchange – share facts
Market Cap of ~NOK 526m
per 31 August 2009
23.6 million shares
10 largest hold 58%
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Main shareholders per 1 Sep 2009 Percent
PARO AS 14.74%
VERDANE PRIVATE EQUITY AS 9.19%
VERDIPAPIRFOND ODIN NORGE 8.50%
LUDWIG MACK AS 7.47%
SUNDT AS 4.15%
HARTVIG WENNBERG AS 3.63%
NORDEA BANK DENMARK AS 3.33%
NORGESINVESTOR PROTO AS 2.96%
GUNNAR RØRSTAD 2.56%
OSLO PENSJONSFORSIKRING AS 2.20%
SUM 10 LARGEST 58.73%
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NOK/share
Biotec Pharmacon(OSE ticker "Biotec")
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
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SBG - Clinical development portfolio
Addressing unresolved medical problems in major disease areas
No well established therapies, few new product candidates in development
Commercial aspects of SBG:
• Innovative products - attractive pricing,
• Underdeveloped market - high growth potential,
• Hospital products - easier market access
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Preclinical Phase I Phase II Phase III NDA
Diabetic ulcers
Oral mucositis
Immunotherapy of cancer
IBD
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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
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CR3 (CD11b/CD18)-receptor SBG
Toll like receptor 2/6
AB
C
Dectin-1
“Human b-glucan receptor”
In-vitro resultsSBG stimulates cytokine production in macrophages
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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
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
Proof of concept – Ulcers and woundsSBG treatment of ulcers in diabetic mice
Statistically significant
difference in favor of
SBG vs. non-treated
control group at day 15
Methodology;
Wounds established on the
back of diabetic C57NI/KS-
db/db mice under general
anesthesia
Wound treatment with topical
application of SBG in active
group
18%
47%
0%
10%
20%
30%
40%
50%
60%
Non-treated control
SBG
Wound-size reduction (%)
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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
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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
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
• Proportion that heals within 12 weeks
• Time to healing of target ulcers
• % change in target ulcer area
• Recurrence within 12 weeks after healing
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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
2 Pivotal Trials in Europe - Phase IIIDiabetic foot ulcers
Diabetic foot ulcers Milestone schedule
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YTD • Completed patient inclusion in both studies
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 July 2010
Proof of Concept – clinical phase IISBG for prevention and treatment of oral mucositis
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SBG
Placebo
Patients developing severe Oral Mucositis (%)
Duration of therapy (days) n=36Source: Sook Bin Woo, eMedicine, Chemotherapy-induced Oral Mucositis
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 in Europe - Phase IIIOral Mucositis
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Patient population
• Number of patients; n=130
• 129 patients enrolled
• No changes made after sample size
reassessment
Primary endpoint
• Incidence of OM CTC grade 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 grade 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.
Proof of concept – CancerSBG and monoclonal antibodies in cancer
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
+ 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
Proof of concept – IBDSBG in the treatment of ulcerative colitis
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*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
Oral SBG treatment stimulates expansion of
Peyer’s patches and mesenteric lymph nodes (not shown) Sandvik et al. 2008 submitted
Preclinical Phase I Phase II Phase III NDA
Diabetic ulcers
Oral mucositis
Immunotherapy of cancer
IBD
SBG – Partnering Opportunities
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Open for partnering discussions with both global
and regional partners
Open for partnering opportunities for SBG for all
disease indications
Summary
SBG works
Established Proof of Concept in four indications; Diabetic foot
ulcer, oral mucositis, immunotherapy of cancer, and IBD
Addressing serious unresolved medical problems in major
market segments
Well advanced clinical program
Filing for marketing authorisation in Europe in July 2010 for
diabetic foot ulcer
Initiated partnering discussions
Open to partnerships for all indications in all markets
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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