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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
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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
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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
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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
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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
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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)
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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
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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)
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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
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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
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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
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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
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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
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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