Download Immunity for Life TM DnB NOR Markets Health Care Summit 2006

Immunity for Life TM
DnB NOR Markets
Health Care Summit 2006
Prof. Dr. Jan Raa, Chief Scientific Officer
19 September 2006
A biomedical company
Pharmaceutical development program
+
Cash generating businesses
2
Business structure
Biotec Pharmacon ASA
(Tromsø/Oslo)
Marine bioproducts and
bioprospecting
(Tromsø)
100%
Immunocorp AS
(Oslo)
• Consumer health products (Immutol, Immuderm)
• Animal health products (MacroGard)
100%
Immunocorp
(Irvine, California)
3
Cash generating businesses
High-margin non-pharmaceutical products with good growth potentials,
based on immune modulating compounds and DNA-modifying enzymes
Consumer health
33,8 MNOK in 2005
Animal health & nutrition
23,8 MNOK in 2005
Biochemicals
11,2 MNOK in 2005
4
The pharmaceutical program
1) Basic R&D (Tromsø, Oslo, USA, Berlin)
2) Clinical trials:
A) Treatment of diabetic ulcers
–
–
Phase II study completed (Russia)
Phase II study ready to start (England)
B) Immunotherapy of cancer
–
–
Phase I/II - Neuroblastoma (New York)
Phase I/II - Breast cancer (Oslo)
–
Phase I/II - Non-Hodgkins lymphoma (Oslo)
C) Prevention of oral mucositis
–
Phase II study completed (England)
D) Treatment of burn wounds (Bergen)
5
How it started
*
Two cutting-edge discoveries (1980-ies)
on the effect of beta-glucans on:
Glucan treated
15
Tumour diameter (mm)
Scientific foundation: Biochemistry
and innate immunity
Control
10
5
0
2)
0
Cancer: Beta-glucan caused complete
disappearance of tumors in mice
Resistance to infections: Oral betaglucan enhanced resistance to infections
and the efficacy of injected vaccines
(first demonstrated with salmon)
7
14
21
Days
100
90
Control
80
% mortality
1)
70
60
50
MacroGard
40
30
20
10
0
0
78
88
98
108
118
Days after onset of feeding with MacroGard
6
The pharmaceutical product candidate
SBG – Soluble Beta-Glucan
• An ”alarm signal molecule”
- present in cell walls of yeast (a beta-1,3/1,6-glucan)
- alien to the human body
• Mobilizes immune mechanisms involved in:
- the body’s own destruction of cancer cells
- infection defence
- wound healing
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7
Biotec Pharmacon’s in-house GMP-production of pharmaceutical grade
SBG (approved by Norwegian authorities, SLV)
8
Mode of action
SBG binds to specific receptors on macrophages and other white
blood cells in the body’s innate front-line defence, resulting in:
Receptors
Macrophage
Enhanced
•
wound/ulcer healing
•
anti-cancer mechanisms
•
infection defence
•
vaccine efficiency
”There is at bottom
only one genuinely
scientific treatment
for all diseases, and
that is to stimulate the
phagocytes”.
In ”The Doctors
Dilemma” by
G.B.Shaw, inspired by
Metchnikoff’s Nobel
Prize adress in 1908.
SBG
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SBG in diabetic ulcers
• Wound healing
– Wounds will normally heal without complications in individuals with
normal immune functions and active macrophages
– Macrophages play a key role in regeneration of damaged tissues and in
infection defence
• Diabetic ulcers
– Macrophage activity is impaired in individuals with diabetes - a reason
why wounds may develop into chronic ulcers (in particular leg and foot
ulcers)
– Scientists affiliated with Biotec Pharmacon discovered that beta-glucan
reactivates diabetic macrophages and enhances wound healing in animals
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Proof-of-concept study in humans
• Open clinical study with 20 patients:
– The results showed extraordinary good effect of SBG compared to best
available alternative treatment (control group)
– Most of the ulcers treated with SBG had healed in 35 days compared to
only two in the control group
(Dr. T. Zykova, University Hospital, Archangelsk)
11
Clinical studies (phase II) with SBG on diabetic ulcers
• A double-blinded phase II study with diabetic ulcer
patients has been completed in Russia
• A second phase II study has been approved in the U.K.
and is ready for start up
• Planning of a phase III study
12
Timeline
Diabetic ulcers
Timeline 2006 - 2008:
Start of
trial
Phase II, Russia
Q2-05
Phase II, UK
Q3-06
Q1
2006
Q2
Q3
Q4
Q1
2007
Q2
Q3
Q4
Q1
2008
Q2
Q3
X
Partnering
= Clinical trial
= Partnering
X = Trial data
= Conclusion of patient treatment and expected results
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Q4
Diabetic ulcers – market
• 70 million people with diabetes in OECD
• 3.5 million patients are treated for diabetic foot ulcers
annually
• Estimated market of USD 3.5 billion growing at 1215% per year
• High cost of treatment; wound healing products
account for approximately 10% of total cost
• Blockbuster potential if proved effective; current
treatment cost of Regranex from Johnson & Johnson
more than $1,000
14
Immunotherapy of cancer
Basic idea
The body’s immune system should ”perceive” tumor cells as alien and destroy
them like it destroys infectious microorganisms
Two strategies:
1) Vaccination with components unique for cells in the tumor
2) Injection of pre-fabricated antibodies (mAbs = monoclonal antibodies)
Therapeutic efficiency
Not in line with expectations
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Total sales of mAbs
• Currently, 19 different mAbs approved for
therapeutic use
Global sales of Antibody therapeutics
• Revenue in 2004: Excess of $10.5 billion,
• Projected sale of mAbs of $30 billion by
2010 (50 % cancer)
Cancer mAbs sales in 2005:
- Rituxan: US$ 3.3 billion
- Herceptin: US$ 1.7 billion
- Avastin: US$ 1.3 billion
30
Revenues in USD Bn
an increase of 44% from 2003
35
25
20
15
10
5
0
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2007 2010
YEAR
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Immunotherapy of cancer
17
Biotec Pharmacon’s concept
Oral SBG + injected mAbs:
• SBG mobilizes innate immune mechanisms that kill cancer cells
”tagged” by injected mAbs
• Proof of concept data from Memorial Sloan-Kettering Cancer Center
(MSKCC), New York, in 2003 and 2004 showed that SBG elicits strong
antitumour effect of injected mAbs
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Immunotherapy of cancer
• Monoclonal antibodies (mAbs) bind to (”tag”) cancer cells
• SBG triggers immune destruction of cancer cells ”tagged” by mAbs
mAb
SBG + mAb
EXAMPLE:
Effect of a monoclonal
antibody (mAb) alone and in
combination with oral SBG on
tumour development in mice
inoculated with human cancer
cells
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Literature quotation
“Moreover, mAbs that have virtually no tumor
regression activity when used alone are able to
mediate complete regression when given
in combination with beta-glucan”.
Trends in Immunology, Vol.25 No.3 March 2004
20
Clinical studies (phase I/II) with SBG +mAbs
• Memorial Sloan-Kettering Cancer Center, New York:
– Neuroblastoma (15 patients)
– SBG + mAb 3F8
• Ullevål University Hospital/ Tromsø University Hospital :
– Breast cancer (12 patients)
– SBG + Herceptin
• Rikshospitalet-Radiumhospitalet HF:
– Lymphoma (12 patients)
– SBG + Rituxan/MabThera
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Timeline
Immunotherapy of cancer
Timeline 2006 - 2008:
Start of
trial
Q1
2006
Q2
Q3
Q4
Q1
2007
Q2
Q3
Q4
Q1
2008
Q2
Q3
Immunotherapy of cancer:
Phase I/II, MSKCC, New York
Q4-05
Phase I/II, Ullevaal, Oslo
Q4-06
Phase I/II, Radiumhospitalet, Oslo
Q4-06
Partnering, cancer
= Clinical trial
= Partnering
X = Trial data
= Conclusion of patient treatment and expected results
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Q4
Immunotherapy of cancer – market
• Approximately 5 million new cancer incidents
each year in OECD
• Sales of cancer antibodies (mAbs) reached USD
5 billion in 2004; expected to triple by 2010.
• Roche and Genentech major players
• High cost of treatment with mAbs and modest
therapeutic effect
• Blockbuster potential if SBG can show improved
effect of mAbs; current treatment cost with mAbs
$20-$45,000.
23
Perspective and implications
If human clinical studies confirm proof-of-concept data
with animals, showing that SBG improves the
effectiveness of cancer monoclonal antibodies - even to
a small degree - SBG represents block-buster potential
within cancer treatment!
24
Other clinical trials
• Prevention of oral mucositis in cancer patients
-
A clinical phase II trial completed at the Royal Marsden &
The Institute of Cancer Research in London
-
EMEA has granted Orphan drug designation for SBG used
in the prevention of oral mucositis
• Burn wounds
- A clinical phase I/II trial on patients with burn wounds
25
Business model – pharmaceuticals
• Retain ownership and strategic flexibility by completing on-going
clinical studies
• Partner with international pharmaceutical or biotechnology companies
with capabilities in late stage clinical development, regulatory
compliance, marketing and sales
• Income through up-front licence fees, milestone fees, royalty and sales
of SBG to licencees
26
Product pipeline
1) Immunotherapeutic and -prophylactic treatment
of influenza
2) New antibiotic principles from marine genes
3) New marine gene products for Life science
applications
4) Product formulations preventing and treating
gingivitis and periodontitis
27
Share information
Listed on Oslo Børs
in November 2005
TICKER: BIOTEC
Number of shares outstanding: 21.489.010
Own shares:
832.000 (3.9%)
Number of shareholders:
475
Market cap (14.09.06):
MNOK 902
Share price development since IPO
20 largest shareholders:
Paro AS
Four Seasons Private Equity AS
Ludwig Mack AS
Odin Norge
Hartvig Wennberg AS
Nordea Bank Denmark AS
Gunnar Rørstad
Jan Raa
NorgesInvestor Proto AS
Knut Eirik Andersen
B Skaugen AS
MP Pensjon
Anchor Secondary 2 Holding AS
VPF Avanse Norden
Arne Handeland
Holberg Norden Verdi
Hilde Raa
DnB NOR Norden (III)
Cat Invest I
Violina AS
17.84%
10.25%
8.92%
8.77%
4.00%
3.78%
3.75%
2.83%
2.38%
2.13%
1.78%
1.63%
1.12%
1.09%
0.94%
0.85%
0.85%
0.69%
0.69%
0.69%
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