Immunity for Life TM

Transcription

1 Immunity for Life TM DnB NR Markets Health Care Summit 2006 Prof. Dr. Jan Raa, Chief Scientific fficer 19 September 2006

2 A biomedical company Pharmaceutical development program + Cash generating businesses 2

3 Business structure Biotec Pharmacon ASA (Tromsø/slo) Marine bioproducts and bioprospecting (Tromsø) 100% Immunocorp AS (slo) Consumer health products (Immutol, Immuderm) Animal health products (MacroGard) 100% Immunocorp (Irvine, California) 3

4 Cash generating businesses High-margin non-pharmaceutical products with good growth potentials, based on immune modulating compounds and DNA-modifying enzymes Consumer health Animal health & nutrition Biochemicals 33,8 MNK in ,8 MNK in ,2 MNK in

5 The pharmaceutical program 1) Basic R&D (Tromsø, slo, 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 (slo) Phase I/II - Non-Hodgkins lymphoma (slo) C) Prevention of oral mucositis Phase II study completed (England) D) Treatment of burn wounds (Bergen) 5

6 How it started Scientific foundation: Biochemistry and innate immunity * Two cutting-edge discoveries (1980-ies) on the effect of beta-glucans on: 1) Cancer: Beta-glucan caused complete disappearance of tumors in mice 2) Resistance to infections: ral betaglucan enhanced resistance to infections and the efficacy of injected vaccines (first demonstrated with salmon) Tumour diameter (mm) % mortality Glucan treated Control Days Control MacroGard Days after onset of feeding with MacroGard

7 An alarm signal molecule The pharmaceutical product candidate SBG Soluble Beta-Glucan - 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 H C H 2 H H H CH 2 H H H H CH 2 H H CH 2 H H m H H n CH 2 H H CH 2 H H H H H C H 2 CH 2 H H H H CH 2 H H H CH 2 H H H m H n CH 2 H H CH 2 H H H C H 2 H 7

8 Biotec Pharmacon s in-house GMP-production of pharmaceutical grade SBG (approved by Norwegian authorities, SLV) 8

9 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 SBG 9

10 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 10

11 Proof-of-concept study in humans pen 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

12 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

13 Timeline Diabetic ulcers Timeline : Start of trial Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase II, Russia Q2-05 X Phase II, UK Q3-06 Partnering = Clinical trial = Partnering X = Trial data = Conclusion of patient treatment and expected results 13

14 Diabetic ulcers market 70 million people with diabetes in ECD 3.5 million patients are treated for diabetic foot ulcers annually Estimated market of USD 3.5 billion growing at 12-15% 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

15 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 15

16 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, an increase of 44% from 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 Revenues in USD Bn YEAR 16

17 Immunotherapy of cancer 17

18 Biotec Pharmacon s concept ral 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 18

19 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 19

20 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

21 Clinical studies (phase I/II) with SBG +mabs Memorial Sloan-Kettering Cancer Center, New York: Neuroblastoma (15 patients) SBG + mab3f8 Ullevål University Hospital/ Tromsø University Hospital : Breast cancer (12 patients) SBG + Herceptin Rikshospitalet-Radiumhospitalet HF: Lymphoma (12 patients) SBG + Rituxan/MabThera 21

22 Timeline Immunotherapy of cancer Timeline : Immunotherapy of cancer: Phase I/II, MSKCC, New York Q4-05 Phase I/II, Ullevaal, slo Q4-06 Phase I/II, Radiumhospitalet, slo Q4-06 Partnering, cancer Start of trial Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 = Clinical trial = Partnering X = Trial data = Conclusion of patient treatment and expected results 22

23 Immunotherapy of cancer market Approximately 5 million new cancer incidents each year in ECD Sales of cancer antibodies (mabs) reached USD 5 billion in 2004; expected to triple by 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,

24 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

25 ther 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 rphan 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

26 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

27 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

28 Share information Listed on slo Børs in November 2005 TICKER: BITEC Number of shares outstanding: wn shares: (3.9%) Number of shareholders: 475 Market cap ( ): MNK 902 Share price development since IP 20 largest shareholders: Paro AS 17.84% Four Seasons Private Equity AS 10.25% Ludwig Mack AS 8.92% din Norge 8.77% Hartvig Wennberg AS 4.00% Nordea Bank Denmark AS 3.78% Gunnar Rørstad 3.75% Jan Raa 2.83% NorgesInvestor Proto AS 2.38% Knut Eirik Andersen 2.13% B Skaugen AS 1.78% MP Pensjon 1.63% Anchor Secondary 2 Holding AS 1.12% VPF Avanse Norden 1.09% Arne Handeland 0.94% Holberg Norden Verdi 0.85% Hilde Raa 0.85% DnB NR Norden (III) 0.69% Cat Invest I 0.69% Violina AS 0.69% 28