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ArcticZymes Technologies — Investor Presentation 2010
Dec 1, 2010
3538_rns_2010-12-01_5f2ce82e-558c-48f9-ac17-a2e3ed04d538.pdf
Investor Presentation
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BIOTEC PHARMACON

BIOTEC PHARMACON
Nordic Health Care Conference
Svein W. F. Lien - CEO
Jan Buch Andersen - Managing Director - Marine Biochemicals AS
1st December 2010
Biotec Pharmacon
Value proposition
Tromsø
Beta -1,3/1,6-glucan
- Reason for phase III failure has been documented
- Company refocused on medical device product
- Partner interest to take medical device to market
- Short way to market
- Pharma path retained through partner interest and dormant development programs
Marine Biochemicals
- Profitable business based on unique cold adapted enzymes
- Strong healthy growth forecast (doubling of sales 2009-2012)
- Strong IP position for marketed products
- Large unexploited market
- Strong pipeline secured through strategic alliances and acquisition
15 years of research in key areas – strong IP based science
BIOTEC PHARMACON
Highlights Beta-Glucans
- There is no good Diabetic Ulcer treatment on the market
- Annual value of the Diabetic Ulcer market of app. USD 1.5 billion
- Soluble Beta-Glucan (SBG) showed good clinical performance against Diabetic Ulcer in phase II and in the part of the phase III study that was conducted with an active product
- Soluble Beta-Glucan (SBG) is likely to be effective in other advanced wound healing applications, opening a USD 5bn+ market
> “No treatment for Diabetic Ulcer really works today”
> Professor William Jeffcote
> Department of Diabetes and Endocrinology, Nottingham City Hospital
BIOTEC PHARMACON
Sub-analysis of clinical data
$2^{\text{nd}}$ phase III batch showed results in line with phase II
| Clinical phase III
SBG in Nottingham study
2^{nd} batch (N=42)
Product stored for 3 months | | |
| --- | --- | --- |
| Product
% healed | Placebo
% healed | p-value |
| 52.4% | 33.3% | 0.22 |

Clinical phase II
Patients with complete healing (%)
4
BIOTEC PHARMACON
Yes, it was stability!
The gel was too fragile
SBG stored in polycarbonate containers perform better than the same batch stored in polyethylene ampoules.
2% SBG in treatment of acute wounds in diabetic mice

Accelerated stability data (37/4C w/ occasional shaking) shows that a more concentrated and solid gel has much better stability than 2% SBG used in the studies


BIOTEC PHARMACON
SBG - Proof of Concept is still valid
- Focus on development of an advanced wound care product, for use in e.g. diabetic ulcer
- First version to be launched as medical device
- Development of drug product remains an option, with different technology at a later stage
- Additional applications:
- Immunotherapy of cancer, Phase I with MSKCC
- Inflammatory bowel disease (IBD), Pre-clinical
- Asthma - feasibility

BIOTEC PHARMACON
Price level and composition:
| Product name | Producer | Size | Main component 1 (ex water) | Main component 2 (ex water) | Approx. price, EUR |
|---|---|---|---|---|---|
| Normlgel | Mölnlycke | 5/10g | Xanthan gum | NaCl | 8 (5g) |
| Intrasite | S&N | 8/15/25 | Croscarmellose (CMC) | Propylene glycol | 10 (8g) |
| Purilon | Coloplast | 15g | CMC | Alginate | 10 |
| Tegaderm | 3M | 15g | Propylene glycol | Guar gum | 10 |
| AquaSite | Derma Sc | 28g | "Special formulation" | Glycerine | 8 |
| Curasol | Healthpoint | 28g | Glycerin | glyceryl polyacrylate | 10 |
| Xelma | Mölnlycke | 0.5/1 ml | Extracellular matrix | Prop.glyc. alginate | 90 (0.5ml) |
| Regranex | Systagenix | 15g | rhPDGF | Carmellose (CMC) | 600 |
Class 2B Device
Class 3 Device
Drug
BIOTEC PHARMACON
We know we can make a medical device:
- Received general confirmation that a SBG topical wound product can be classified as a Medical Device in class IIb
Further to your query of the 31st August 2010 regarding the classification of Woulgan BioGel, I would like to confirm that the product appears to fall within the definition of a medical device. We consider that the product should be classified as a Class IIb medical device under rule 4.
Irish Medicines Board
- This means that a product may be developed and launched over the next 15-18 months
- There are pros and cons with the various classifications as to e.g. product claims but this leaves us with a certain freedom
BIOTEC PHARMACON
Time and cost for a class 2B device
| Activity | Timing | External cost (NOK) |
|---|---|---|
| Product development including two additional animal models | Started –2011 | 2.0 M |
| QA for ISO 13485, needed for CE marking | Started – end 2011 | 1.0 M |
| Clinical study- Dependent on partner pref. | Mid 2011 – launch | 4.0 M |
| Regulatory approvals EU and US = Launch | H1 2012 (EU) | |
| H2 2012 (US) | 1.5 M | |
| Miscellaneous | 1.0 M |
In addition comes internal cost of <NOK 3 million per month ex. contribution from Maine Biochemcicals
BIOTEC PHARMACON
Partner process
- Partner talks ongoing - well positioned in the topical wound care market
- First goal is a two-step partnership:
- A joint development project to ensure best possible product design and product(s) competitiveness
- A joint launch and market penetration program to ensure maximum growth and value creation
- Biotec strategy = Medical Device
- Will be flexible to get the best partner agreement
Nordic Health Care Conference
Marine Biochemicals AS
Jan Buch Andersen, Ph.D.
Managing Director
E-mail: [email protected]
Telephone: +47 46 74 61 71
Website: www.marinebiochem.com

MARINE
BIOCHEMICALS
Overview and outlook
- Profitable and growing
- Unique IP protected products for PCR sample preparation – removal of contaminants
- Market attractive (~ USD 2 bn) and growing at >10%/Y. Enzyme part of market 5-10%
- Unexploited market opportunities with current products
- We are respected for our service and product quality by our customers
Customer testimonial
– Cod UNG at Siemens:
Siemens also uses Cod UNG in its Versant kPCR assay for HCV, which is not yet on the market.
Wagner said that Marine Biochem is "just terrific to work with. They have amazing customer service and ... even though they are so small, they manufacture really high-quality products, which is really unusual in this industry. It's easy to find little research-y things that you can buy, but to be able to use them in an IVD product is great."
Cynthia Wagner, Senior Research Scientist, Siemens Healthcare Diagnostics, Berkeley
PCR Insider 1 April 2010
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1 December 2010
Nordic Health Care Conference, DnB NOR, Oslo
MARINE BIOCHEMICALS
Offering new opportunities in hypersensitive PCR reactions
Article on analysis of ancient DNA using hypersensitive PCR
Cod UNG: Thus, codUNG is roughly 100 fold more efficient than the bacterial UNG
HL-dsDNase:
In conclusion, the hl-dsDNase treatment is an efficient way to decontaminate PCR reagents that cannot be decontaminated by irradiation, in particular Taq DNA polymerase and dNTPs.
Decontamination of all reagents, including primers, is particularly important for forensic analyses and studies of ancient human remains where any reagent can be contaminated with human DNA.
Champlos et al. (2010): PLoS ONE 5(9): e13042.
doi:10.1371/journal.pone.0013042
- Enzymes from Marine Biochemicals will reduce background of qPCR tests by elimination of contaminating DNA
- Simplified workflow by integration of processes – suitable for automation
- DNase digestion during sample preparation
- No loss of precious sample
- Enzyme is heat-inactivated – no extraction with loss involved
- Allows for multistep enzyme reactions by heat-inactivation of previous enzyme
- Documented effect in the most critical analyses (publication on ancient DNA)
1 December 2010
Nordic Health Care Conference, DnB NOR, Oslo
MARINE BIOCHEMICALS
Gearing for international expansion
Key Issue: Outstanding products – few customers – broad applications
Focus I: Exhibitions to generate sales and trial requests
Successful for 2010 – 89 new trials initiated vs 9 last year
Focus II: Optimize supply chain – local warehouses
Focus III: Increase fields sales activity for 2011
Sales representatives USA and Europe
Focus IV: Transition from non-branded to branded sales
Number of OEM customers up 1,3X 2009 - 2010
Direct customers up 3X 2009 - 2010
Focus V: Recognition by key opinion leaders
Gregg Shipley at XGen, San Diego, PCR Insider and
Labmanager.com webcast 23 July
New Roche kit with our dsDNase:
Key Opinion Leader testimonial
Their Transcriptor runs at 55 °C, which is actually a pretty toasty reverse transcriptase reaction; but they run the DNase reaction, even though it's suboptimal, at 29 °C to do the DNAse, and then they go on and make the cDNA... boy, the data looks pretty nice so far
Gregg Shipley, Professor UTHSC-Houston, PCR Insider 31 March 2010

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1 December 2010
Nordic Health Care Conference, DnB NOR, Oslo
MARINE BIOCHEMICALS
New products out of Bioprospecting
- Long tradition for collaboration with academic institutions give access to:
- Unique product candidates
- Strong product knowledge
- Strong IP protection
- Acquisition of Marimol secured exclusive rights to commercialize outcome of MARZymes project
- Participation as exclusive enzyme partner in MabCent is starting to generate new product candidates
- New projects being initiated on eukaryotic microorganisms and viruses
STRONG PIPELINE BUILDING UP!

1 December 2010
Nordic Health Care Conference, DnB NOR, Oslo
MARINE BIOCHEMICALS
BIOTEC PHARMACON
Summary
| Beta-glucans | Marine Biochemicals |
|---|---|
| - Developing a wound healing product for Diabetic Ulcer and potentially other applications | |
| - Target is to develop a Medical Device for launch in 2012 | |
| - Large uncovered market need and value potential for a wound healing device | |
| - Partner discussions ongoing | - Remain committed to doubling of revenue in 2009-2012 |
| Large unexplored potential in current product range | |
| - Increasing international sales footprint | |
| Program for further development of sales & marketing platform and activities | |
| - Strong R&D partnering structure | |
| Essential to develop new product candidates and secure long-term growth |
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BIOTEC PHARMACON