AM-1 an innovative anti-microbial preserving agent from fungi source. CLIB-Forum Biotechnologie in der Lebensmittelindustrie, July 2013

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1 AM-1 an innovative anti-microbial preserving agent from fungi source CLIB-Forum Biotechnologie in der Lebensmittelindustrie, July 2013

2 Mission of INS IMD Natural Solutions ( INS ) aims to develop and commercialize groundbreaking ingredients - with a special focus on preserving agents - derived from "all" natural sources. The main target markets are in the Food & Beverages as well as the Personal Care industries. INS inherited the Bayer global Natural Products Research has 50% share in IMAX Discovery GmbH targeting Flavor Modulators (JV with AXXAM SpA) Food Beverage Cosmetics Personal Care Know-how 2

3 Trends in Consumer Markets Increasing aging population corresponds with higher consumer awareness Cost benefits of prevention rather than disease treatment regarded by societies Strongly increased demands in innovative products that Improve quality of life Have specific health benefits Can be self medicated High demands for innovative products (e.g. prevent cardio-vascular diseases, inhibit growth of resistant germs) but lack of adequate solutions +6% 14,015 1,173 Preservatives Food and Pharma getting closer +7% 9, ,071 3,399 Cosmetics - Haircare Cosmetics - Skincare INS well positioned in meur 7, ,396 1,648 2,578 as innovator 2,143 3,303 4,591 7,372 Functional Foods Source: Datamonitor ICD, CSM, IMD market intelligence; estimates based on information available to IMD 3

4 Broad Technology Foundation Integrated Natural Product (NP) Solutions Platform Largest Pure NP Collection Largest Collection of Biological Data on NPs Top Tier NP Source Collection Perfected, Integrated NP Discovery Engine Experienced NP Discovery Team wn Candidate Portfolio 15,000 Compounds 12 Mio. Data Points 46,000 Sources 5 Mio. EUR Equipment Longterm Experience 2 Leads + Backups 4

5 Food PRESERVATIVE MARKET is large Total market for preserving ingredients values between 2.5-3bn US$ Food is dominated by organic acids at 480 m : sorbic, benzoic acetic, propionic acid Existing product solutions are under scrutiny (safety, efficacy, consumer perception) New solutions are seriously requested by food/cosmetic industry AM-1 was identified, designed and developed by INS to match such needs 5

6 AM-1 producer organism and core structure 1'' 1''' 1' 5' H 1 2 Fungi strain distributed circumtropic (Africa, America, Asia, Australia) Fruit body eaten in China, Africa Core structure of AM-1, a glycolipid ( Biosurfactant ) type 6

7 AM-1 - a potent Anti-Microbial agent Excellent activity against yeasts Fair activity against gram positive bacteria and molds Important food organisms (zygomycetes, bacilli, clostridia, Lactobacillus plantarum) affected Important pathogenic organisms (Bacillus cereus, Candida albicans, Candida glabrata, S. aureus, Enterococcus faecalis) affected Long lasting activity shown in water media Bactericidal activity confirmed via germ count reduction Active in food/beverage/cosmetic application tests 7

8 AM-1: Microbial Production Stable strains available allowing for reliable fermentation process (>100 individual fermentations yet conducted) production yield of AM-1 exceeds multi gram/litre scale Cost efficient AM-1 preparation developed simple media developed AM-1 Material available in multi gram scale at proven specification Cost of Goods optimisation in progress 8

9 Fermentation yields a specific Glycolipid composition Comprehensive work up, sample preparation and handling elaborated QC parameter, analytics and specification determined AM-1 represents a highly enriched bioactive product 9

10 AM-1: preparation process of material Fermentation broth 1) ph adjustment to ph8 2) Centrifugation 3) Filtration (T100) 4) Filtration (0.45 µm) separation Culture filtrate Mycelium 1) ph chromatography 2 2.5, 4 C 2) Washing with water Precipitation waste Crude product 1) ph washing 6 2) freeze-drying Freeze 100l-3000l scale Kg scale yielded AM-1 (sodium salt) 10

11 Development status IMD AM-1 Safety Gentox, LD50 and rat tox completed; Skin sensitization negative taste neutral Production 100l to 3000l transfer conducted Application testing Advanced for Food and Cosmetic applications Regulatory Process Completed for Cosmetic use IP PCT Patent application filed 11

12 Go to Market Beverage Cosmetics Medical device INS AM-1 production Distribution Hub Dairy Meat Preservation Household 12

13 INS also offers Natural Product R&D Services Data Bases Project Know How Technology Sources Libraries/ Logistics >200 projects conducted >700 assays applied Bioactive Lead Discovery / Screening Natural Product chemistry and analytical characterization Sourcing and fermentation Process development /Bridging to production Medium scale production capabilities (in-house) Large scale production capabilities (with partner) Service Business: Pharma/AH, Agro 13

14 Thank you!

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