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Clinically-Documented Probiotics for Human Health

Clinically-Documented Probiotics for Human Health. Brian Peeters Strategic Sales Manager Chr. Hansen A/S. Agenda. Introduction Why Chr. Hansen as Preferred Supplier Basics of Probiotics Market Trends Designing a Probiotic Product for the Military. Chr. Hansen…. Company founded in 1874

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Clinically-Documented Probiotics for Human Health

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  1. Clinically-Documented Probiotics for Human Health Brian Peeters Strategic Sales Manager Chr. Hansen A/S

  2. Agenda Introduction Why Chr. Hansen as Preferred Supplier Basics of Probiotics Market Trends Designing a Probiotic Product for the Military

  3. Chr. Hansen… • Company founded in 1874 • Fermenting bacteria cultures for more than 100 years • 2,500 employees in 30 countries • Turnover of 500M EUR with double-digit organic growth • 6% of turnover spent on R&D • 225 employees in Research & Development • State-of-the-art production facilities • GMP pharma & food, Kosher, QC, HACCP,ISO 9002 • Production facilities on 5 continents • Strong partnerships with customers • Everyday more than 500 million people consume products containing Chr. Hansen ingredients Founder Danish Pharmacist Christian D.A. Hansen …when science matters

  4. Chr. Hansen Group serving global customers all over the world with >25 offices

  5. Chr. Hansen Organizational Structure Health & Nutrition Division is dedicated solely to Probiotics Chr. Hansen Cultures & Enzymes Health & Nutrition Natural Colors

  6. Chr. Hansen - World’s Largest Lactic Acid Bacteria PlantLocation: Avedore, Denmark

  7. Agenda Introduction Why Chr. Hansen as Preferred Supplier Basics of Probiotics Market Trends Designing a Probiotic Product for the Military

  8. Why Partner with Chr. Hansen? • Documented Efficacy and Safety • More than 450 research papers supporting Chr. Hansen probiotic strains • More than 80 human clinical studies documenting strain efficacy • Strains selected among the 8,700 strain deposits in Chr. Hansen’s cell bank in Denmark • Extensive QC programs (cGMP) • Been producing and selling probiotics for >20 years • Scientific expertise • 6% of turnover spent on R&D • 225 employees in Research & Development • Patented processes and concepts • Novel equipment and production technologies • Strong research team developing new probiotics strains

  9. Why Partner with Chr. Hansen? • Product Supply • Market leader with world’s largest lactic acid bacteria plant • Pharmaceutical Production (Pharma cGMP) • Global quality and safety policy ensuring high standard in food production (ISO 9001/HACCP) • Consumer Friendly • Well-established safety • GMO-free products • “Big 8” Allergen-free products available • Internationally & Locally Affiliated • ISAPP, IPA, Norfood, PROBDEMO, LABIP • Leading probiotic research groups at universities & institutes

  10. Agenda Introduction Why Chr. Hansen as Preferred Supplier Basics of Probiotics Market Trends Designing a Probiotic Product for the Military

  11. Definition of “Probiotics” • The World Health Organization (WHO) and the Food and Agriculture Association (FAO) define probiotics as: “Live microorganisms that when consumed in adequate amounts confer a health benefit on the host.”

  12. Introduction to Probiotics Probiotics means ”for life” in Latin Probiotics are live bacteria with health benefits First scientist to discover health benefits of probiotics was immunologist Dr. Eli Metchnikoff • Received Nobel Prize in 1908 10x more bacterial cells in human body (~1014) than there are human tissue cells (~1013) Gastrointestinal tract is largest immune organ in human body (80% of Immune System is located here) Probiotics first commercialized via yogurts: • Yakult introduced in Japan in 1935 • Danone’s Activia introduced in France in 1987, U.S. in 2006

  13. Strain TaxonomyNote: Overview not exhaustive Bacterial group Bacterial genus Bacterial species Bacterial sub-species Bacterial strains Lactid acid bacteria Lactobacillus paracasei paracasei subsp. paracasei CRL-431 Bifidobacterium acidophilus paracasei subsp. tolerans LC-01 F-19 Enterococcus fermentum Weissella reuteri Carnobacterium delbrueckii Streptococcus rhamnosus Lactococcus plantarum

  14. Strengthen the immune system Inhibit adhesion of pathogencells Modulates cytokine production Produce surface- active substances Produce hydrogen peroxide Inhibit growth of pathogen cells Produce acids Work as co-aggregation molecules Produce bacteriocins Block the spread of pathogens Inhibit growth of pathogens Probiotics – Mechanisms of Action Probiotic strain

  15. Strengthen the immune system Inhibit adhesion of pathogencells Modulates cytokine production Produce surface- active substances Produce hydrogen peroxide Inhibit growth of pathogen cells Produce acids Work as co-aggregation molecules Produce bacteriocins Block the spread of pathogens Inhibit growth of pathogens Probiotics – Mechanisms of Action Probiotic strain

  16. Agenda Introduction Why Chr. Hansen as Preferred Supplier Basics of Probiotics Market Trends Designing a Probiotic Product for the Military

  17. Scientific interest in probiotics has grown significantly since 2000… PubMed Articles on Probiotics (#)

  18. …and so has the number of probiotic trials Probiotic trials registered on www.clinicaltrials.gov NIH (#) US trials Non-US trials

  19. Increasing interest in probiotics seen in recent yearsDietary supplements: Gone from 16 launches in ‘02 to 75 launches in ‘07 Probiotic product launches globally (#) 669 594 Other 491 Cheese 394 Diet. suppl. 242 150 Fermented milks Source: Mintel database; Global launches

  20. Increasing number of dietary supplement probiotic product launches in 2007 (driven by Europe) Probiotic product launches globally; dietary supplements (#) 75 Rest of World 54 51 Europe 38 31 16 Japan US Source: Mintel database; Global launches ~35% average annual growth last 5 years

  21. Chr. Hansen sees market drivers in probiotic supplement market continuing to feed a strong growth General interest in self-medication Taboo on intestinal issues declining Probiotic supplements expected to continue double-digit growth Demographic shift Trend towards ”natural cure” rather than pharma Consumer awareness below 50% in most countries

  22. Agenda Introduction Why Chr. Hansen as Preferred Supplier Basics of Probiotics Market Trends Designing a Probiotic Product for the Military

  23. Designing a Probiotic Product for the Military 1 Indication 2 8 Regulatory / Claim Other Shelf stability Strain(s) Your product 7 3 Potency Survival through stomach Dosage form 6 4 5

  24. Indica- tion Chr. Hansen offers different indication concepts 1. Everyday Intestinal Balance 2. Antibiotic Associated Diarrhea 3. Traveler's Diarrhea 4. Children's Diarrhea 5. Immune Boost 6. Atopic Eczema* 7. Bacterial Vaginosis *Concept supported by fewer clinical studies

  25. Indica- tion Chr. Hansen offers different indication concepts 1. Everyday Intestinal Balance 3. Traveler's Diarrhea 5. Immune Boost *Concept supported by fewer clinical studies

  26. Indica- tion Chr. Hansen offers different indication concepts 1. Everyday Intestinal Balance 2. Antibiotic Associated Diarrhea 3. Traveler's Diarrhea 4. Children's Diarrhea 5. Immune Boost 6. Atopic Eczema* 7. Bacterial Vaginosis *Concept supported by fewer clinical studies

  27. Indica- tion 1. Everyday intestinal balance • Covers a broad range of discomfort such as bloating, slow constipation, diarrhea, and slight irritable bowel • Surveys show 15-20% of consumers are concerned about their digestive health • 12% of people worldwide suffer from self-defined constipation according to large global omnibus study from 2006 • Americas and Asia Pacific suffer nearly twice (17%) as much as their European counterparts (9%) • 40% of constipation sufferers attempt to treat their constipation by changing their nutrition, despite research showing that diet and lifestyle are not necessarily to blame for the occurrence of constipation • Less than 1/3 of sufferers use laxatives

  28. Indica- tion Chr. Hansen offers different indication concepts 1. Everyday Intestinal Balance 2. Antibiotic Associated Diarrhea 3. Traveler's Diarrhea 4. Children's Diarrhea 5. Immune Boost 6. Atopic Eczema* 7. Bacterial Vaginosis *Concept supported by fewer clinical studies

  29. Indica- tion 3. Traveler's Diarrhea • “Travelers' diarrhea is the most common illness affecting travelers. Each year between 20%-50% of international travelers, an estimated 10 million persons, develop diarrhea” -Centers for Disease Control and Prevention, U.S. Department of Health and Human Services • Duration of travelers' diarrhea usually limited to 2-5 days • In some cases, symptoms may persist for months or even years • Probiotic supplementation reduces the risk of diarrhea caused by foreign bacteria from water, vegetables, fruit, etc. • Diarrhea is caused mainly by intake of E. coli, Salmonella, or Campylobacter • Target group: Those persons traveling to “high-risk” destinations where the food or water supply may contain “non-native” or pathogenic organisms such as E. coli.

  30. Indica- tion Chr. Hansen offers different indication concepts 1. Everyday Intestinal Balance 2. Antibiotic Associated Diarrhea 3. Traveler's Diarrhea 4. Children's Diarrhea 5. Immune Boost 6. Atopic Eczema* 7. Bacterial Vaginosis *Concept supported by fewer clinical studies

  31. Indica- tion 5. Immune Boost • 80% of the body’s immune cells are located in the gastrointestinal tract • Having the right bacterial balance is important for optimizing the immune system • Increased levels of IgA and phagocytes (immune cells and cells which can engulf and destroy harmful components), the better the immune system fights unwanted components • Probiotics are proven to be able to strengthen natural defenses and stimulate the immune system • Immune health is the second largest indication area within probiotics after intestinal health • Target group: Those who are under consistently high levels of stress and/or those who have a weak or compromised immune system.

  32. Chr. Hansen’s Clinically-Documented Probiotic Strains • Bifidobacterium (BB-12®) • Lactobacillus acidophilus (LA-5®) • Lactobacillus paracasei ssp. paracasei (CRL-431™) • Lactobacillus rhamnosus (GR-1®) • Lactobacillus reuteri (RC-14®) • Lactobacillus rhamnosus GG (LGG®) • Streptococcus thermophilus (TH-4™) BB-12® LA-5® CRL-431™

  33. Strain Other Chr. Hansen Strains • Lactobacillus delbrueckii ssp. bulgaricus LBA-40 • Lactobacillus delbrueckii ssp. bulgaricus LBY-27 • Lactobacillus paracasei ssp. paracasei LC-01 • Lactobacillus rhamnosus LC-69 • Bifidobacterium infantis BB-02 • Bifidobacterium longum BB-46 • Streptococcus thermophilus STY-31

  34. Strain Chr. Hansen stains have documented efficacy>450 research and clinical evaluations and >80 human clinical studies

  35. Strain Chr. Hansen stains have documented efficacy>450 research and clinical evaluations and >80 human clinical studies

  36. Strain Chr. Hansen with >450 scientific publications Scientific publications registered by strain (#) Source: CH internal abstract database

  37. Strain BB-12 + LA-5 for everyday intestinal balanceClinical study example BB-12 and LA-5 tested on 15 healthy adults with tendency to constipation Shioya et al.2000 (days) *

  38. BB-12 for everyday intestinal balanceClinical study example BB-12 tested on 209 elderly with constipation living in residential homes Pitkälä et al. 2007 (%) * *

  39. Quatro-Cap-4 for Lowering Risk of Traveler's DiarrheaClinical study example 165 tourists going to Egypt were treated with Quatro caps or placebo: 1 cap 3 times daily starting 2 days prior to departure ending the last day of travel Black et al. 1989 ; Black 1995 Share of tourists with diarrhea Share of tourists with diarrhea * * Trial I Trial II Trial 2 n = 41 n = 40 n = 45 n = 39

  40. BB-12 for Everyday Immune BoostClinical study example Effect of BB-12 on phagocytic activity in 14 healthy adults Schiffrin et al. 1997 Share active phagocytes (%) * * BB-12

  41. Dosage form Dosage Forms Standard forms: • Capsules • Sticks • Powder blends • Chewable tablets Individual customization: • Capsules • Sticks • Chewable tablets • Sachets • Tablets and more upon request…

  42. Dosage form Dosage Forms….For the Military 1st Choice Standard forms: • Capsules • Sticks • Powder blends • Chewable tablets Individual customization: • Capsules • Sticks • Chewable tablets • Sachets • Tablets and more upon request…

  43. Dosage form Dosage Forms….For the Military 2nd Choice 1st Choice Standard forms: • Capsules • Sticks • Powder blends • Chewable tablets Individual customization: • Capsules • Sticks • Chewable tablets • Sachets • Tablets and more upon request…

  44. Dosage form Dosage Form: Sticks • Best dosage form for wide range of ambient temperature and humidity fluctuations • Relatively little loss of viable organisms @ 25C over 18 months • Very low sugar content (maximum 0.4 g sugar per dose) • Can be customized to contain higher doses to further extend shelf-life over time at various temperature ranges • Consumer Appeal • Easy to take – no tablets to swallow • Easy to consume – only a small amount of powder (1g) • Easy to mix into foods and drinks - cold or lukewarm • Easy to open – tear off top • Easy to carry – in your pocket, bag or lunch box • Easy to store – room temperature storage is ok • Selections • Taste: Vanilla, neutral or per your selection • Technology: Soluble or non-soluble

  45. Dosage form Dosage Form: Capsules • Consumer benefits • Easy to take – small capsule size • Easy to open – for powder administration • Easy to carry – Alu-tube or blister card • Easy to store – at room temperature • Easy to relate to – capsules are a traditional dosage form for supplements • Selections for capsule type • Type: Gelatin or Vegetables (Vegetable recommended) • Size: 000 – 5 (size 3 recommended)

  46. Dosage form Other Dosage Forms • Powders • Delivered in small vial to consumer to take a tablespoon and sprinkle onto food or beverage • Also relevant dosage form when used for infant formula • Chewable Tablets • Children-friendly • Sachets • Sachets are quadrant-shaped bags with powder… • …different from sticks being rectangle bags • Tablets • Typically 500-1500 mg per tablet

  47. Potency What is potency? • What is a CFU? • CFU = Colony Forming Units • One CFU = one live bacteria cell • “Live” defined as being able to multiple and thereby form a colony • How to count the cells? • Small amounts of powder is weighing and diluted up to commonly 1,0 E+09 • Suitable dilutions with lactic acid bacteria are poured onto plates and mixed with medium • After anaerobic incubation commonly 3 days at 37oC, the colonies are manually counted • Different cell count is seen as cells are live microorganisms • Only cells assessed as being colony forming are to be counted • What is potency? • Potency is minimum number of CFU in one gram (powder) or in one dosage (capsules, tablets, etc) • Example: Potency of 1.0 E+09 per capsule means there is minimum 1 billion CFU per capsule • Which potency to communicate to consumers? • Best practice towards consumers is to state minimum potency at end of shelf life Chr. Hansen recommends products providing a daily dose of 1 to 10 Bil CFU

  48. Potency Chr. Hansen guarantees potency at point in value chain agreed with customer Bulk dosage forms Final dosage form Powder production Boxing & labeling Distri-bution Store shelfing Consump-tion End of shelf life Potency point #1 Potency point #2 Potency point #3 Potency point #4 Illustrative example of potency decline: 6.5B 5.5B 5B 1B Chr. Hansen guarantees CFU count all the way to potency point #4 when delivering in final packaging material

  49. Shelf stability “The Shelf-Life Equation” = × × Shelf life Water Activity Temperature Oxygen Rule-of-thumb recommendation: 24 months = ≤0.15 aw x x ≤25OC ≤5%

  50. Shelf stability What we do to maximize shelf stability I. Strain • Strains selected based on superior stability II. Excipients • Excipients with extra low aw chosen III. Handling • Raw materials and products are handled in such a way that we minimize exposure to aw, temperature, and oxygen IV. Production • We minimize mechanical processing • We add probiotics as close to final filling as possible • We have for customers preparred Standard Operating Procedures • We discuss choice of product packaging with our customers • Air tight • Moisture impermeable • Oxygen free (filled with nitrogen) V. Packaging

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