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

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Presentation on theme: "Clinically-Documented Probiotics for Human Health Brian Peeters Strategic Sales Manager Chr. Hansen A/S."— Presentation transcript:

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

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

3 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 4 Chr. Hansen Group serving global customers all over the world with >25 offices

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

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

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

8 8 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 Why Partner with Chr. Hansen?

9 9 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 Why Partner with Chr. Hansen?

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

11 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 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 x more bacterial cells in human body (~10 14 ) than there are human tissue cells (~10 13 ) 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 13 Strain Taxonomy Note: Overview not exhaustive Bacterial genus Bacterial species Bacterial sub-species paracasei subsp. paracasei Bacterial strains paracasei acidophilus fermentum Lactobacillus Bifidobacterium Enterococcus Lactid acid bacteria Bacterial group CRL-431 LC-01 reuteri delbrueckii rhamnosus plantarum Weissella Carnobacterium Streptococcus Lactococcus paracasei subsp. tolerans F-19

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

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

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

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

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

19 19 Increasing interest in probiotics seen in recent years Dietary supplements: Gone from 16 launches in ‘02 to 75 launches in ‘ Probiotic product launches globally (#) Fermented milks Diet. suppl. Cheese Other Source: Mintel database; Global launches

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

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

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

23 23 Designing a Probiotic Product for the Military Indication Regulatory / Claim Strain(s) Dosage form Shelf stability Survival through stomach Potency Other Your product

24 24 Chr. Hansen offers different indication concepts Indica- tion 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 25 Chr. Hansen offers different indication concepts Indica- tion 1. Everyday Intestinal Balance 3. Traveler's Diarrhea 5. Immune Boost *Concept supported by fewer clinical studies

26 26 Chr. Hansen offers different indication concepts Indica- tion 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 27 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 Indica- tion

28 28 Chr. Hansen offers different indication concepts Indica- tion 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 29 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. Indica- tion

30 30 Chr. Hansen offers different indication concepts Indica- tion 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 31 5. Immune Boost Indica- tion 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 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 33 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 Strain

34 34 Chr. Hansen stains have documented efficacy >450 research and clinical evaluations and >80 human clinical studies Strain Strains Intestinal balance Antibiotic Assoc. Diarrhea Traveler's Diarrhea Children's Diarrhea Immune boost Atopic Eczema Bacterial Vaginosis BB BB-12 + LA-5 64 BB-12 + TH-4 4 CRL CRL BB LGG BB-12 + LGG 12 BB-12 + LA-5 + LBY-27 + STY BB-12 + LA-5 + LGG 1 GR-1 + RC-14 8

35 35 Chr. Hansen stains have documented efficacy >450 research and clinical evaluations and >80 human clinical studies Strain CHR Product Strains Intestinal Balance Antibiotic Assoc. Diarrhea Traveler's Diarrhea Children's Diarrhea Immune Boost Atopic Eczema Bacterial Vaginosis BB-12 Stick BB AB-CapBB-12 + LA BB-12 + TH-4 4 CRL CRL BB-12 1 LGG BB-12 + LGG 12 Quatro- Cap BB-12 + LA-5 + LBY-27 + STY BB-12 + LA-5 + LGG 1 GR-1 + RC-14 8

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

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

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

39 39 Quatro-Cap-4 for Lowering Risk of Traveler's Diarrhea Clinical study example * Share of tourists with diarrhea n = 41n = 40n = 45n = 39 Trial ITrial II * 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 ; Black 1995 Trial 2

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

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

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

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

44 44 Dosage Form: Sticks Best dosage form for wide range of ambient temperature and humidity fluctuations Relatively little loss of viable 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 Dosage form

45 45 Dosage Form: Capsules Dosage form 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 46 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 mg per tablet Dosage form

47 47 What is potency? Potency Chr. Hansen recommends products providing a daily dose of 1 to 10 Bil CFU 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 37 o C, 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

48 48 Chr. Hansen guarantees potency at point in value chain agreed with customer Powder production Bulk dosage forms Final dosage form Boxing & labeling Distri- bution Store shelfing Consump- tion 1B Illustrative example of potency decline: 5B5.5B6.5B End of shelf life Potency point #1 Potency point #2 Potency point #3 Potency point #4 Chr. Hansen guarantees CFU count all the way to potency point #4 when delivering in final packaging material Potency

49 49 “The Shelf-Life Equation” Shelf stability ≤ 25 O C ≤0.15 a w ≤ 5% Shelf life × =× Water ActivityTemperatureOxygen 24 months=xx Rule-of-thumb recommendation:

50 50 What we do to maximize shelf stability I. Strain II. Excipients III. Handling IV. Production V. Packaging Strains selected based on superior stability Excipients with extra low a w chosen Raw materials and products are handled in such a way that we minimize exposure to a w, temperature, and oxygen 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) Shelf stability

51 51 Types of packaging Shelf stability Recommended for capsules and tablets Alu-tube Glass container Plastic container w/ desiccant Stick Sachet Recommended for powder Not optimal, but best blister type Alu-alu blister Not recommended Plastic Container (PET) Aclar blister PVDC-alu blister

52 52 Desiccant Shelf stability Desiccant lid Desiccant lining Desiccant bags Desiccant applicationsDesiccants reduce water activity level Water activity (Molecular Sieve) Desiccant types Bentonite Activated clay Absorbs moisture steadily in given period Silicagel Chemically produced salt Absorbs moisture steadily in given period Molecular Sieve Crystallized aluminum silicate Absorbs moisture quickly within short period (up to 20% of its own weight)

53 53 Moisture Vapor Transmission Rate by type of packaging material Shelf stability Moisture Vapor Transmission Rate (MVTR) The rate at which moisture will permeate through a barrier over time Measures the barrier performance of different types of packaging Freeze-dried products are very hygroscopic and will absorb available moisture quickly High-barrier packaging materials (glass, aluminum, and plastic vial) are recommended for reducing moisture and oxygen migration. MVTR examples Glass0 Aluminum0 HDPE3,8 PVDC4,0 PP6-10 LDPE18-23 PET19-46 Measured at 37.8°C and 100% RH (g/25μ/m2/day) Plastic vial with desiccant lining permits 0.5mg moisture to enter vial, but desiccant absorbs 1g of moisture

54 54 Summary Supplementation with Probiotics may help soldiers prevent pathogen-based GI disturbances such as food poisoning, water contamination, etc. Probiotics have been shown to increase the strength of the immune system of individuals who are under chronically-high levels of stress In the field, the best dosage form for soldiers would be the probiotic stick or sachet In the military food service setting, making single serve packets of probiotic capsules available with meals would be ideal. GOAL FOR END RESULT: Improved overall health of the soldiers and thus possibly significant cost savings for the Military (via reduced healthcare and sick leave).

55 55 Together we improve the quality of food and health for people all over the world THANK YOU! For more information, please contact: Brian Peeters Office: (415)


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