Romane Catalogo Indice 4/1/21:Layout 1 04/01/21 16:50 Pagina 1

OUROUR PRPROBIOTICOOBIOTTIC STRAINSSTRRAINSS

OurOur IInnovativennovative 64 Strains:Sttrains:i ReadyReady fforor YYourour HealthHeallth Romane Catalogo Indice 4/1/21:Layout 1 04/01/21 16:51 Pagina 2

THERAPEUTIC IndEx

GastroenteroloGy pag. 5

ImmunoloGy pag. 19

DermatoloGy pag. 23

antI-aGInG pag. 25

CarDIoloGy/metabolIsm pag. 28

DIetetICs pag. 29

GIneColoGy pag. 31

uroloGy pag. 39

Gut-braIn pag. 43

oral Care pag. 47

teChnoloGIes pag. 48 Romane Catalogo Indice 4/1/21:Layout 1 04/01/21 16:51 Pagina 3

Probiotical is driving innovation since 1985. Our expertise comprises strain selection, advanced R&D, production of strains to finished products with all guarantees of stability and demonstrated efficacy in many functionalities.

Our strains can be proposed in allergen-free quality, microencapsulated, and standardized in different concentrations.

Strains available as raw material can be provided in bulk or as customized finished products.

Strains available as finished dosage form can be provided only as Probiotical finished products. Romane Catalogo Indice 4/1/21:Layout 1 04/01/21 16:51 Pagina 5

STRAInS & blEndS IndEx

Bifidobacterium • breve - BR03™ (DSM 16604) Gastroenterology: Strain: pag. 8, 17 - Blend: pag. 5, 6, 8, 10, 12, 14 ; Anti-aging: Strain pag. 22, 25 ; Dermatology: Blend: pag. 24 ; • Bifidobacterium adolescentis - BA02 (DSM 18351, formerly Dietetics: Strain: pag. 29 - Blend: pag. 29 ; Urology: Strain: pag. 37, 40 ; ALB 1) Gastroenterology: Blend: pag. 8 Gut-brain : Strain: pag 44 - Blend: pag 46 • Bifidobacterium animalis subsp. lactis - BA05 • Bifidobacterium breve - B632™ (DSM 24706) (DSM 18352) Gynecology: Strain: pag. 37 Gastroenterology: Blend : pag. 5, 6 ; Immunology: Blend : pag. 21 ; Urology: Strain: pag. 40 • Bifidobacterium animalis subsp. lactis - Bb1 • - MB113 (DSM 23732) (DSM 17850) Anti-aging: Strain: pag. 26 ; Gynecology: Bifidobacterium breve Cardiology/metabolism: Strain: pag 27 - Blend: pag 27 Strain: pag. 37 ; Urology: Strain: pag. 41, 42 • Bifidobacterium infantis - BI02 (DSM 24687, formerly • Bifidobacterium animalis subsp. lactis - BS01™ MB287) Cardiology/metabolism: Strain: pag. 28 (LMG P-21384) Gastroenterology: Strain: pag. 7 , Blend: pag. 8, 12 , Immunology: Strain pag. 21 - Blend: pag. 20 ; • Bifidobacterium longum - W11 (LMG P-21586) Dermatology: Blend: pag. 23 ; Anti-aging: Strain: pag. 25 ; Gastroenterology: Strain: pag. 9; Gut-brain : Strain: pag 45 Gut-brain : Strain: pag. 44 - Blend: pag. 46 • Bifidobacterium longum - BL03 (DSM 16603) Gastroenterology: Blend: pag. 8, 12 , Urology: Strain : pag. 42 ; Gut-brain : Blend: pag 46 • Bifidobacterium animalis subsp. lactis - BS05 (DSM 23032) Anti-aging: Strain: pag. 25 • Bifidobacterium longum - 04 (DSM 23233) Cardiology/metabolism: Blend: pag. 27 ; Dietetics: Strain: pag. 30 ; • Bifidobacterium animalis subsp. lactis - BS07 (MB 2409) Gut-brain : Blend: pag. 43 Cardiology/metabolism: Strain: pag. 27 • Bifidobacterium longum - DLBL07 (DSM25669) Anti-aging: Blend: pag. 27 • Bifidobacterium animalis subsp. lactis - MB2409 (DSM 23733) Cardiology/metabolism: Blend: pag. 27 • Bifidobacterium longum - DLBL08 (DSM 25670) Anti-aging: Blend: pag. 27 • Bifidobacterium bifidum - BB01 (DSM 22892) Gastroenterology: Strain: pag. 14 • Bifidobacterium longum - DLBL09 (DSM 25671) Anti-aging: Blend: pag. 27 • Bifidobacterium bifidum - BB06 (MB 107) • Bifidobacterium longum - DLBL10 (DSM 25672) Cardiology/metabolism: Strain: pag. 27 Anti-aging: Blend: pag. 27 • Bifidobacterium bifidum - MB109 (DSM 23731) • Bifidobacterium longum - DLBL11 (DSM 25673) Cardiology/metabolism: Strain: pag. 27 - Blend: pag. 27 Anti-aging: Blend: pag. 27 Romane Catalogo Indice 4/1/21:Layout 1 04/01/21 16:51 Pagina 6

Lactobacillus • Limosilactobacillus fermentum - LF5 (CNCM I-789) (formerly fermentum ) Gastroenterology : Strain: pag. 17 ; Gynecology: Strain: pag. 31, 36 • Lactobacillus acidophilus - LA02 (DSM 21717) Gastroenterology: Strain: pag. 13, 15 - Blend: pag. 10 ; Anti-aging: • Limosilactobacillus fermentum - LF08 (DSM 18297) Strain pag. 22 ; Gynecology: Blend: pag. 33 ; Urology: Strain: pag. 40 ; (formerly Lactobacillus fermentum ) Gynecology: Strain: pag. 31 Gut-brain : Strain: pag 42, 44 • Limosilactobacillus fermentum - LF09 (DSM 18298) • Lactobacillus acidophilus - LA06 (DSM 23033) (formerly Lactobacillus fermentum ) Gastroenterology : Strain: pag. 17 ; Anti-aging: Strain: pag. 25 Gynecology: Strain: pag. 31

• Lactobacillus acidophilus - CRL1294 (DSM 24513) • Limosilactobacillus fermentum - LF10 (DSM 19187) (under worldwide exclusive license from the CERELA) (formerly Lactobacillus fermentum ) Gastroenterology : Strain: pag. 17 ; Gynecology: Strain: pag. 33 Gynecology: Strain: pag. 32 - Blend: pag. 33, 36 ; Gut-brain : Blend: pag. 45

• Lacticaseibacillus casei - LC03 (DSM 27537) • Limosilactobacillus fermentum - LF11 (DSM 19188) (formerly ) (formerly Lactobacillus fermentum ) Gastroenterology : Strain: pag. 17 ; Gastroenterology: Strain: pag. 14 Gynecology: Strain: pag. 32

• Lacticaseibacillus casei - LC04 (DSM 33400) • Limosilactobacillus fermentum - LF15 (DSM 26955) (formerly Lactobacillus fermentum ) Gynecology: Blend: pag. 36 Gynecology: Strain: pag. 16

• Lactobacillus crispatus - LCR01 (DSM 24619) • Limosilactobacillus fermentum - LF16 (DSM 26856) (formerly Lactobacillus fermentum ) Gynecology: Strain: pag. 32 ; (under worldwide exclusive license from the CERELA) Gut-brain : Blend: pag. 43 Gynecology: Strain: pag. 38 • Limosilactobacillus fermentum - LF26 (DSM 33402) • Lactobacillus crispatus - CRL1251 (DSM 24438) (formerly Lactobacillus fermentum ) Gastroenterology: Strain: pag. 16 (under worldwide exclusive license from the CERELA) Gynecology: Strain: pag. 34 • Limosilactobacillus fermentum - ME-3 (DSM 14241) (formerly Lactobacillus fermentum ) Cardiology/metabolism: Strain: pag. 28 • Lactobacillus crispatus - CRL1266 (DSM 24439) (under worldwide exclusive license from the CERELA) • Lactobacillus gasseri - LGS06 (DSM 32405) Gynecology: Strain: pag. 35 Dietetics: Strain: pag. 30 ; Gynecology: Strain: pag. 38

• Lactobacillus delbrueckii subsp. bulgaricus - LDB01 • Lactobacillus gasseri - CRL1259 (DSM 24512) (DSM 16606) Gastroenterology : Strain: pag. 14 (under worldwide exclusive license from the CERELA) Gynecology: Strain: pag. 33 • Lactobacillus delbrueckii subsp. delbrueckii - LDD01 (DSM 22106) Gastroenterology : Strain: pag. 5 , 15 - Blend: pag. 6,13 ; • Lacticaseibacillus paracasei - LPC00 (LMG P-21380) Urology: Strain: pag. 40 ; Gut-brain : Blend: pag. 45 ; (formerly ) Gastroenterology : Strain: pag. 13 ; Oral care : Blend: pag. 47 Immunology: Blend: pag. 22 Romane Catalogo Indice 4/1/21:Layout 1 04/01/21 16:51 Pagina 7

• Lacticaseibacillus paracasei - LPC09 (DSM 24243) • Lacticaseibacillus rhamnosus - LR04 (DSM 16605) (formerly Lactobacillus paracasei ) Gastroenterology : Strain: pag. 16 ; (formerly ) Gastroenterology : Strain: pag. 11, Urology: Strain: pag. 30 - Blend: pag. 39 , 41 15, 16, 18 - Blend: pag. 11, 16 ; Immunology: Blend: pag. 20 ; Urology: Blend: pag. 39 • Lacticaseibacillus paracasei subsp. paracasei - CRL1289 (DSM 24440) (formerly Lactobacillus paracasei ) • Lacticaseibacillus rhamnosus - LR05 (DSM 19739) (under worldwide exclusive license from the CERELA) (formerly Lactobacillus rhamnosus ) Immunology: Blend: pag. 19 ; Gynecology: Strain: pag. 35 Dermatology: Blend: pag. 23 • Lactiplantibacillus pentosus - LPS01 (DSM 21980) • Lacticaseibacillus rhamnosus - LR06 (DSM 21981) (formerly Lactobacillus pentosus ) (formerly Lactobacillus rhamnosus ) Gastroenterology : Strain: pag. 15 - Gastroenterology : Strain: pag. 15 - Blend: pag. 13 ; Urology: Blend: pag. 13 ; Anti-aging: Strain: pag. 25 ; Urology: Strain: pag. 37 ; Strain: pag. 39 ; Oral care : Blend: pag. 47 Gut-brain : Blend: pag 43 - Strain: pag. 44 ; Oral care : Blend: pag. 47 • Lactiplantibacillus plantarum - LP01™ (LMG P-21021) • Ligilactobacillus salivarius - CRL1328 (DSM 24441) (formerly Lactobacillus plantarum ) Gastroenterology : Strain: pag. 7, (formerly ) (under worldwide exclusive license 15, 16 - Blend: pag. 6, 8, 10, 13 ; Immunology: Blend: pag. 19, 22 ; from the CEntro de REferencia para LActobacilos, Argentina) Anti-aging: Strain : pag. 25 ; Gynecology: Blend: pag. 36 ; Urology: Gastroenterology : Strain : pag.16 ; Gynecology: Strain: pag. 34 ; Strain: pag. 42 - Blend: pag. 39, 42 ; Gut-brain : Strain: pag. 44 - Urology: Strain: pag. 40 Blend: pag. 43, 45 ; Oral care : Blend: pag. 47 • Ligilactobacillus salivarius - LS01™ (DSM 22775) • Lactiplantibacillus plantarum - LP02 (LMG P-21020) (formerly Lactobacillus salivarius ) Gastroenterology: Strain: pag. 16 ; (formerly Lactobacillus plantarum ) Immunology: Blend: pag. 22 ; Dermatology: Strain: pag. 23 - Blend: Gastroenterology : Strain: pag. 15 ; Immunology: Blend: pag. 19 ; pag. 24 ; Anti-aging: Strain: pag. 25 ; Gut-brain : Strain: pag. 44 Gynecology: Blend: pag. 36 ; Urology: Strain: pag. 39 • Ligilactobacillus salivarius - LS03 (DSM 22776) • Lactiplantibacillus plantarum - LP09 (DSM 25710) (formerly Lactobacillus salivarius ) Dermatology: Strain: pag. 23 ; (formerly Lactobacillus plantarum ) Gastroenterology : Strain: pag. 17 Gut-brain : Blend: pag 44 • Lactiplantibacillus plantarum - LP14 (DSM 33401) • Lactococcus lactis - LLC02 (DSM 29536) (formerly Lactobacillus plantarum ) Gastroenterology : Strain: pag. 15, 16 Gastroenterology: Blend: pag. 6 • Limosilactobacillus reuteri - Lb26 (DSM 16341) (formerly Lactobacillus reuteri ) Anti-aging: Strain: pag. 26 ; Urology: Streptococcus Strain: pag. 41

• Limosilactobacillus reuteri - LRE02 (DSM 23878) (formerly • Streptococcus thermophilus - FP4 (DSM 18616) Lactobacillus reuteri ) Gastroenterology : Strain: pag. 16 , Immunology : Dietetics: Blend: pag. 29 Strain: pag. 21 ; Gynecology: Strain: pag. 37 ; Urology: Strain: pag. 42 • Streptococcus thermophilus - YO8 (DSM 17843) • Lacticaseibacillus rhamnosus - GG (ATCC 53103) Gastroenterology : Strain: pag. 14 (formerly Lactobacillus rhamnosus ) Gastroenterology : Strain: pag. 11 - Blend: pag. 12 ; Immunology: Strain: pag. 20 ; Gut-brain : Strain: pag. • Streptococcus thermophilus - ST10 (DSM 25246) 44 - Blend: pag 46 ; Oral care : Strain: pag. 47 Gastroenterology : Strain: pag. 14 c i BR03™ (DSM 16604) l

Bifidobacterium breve - o c + y

Bifidobacterium breve - B632™ (DSM 24706) New Study b a

DAILY DOSAGE IN CLINICAL STUDY 1,3) BR03 100 million CFU + B632 100 million CFU FINISHED DOSAGE FORM b

-

FUNCTIONALITY Gaseous colic • Prevention of gastrointestinal symptoms • Rebalance of the intestinal microbiota in children and in infants y • Inhibition of Enterobacteriaceae and of other coliforms isolated from colicky infants g o l

SCIENTIFIC SUPPORT o r

Human clinical trials In vitro studies e t

1) Bona G. et al. The association of BR03 and B632 is effective to pre- a) Simone M. et al. The Bifidobacterium breve B632 Inhibited n

vent colics in bottle-fed infants: a pilot, controlled, randomized and dou - the Growth of Enterobacteriaceae within Colicky Infant Microbiota Cultu - e o

ble blind study. Published in J Clin Gastroenterol, 2016. res. BioMed Research International 1- 6, 2014. r t

2) Aloisio I. et al. Three-Month Feeding Integration With Bifidobacterium b) Aloisio I. et al. Characterization of Bifidobacterium spp. strains for the s Strains Prevents Gastrointestinal Symptoms in Healthy Newborns. Fron - treatment of enteric disorders in newborns. Appl Microbiol Biotechnol a tiers in , May 2018, art. 39. 2012, 96:1561–1576. G 3) Mogna L. et al. Capability of the Two Microorganisms Bifidobacterium c) Nicola S. et al. Interaction between probiotics and human immune breve B632 and Bifidobacterium breve BR03 to Colonize the Intestinal cells: the prospective anti-inflammatory activity of Bifidobacterium breve Microbiota of Children J Clin Gastroenterol, 2014. Suppl. 1, November/ BR03. AgroFOOD, 2010; 21(2):S44-47. December, Vol. 48. d) Mogna L. et al. Assessment of the In Vitro Inhibitory Activity of Specific See next page for other studies on this combination in celiac disease Probiotic Against Different Escherichia coli strains. J Clin Ga - stroenterol. 2012; 46 Suppl.S29-32. e) Del Piano M. et al. In Vitro Sensitivity of Probiotics to Human Pancrea - tic Juice. J Clin Gastroenterol. Vol 42, Suppl. 3, Part 2, Sept. 2008. (DSM 20074 was re-deposited as 22106).

Lactobacillus delbrueckii subsp. delbrueckii - LDD01 (DSM 22106) FINISHED DOSAGE FORM FUNCTIONALITY Gaseous colic • Inhibition of E. coli , including toxinogenic O157:H7 • Inhibition of Klebsiella pneumoniae and of different coliforms isolated from colicky infants SCIENTIFIC SUPPORT In vitro studies c) Mogna L. et al. In Vitro Inhibition of Klebsiella pneumoniae by Lacto - a) Savino F. et al. Antagonistic effect of Lactobacillus strains against gas- bacillus delbrueckii subsp. delbrueckii LDD01 (DSM 22106): An Inno - producing coliforms isolated from colicky infants. BMC Microbiology vative Strategy to Possibly Counteract Such Infections in Humans? J Clin 2011, 11:157. Gastroenterol. 2016 Nov/Dec;50 Suppl 2, Proceedings from the 8th Pro- b) Mogna L. et al. Assessment of the In Vitro Inhibitory Activity of Specific biotics, Prebiotics & New Foods for Microbiota and Human Health mee - Probiotic Bacteria Against Different Escherichia coli strains. J Clin Ga - ting held in Rome, Italy on September 13-15, 2015:S136-S139. stroenterol. 2012;46 Suppl.S29-32.

5 e BR03™ (DSM 16604) s Bifidobacterium breve - a e

+ s i

Bifidobacterium breve - B632™ (DSM 24706) d

c

DAILY DOSAGE IN CLINICAL STUDY 1) BR03 100 million cells + B632 100 million cells FINISHED DOSAGE FORM a i l

• 2-4) BR03 1 billion CFU + B632 1 billion CFU e C

FUNCTIONALITY Decrease inflammation in celiac disease -

y SCIENTIFIC SUPPORT g

Human clinical trials 3) Quagliariello A. et al. Effect of Bifidobacterium breve on the Intestinal o l

1) Mogna L. et al. Capability of the two microorganisms B632 and BR03 Microbiota of Coeliac Children on a Gluten Free Diet: A Pilot Study. Nu - o to colonize the intestinal microbiota of children. J Clin Gastroenterol. trients. 2016 Oct 22;8(10). pii:E660. r e 2014; 48 Suppl:S37-39. t

4) Primec M. et al. Clinical intervention using Bifidobacterium strains in n

2) Klemenak M. et al. Administration of decreases the production of celiac disease children reveals novel microbial modulators of TNF- a and e o

TNF- α in children with celiac disease. Dig Dis Sci (2015). short-chain fatty acids. Clinical Nutrition 2018, 1-9. r t

See precedent page for studies in infant colics. s a G Lactiplantibacillus plantarum - LP01™ (LMG P-21021) (formerly Lactobacillus plantarum ) n

LLC02 (DSM 29536) o Lactococcus lactis - New Studies i

+ t a r

Lactobacillus delbrueckii subsp. delbrueckii - LDD01 (DSM 22106) a p

• • e DAILY DOSAGE IN CLINICAL STUDY LP01 1 billion cells LLC02 800 million cells LDD01 200 million cells FINISHED DOSAGE FORM r p

l

FUNCTIONALITY Opposing dysbiosis and improving symptoms such as abdominal pain and bloating in patients e

with Inflammatory bowel diseases, in patients having undergone abdominal surgery and in patients after colonoscopy w o b

/

SCIENTIFIC SUPPORT y

Human clinical trial 3) Bonavina L, Ariani A, Ficano L, Iannuzziello D, Pasquale L, Aragona r e

1) Bonavina L, Arini A, Ficano L, Iannuzziello D, Pasquale L, Aragona SE, SE, Drago L, Ciprandi G, On Digestive Disorders ISG. Lactobacillus g r

Ciprandi G, On Digestive Disorders ISG. Abincol® ( Lactobacillus plantarum plantarum LP01, Lactobacillus lactis subspecies cremoris LLC02, and u s

LP01, Lactobacillus lactis subspecies cremoris LLC02, Lactobacillus del - Lactobacillus delbrueckii LDD01) in patients undergoing bowel pre - l a

brueckii LDD01), an oral , pragmatic use in patients with chro - paration. Acta Biomed. 2019 Jul 10;90(7-S):13-17. n nic intestinal disorders. Acta Biomed. 2019 Jul 10;90(7-S):8-12. i In vitro studies m 2) Bonavina L, Arini A, Ficano L, Iannuzziello D, Pasquale L, Aragona SE, o a) Mogna L. et al. Assessment of the In Vitro Inhibitory Activity of Spe - d Ciprandi G, On Digestive Disorders ISG. Post-surgical intestinal dysbiosis: b

cific Probiotic Bacteria Against Different Escherichia coli strains. J Clin a

use of an innovative mixture ( Lactobacillus plantarum LP01, Lactobacillus / Gastroenterol. 2012;46 Suppl.S29-32.

lactis subspecies cremoris LLC02, Lactobacillus delbrueckii LDD01). Acta D

b) Deidda F. et al. (2020) How Probiotics may Kill Harmful Bacteria: b

Biomed. 2019 Jul 10;90(7-S):18-23. I The in vitro Activity against Some Haemolytic Strains. J. Prob. Health.

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of Acute Respiratory Infections (ARI) during the cold season • Inhibition of intestinal and respiratory pathogens Immune stimulation SCIENTIFIC SUPPORT Human clinical trial In vitro study Pregliasco F. et al. A New Chance of Preventing Winter Diseases by the a) Mogna L. et al. Micronized Cells of the Probiotic Strain Bifidobacterium Administration of Symbiotic Formulations. Journal of Clinical Gastroente- lactis BS01 Activate Monocyte Polarization: A New Approach. J Clin Ga- rology, 2008; 42(2): 224-233. stroenterol. 2018;52:S57-S61. b) Mogna L. et al. Assessment of the in vitro inhibitory activity of specific + Internal data on immune stimulation and anti-pathogen activity available probiotic bacteria against different Escherichia coli strains (LP02, LR04). upon request for certain strains J Clin Gastroenterol. 2012; 46 Suppl:S29-32. c) Deidda F. et al. (2020) How Probiotics may Kill Harmful Bacteria: The - Immunology in vitro Activity against Some Haemolytic Strains. J. Prob. Health 8:216 LR04).

Lacticaseibacillus rhamnosus - GG (ATCC 53103) (formerly Lactobacillus rhamnosus) RAW MATERIAL FUNCTIONALITY / SCIENTIFIC SUPPORT AND FINISHED DOSAGE FORM The most studied probiotic strain in the world, over 1000 publications available, including immune support, anti-pathogen activity and digestive health

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Immunology - allergic rhinitis Immunology - asthma s i t

Ligilactobacillus salivarius - LS01™ (DSM 22775) i t (formerly Lactobacillus salivarius ) a m r

DAILY DOSAGE IN CLINICAL STUDY 1,2,3) 2 billion CFU FINISHED DOSAGE FORM e d

4) 5 billion CFU + 2 billion CFU of Streptococcus thermophilus ST10 c + Tara gum i p o FUNCTIONALITY Treatment of atopic dermatitis • Improvement of the Quality of Life in subjects with Atopic Dermatitis t A

• • •

Skin health Inhibition of C. acnes (formerly classified as P. acnes )–induced IL-8 release Inhibition of S. aureus -

SCIENTIFIC SUPPORT y g

Human clinical trials In vitro studies o l

1) Drago L. et al. Effects of Lactobacillus salivarius LS01 (DSM 22775) a) Drago L. et al. Strain-dependent release of cytokines modulated by o treatment on adult atopic dermatitis: a randomized placebo-controlled Lactobacillus salivarius human isolates in an in vitro model. BMC Res t a study. Int J Immunopathol Pharmacol. 2011; 24(4):1037-48. Notes. 2010; 3:44. m 2) Drago L. et al. Changing of fecal flora and clinical effect of L. salivarius b) Deidda F. et al. New Approach in Acne Therapy, A Specific Bacte - r e LS01 in adults with atopic dermatitis. J Clin Gastroenterol. 2012; 46 riocin Activity and a Targeted Anti IL-8 Property in Just 1 Probiotic D Suppl:S56-63. Strain, the L. salivarius LS03. (LS01, LS02, LS03) J Clin Gastroenterol 3) Niccoli A. et al. Preliminary results on clinical effects of probiotic Lac - 2018;52:S78-S81. tobacillus salivarius LS01 in children affected by atopic dermatitis. J Clin c) Deidda F. et al. (2020) How Probiotics may Kill Harmful Bacteria: The Gastroenterol. 2014; 48 Suppl:S34-36. in vitro Activity against Some Haemolytic Strains. J. Prob. Health 8:216. 4) Drago L. et al. Treatment of atopic dermatitis eczema with a high con - + Refer to next page for further studies on LS01 associated with B. centration of Lactobacillus salivarius LS01 associated with an innovative breve BR03 gelling complex. J Clin Gastroenterol. 2014; 48 Suppl:S47-511.

Bifidobacterium animalis subsp. lactis - BS01™ (LMG P-21384) + Lacticaseibacillus rhamnosus - LR05 (DSM 19739) (formerly Lactobacillus rhamnosus ) DAILY DOSAGE IN CLINICAL STUDY BS01 1 billion cells + LR05 1 billion cells + 2.5 g FOS RAW MATERIAL AND FINISHED DOSAGE FORM FUNCTIONALITY Atopic dermatitis

SCIENTIFIC SUPPORT Human clinical trial Manzotti G. et al. Probiotics as a Novel Adjuvant Approach to Atopic + Immunomodulation in vitro data available upon request Dermatitis. Journal of Contemporary Immunology (2014) Vol. 1 No. 2 pp. 57-66.

23 a i Ligilactobacillus salivarius - LS01™ (DSM 22775) (formerly Lactobacillus salivarius ) r a c i t Bifidobacterium breve - BR03™ (DSM 16604) + r u

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DAILY DOSAGE IN CLINICAL STUDY LSO1 1,3,4) 2 billion CFU + BR03 2 billion CFU FINISHED DOSAGE FORM i n

2) LSO1 1 billion CFU + BR03 1 billion CFU o r h c

FUNCTIONALITY • Reduce frequency, duration and intensity of Atopic Dermatitis symptoms Improvement of the Quality of Life in subjects with ,

Atopic Dermatitis (AD) • Rosacea • Chronic urticaria • Skin health a e c a

SCIENTIFIC SUPPORT s o R

Human clinical trials In vitro studies - 1) Iemoli E. et al. Probiotics reduce gut microbial translocation and improve a) Deidda F. et al. New Approach in Acne Therapy: A Specific Bacte - y

adult atopic dermatitis. J Clin Gastroenterol. 2012; 46 Suppl:S33-40. riocin Activity and a Targeted Anti IL-8 Property in Just 1 Probiotic g

Strain, the L. salivarius LS03. J Clin Gastroenterol. 2018 May 18. o 2) Licari A. et al. Efficacia clinica di Lactobacillus salivarius LS01 e Bifido - l bacterium breve BR03 in pazienti pediatrici affetti da dermatite atopica. Il b) Drago L. Immunomodulatory Effects of Lactobacillus salivarius LS01 o t medico pediatra 2016;38-42. and Bifidobacterium breve BR03, alone and in combination, on Peri - a

3) Nettis E. et al. Probiotics and refractory chronic spontaneous urticaria. pheral Blood Mononuclear Cells of Allergic Asthmatics. Allergy Asthma m Immunol Res. 2015 July; 7(4):409-413. r Eur Ann Allergy Immunol 2016, Vol 48, N 5, 182-187. e c) Deidda F. et al. (2020) How Probiotics may Kill Harmful Bacteria: The 4) Fortuna M. C. et al. A case of Scalp Rosacea treated with low dose do - D in vitro Activity against Some Haemolytic Strains. J. Prob. Health 8:216 xycycline and probiotic therapy and literature review on therapeutic options. (LS01). Dermatologic Therapy ISSN 1396-0296.

+ Refer to precedent page for additional studies on LS01 alone in atopic dermatitis e

Ligilactobacillus salivarius - LS03 (DSM 22776) n c A (formerly Lactobacillus salivarius ) -

RAW MATERIAL y

FUNCTIONALITY Acne - Anti-pathogen activity: inhibition of C. acnes (formerly classified as P. acnes ) and its AND FINISHED DOSAGE FORM g

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Deidda F. et al. New Approach in Acne Therapy: A Specific Bacteriocin r Activity and a Targeted Anti IL-8 Property in Just 1 Probiotic Strain, the L. e salivarius LS03. J Clin Gastroenterol. 2018 May 18. D

24

t

BS05 (DSM 23032) n Bifidobacterium animalis subsp. lactis - a d i x

Lactobacillus acidophilus - LA06 (DSM 23033) o i t

FINISHED DOSAGE FORM n A •

FUNCTIONALITY Antioxidant activity Reduced glutathione (GSH) and increased superoxide dismutase production -

SCIENTIFIC SUPPORT g n In vitro and animal model studies Deidda F. et al. (2020) How Probiotics may Kill Harmful Bacteria: The in i vitro Activity against Some Haemolytic Strains. J. Prob. Health 8:216 g a) Amaretti A. et al. Antioxidant properties of potentially probiotic bacteria: in a - vitro and in vivo activities. Appl Microbiol Biotechnol. 2013; 97(2):809-17. (LA06). i t n A

Ligilactobacillus salivarius - LS01™ (DSM 22775) New data (formerly Lactobacillus salivarius ) FINISHED DOSAGE FORM Lactobacillus acidophilus - LA02 (DSM 21717) Bifidobacterium breve - BR03™ (DSM 16604) Lactiplantibacillus plantarum - LP01™ (LMG P-21021) (formerly Lactobacillus plantarum ) Lacticaseibacillus rhamnosus - LR06 (DSM 21981) (formerly Lactobacillus rhamnosus )

Bifidobacterium animalis subsp. lactis - BS01™ (LMG P-21384) New data RAW MATERIAL AND FINISHED DOSAGE FORM FUNCTIONALITY Antioxidant activity • Reduced glutathione (GSH) and increased superoxide dismutase production • Anti-pathogen activity

SCIENTIFIC SUPPORT In vitro studies a) Magistrelli L et al. (2019) Probiotics May Have Beneficial Effects in Parkin - c) Deidda F. et al. (2020) How Probiotics may Kill Harmful Bacteria: The son’s Disease: In vitro Evidence. Front. Immunol. 10:969. in vitro Activity against Some Haemolytic Strains. J. Prob. Health 8:216 b) Mogna L. et al. Assessment of the in vitro inhibitory activity of specific (LA02 LS01, LP01). probiotic bacteria against different Escherichia coli strains (LP01, LP02, LR04, LR06, LPS01, LDD01, BR03, B632). J Clin Gastroenterol. 2012; 46 Suppl:S29-32.

25

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Lb26 (DSM 16341) (formerly Lactobacillus reuteri ) n Limosilactobacillus reuteri - a d (under worldwide exclusive license from BIOMAN for nutraceutical and pharma applications) i x o i

RAW MATERIAL t

AND FINISHED DOSAGE FORM n •

FUNCTIONALITY Carrier of with high bioavailability Organic selenium from probiotic strain allergen A

free with High Bioavailability: Protection of DNA, proteins and lipids from oxidative damage -

g

SCIENTIFIC SUPPOR n In vitro studies c) Galano E. et al. Privileged Incorporation of Selenium as Selenocysteine i g

a) Mogna L. et al. Selenium and internalized by Lactobacillus buchneri in Lactobacillus reuteri Proteins Demonstrated by Selenium-specific Ima - a - i

Lb26 (DSM 16341) and Bifidobacterium lactis Bb1 (DSM 17850): impro - ging and Proteomics. Molecular & Cellular Proteomics 12.8, 2013. t ved bioavailability using a new biological approach. J Clin Gastroenterol. d) Mangiapane E. et al. Selenium effects on the metabolism of a Se-meta - n 2012; 46 Suppl:S41-5. bolizing Lactobacillus reuteri : analysis of envelope-enriched and extracel - A b) Mangiapane E. et al. An integrated proteomic and physiological appro - lular proteomes. The Royal Society of Chemistry, 2014. ach to understand the adhesion mechanism of the probiotic Lactobacillus e) Mangiapane E. et al. Selenium and Selenoproteins: An Overview on Dif - reuteri Lb26 DSM16341. Journal of integrated Omics, 2013. ferent Biological Systems. Current Protein and Peptide Science, 2014, 15, 598-607.

Bifidobacterium animalis subsp. lactis - Bb1 (DSM 17850) (under worldwide exclusive license from BIOMAN for nutraceutical and pharma applications) RAW MATERIAL AND FINISHED DOSAGE FORM FUNCTIONALITY Carrier of zinc with High Bioavailability: • Normal function of the immune system • Normal DNA synthesis and cell division • Protection of DNA, proteins and lipids from oxidative damage • Maintenance of normal bone • Normal cognitive function • Fertility and reproduction

SCIENTIFIC SUPPORT In vitro study Mogna L. et al. Selenium and zinc internalized by Lactobacillus buchneri Lb26 (DSM 16341) and Bifidobacterium lactis Bb1 (DSM 17850): im- proved bioavailability using a new biological approach. J Clin Gastroen- terol. 2012; 46 Suppl:S41-5.

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SCIENTIFIC SUPPORT s e

Human clinical trial In vitro and in vivo testing l Guardamagna O. et al. Bifidobacteria supplementation: effects on plasma Bordoni et al. Cholesterol-lowering probiotics: in vitro selection and in o h lipid profile in dyslipidemic children. Nutrition (2014), doi: 10.1016/ j.nut. vivo testing of Bifidobacteria . Appl. Microbiol. Biotechnol. 2013. C

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SCIENTIFIC SUPPORT a

In vitro and in vivo testing C Bordoni et al. Cholesterol-lowering probiotics: in vitro selection and in vivo testing of Bifidobacteria . Appl. Microbiol. Biotechnol. 2013. 97:8273-8281.

Bifidobacterium infantis - BI02 (DSM 24687, formerly MB287) RAW MATERIAL FUNCTIONALITY Cardiovascular health • Cholesterol lowering AND FINISHED DOSAGE FORM SCIENTIFIC SUPPORT Internal in vitro data on Bile Salt Hydrolase (BSH) production available upon request

Limosilactobacillus fermentum - ME-3 (DSM 14241) (formerly Lactobacillus fermentum ) (under license from the University of Tartu for food applications) RAW MATERIAL FUNCTIONALITY Cardiovascular health • LDL-cholesterol lowering • Antioxidant properties AND FINISHED DOSAGE FORM SCIENTIFIC SUPPORT Many scientific studies are available, including several human clinical trials

28 e c

Bifidobacterium breve - BR03™ (DSM 16604) n + a m - FP4 (DSM 18616) r

Streptococcus thermophilus o f r

DAILY DOSAGE IN CLINICAL STUDY 1) 5 billion CFU + 5 billion CFU RAW MATERIAL e

AND FINISHED DOSAGE FORM p

s

• t

FUNCTIONALITY Immune response improving Performance enhancing r o

SCIENTIFIC SUPPORT p S

Human clinical trials In vitro studies -

1) Jäger R. et al. Probiotic Streptococcus thermophilus FP4 and Bifido - a) Nicola S. et al. Interaction between probiotics and human immune s c bacterium breve BR03 Supplementation Attenuates Performance and cells: the prospective anti-inflammatory activity of Bifidobacterium breve i t

Range-of-Motion Decrements Following Muscle Damaging Exercise. Nu - BR03. AgroFOOD, 2010; 21(2):S44-47. e trients. 2016 Oct 14;8(10). pii: E642. t b) Mogna L. et al. Assessment of the in vitro inhibitory activity of specific e i 2) Pane M. et al. , Probiotics, and Sport: From Clinical Evi - probiotic bacteria against different Escherichia coli strains (BR03). J Clin D dence to Agonistic Performance. J Clin Gastroenterol, 2018;52:S46-S49. Gastroenterol. 2012; 46 Suppl:S29-32.

+ Internal data available upon request on CLA production and protection of gut epithelial barrier with BR03 (TEER)

Bifidobacterium breve - BR03™ (DSM 16604) t n

RAW MATERIAL e

AND FINISHED DOSAGE FORM m •

FUNCTIONALITY Restoration of a better dietary ω-6/ ω-3 balance Conjugated linoleic acids (CLA) production e

• Prospective use in the treatment of obesity g a n

SCIENTIFIC SUPPORT a m

In vitro studies + Internal data available upon request on CLA production and protection t a) Nicola S. et al. Interaction between probiotics and human immune of gut epithelial barrier with BR03 (TEER) h g cells: the prospective anti-inflammatory activity of Bifidobacterium breve i e BR03. AgroFOOD, 2010; 21(2):S44-47. + On going clinical study in combination with B. breve B632 in weight W

management and insulin sensitivity in obese children - b) Mogna L. et al. Assessment of the in vitro inhibitory activity of specific probiotic bacteria against different Escherichia coli strains. J Clin Gastro - s c i

enterol. 2012; 46 Suppl:S29-32. t e t e + Internal data available upon request on CLA production and protection of gut epithelial barrier with BR03 (TEER) i D

29 t

04 (DSM 23233) n

Bifidobacterium longum - e

DAILY DOSAGE IN CLINICAL STUDY 1 billion CFU FINISHED DOSAGE FORM m e g

FUNCTIONALITY Restoration of a better dietary ω-6/ ω-3 balance • Conjugated linoleic acids (CLA) production a • • n

Prospective use in the treatment of obesity Cholesterol management a m

SCIENTIFIC SUPPORT t h

Human clinical trial g i

Guardamagna O. et al. Bifidobacteria supplementation: effects on pla - e W

sma lipid profile in dyslipidemic children. Nutrition (2014). -

Internal data available upon request s c i t e t e i

Lactobacillus gasseri - LGS06 (DSM 32405) D RAW MATERIAL AND FINISHED DOSAGE FORM FUNCTIONALITY Weight management

SCIENTIFIC SUPPORT Scientific publications are available on gasseri strains on weight loss and reduction of visceral fats

30 a d

Limosilactobacillus fermentum - LF5 (CNCM I-789) (API) (formerly Lactobacillus fermentum ) i d

DAILY DOSAGE IN CLINICAL STUDY 1,2,3,4) 1 billion CFU FINISHED DOSAGE FORM n a C

FUNCTIONALITY Vaginal health • Inhibition of Candida strains • Treatment of vulvovaginal candidiasis (VVC) -

SCIENTIFIC SUPPORT y g

Human clinical trials In vitro studies o 1) Presidio Ospedaliero Delmati, Divisione di Ostetricia - Ginecologia. LF5 a) Deidda F. et al. The In Vitro Effectiveness of Lactobacillus fermentum l o

- LAB: studio di tollerabilità locale e di attività in pazienti affette da Can - Against Different Candida Compared With Broadly Used Azoles. c dida albicans . 1992. J Clin Gastroenterol, Vol 50, Supp. 2, November/December 2016. e n

2) Centro di ricerca: USSL Lombardia 55 - Presidio Ospedaliero Delmati, b) Deidda F. et al. In Vitro Activity of Lactobacillus fermentum LF5 Against y

S. Angelo Lodigiano, Divisione di Ostetricia-Ginecologia, Primario: Dott. Different Candida Species and Gardnerella vaginalis A New Perspective G Francesco Rovere. LF5 (lAB): Studio di dose range finding in pazienti af - to Approach Mixed Vaginal Infections? J Clin Gastroenterol Volume 50, fette da Candida albicans . 1992. Supp. 2, November/December 2016. 3) Donini G. Studio clinico sull’efficacia e la tollerabilità di LF5 (LAB) cap - sule vaginali in confronto a placebo in pazienti affette da Candida Albicans . Ospedale S. Salvatore, Divisione Ostetrico-Ginecologica, Pesaro. 1992. 4) Rovere F. Local tolerability and activity study in patients suffering from Candida albicans (“Delmati2 Hospital, Italy, 1992).

Limosilactobacillus fermentum - LF08 (DSM 18297) (formerly Lactobacillus fermentum ) RAW MATERIAL FUNCTIONALITY Inhibition of Candida strains AND FINISHED DOSAGE FORM

SCIENTIFIC SUPPORT: Internal vitro data, available upon request

Limosilactobacillus fermentum - LF09 (DSM 18298) (formerly Lactobacillus fermentum ) FINISHED DOSAGE FORM FUNCTIONALITY Restoration of a physiological gut barrier • Inhibition of Candida growth • Strain from brushing of the gut mucosa

SCIENTIFIC SUPPORT: In vitro data In vitro study Deidda F. et al. The In Vitro Effectiveness of Lactobacillus fermentum Against Different Candida Species Compared With Broadly Used Azoles. J Clin Gastroenterol. 2016 Nov/Dec;50 Suppl 2, S171-S174

31 a

(formerly Lactobacillus fermentum d Limosilactobacillus fermentum - LF10 (DSM 19187) ) i d

DAILY DOSAGE IN CLINICAL STUDY 1,2) 400 million CFU FINISHED DOSAGE FORM n a C

FUNCTIONALITY Vaginal health • Inhibition of Candida strains • Counteraction of vulvovaginal candidiasis (VVC) -

SCIENTIFIC SUPPORT y g

Human clinical trials In vitro study o l

1)Vicariotto F. et al. Effectiveness of the association of 2 probiotic strains Deidda F. et al. In vitro effectiveness of Lactobacillus fermentum against o formulated in a slow release vaginal product, in women affected by vul - different Candida species compared with broadly used azoles. Journal c vovaginal candidiasis: a pilot study. J Clin Gastroenterol. 2012; 46 e

of Clinical Gastroenterology, 2016;50:S171-S174. n

Suppl:S73-80. y

2) Murina F et al. Can Lactobacillus fermentum LF10 and Lactobacillus G acidophilus LA02 in a Slow-release Vaginal Product be Useful for Pre - vention of Recurrent Vulvovaginal Candidiasis? A Clinical Study. J Clin Gastroenterol 2014;48:S102-S105.

Limosilactobacillus fermentum - LF11 (DSM 19188) (formerly Lactobacillus fermentum )

FUNCTIONALITY Vaginal health • Inhibition of Candida strains FINISHED DOSAGE FORM • Counteraction of vulvovaginal candidiasis (VVC)

SCIENTIFIC SUPPORT In vitro data Deidda F. et al. In vitro effectiveness of Lactobacillus fermentum against different Candida species compared with broadly used azoles. Journal of Clinical Gastroenterology, 2016;50:S171-S174.

Limosilactobacillus fermentum - LF16 (DSM 26856) (formerly Lactobacillus fermentum ) FINISHED DOSAGE FORM FUNCTIONALITY Vaginal health • Inhibition of Candida growth

SCIENTIFIC SUPPORT Internal in vitro data, available upon request

32 SCIENTIFIC SUPPORT FUNCTIONALITY DAILY DOSAGE IN CLINICAL STUDY Lactobacillus acidophilus Lactobacillus gasseri SCIENTIFIC SUPPORT (under exclusive worldwide license from the CERELA) FUNCTIONALITY Limosilactobacillus fermentum tan wt poitc rpris o aia eihla cls Biocell, cells. epithelial 2001;25(3):265-273; vaginal to properties probiotic with strains OcanaV.Nader-Macias and AdhesionLactobacillusME.of vaginalb) richia coli, Journal of Medical Microbiology, 2003;52-1-8. tobacillus acidophilus TomasMSJ. Et al. a) Growth and production by vaginal 48:S102-105. tionRecurrentof Vulvovaginal Candidiasis? ClinGastroenterol.J 2014; acidophilus MurinaF. 2) et al. Can candidiasis: a pilot study. Jmulated Clin Gastroenterol. in a slow 2012; release Vicariotto46 Suppl:S73-80.1) vaginal F. product,et al. Effectivenessin women affectedof the associationby vulvovaginal of 2 probiotic strains for- I H n u

v m i t r a o n s

c t u l i d n y i LA02 in a Slow-release Vaginal Product be Useful for Preven- c al

t r Vaginal health Vaginal health and inhibition of urogenital pathogens and activity of lactobacilli i a l s CRL 1259, and inhibition of uropathogenic Esche- Lactobacillusfermentum • Inhibition of FOS + Arabinogalactan+ 1,2) LA02 400 million CFU + LF10 400 million CFU + Carbon dioxide • - CRL1259 (DSM 24512) Counteraction of Candida LF10and - strains LA02 (DSM 21717) Lactobacillus - LF10 (DSM 19187) Candida • Innovative effervescent slow release tablet for enhanced delivery Lac- vulvovaginitis cells. Letters in Applied Microbiology ISSN 0266-8254; bacillivitroinadhesionon urogenital of pathogens vaginalto epithelial Zàrate G. and Nader-Maciasd) ME. Influence of probiotic vaginal lacto- Science, 2005; 62(4). tobacilli isolated from Argentinean women. TomasBritish JournalMSJ. Etof c) Biomedicalal. Characterization of potentially probiotic vaginal lac- (LA02). invitro Activity against Some Haemolytic Strains. J. Prob. Health 8:216 Deidda F.b) et al. (2020) How Probiotics may Kill Harmful Bacteria: The J Clin Gastroenterol. 2016; 50:S171-S174 (LF10). Against Different Deidda F.a) et al. The In Vitro Effectiveness of I n

v i t r o

s t u d y + Candida (formerly Species Compared With Broadly Used Azoles. Lactobacillus fermentum FINISHED DOSAGE FORM FINISHED DOSAGE FORM Lactobacillus fermentum 33 )

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Gynecology - Pregnancy SCIENTIFIC SUPPORT Neisseria gonorrhea and Trichomonas vaginalis presentantagonisticCandidaalbicans,toactivityfound againstasvaginalpathogensbeen such gasserihave strains of andpretermbirthearly gasserispeciesisa naturally predominant L. inthehealthy vaginal ecosystem. Literature shows that gasseri isassociated withdecreased a risk of Lactobacillus gasseri minated by L. crispatus are less at risk of bacterial vaginosis, miscarriage, crispatus preterm is birthL. a speciesand sexually naturally transmissible predominant diseases in the healthy vaginal ecosystem. A body of literature shows that women with a vaginal ecosystem do- Lactobacillus crispatus FUNCTIONALITY SCIENTIFIC SUPPORT FUNCTIONALITY Vaginal health Vaginal health • • Rebalance of a healthy vaginal microbiota Rebalance of a healthy vaginal microbiota - LGS06 (DSM 32405) - LCR01 (DSM 24619) • Inhibition of Candida AND FINISHED DOSAGE FORM AND FINISHED DOSAGE FORM RAW MATERIAL RAW MATERIAL 38

Gynecology - Pregnancy and Vaginal health 39-42 Urology web:Layout 1 04/01/21 16:11 Pagina 39

Lactiplantibacillus plantarum - LP01™ (LMG P-21021) (formerly Lactobacillus plantarum)+ Uti Lacticaseibacillus paracasei - LPC09 (DSM 24243) (formerly Lactobacillus paracasei) + Streptococcus thermophilus - ST10 (DSM 25246) DAILY DOSAGE IN CLINICAL STUDY 1) LP01 2.5 billion cells + LPC09 1 billion cells + ST10 1 billion cells FINISHED DOSAGE FORM Urology - - Urology

FUNCTIONALITY Cystitis • Inhibition of E. coli • Metabolization of oxalates, prevention of kidney stones

SCIENTIFIC SUPPORT Clinical study In vitro studies 1) Vicariotto F. Effectiveness of An Association of a Cranberry Dry a) Mogna L. et al. Assessment of the in vitro inhibitory activity of spe- Extract, D-Mannose, and the 2 Microorganisms Lactobacillus planta- cific probiotic bacteria against different Escherichia coli strains. J Clin rum LP01 and Lactobacillus paracasei LPC09 in Women Affected by Gastroenterol. 2012; 46 Suppl:S29-32. Cystitis. Journal of Clin Gastroenterol 2014;48:S96-S101. b) Mogna L. et al. Screening of different probiotic strains for their in vitro ability to metabolise oxalates: any prospective use in humans? J + Internal data on anti-inflammatory and anti-oxidant properties avai- Clin Gastroenterol. 2014; 48 Suppl:S91-95 (LPC09, LP01). lable upon request c) Deidda F. et al. (2020) How Probiotics may Kill Harmful Bacteria: The in vitro Activity against Some Haemolytic Strains. J. Prob. Health 8:216.

Lactiplantibacillus plantarum - LP01™ (LMG P-21021) (formerly Lactobacillus plantarum) Lactiplantibacillus plantarum - LP02 (LMG P-21020) (formerly Lactobacillus plantarum) Lacticaseibacillus rhamnosus - LR04 (DSM 16605) (formerly Lactobacillus rhamnosus) Lacticaseibacillus rhamnosus - LR06 (DSM 21981) (formerly Lactobacillus rhamnosus) Lactiplantibacillus pentosus - LPS01 (DSM 21980) (formerly Lactobacillus pentosus) Bifidobacterium breve - BR03™ (DSM 16604) RAW MATERIAL FUNCTIONALITY Cystitis • Inhibition of E. coli, E. faecalis and K. pneumoniae among other AND FINISHED DOSAGE FORM SCIENTIFIC SUPPORT In vitro study a) Mogna L. et al. Assessment of the in vitro inhibitory activity of specific probiotic b) DDeidda F. et al. (2020) How Probiotics may Kill Harmful Bacteria: bacteria against different Escherichia coli strains (LP01, LP02, LR04, LR06, The in vitro Activity against Some Haemolytic Strains. J. Prob. Health LPS01, LDD01, BR03, B632). J Clin Gastroenterol. 2012; 46 Suppl:S29-32. 8:216 (LP01, LR04). + Internal data on anti-inflammatory and anti-oxidant properties available upon request for some of these strains

39 39-42 Urology web:Layout 1 04/01/21 16:11 Pagina 40 i LDD01 (DSM 22106) t Lactobacillus delbrueckii subsp. delbrueckii - U

-

FINISHED DOSAGE FORM

FUNCTIONALITY Inhibition of pathogens E. coli , Klebsiella and gas-producing coliforms y g o

SCIENTIFIC SUPPORT l

In vitro studies c) Mogna L. et al. In Vitro Inhibition of Klebsiella pneumoniae by Lacto - o r a) Mogna L. et al. Assessment of the in vitro inhibitory activity of specific bacillus delbrueckii subsp. delbrueckii LDD01 (DSM 22106): An Inno - U probiotic bacteria against different Escherichia coli strains. J Clin Gastro - vative Strategy to Possibly Counteract Such Infections in Humans? J Clin enterol. 2012; 46 Suppl:S29-32. Gastroenterol. 2016 Nov/Dec;50 Suppl 2, Proceedings from the 8th Pro- b) Savino F. et al. Antagonistic effect of Lactobacillus strains against gas- biotics, Prebiotics & New Foods for Microbiota and Human Health mee - producing coliforms isolated from colicky infants. BMC Microbiology ting held in Rome, Italy on September 13-15, 2015:S136-S139. 2011, 11:157.

Bifidobacterium breve - B632™ (DSM 24706) FINISHED DOSAGE FORM FUNCTIONALITY Inhibition of pathogens E. coli and Enterobacteriaceae

SCIENTIFIC SUPPORT In vitro studies b) Simone M. et al. The Probiotic Bifidobacterium breve B632 Inhibited a) Mogna L. et al. Assessment of the in vitro inhibitory activity of specific the Growth of Enterobacteriaceae within Colicky Infant Microbiota Cultu - probiotic bacteria against different Escherichia coli strains (LP01, LP02, res. BioMed Research International 1-6, 2014. LR04, LR06, LPS01, LDD01, BR03, B632). J Clin Gastroenterol. 2012; 46 Suppl:S29-32.

Ligilactobacillus salivarius - CRL 1328 (DSM 24441) (formerly Lactobacillus salivarius ) RAW MATERIAL FUNCTIONALITY Prevention of urogenital infections • Inhibition of Enterococcus faecalis , Enterococcus faecium AND FINISHED DOSAGE FORM and Neisseria gonorrhea • Inhibition of Candida

SCIENTIFIC SUPPORT In vitro studies d) Rovere F. Local tolerability and activity study in patients suffering from a) Ocana V. et al. Characterization of a bacteriocin like substance produced Candida albicans (Delmati2 Hospital, Italy, 1992). by a vaginal Lactobacillus salivarius strain. Applied and Environmental Mi - e) Gillor O. et al. The dual role of as anti- and probiotics. Appl crobiology, 1999; 65(12):5631-5635. Microbiol Biotechnol. 2008 December; 81(4): 591–606. doi: 10.1007/ b) Ocana V. et al. Surface characteristics of lactobacilli isolated from human s00253-008-1726-5. vagina. J. Gen. Appl. Microbiol., 1999; 45:203-212. f) Dover S.E. et al. Natural antimicrobials and their role in vaginal health: a c) Tomas MSJ. et al. Influence of pH, temperature and culture media on short review. Int J Probiotics Prebiotics. 2008 ; 3(4): 219–230. the growth and bacteriocin production by vaginal Lactobacillus salivarius g) Juárez Tomás M.S. et al. Viability of vaginal probiotic lactobacilli during re - CRL 1328. Journal of Applied Microbiology, 2002; 93: 714-724. frigerated and frozen storage. Anaerobe, Vol 10, Issue 1, February 2004, 1-5.

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Urology - Prostate health y t i l

Bifidobacterium longum - 04 (DSM 23233) + New Study a u q

Limosilactobacillus fermentum - LF16 (DSM 26856) (formerly Lactobacillus fermentum ) + p e e l s Lactiplantibacillus plantarum - LP01™ (LMG P-21021) (formerly Lactobacillus plantarum ) + d n a Lacticaseibacillus rhamnosus - LR06 (DSM 21981) (formerly Lactobacillus rhamnosus ) d

DAILY DOSAGE IN CLINICAL STUDY 1 billion cfu/afu per strain FINISHED DOSAGE FORM o o M • • FUNCTIONALITY Improvement of the quality of sleep Reduction of fatigue and anger Improvement of mood -

• Inhibition of E. coli and Candida n i a

SCIENTIFIC SUPPORT r b

Human clinical trial In vitro studies - t

Marotta A. et al., Effects of Probiotics on Cognitive Reactivity, Mood, a) Mogna L. et al. Assessment of the in vitro inhibitory activity of specific u

and Sleep Quality, 2019 Frontiers in Psychiatry. probiotic bacteria against different Escherichia coli strains (LP01, LP02, G LR04, LR06, LPS01, LDD01, BR03, B632). J Clin Gastroenterol. 2012; Data is available upon request on the preclinical rationale of selection 46 Suppl:S29-32. for these strains b) Deidda F. et al. (2020) How Probiotics may Kill Harmful Bacteria: The in vitro Activity against Some Haemolytic Strains. J. Prob. Health 8:216 (LP01).

43 Ligilactobacillus salivarius - LS01™ (DSM 22775) (formerly Lactobacillus salivarius) New Study FINISHED DOSAGE FORM

Lactiplantibacillus plantarum - LP01™ (LMG P-21021) (formerly Lactobacillus plantarum) parkinson Lactobacillus acidophilus - LA02 (DSM 21717) Lacticaseibacillus rhamnosus - LR06 (DSM 21981) (formerly Lactobacillus rhamnosus) Bifidobacterium animalis subsp lactis - BS01™ (LMG P-21384) Gut-brain - - Gut-brain Bifidobacterium breve - BR03™ (DSM 16604) RAW MATERIAL SCIENTIFIC SUPPORT AND FINISHED DOSAGE FORM In vitro study Magistrelli L et al. (2019) Probiotics May Have Beneficial Effects in Parkinson’s Disease: In vitro Evidence. Front. Immunol. 10:969.

Lacticaseibacillus rhamnosus - GG (ATCC 53103) (formerly Lactobacillus rhamnosus) DAILY DOSAGE IN CLINICAL STUDY 1) 10 billion CFU RAW MATERIAL AND FINISHED DOSAGE FORM FUNCTIONALITY Autism and ADHD prevention SCIENTIFIC SUPPORT

Human clinical trial autism, aDHD Anna Pärtty et al. A possible link between early probiotics intervention and the risk of neuropsychiatric disorders later in childhood: a randomi- zed trial. Pediatric Research, Volume 77, Number 6, June 2015. Gut-brain - - Gut-brain

44 52:3259-3265. 2007; Sci Dis Dig study. placebo-controlled double-blind, domized, ran- a encephalopathy: hepatic minimal in treatment (FOS) charides al. et M. Malaguarnera SCIENTIFIC SUPPORT DAILY DOSAGE IN CLINICAL STUDY Bifidobacterium longum FUNCTIONALITY in amyotrophic lateral sclerosis. BMC Med2) June.Di Gioia et al. A prospective longitudinalPossible study Novelon theTherapeutic microbiota Mazzini Strategies.compositionL. 1) et al. Potential J ClinRole of Gut Gastroenterol,Microbiota in ALS Pathogenesis Vol 00,and N 00, 2018. H H Streptococcus thermophilus Ligilactobacillus salivarius SCIENTIFIC SUPPORT DAILY DOSAGE IN CLINICAL STUDY Lactobacillus delbrueckii Limosilactobacillus fermentum Lactiplantibacillus plantarum u u m m a a n n

c cl l i i n n i i c c al al

t t r r i i Minimal hepatic encephalopathy • a a Rebalance of intestinal microbiota l l

Bifidobacterium longum Bifidobacterium 1-2) LF10 4 billion CFU + LDD01 2 billion CFU + LP01 2 billion CFU LS03 2+ billion CFU + ST10 5 billion CFU 5 billion CFU + FOS with fructo-oligosac- with • - subsp. - Reduction of gastro-intestinal discomfort related to IBS LS03 (DSM 22776) • - - W11 (LMG P-21586) Non-transmissible rifamycins resistance LP01™ (LMG P-21021) ST10 (DSM 25246) - LF10 (DSM 19187) delbrueckii (formerly New Study - (formerly LDD01 (DSM 22106) (formerly Lactobacillus salivarius Lactobacillus fermentum Lactobacillus plantarum AND FINISHED DOSAGE FORM FINISHED DOSAGE FORM RAW MATERIAL + ) + ) ) + + 45

Gut-brain - encephalopathy Gut-brain - SLa gical symptoms and sex comparisons. J Transl Med 2018, 16:24. myalgicencephalomyelitis chronic/ fatigue syndrome: neuropsycholo- Open-labelal.Walliset A. pilot treatmentfor targeting dysbiosisgut in H FUNCTIONALITY SCIENTIFIC SUPPORT DAILY DOSAGE IN CLINICAL STUDY Bifidobacterium longum Bifidobacterium breve Bifidobacterium animalis Lacticaseibacillus rhamnosus u m a n

cl i n i c al

t r i Sleep improvement and cognitive symptoms improvement in patients with encephalomyelitis/ chronic fatigue syndrome a l

GG 25 billion cfu + BS01 15 billion cfu + BR03 5 billion cfu + BL03 5 billion cfu - BR03™ (DSM 16604) - BL03 (DSM 16603) subsp. - GG (ATCC 53103) lactis - BS01™ (LMG P-21384) (formerly Lactobacillus rhamnosus AND FINISHED DOSAGE FORM RAW MATERIAL + + ) + 46

Gut-brain -chronic fatigue, myalgic encephalomyelitis s i Lacticaseibacillus rhamnosus - LR06 (DSM 21981) (formerly Lactobacillus rhamnosus ) s o t i l Lactiplantibacillus pentosus - LPS01 (DSM 21980) (formerly Lactobacillus pentosus ) + a h

-

Lactiplantibacillus plantarum - LP01™ (LMG P-21021) (formerly Lactobacillus plantarum ) + e r a c

Lactobacillus delbrueckii subsp. delbrueckii - LDD01 (DSM 22106) l a

DAILY DOSAGE IN CLINICAL STUDY LR06 1.5 billion CFU + LPS01 1.5 billion CFU + LP01 1.5 billion CFU FINISHED DOSAGE FORM r

+ LDD01 500 million CFU O

FUNCTIONALITY Restoration of a healthy oral flora • Improvement of the incidence and severity of bad breath (halitosis) • Inhibition of pathogens and Volatile Sulphur Compounds producing bacteria

SCIENTIFIC SUPPORT Human clinical trial In vitro studies Del Piano M. et al. Correlation between specific bacterial groups in the a) Mogna L. et al. In Vitro Inhibition of Klebsiella pneumoniae by Lacto - oral cavity and the severity of halitosis: any possible beneficial role for se - bacillus delbrueckii subsp. delbrueckii LDD01 (DSM 22106). An Inno - lected Lactobacilli? J Gastroint Dig Syst, 2014; 4:197. vative Strategy to Possibly Counteract Such Infections in Humans? J Clin Gastroenterol, Vol 50, Supp. 2, November/December 2016. + Refer to gastroenterology section for further clinical studies on this blend b) Mogna L. et al. Assessment of the in vitro inhibitory activity of specific probiotic bacteria against different Escherichia coli strains (LP01, LR06, + Internal data on immunomodulation, anti-oxidant activity and epithelial LPS01, LDD01). J Clin Gastroenterol. 2012; 46 Suppl:S29-32. barrier effect (TEER in Caco2 cells) available upon request for some of these strains c) Deidda F. et al. (2020) How Probiotics may Kill Harmful Bacteria: The in vitro Activity against Some Haemolytic Strains. J. Prob. Health 8:216 (LP01). s

Lacticaseibacillus rhamnosus - GG (ATCC 53103) (formerly Lactobacillus rhamnosus ) e i • r DAILY DOSAGE IN CLINICAL STUDY 1) 5 billion CFU (uncoated) 1 billion cells (microencapsulated) RAW MATERIAL a

AND FINISHED DOSAGE FORM c

• • -

FUNCTIONALITY Oral health Caries prevention Inhibition of Streptococcus mutans e

SCIENTIFIC SUPPORT r a

One of the most recognized probiotic strains in the world, with over 1000 c publications and 300 clinical trials including several demonstrated signi - l a ficant benefits in oral health and caries prevention r O

47

s

e All our strains are available with the application of our proprietary technologies: i

g

o

l

Microencapsulation o

n

Protect the probiotics from gastric acid, human bile and pancreatic secretions. h

c

Improve stability in the Finished Dosage Form. e

T

SCIENTIFIC SUPPORT

Human trials coated Strains. (LP01, BR03) J Clin Gastroenterol, Vol 44, Supp. 1,

n

o 1) Del Piano M. et al. Comparison of the Kinetics of Intestinal Coloni - September 2010. i

t

a zation by Associating 5 Probiotic Bacteria Assumed Either in Micro - l

u encapsulated or in a Traditional, Uncoated Form. (LA02, LR04, GG, Comment: s

p

LR06, BS01) J Clin. Gastroenterol 2012;46:S85-S92. Del Piano M. et al. Is microencapsulation the future of probiotic prepa - a

c

2) Del Piano M. et al. Evaluation of the Intestinal Colonization by Mi - rations? The increased effìcacy of gastro-protected probiotics. Gut Micro - n

e croencapsulated Probiotic Bacteria in Comparison With the Same Un - bes 2:2, 120 123 March April 2011. o

r

c

i

m

Flow cytometry y r

Methodology of enumeration of live, microencapsulated and/or inactivated bacteria, with increased accuracy t e

compared to plate count, and retrieving more information on the bacteria’s status. m o t y

SCIENTIFIC SUPPORT c

Scientific support on Flow Cytometry Methodology: 3) Foglia C et al. New insights in enumeration methodologies of probiotic w o 1) Pane M. et al. Flow cytometry rapid quantification of probiotic bacteria cells in finished products. J Microbiol Methods. 2020 Aug;175:105993. l F in lyophilised cultures and commercial products. Nutrafoods, 2013, Further publications and an ISO standard, ISO 19344 IDF 232, support 12:N35-N37. the use of this method for enumeration of live bacteria 2) Pane M. et al. Flow Cytometry Evolution of Microbiological Methods for Probiotics Enumeration. J Clin Gastroenterol 2018;52:S41-S45. e

Allergen free e r f

Allows an improved safety profile including for pediatric population, and probiotics that can be assumed by all. n e g r

SCIENTIFIC SUPPORT e l Scientific support on Allergen-free probiotics production: Our probiotics can be produced in absence of all allergens listed in EU l A Mogna G. et al. Allergen-free Probiotics. J Clin Gastroenterol 2008; 1169/2011 Annex II S201-S204.

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