from conception to commercialization

8
LALLEMAND HEALTH SOLUTIONS COMPLETE SOLUTIONS. DESIGNER GUIDE.

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Page 1: FROM CONCEPTION TO COMMERCIALIZATION

LALLEMAND HEALTH SOLUTIONS

COMPLETE SOLUTIONS. DESIGNER GUIDE.

FROM CONCEPTION TO COMMERCIALIZATION

Page 2: FROM CONCEPTION TO COMMERCIALIZATION

OO O OO

ChildrenWomen

Men

Infants, toddlers

Seniors

FOR YOU TO SUCCESSFULLY REACH YOUR TARGET

Whole family

Our probiotics already enhance lives in countless ways, who’s next?We currently manufacture more than 450 unique formulas each year, marketed in more than 60 countries, covering many health segments from gastrointestinal health, immunity, women’s health and oral health to mood balance. Help us understand who YOUR end-consumer is and the benefit they will expect from your probiotic solution.

They have

O A global lifestyle approach

O A specific health condition or concern

Specify: ..........................................................................................................................................................................................................................................

Their priorities are(rank from 1 to 5, 1 being the top priority)

O Price

O Experienced efficacy of the product

O Product features / formulation

O Trust in the brand / the company

O Product documentation

Other, specify: ....................................................................................................................................................................................................................................

Page 3: FROM CONCEPTION TO COMMERCIALIZATION

LALLEMAND HEALTH SOLUTIONS

COMPLETE SOLUTIONS. DESIGNER GUIDE.

YOU ARE UNIQUEHelp us be 100% relevant to YOUR needsOur solutions are customized to YOUR needs, so the better we know you from the start, the more likely our proposals will be to hit the mark. Over the past 80 years, LHS has developed partnerships of all kinds and we know for a fact that each and every partner is unique. Here are some of the key aspects we take into account when developing a new probiotic solution.

You have worked with probiotics for…

If you already have a line of probiotics, please provide all relevant details to see how our new solution would best fit.

AND SO SHOULD OUR SOLUTION BE

Business activity

O A supplier

Specify: ..........................................................

.............................................................................

O Other activityO A manufacturer

O Service provider, consultant O R&D

Industry

O Dietary Supplements

O Pharmaceutical products

O Food and beverage

Distribution channels

O Pharmacies

O Mail order, TV shop, internet

Specify: ......................................

.........................................................

O Health food stores

O Health professionals, dispensaries

Specify: ..........................................

.............................................................

O MLM

O Drugstores, supermarkets, food stores

Company size O 1-9 O 10-49 O 50-200 O 200-1000 O >1000

You plan to launch a new probiotic solution within the next...O 6 months O 6-12 months O > 1 year Specify: ........................................................................................................

Your objective is to launch O 1 formula O 2-3 formulas O A complete range

Under which registration status? Specify: .................................................................................................................................................

Specify: ...........................................................................................................................................................................................................................................................

Geographic coverage

O Worldwide O World region O Specific countries

YOU ARE

PROBIOTICS & YOU

Years0 1 2 3 4 5 10 15 20

Page 4: FROM CONCEPTION TO COMMERCIALIZATION

WOULD YOU PREFERREADY-TO-MARKET DOCUMENTED FORMULAS?

Lacidofil®• 26 clinical studies: 13 in children / 13 in adults• Drug status in many countries with a pharmacovigilance program, for the prevention

and treatment of AAD and acute diarrhea in pediatric GI disease• Other GI applications: 2 studies on IBS, 2 on lactose intolerance, 5 on H. pylori

IBacilluS+ • 140+ clinical studies: acute diarrhea, AAD, ulcerative colitis and IBS (claim in Canada - NPN)

Lafti® B94• 4 clinical studies: 2 on infectious diarrhea in children, 2 in NEC (necrotizing

enterocolitis) on premature and CCHD (cyanotic congenital heart disease) infants• Selected from among 40 Bifidobacterium strains for its good synergy with

fibers (breakdown of FOS & inulin)

Lafti® L10 • 1 clinical study on IBS-like symptoms

Probio’Stick® • 1 clinical study on GI symptoms related to stress in active people

S. Boulardii • 100+ publications, the one and only probiotic yeast• Manufactured as an API, several grades available (ground, freeze dried with or

without lactose) in capsules, sachets, orodispersible sticks or as an ingredient for a Probiotic 2.0 formula

ProbioKid®

ProbioStim®• 5 clinical studies in children: 1 on winter infection, 1 on RTI (respiratory tract infection)

and wheezing, 2 safety studies in infants

Rosell® -71 • 1 clinical study: helps reduce the incidence of cold-like symptoms in stressed adults (claim in Canada – NPN)

Lafti® L10 • 3 clinical studies in active people: 2 in athletes, 1 in stressed students

Lacidofil® • 2 clinical studies in pregnant women

Fermalac® • 3 clinical studies as adjunctive treatment for vaginal infections

Cysbiotic® • Potent strain for women’s health combined with standardized cranberry

Probio’Stick® • 2 clinical studies for GI health and mood disorders

Probio’Stick®

• Pioneering R&D work on the brain-gut-axis, 4 mechanistic studies in vivo• 2 clinical studies with the first ever showing the positive effect of a probiotic on

psychological stress• The first and only probiotic with approved health claims in the gut-brain axis area

in Canada

Oralis SB• One of the most documented formulas in oral health • 4 clinical studies: 2 on caries and 2 on gingivitis with similar or better results

than standard mouthwash

�All our documented formulas exist in several dosage forms with stability data and complete registration dossier.

OR

Page 5: FROM CONCEPTION TO COMMERCIALIZATION

WOULD YOU PREFERSPECIFIC CUSTOMIZED BLEND?

At Lallemand Health Solutions, we have focused a great deal of our research resources in documenting in vitro and in vivo the modes of action of our probiotic strains and in further corroborating their potency in humans with state of the art clinical studies. Today, we are proud to provide one of the largest portfolios of proprietary strains, with their potential areas of application. Relevance rates from + to +++ for the highest with available clinical studies.

LACTOBACILLI BIFIDOBACTERIA OTHERS

L. r

ham

nos

us

Ros

ell®

-11

L. h

elve

ticu

s R

osel

l®-5

2

L. c

asei

Ros

ell®

-215

L. r

ham

nos

us

Ros

ell®

-343

L. a

cid

oph

ilus

Ros

ell®

-418

L. p

lan

taru

m R

osel

l®-1

012

L. h

elve

ticu

s La

fti®

L10

L. p

arac

asei

Laf

ti® L

26

L. c

asei

HA

-108

L. r

ham

nos

us

HA

-111

L. b

revi

s H

A-1

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L. r

ham

nos

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HA

-114

L. s

aliv

ariu

s H

A-1

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L. p

lan

taru

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A-1

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L. a

cid

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-122

L. h

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A-1

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L. f

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A-1

79

L. r

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A-1

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L. p

arac

asei

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B. i

nfa

nti

s R

osel

l®-3

3

B. b

reve

Ros

ell®

-70

B. b

ifid

um

Ros

ell®

-71

B. l

ong

um

Ros

ell®

-175

B. l

acti

s La

fti®

B94

B. i

nfa

nti

s H

A-1

16

B. b

reve

HA

-129

B. b

ifid

um

HA

-132

B. l

ong

um

HA

-135

B. l

acti

s H

A-1

94

S. b

oula

rdii

CN

CM

-107

9

Bac

illu

s su

bti

lis R

osel

l®-1

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Bac

illu

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A-1

24

En

tero

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ium

R

osel

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En

tero

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A-1

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Ped

ioco

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ctic

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osel

l®-1

001

Lact

obac

illu

s d

elb

ruec

kii

Ros

ell®

-187

Str

epto

cocc

us

ther

mop

hilu

s R

osel

l®-8

3

Str

epto

cocc

us

ther

mop

hilu

s H

A-1

10

Lact

ococ

cus

lact

is

Ros

ell®

-105

8

Lact

ococ

cus

lact

is H

A-1

36

Pro

pio

nib

acte

riu

m

freu

den

reic

hii

HA

-182

Pro

pio

nib

acte

riu

m

freu

den

reic

hii

HA

-273

GU

T

HEALTHY GUTLifestyle-induced gut discomfort, constipation, IBS

+++ +++ + +++ + + +++ + + + + + + + + + + + + + + + +++ ++ + + + + + +++ +++ + +++ + + + + + + + + +

DEFENSESAcute diarrhea, AAD, C. difficile and H. pylori infections

+++ +++ +++ + + + + +++ +++ + +++ + +++

CRITICAL CARE UC, NEC, Perioperative support +++ +++ ++ +++ +++ +++

IMM

UN

ITY

CHILDREN

Global immune support +++ +++ + +++ + + + + + +++ +++ +++ + +++

URT and GI infections +++ +++ +++ + + + +++ +++ +++ + +++

Atopic disorders ++ ++ ++ + + + +

ADULTS

Global immune support ++ ++ + +++ ++ + + ++ ++ +++ ++ +++

Common winter infections ++ ++ +++ + + ++ +++ +++

Active People ++ +++ ++ + ++ +++ ++ ++

SENIORS

Global immune support + ++ + ++ + + + + ++ ++ + +

Influenza and URTI + + ++ + + + ++ ++ +

Inflammaging ++ + + + + ++ + +

WO

ME

N'S

HE

ALT

H

FEMININE HEALTH

Bacterial vaginosis +++ +++ + ++ ++ + + + ++

Vulvovaginal candidiasis ++ ++ ++ + + + +

UTI ++ ++ + + + + ++

EVERYDAY HEALTH

GI discomfort +++ +++ ++ + + + ++ + + + +++ ++

Immunity + +++ +++ + + ++ +

Mood disorders ++ +++ + + + +++

AGE SPECIFIC HEALTH

Child-bearing age +++ +++ + ++ + + + ++ + + + +++ ++

Pregnancy +++ +++ ++ + + + + ++

Menopause + + + ++ + + + ++

BR

AIN

-GU

T

AX

IS

GUT

Stress-induced gut discomfort: abdominal pressure, flatulence, bloating

++ +++ + +++

MOOD Psychological stress resulting from life events ++ +++ +++ +++

OR

AL

H

EA

LTH

CARIES Destruction of the tooth enamel +++ +++ +++ ++ ++ + + + + ++ +++ + +

GINGIVITIS Inflammation of the gums +++ +++ +++ +++ + + ++ +++

HALITOSIS Bad breath + + + ++ ++

C ANDIDIASIS Yeast infection +++ + + + + +

Probiotic 2.0Optimal combination with S. boulardii

GI health P P P P P P P P P POral Health P P P P P P P P P

Other features

Halal grade available P P P P P P P P P P P P P P P P P P PNon Dairy P P P P P

Can be provided as API P P P P P

Probiocap technology P P P P

Page 6: FROM CONCEPTION TO COMMERCIALIZATION

At Lallemand Health Solutions, we have focused a great deal of our research resources in documenting in vitro and in vivo the modes of action of our probiotic strains and in further corroborating their potency in humans with state of the art clinical studies. Today, we are proud to provide one of the largest portfolios of proprietary strains, with their potential areas of application. Relevance rates from + to +++ for the highest with available clinical studies.

LACTOBACILLI BIFIDOBACTERIA OTHERS

L. r

ham

nos

us

Ros

ell®

-11

L. h

elve

ticu

s R

osel

l®-5

2

L. c

asei

Ros

ell®

-215

L. r

ham

nos

us

Ros

ell®

-343

L. a

cid

oph

ilus

Ros

ell®

-418

L. p

lan

taru

m R

osel

l®-1

012

L. h

elve

ticu

s La

fti®

L10

L. p

arac

asei

Laf

ti® L

26

L. c

asei

HA

-108

L. r

ham

nos

us

HA

-111

L. b

revi

s H

A-1

12

L. r

ham

nos

us

HA

-114

L. s

aliv

ariu

s H

A-1

18

L. p

lan

taru

m H

A-1

19

L. a

cid

oph

ilus

HA

-122

L. h

elve

ticu

s H

A-1

28

L. f

erm

entu

m H

A-1

79

L. r

eute

ri H

A-1

88

L. p

arac

asei

HA

-196

B. i

nfa

nti

s R

osel

l®-3

3

B. b

reve

Ros

ell®

-70

B. b

ifid

um

Ros

ell®

-71

B. l

ong

um

Ros

ell®

-175

B. l

acti

s La

fti®

B94

B. i

nfa

nti

s H

A-1

16

B. b

reve

HA

-129

B. b

ifid

um

HA

-132

B. l

ong

um

HA

-135

B. l

acti

s H

A-1

94

S. b

oula

rdii

CN

CM

-107

9

Bac

illu

s su

bti

lis R

osel

l®-1

79

Bac

illu

s su

bti

lis H

A-1

24

En

tero

cocc

us

faec

ium

R

osel

l®-2

6

En

tero

cocc

us

faec

ium

H

A-1

27

Ped

ioco

ccu

s ac

idila

ctic

i R

osel

l®-1

001

Lact

obac

illu

s d

elb

ruec

kii

Ros

ell®

-187

Str

epto

cocc

us

ther

mop

hilu

s R

osel

l®-8

3

Str

epto

cocc

us

ther

mop

hilu

s H

A-1

10

Lact

ococ

cus

lact

is

Ros

ell®

-105

8

Lact

ococ

cus

lact

is H

A-1

36

Pro

pio

nib

acte

riu

m

freu

den

reic

hii

HA

-182

Pro

pio

nib

acte

riu

m

freu

den

reic

hii

HA

-273

GU

T

HEALTHY GUTLifestyle-induced gut discomfort, constipation, IBS

+++ +++ + +++ + + +++ + + + + + + + + + + + + + + + +++ ++ + + + + + +++ +++ + +++ + + + + + + + + +

DEFENSESAcute diarrhea, AAD, C. difficile and H. pylori infections

+++ +++ +++ + + + + +++ +++ + +++ + +++

CRITICAL CARE UC, NEC, Perioperative support +++ +++ ++ +++ +++ +++

IMM

UN

ITY

CHILDREN

Global immune support +++ +++ + +++ + + + + + +++ +++ +++ + +++

URT and GI infections +++ +++ +++ + + + +++ +++ +++ + +++

Atopic disorders ++ ++ ++ + + + +

ADULTS

Global immune support ++ ++ + +++ ++ + + ++ ++ +++ ++ +++

Common winter infections ++ ++ +++ + + ++ +++ +++

Active People ++ +++ ++ + ++ +++ ++ ++

SENIORS

Global immune support + ++ + ++ + + + + ++ ++ + +

Influenza and URTI + + ++ + + + ++ ++ +

Inflammaging ++ + + + + ++ + +

WO

ME

N'S

HE

ALT

H

FEMININE HEALTH

Bacterial vaginosis +++ +++ + ++ ++ + + + ++

Vulvovaginal candidiasis ++ ++ ++ + + + +

UTI ++ ++ + + + + ++

EVERYDAY HEALTH

GI discomfort +++ +++ ++ + + + ++ + + + +++ ++

Immunity + +++ +++ + + ++ +

Mood disorders ++ +++ + + + +++

AGE SPECIFIC HEALTH

Child-bearing age +++ +++ + ++ + + + ++ + + + +++ ++

Pregnancy +++ +++ ++ + + + + ++

Menopause + + + ++ + + + ++

BR

AIN

-GU

T

AX

IS

GUT

Stress-induced gut discomfort: abdominal pressure, flatulence, bloating

++ +++ + +++

MOOD Psychological stress resulting from life events ++ +++ +++ +++

OR

AL

H

EA

LTH

CARIES Destruction of the tooth enamel +++ +++ +++ ++ ++ + + + + ++ +++ + +

GINGIVITIS Inflammation of the gums +++ +++ +++ +++ + + ++ +++

HALITOSIS Bad breath + + + ++ ++

C ANDIDIASIS Yeast infection +++ + + + + +

Probiotic 2.0Optimal combination with S. boulardii

GI health P P P P P P P P P POral Health P P P P P P P P P

Other features

Halal grade available P P P P P P P P P P P P P P P P P P PNon Dairy P P P P P

Can be provided as API P P P P P

Probiocap technology P P P P

Page 7: FROM CONCEPTION TO COMMERCIALIZATION

WHAT IF YOU COULD CHOOSE BOTH...? All our documented formulas

can be marketed as is… or AS AN INGREDIENT!

SOMEWHAT OVERWHELMED? Now that we know who you are and who you want to target for which benefit, let us guide you through our strains offer and funnel down for you the best strains and combinations with complementary effects to meet your needs. We will provide you all the way down the line with all the consolidated scientific documentation to support your launch.

YOU ARE ALMOST THERE!

IN NEED OF ANOTHER INGREDIENT?• Prebiotic• Vitamins• Minerals• Flavors• Others

We have selected for you a large range of ingredients with proven compatibility with our probiotic strains and blends, several backed by specific approved health claims (Selenium, Vitamin D, B Vitamins, Vitamin C...) to consolidate your formula positioning in your market. And if we do not yet have the one you want, the Lallemand applied research facility in Toulouse is there to assess feasibility before industrial scale up.

CHOOSE YOUR DOSAGE FORM• Powder• Orodispersible powder• Capsules • Enteric-coated capsules• Chewable tablets

CHOOSE YOUR PACKAGING OPTIONS• ACLAR blisters• Alu-alu blisters• Bottles• Sachets• SticksAnd what about a box? a leaflet maybe?

ANY OTHER SPECIFIC REQUIREMENT?

YOURPRODUCT

Page 8: FROM CONCEPTION TO COMMERCIALIZATION

CERTIFIEDPRODUCTIONCENTRES

COMMERCIALOFFICES

SCIENTIFICRESEARCHCENTRES

Blagnac(France)

Montreal(Canada)

Toulouse(France)

Saint-Simon(France)

Vienna(Austria)

Mirabel(Canada)

Quebec(Canada)

Kuala Lumpur(Malaysia)

Beijing(China)

Birkerod(Denmark)

Czech Teschen(Czech Republic)

FOR MORE INFORMATION, PLEASE CONTACT: [email protected] or www.lallemand-health-solutions.comThis is business-to-business information not intended for the final consumer. It is based on our own research and development work and is, to the best of our knowledge, reliable. However, Lallemand  does not assume any liability resulting from the  use of its products, as conditions of use are beyond our control. The information provided should not be used as a substitute for any form of advice  and in all cases, producers and marketers should check local regulatory requirements before use  as different claims may be made depending on the regulations applicable in each country.

As a complete probiotic solution provider, we deliver probiotics of unparalleled quality.

At Lallemand Health Solutions, delivering the best probiotic strains and products is just the start; we make sure each client gets our utmost attention and each project benefits from a customized service plan. Ongoing support from our committed team is embedded in our values.

WE PROVIDE CUSTOMIZED SERVICES FROM REGULATORY TO MARKETINGOur team of regulatory experts maintains regular dialogue with authorities worldwide (e.g. Health Canada, US FDA, EFSA, TGA, ANVISA) for: Consultation as industry experts for the development of policies pertaining to probiotics

Successful registration/authorization of LHS probiotics Advocacy and regulatory intelligence in collaboration with trade associations and working groups

Our leading team of dedicated researchers, business development managers and marketers are available to our partners for scientific conferences, training seminars, continuous medical education, product launches or refresher courses for product line extensions.

FROM CONCEPTION TO COMMERCIALIZATION

years of know-how80+

countries60+

proprietary strains40+

formulas450+

QUALITY PROBIOTICS. COMPLETE SOLUTIONS.

CONTACT: [email protected]

WEBSITE: WWW.LALLEMAND-HEALTH-SOLUTIONS.COM

LALLEMANDHEALTH SOLUTIONS

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