Respiratory Probiotics for Asthma & AR

1. 1
AAP-2

2. 22
Upper Respiratory
complications
Problem in
Nose , Eye , Sinus
Lower Respiratory
Complications
Problem in Trachea ,Lungs
,Alveoli
Asthma
Pleurisy
Chronic
Bronchitis
Chronic
Obstructive
Pulmonary
Disease(COPD)
Rhinosinusitis
or sinusitis
Nasal
Polyps
Allergic
Rhinitis
(AR)
Pharyngitis
Nasal
Congestion
Emphysema
RESPIRATORY COMPLICATIONS
Lung Cancer
Influenza
Pneumonia
Nasopharyngitis
(rhinopharyngitis or the common cold)
Laryngitis

3. RESPIRATORY, A GROWTH DRIVER FOR IPM.
3Indian Pharma Market March 2016 Update, AIOCD
FY2016, anti-diabetic segment grew at the fastest pace of about 32.9%, followed by
urology and respiratory segments which grew 29.5% and 27.8%, respectively.

4. 4
DISEASE PREVALENCE AIRWAY DISORDERS
(AR, ASTHMA & COPD)
4
• The burden of asthma is immense, with more than
300 million individuals currently suffering from
asthma worldwide, about a tenth of those living in
India 30 million
• 1 in 13 kids suffer from allergy
• Respiratory diseases cause one in every five deaths
in India, with Y-o-Y growth of 5.4%.
• The prevalence of asthma has been estimated to
range 3-38% in children and 2-12% in adults
• AR Accounts for more than 10 million missed days
from work and an estimated 13 million missed
school days annually because of uncontrolled
symptoms
• 12.7-fold increased risk for uncontrolled asthma
compared with patients without allergic rhinitis.17
17. Allergy. 2008;63:564-569.

5. NO OF PATIENTS DIAGNOSED WITH ASTHMA
WHILE GETTING TREATMENT FOR AR.
5
Ref: Bousquet, CEA 2005

6. 66
SIZE OF OPPORTUNITY:
AR PATIENTS POPULATION
80% have Allergic Rhinitis
Incidence of Asthma: According to ICMR Report 13
Million people above the age of 15 suffers from Asthma
10.4 million patients of Allergic Rhinitis

7. HEADLINE I HEADLINE
Fulfilment(Chances 99%)Treatment & Fulfilment (Chances 80%)Presentation & Diagnosis
ENT CHESTPediatrics/CP/GP
Prescription
Hospitalpharmacy/Chemist
TREATMENT JOURNEY MAP OF A ALLERGIC RHINITIS PATIENT
Patients buy the drugs
Patients with
Symptoms like
sneezing
• runny nose
• stuffy nose
• itchy nose
• coughing
• sore or scratchy
throat
• itchy eyes
• watery eyes
Patients presentation & Origination
Patients physical ( Chest & Oro
Phyringial)
exam alone, History taking
CureAdherence
BO: Behavioral
Objective
Community
Home
Remedies
-Steam
-Ginger
-Turmeric
-Garlic
-Vicks
-Eucalyptus
Oil
/ Chemist
Help
For (2-8 weeks)
Patients physical
exam, History
taking, MRI
Patients physical exam ,
History taking, LFT
8-12 weeksFew hours to (2 -3 Days)
Prevalence of
Allergic Rhinitis is
25-30%
prevalence of
asthma is 3-38% in
children and
2-12% in adults
Patient History
1 in 13 kids suffer
from allergy
33% children with
one allergic parent
will develop an
allergy
70% children with
two allergic parents,
develop an allergy
BO: Therapy should betaken for 3 months
Patient should take
it for 6 weeks
Events Diagnosis
20-30% patients may
present with
following symptoms
- Inability to sleep from
symptoms keeping
you up at night
- Development or
worsening of asthma
symptoms
frequent ear infections
- Sinusitis or frequent
sinus infections
- Absences from
school or work
because of reduced
productivity
- Frequent headaches
Rx @ Pedia
Nasal saline irrigation & oral
decongestants
(pseudoephedrine or
phenylephrine) Oral Anti-
Histamine Syrup, sinarest syrup
Antibiotics Syrup/DT
patients with moderate-to-severe allergic rhinitis, multiple medications were typically necessary
Rx @ Chest
fixed-dose intranasal combination
therapy that includes fluticasone
propionate (a corticosteroid) plus
azelastine hydrochloride, Leukotriene
receptor antagonists (LTRAs) , Saline
douching, and intranasal
decongestants, Cromolyn sodium,
Immuno Therapy
Allergic rhinitis may
be seasonal,
perennial, or
episodic
Finally, patients who cannot achieve
disease control using pharmacotherapies
may be considered for immunotherapy
and, in specific cases, surgery.
For patients with intermittent symptoms (e.g. those allergic to pollens)
it has been demonstrated that if therapy with topical nasal
corticosteroids is begun a week or two before symptoms are
expected, symptoms have delayed onset and reduced severity
Patients with persistent allergic rhinitis, such as those allergic
to perennial allergens (e.g. house dust mite, animals or
indoor moulds) or those with mixed seasonal and perennial
allergies, need longer term therapy.
three to six months after complete symptom control. If symptoms
recur, the treatment should be restarted for 6–12 months or even for
life. There are some concerns about possible lining atrophy with
long-term use of intranasal steroids.
Rx @ ENT
Nasal saline irrigation and
intranasal decongestants, such
as oxymetazoline, Oral Anti-
Histamine Syrup, Intranasal
corticosteroid,Montelukast with
Levoceterizine, , Cromolyn
sodium,Surgery if DNS
Molecule Choice:
Co-Rx
BO:
1. A Preferred Co-Rx option with Oral Antihistsmines & Topical Nesal Saline
2. Before Starting Steroids Therapy also before Immunotherapy
3. In Atopi
4. Preterm Baby
5. In Patient with history of sesonal AR
6. Co-Rx with ICS + LABA in Uncontrol Asthma & Atopy
7. In Patients of recurrent upper airways infection
:
Atopi :
The current prevalence is
estimated to be between
10.0% to 15.6% (5-15% of
school children and 2-10%
of adults)
Environmental controls, pharmacotherapy, and immunotherapy

8. 9
9
LIMITATION
OF CURRENT TREATMENT OPTIONS
Sl No.
Current Treatment
Option
Limitations
1 Systemic Antihistamines
Only for Symptomatic Relief &
Side-effects like Sedation & disturbed
cognition
2 INCS Rebound of Symptoms & Side-effects
3 Nasal Decongestants
Rebound & Nasal Remodelling, don’t
control bronchial inflammation
4 ICS/LABA
Long term Therapy & Requires Routine
Dosage Titration
5
Anti-Leukotrienes with
Histamine Oral solids
Long Term therapy, May not display
response in a few
6 Immunotherapy
Side effects are itching or burning of the
mouth or lips and gastrointestinal
symptoms., Needs allergologist Support

9. ALLERGIC RHINITIS AND UNMET
THERAPEUTIC NEEDS
10

10. NO NEW DRUGS IN ASTHMA IN NEXT 20 YEARS
11
I think it will be difficult to develop
better asthma treatments in the next 20
years,”
Professor Peter Barnes
“There haven’t been any novel asthma
drugs in the past 20 years,
and there are no prospects for any in the
next 20 years for mild-to-moderate cases.
Keith Allan, head of global advocacy at
Novartis concurred.

11. GUIDELINES HIGHLIGHTS ANTI-IGE TREATMENT
12HDM: House Dust Mite
Immuno related therapy is getting more prominence now days
mild
intermittent
mild
persistent
moderate
severe
intermittent
moderate
severe
persistent
avoidance of allergens, irritant and pollutants
immunotherapy
intranasal decongestant (<10 days) or oral decongestant
intranasal steroid
oral or local nonsedative H1-blocker
leukotriene receptor antagonists
ARIA Guideline
GINA Guideline

12. RISING ACCEPTANCE OF IMMUNOTHERAPY
13
Allergy Immunotherapy Market 2018 Highlights by Allergy Type and
Treatment | Phenomenal Growth of 10.85% by 2023
Posted: Apr 11, 2018 7:03 PM IST
The Global Allergy Immunotherapy Market was around USD 2,100.0 million in
2016 and is expected to reach USD 4,324.7 million by 2023 which is a projected
CAGR of 10.85%

13. CURRENT MANAGEMENT IN DEVELOPED
WORLD
14
Category Class Molecule Top Global
Brands
Availability
in India
DRUG
Anti-Histaminics
Cetrizine/
Levocetrizine/
Loratidine
ZYRTEC Available
Corticosteroids
Fluticasone
/Budenoside/
Mometazone
ADVAIR* Available
Leukotriene
Inhibitors
Montelukast SINGULAIR Available
Decongestants
Oxymetazoline/
Phenylephrine
EQUATE Available
Mast Cell
Stabilizers
Cromolyn Sodium INTAL Available
PROBIOTIC
Anti Allergic
Probiotic
Lactobacillus
Paracasei LP33
BION
(Marketed by
Merck AG.)
Unexplored in
India

14. TIME IS FOR TARGET SPECIFIC PROBIOTICS
15
 Dental Probiotics
 Respiratory Probiotics
 Gut Probiotics
 Metabolic Probiotics
 Kidney Probiotics
 Vaginal Probiotics
 Cancer Probiotics

15. 16
ADVANCEMENT IN THE PROBIOTICS
• Probiotics are not only live bacteria and yeasts but also can be Heat killed microbes
• Organ Specific treatment by Probiotics is now trending in the market
Dental Care Probiotic
• Heat Killed L. paracasei GMNL 33
Diabetes Care Probiotic
• Lactobacillus reuteri GMNL 263
Kidney Health Probiotic
• S.thermophilus(KB19)
• L.acidophilus (KB27)
• B.longum (KB31)
Respiratory Care Probiotic
• Heat Killed Lactobacillus Paracasei GMNL 133
• Heat killed Lactobacillus Fermentum GM090
Probiotic for Weight Management
• Lactobacillus gasseri BNR17
Vaginal Probiotic
• Lactobacillus reuteri (RC-14)
Mood Probiotics
• Bifidobacterium Longum,Lactobacillus Rhamnosus
• Lactobacillus Helveticus,Lactobacillus Plantarum
• Bifidobacterium Animalis

16. ERS & AAAAI INNITIATIVE ON
RESPIRATORY PROBIOTICS
SEVERAL ARTICLES IN ERS & AAAI OFFICIAL JOURNALS
17

17. 18
PROBIOTICS FOR PREVENTING
ACUTE URTI. (REVIEW)

18. 19
19
PROBIOTICS FOR LUNG DISEASES

19. 2020
CONCLUSIONS
The current systematic review and meta-analysis suggested that probiotics
administered prenatally and postnatally could reduce the risk of atopy…
ROLE OF PROBIOTICS IN ATOPY

20. COMPLEMENTARY EFFECT OF PROBIOTICS
AFTER IMMUNOTHERAPY
21
Probiotics Enhances the effect of allergen specific immunotherapy

21. 2222
Korean J Pediatr. 2013 Sep;56(9):369-76. doi: 10.3345/kjp.2013.56.9.369. Epub 2013 Sep
30.
Clinical efficacy and mechanism of probiotics in allergic diseases.
Kim HJ1, Kim HY, Lee SY, Seo JH, Lee E, Hong SJ
Abstract
A complex interplay between genetic and environmental factors partially contributes to the
development of allergic diseases by affecting development during prenatal and early life.
To explain the dramatic increase in the prevalence of allergic diseases, the hygiene
hypothesis proposed that early exposure to infection prevented allergic diseases. The
hygiene hypothesis has changed to the microbial hypothesis, in which exposure to
microbes is closely linked to the development of the early immune system and allergic
diseases. The intestinal flora may contribute to allergic disease through its substantial effect
on mucosal immunity. Based on findings that exposure to microbial flora early in life can
change the Th1/Th2 balance, thus favoring a Th1 cell response, probiotics may be
beneficial in preventing allergic diseases. However,
UNIQUE MOA OF PROBIOTIC IN ALLERGY

22. TEXT BOOK ENDORSEMENT ON THE ROLE OF
TH1/TH2 IMBALANCE IN ASTHMA
23

23. 2424
FIRST RESPIRATORY PROBIOTICS FROM MERCK.AG.
Merck submit probiotic allergy health claim
15-Oct-2012 By Shane Starling
German pharma giant Merck has teamed with probiotics ingredients player

24. 25
ABOUT THE INNOVATOR
Leader in Functional probiotics in Asia.
Leader in Technological Advancement of Probiotics
GenMont is developing various highly safe, no side-effect, the best probiotic products
to promote human health and the quality of life.
Well Known for Heat Killed Probiotics
MERCK promotes their Brand BION ALLERGO which is composed of
Lactobacillus Paracasei LP-33 in collaboration with Genmont
Taiwan

25. IN THE WORLD OF RESPIRATORY MEDICINES ALMOST EVERYTHING
HAS BEEN TRIED AND TESTED IN INDIA, EXCEPT ONE…
32
• Immunomodulators• Antileukotrienes or
leukotriene modifiers
• Cromolyn sodium
• Inhaled corticosteroids
• Long-acting inhaled
beta2-agonists (always
administered with
another asthma-related
drug)
• Methylxanthines
• Oral corticosteroids
• Respiratory Probiotics
Evidence Based Respiratory Probiotics Available Globally Since 2012…

26. 33
33
Treats the root cause of Allergy, both for Prevention & Treatment
acts in Gut-lung axis(GLA)
IN Allergic Rhinitis & Asthma
A novel Respiratory Probiotics
Now available in India
AAP2 Lactobacillus paracasei GMNL-133 (2 billion cells)
Lactobacillus fermentum GMN-090 (2 billion cells)
 Immuno modulatory activity, Balances Th1 and
Th2 activity which is the root cause for the Allergic
disorders
 Also Endorsed by Nelson Text book of Pediatrics

27. 34
AAP-2 CLINICAL EVIDENCE
Clinical Trial -1 Clinical Trial -2 Clinical Trial -3 Clinical Trial -4
Patient
Condition
Perennial Allergic
Rhinitis > 1 year
Patients RQLQ>2 Mite Induced Perennial
Allergic Rhinits
Perennial Allergic
Rhinitis > 1 year
Age > 5 years of Age 18-60 Years 13-19 Years > 5 years of Age
Number of
Patients
80 425 57 60
Study type Randomized Double
Blind Placebo
Controlled Study
Randomized
double blind
(Loratidine vs
Loratidine +AAP-
2)
Randomized Double
Blind Placebo
Controlled Study
Randomized Double
Blind Placebo Controlled
Study(Live probiotic vs
Heatkilled vs Placebo
Duration 30 days 35 days 90 days 30 days
Outcomes Significant
Improvement
inOverall QoL score
Additional 17.7%
reduction in with
combination QLQ
global score
IgE reduced by 20.83% Both showed significant
impact on symptoms
Published in Pediatric Allergy and
Immunology
European Journal
of Clinical
Nutrition
Tung’s Med J Vol.2
No.1
Pediatric Allergy and
Immunology
Treats the root cause of Allergy
IN ALLERGIC RHINITIS & ASTHMA
A NOVEL RESPIRATORY PROBIOTICS
NOW AVAILABLE IN INDIA
AAP2
Clinical Evidence that Support AAP2

28. 35
• Strength –Dose – OD in Children/BID in Adults
• For a better benefit Min. Duration of therapy– 30 days
AVAILABLE AS
AAP2 SACHET & CAPSULES

29. 36
36
ONE OF THE BEAUTIES OF MODERN MEDICAL SCIENCE, IT CAN
ARTICULATE MANY ALTERNATE TREATMENT STRATEGY FOR THE SAME DISEASE …
CURRENT
TREATMENT
STRATEGY
In the management of Asthma & AR,
A Novel Treatment strategy that acts before the production of IgE …

30. AR & ITS UNMET NEED
37
There are
many
guidelines &
Related
therapies still
19% AR
patients remain
uncontrolled
and 13% have
poor quality of
life

31. 38
38
AAP-2
CURRENT
TREATMENT
STRATEGY
Treats the root cause of Allergy, both for Prevention & Treatment
IN ALLERGIC RHINITIS & ASTHMA
A NOVEL RESPIRATORY THERAPY THAT ACTS IN GUT-LUNG AXIS(GLA)
AVAILABLE GLOBALLY SINCE 2012
NOW AVAILABLE IN INDIA
AAP2 Lactobacillus paracasei GMNL-133 (2 billion cells)
Lactobacillus fermentum GMN-090 (2 billion cells)
 Immuno modulatory activity, Balances Th1
and Th2 activity which is the root cause for
the Allergic disorders
 Also Endorsed by Nelson Text book of
Pediatrics

32. BUSINESS PROJECTION
42
 Patient/Disease prevalence Route
 Co-Rx Route
 Based on the productivity of Internal field force

33. 43
Total Indian Population – 134 Cr.
AAP2 Scope in Pediatric
SKU: 29,73,77,304
Sachet /Annum- INR 535 Cr.
AAP2 Scope in Adult
SKU: 6,28,45,060
Capsules/Annum
INR 94 Cr.
Suffering from AR (16%)
386,64,366
(15-25) years old
Population
2416,52,287
Home Remedies (90%)
347,97,929
Chemist/Pharmacy (70%)
243,58,551
Pediatrician (20%)
135,32,528
Home Remedies (90%)
676,62,640
Suffering from AR (20%)
751,80,712
(0-14) Years old population
3759,03,558
ENT (25%)
33,83,132
GP/CP(40%)
97,43,420
ENT(25%)
24,35,855
Chest (5%)
1,69,157
Chest (5%)
2,43,586Pediatrics
Adult

34. SCOPE FOR AAP-2 SACHETS IN PEDIATRIC
POPULATION- 535 CR.
44
Speciality Pediatrics Population RXs/Annum Units Value
Pedia 135,32,528 40,59,758 243,585,505 438 Cr.
ENT 33,83,132 8,45,783 50,746,980 92 Cr.
Chest 1,69,157 50,747 30,44,819 5 Cr.
Hypothesis:
• Considering 30% of the Patients got the treatment with AAP-2 (2 months Therapy-
1 Sachet/Day) at Pediatrics
• Considering 25% of the Patients got the treatment with AAP-2 (2 months Therapy-
1 Sachet/Day) at ENT
• Considering 30% of the Patients got the treatment with AAP-2 (2 months Therapy-
1 sachet /Day) at Chest MRP/Sachet-30 Rs
PTS/Sachet -18 Rs

35. SCOPE FOR AAP-2 CAPSULES IN ADULT
POPULATION- 94 CR.
45
Speciality Pediatrics Population RXs/Annum Units Value
ENT 24,35,855 4,87,171 584,60,521 88 Cr.
Chest 2,43,586 36,538 43,84,539 6 Cr.
Hypothesis:
• Considering 20% of the Patients got the treatment with AAP-2 (2 months Therapy-
2 Capsules/Day) at ENT
• Considering 15% of the Patients got the treatment with AAP-2 (2 months Therapy-
2 Capsules/Day) at Chest
MRP/Capsule-25 Rs
PTS/Capsule -15 Rs

36. 46
Total Indian Population – 134 Cr.
AAP2 Scope in Pediatric
SKU-33,15,469
Sachet /Annum- INR 6 Cr.
AAP2 Scope in Adult
SKU:21,92,26,954
Capsules/Annum
INR 328 Cr.
Suffering from Asthma (15%)
144,991,372
(>15) years old
Population 966,609,148
Pediatrician (60%)
15,787,949
Suffering from Asthma (7%)
26,313,249
(0-14) Years old population
3759,03,558
GP/CP(60%)
86,994,823
Chest (5%)
789,397
Chest (30%)
26,098,447
Pediatrics
Adult
Asthma with Comorbid AR (70%)
552,578
Asthma with Comorbid AR (70%)
18,268,913

37. 47
SCOPE FOR AAP-2 SACHETS IN PEDIATRIC
POPULATION- 6CR.
47
Specialty Asthmatic patients
with Comorbid AR
RXs/Annum Units Value
Chest 552,578 55,258 33,15,469 6 Cr.
Hypothesis:
• Considering 10% of the Patients got the treatment with AAP-2 (2 months Therapy-
1 Sachet/Day)
MRP/Sachet-30 Rs
PTS/Sachet -18 Rs

38. 48
SCOPE FOR AAP-2 CAPSULES IN ADULT
POPULATION- 328 CR.
48
Specialty Asthmatic patients
with Comorbid AR
RXs/Annum Units Value
Chest 18,268,913 1,826,891 21,92,26,954 328 Cr.
Hypothesis:
Considering 10% of the Patients got the treatment with AAP-2 (2 months Therapy-2
Capsules/Day)
MRP/Capsule-25 Rs
PTS/Capsule -15 Rs

39. 49
POSITIONING
AAP-2 for all perennial Allergic Rhinitis and Atopic Allergies
AAP-2 can be given alone if recurrence of Allergic Rhinitis is detected
Ideal co-prescription with Intra Nasal Decongestants
Ideal co-prescription with Montelukast
Ideal co-prescription with oral Anti Histaminic
AAP2 modulates the Respiratory Immunity & treats the root cause of
allergy

40. RATIONAL BEHIND THE LAUNCH
50
 Current therapies suitable for symptoms relief but AAP2 treat the root cause
 It’s a novel concept
 The concept behind AAP2 Allows sales rep for a lengthy scientific discussion
 Can be a Co-Rx with other Respiratory products

41. 51
PURE RESPI THERAPY MARKET-4939.6 CRORES
2582.4, 52%
1916, 39%
191.4, 4%
249.3, 5%
Bronchodilators
Systemic Anti
Histaminics
Topical Nasal - Steroidal
All other Respiratory
products

42. 52
SCOPE FOR MARKET OF AAP-2
Sr.
No
Category
Sum of MAT
Value Jan 2018
(in Crores )
Sum of
MAT Units
Jan 2018
Co-prescription
Units of AAP-2
(000’s)
Scope
for AAP-2
In INR.
1. Systemic Anti
Histamines
1916 634172.5 63417.25
198 CR.
2. Montelukast &
Combinations
1097.4 141636.6 14163.66
3. Formetrol,
Budesonide
Combinations
815.5 148801 14880.1
4. Topical Nasal
Non Steroidal
Preparations
208.3 54818.6 5481.86
5. Topical Nasal
Steroidal
191.4 9251.3 925.13
Total 4228.6 988680 98868

43. 53
VALUE PROJECTION
• One Rx at Pedia ,90 Sachets
• Value of one Rx:
• Pedia: INR.1800
• One Rx at Adult, 180 capsules
• Adult: INR 2160
• Total Rx :12500 Per Month (500 Doctors x 1 RX
/day)
YEAR.1
Total Revenue:
10cr(approx.)
• One Rx at Pedia ,90 Sachets/
• Value of one Rx:
• Pedia: INR.1800
• One Rx at Adult, 180 capsules
• Adult: INR 2160
• Total Rx :75000 Per Month (1000 Doctors x 3 RX
/day)
YEAR.3
Total Revenue:
40cr(approx.)
53

44. 5454
Indication
Target
Speciality
Positioning
Current
Business
in Value
(Lakh)
Names of the
Players
Top 5
Strategic
Partners
Next 5
Strategic
Partners
Conversion
Strategy
Molecule
Strategy
SDN
Support
AR,
Asthma &
Atopic
Dermatitis
Chest,
ENT,
Pedia &
Derma
AAP2
modulates
the
Respiratory
Immunity &
treats the
root cause of
allergy, ideal
for atopic
allergy
120 Fourts,Indi
abulls &
SDN
Cipla,Lupi
n, Zydus,
Glenmark,
Macleods
Alembic,
SDN,DR
L,Intas
Meeting with
top 5 respi
companies &
discuss the
scope for
probiotics in
respiratory &
sharing the
international
data on AAP2
Evidence
creation
through data
Creation
of Indian
data
through
PMS
ONE PAGE STRATEGY (AAP2)

45. 55
SUPPORT FROM SUNDYOTA NUMANDIS
 Technical Details for the finished formulation
 Scientific Back up
 Marketing Support
 PMS Support
 Brand Life Cycle Support

46. 56
THANK YOU
56
Healthy Lungs for all…