Brand plan for Itraconazole. Insight on new product launch.

1. Itraconazole 100 & 200 mg Capsules

2. Brand Plan: Agenda
‡ Brief Summary
‡ Why Brintra ?
‡ Market Analysis
‡ Competitor Analysis
‡ Top Brands Analysis
‡ Inference On Competitors
‡ Competitors Positioning
‡ Competitors Positioning
Inference
‡ SWOT Analysis
‡ Pathway From Inference
‡ Brintra: Suggested Positioning
‡ Indications
‡ Brintra: Revenue Forecast
‡ Brintra: Brand Strategy

3. Brief Summary
‡ Dermatologists across India has warned of “an epidemic of fungal
infections”
‡ Indiscriminate use of topical steroid cream preparations is leading to
fungal infections becoming resilient
‡ Fungal infections has become relapsing, recurrent and spreads easily
‡ 50 per cent of fungal infections are not reacting to conventional
treatments
‡ Increase in the prevalence of dermatophytosis over the past 4–5 years
across the country
‡ Anti-fungal market has 23% (1891 Cr) share in total derma market
with CAGR of 31%
Source: http://www.thehindu.com/opinion/op-ed/An-era-of-untreatable-skin-infections/article14621962.ece & ims quintiles April MAT

4. Why Brintra ?
‡ Brintra: Itraconazole 100 & 200 mg Capsules is the No. 1 prescribed
drug in the anti-fungal segment
‡ Itraconazole has shown robust incremental growth with CAGR of 74%
with 649 Cr from FY 2014 to 2018
‡ Itraconazole contributes to 8% of market share in total dermatology
segment in India
‡ Itraconazole is the No. 1 prescribed single/monotherapy drug in
dermatology segment
‡ Dermatophytosis is ranked No. 1 in indication seen by dermatologists
in which Itraconazole is the only oral drug preferred
‡ Itraconazole is prescribed by derma, GP, Non-MBBS and Gynecs which
resulted in strong sale volume
Source: ims quintiles April MAT 2018

5. Market Analysis
Value in IPM
649 Cr
5Ys CAGR in IPM
74%
Market Share to AF
Segment (1891 Cr)
31%
Itraconazole Sales Analysis
Source: ims quintiles April MAT 2018
‡ Incremental growth with CAGR of 74% with 649 Cr from
FY 2014 to 2018
‡ Itraconazole market share is 34% to the total anti-fungal
market in India

6. Market Analysis
Dermatophytosis Rx Analysis By Dermats
Rx Share
19%
Total Derma
Rx
415 Lacs
Rx By Derma
78 Lacs
‡ Dermatophytosis is the top indication seen
by Dermats where Itraconazole ranked 1
among prescribed drugs
‡ Dermatophytosis accounts to 19% of Rx
share by dermats
Source: TSA MAT March’ 17 & Rx MAT Feb’ 17

7. Market Analysis
Dermatophytosis + Fungal Infections Rx Analysis By GPs
Rx Share
31%
Total Derma
Rx
345 Lacs
Rx By GPs
105 Lacs
‡ Fungal Infections & Dermatophytosis is the top
indications seen by GPs where Itraconazole
ranked 1 among prescribed drugs
‡ Fungal Infections & Dermatophytosis accounts
to 31% Rx share by GPs
Source: TSA MAT March’ 17 & Rx MAT Feb’ 17

8. Market Analysis
Itraconazole Rx Analysis Vs Others
‡ Itraconazole has seen a good progress in derma
‡ Itraconazole Rx CAGR growth for 4 yrs is 81%
second leading to Luliconazole but leads with 43
Lacs Rx
CAGR in
Rx
81%
Rx by
Derma
43 Lacs
(No. 1 AF)
Source: TSA MAT March’ 17 & Rx MAT Feb’ 17

9. Market Analysis
Itraconazole SKUs
‡ 100 mg value is 245 Cr with CAGR of 34%
‡ 200 mg value is 391 Cr with CAGR of 274%
‡ 200 mg is expected to become 650 Cr in
2019 with current growth rate
‡ It is ideal to launch Itraconazole 100 mg &
200 mg Capsules
100 mg
245 Cr @
38% MS
400 mg
9.2 Cr @
1.4% MS
200 mg
391 Cr @
60% MS
Source: ims quintiles April MAT 2018

10. Competitor Analysis
100 MG
92 Brands
200 MG
85 Brands
400 MG
17 Brands
Dusting Powder
9 Brands
ITRACONAZOLE
‡ Itraconazole launch of new brands where seen sudden surge in last three years due to increase prevalence in
dermatophytosis infections
‡ In 2017 & 2018 139 SKUs has been launched in Itraconazole market with sale value of 163 Cr and this incremental sale
is because of new brands and SKUs
‡ 44 new brands of Itraconazole 200 mg & 31 Itraconazole 100 mg has been launched in 2017
‡ ITRAGREAT has recorded 4.63 Cr in the first year, followed by ITRANOX with 3.83 Cr, & ITRAZOLE 3.35 Cr.
‡ ITASPOR & IT-MAC launched 200 mg 1 X 8s pack which capitalized 18.72 Cr & 18.40 Cr respectively
‡ Only ITRAGREAT has recorded 2.35 Cr in the first year & other brands where less than a Cr
‡ ITASPOR launched 100 mg 1 X 8s pack which capitalized 11.48 Cr in a year
‡ IT-MAC launched 100 1 X 10s pack which capitalized 8.75 Cr in a year
‡ It is evident that Itraconazole 100 mg & 200 mg could be launched as per the market. 400 mg market is least with 9.2
Cr and fungal infections respond well with Itraconazole 100 & 200 mg , hence 400 mg will not be ideal to launch
‡ Dusting powders value is insignificant and mixed response revealed by dermats in causing resistance
Source: ims quintiles April MAT 2018

11. Competitor Analysis
Itraconazole 200 mg
Brands
FY 2018 FY 2017 FY 2016
Value in Cr Gr % Value in Cr Gr % Value in Cr Gr %
ITRACONAZOLE 200 MG 391.00 102.24 193.33 279.22 51.00 999.00
CANDIFORCE 73.53 74.37 42.17 115.37 19.60 970.56
IT-MAC 66.16 97.13 33.60 747.51 3.97 999.00
CANDITRAL 31.70 69.32 18.80 306.41 4.70 999.00
ITRASYS 27.01 14.59 23.60 130.89 10.21 999.00
SYNTRAN 24.90 77.07 14.03 260.59 3.90 999.00
I-TYZA 21.06 50.20 14.02 999.00 1.20 999.00
ITASPOR 20.21 28.57 15.72 151.47 6.26 999.00
‡ Brands above 10 Cr value is considered for competitor analysis
‡ Top 7 brands contributes to 68% of total Itraconazole 200 mg value
‡ CANDIFORCE (Mankind) is ranked No. 1 in terms of value 73.53 Cr with growth of 74.37% followed by
IIT-MAC (Macleods) 66.16 Cr with growth of 97.13%. CANDIFORCE & IT-MAC has strong equation with
GPs and Gynecs which adds an additional flow of business to derma
‡ ITRASYS (Systopic), I-TYZA (Abbott) & ITASPOR (Intas) are the brands having below 50% of growth rest
other brands having more than 50% of growth
Source: ims quintiles April MAT 2018

12. Itraconazole 100 mg
Competitor Analysis
Brands
FY 2018 FY 2017 FY 2016
Value in Cr Gr % Value in Cr Gr % Value in Cr Gr %
ITRACONAZOLE 100 MG 246.00 32.49 185.00 52.32 122.00 57.86
CANDIFORCE 38.95 -1.40 39.50 16.82 33.81 37.84
IT-MAC 29.28 58.70 18.45 335.41 4.24 999.00
ITRASYS 18.25 7.03 17.05 49.42 11.42 211.71
SYNTRAN 15.13 32.69 11.40 40.38 8.20 204.85
CANDITRAL 14.79 1.14 14.62 -12.98 16.80 5.73
SPORANOX 14.36 26.57 11.34 37.35 8.26 25.26
ITASPOR 12.60 4.68 12.04 -3.73 12.50 17.67
I-TYZA 11.49 -14.87 13.49 20.05 11.24 367.84
‡ 8 Brands above 10 Cr value is considered for competitor analysis
‡ Top 8 brands contributes to 63% of total Itraconazole 100 mg value
‡ CANDIFORCE is ranked No. 1 in terms of value 38.95 Cr with growth of -1.40% followed by IT-MAC 29.28
Cr with growth of 58.70%.
‡ IT-MAC, SYNTRAN & SPORANOX are the brands having double digit growth with IT-MAC records the
highest growth 58.70% followed by SYNTRAN 32.69% & SPORANOX 26.57%
‡ CANDIFORCE & I-TYZA are in negative growth with I-TYZA records highest negative growth of -14.49% &
CANDIFORCE -1.40% Source: ims quintiles April MAT 2018

13. Inference On Competitors
‡ 101 Itraconazole brands are available in the market
‡ 100 mg and 200 mg are the main SKUs of Itraconazole
‡ 92 brands are available in 100 mg and 85 brands are available in 200 mg
‡ 13 out of 101 brands contributes to 75% of the total sale value of Itraconazole with
value of 487.25 Cr
‡ Macleods and Glenmark has 3 brands. Mankind, Lupin, Cipla and Sun has 2 brands
in Itraconazole market
‡ Mankind (CANDIFORCE + ITRAGREAT) has the highest volume of Itraconazole with
121.79 Cr followed by Macleods (IT-MAC + ITRAGEN + MONOCAN) with 106.85 Cr
and Glenmark (CANDITRAL + SYNTRAN + CANDITZ) WITH 97.21 Cr.
‡ Mankind, Macleods & Glenmark with 8 brands contributes to 50% volume of total
Itraconazole sales
‡ 44 new brands of Itraconazole 200 mg & 31 brands of 100 mg has been launched
in 2017 to 2018 which is highest number of new products in derma
‡ Itraconazole 400 mg and Dusting powders values are insignificant and mixed
response revealed by dermats in causing resistance for powder

14. Competitors Price Analysis
Itraconazole 200 mg
‡ Rs. 18 per capsule (ITRASYS) is the
lowest and Rs. 35 is the highest
(ITASPOR, SYNTRAN & CANDITRAL)
‡ Top brands in market like CANDIFORCE
(Rs. 20), IT-MAC (Rs. 19.6) & ITRASYS
(Rs. 18) has priced low, hence they
effectively penetrates of price
conscious dermats and mainly no-
dermats like GPs and Gynecs
‡ Pricing is very important for new launch
and low or at par price to CANDIFORCE,
IT-MAC & ITRASYS is to be considered
for captivating market share
Source: ims quintiles April MAT 2018

15. Competitors Price Analysis
Itraconazole 100 mg
‡ Rs. 10 per capsule (IT-MAC &
CANDIFORCE) is the lowest and Rs.
81.25 is the highest (SPORANOX)
‡ Top brands in market like CANDIFORCE
(Rs. 10), IT-MAC (Rs. 10) & ITRASYS (Rs.
12) has priced low, hence they
effectively penetrates of price
conscious dermats and mainly no-
dermats like GPs and Gynecs
‡ Pricing is very important for new launch
and low or at par price to CANDIFORCE,
IT-MAC, ITRASYS &
I-TYZA is to be considered for
captivating market share
Source: ims quintiles April MAT 2018

16. Packing: 100 MG X 4s
MRP: 81.25/Cap
Differentiation: Patented
bead technology. Purity
greater than 96%
Positioning: Original
Itraconazole. Take the
challenge and see the
difference
Communication: Same
Itraconazole beads across
world. Beads imported
from Belgium
SPORANOX
(Janssen)
Packing: 100 MG X 4s / 7s
MRP: 25 / Cap
Differentiation: Uniform
pellet size. Smaller size of
pellets.
Positioning: With quality
at par with innovator
Communication: With
quality in top action
mode. Sealed pellets to
protect from moisture
FIXTRAL
(Dr Reddys)
Packing: 100 MG X 7s
200 mg X 4s
MRP: 27.55/100 MG
Cap, 44/200 MG Cap
Differentiation: Unique
double layered Wurster
coating
Positioning: Perfected to
delivery with perfected
pellet size
Communication:
Immediate release
pellets. 62% faster
dissolution. Better
bioavailability
ITRATUF
(Alkem)
Packing: 100 MG X 4s / 7s
MRP: 25 / Cap
Differentiation: No
differentiation
communicated. But price
is very competitive &
receives more Rx
Positioning: The rational
need in dermatophytosis
Communication: Tinea
infections & in resistant
cases
ITRASYS
(Systopic)
Competitors Positioning

17. 1
•Itraconazole drugs are available in pellets, so most of the brands highlight and
positioned the brand on pellet technology
2
•SPORANOX is the inventor claims 96% purity of Itraconazole with patented bead
technology, where other brands with pellet do not claim as patented
3
•FIXTRAL positioning is different where they differentiate from other brands except from
inventor by positioning like “quality at par with inventor” and they have price advantage
compared to SPORANOX
4
•ITRATUF also differentiate by claiming as double layered coating which helps in better
delivery
5
•CANDIFORCE, IT-MAC & ITRASYS do not talk more on pellets but their main positioning is
on their low price strategy and penetration to derma, GPs & Gynecs
Competitors Positioning
Inference
Positioning of a new Itraconazole brand need to be focused on two parameters:
1. New technology in formulation. 2. Price Advantage.

18. ‡ Big market size of 649 Cr with
CAGR of 74%
‡ Itraconazole Rx CAGR growth for 4
yrs is 81% leading in derma Rx
with 43 Lacs
‡ Itraconazole is prescribed by huge
set of doctors like derma, GPs,
Non-MBBS & Gynecs
‡ 101 brands are already
available in the market
‡ Top 3 brands (CANDIFORCE,
IT-MAC & ITRASYS) with low
pricing strategy has 40% of
market share
‡ Over crowded SKUs with
increase in ambiguity
‡ Fungal disease is becoming epidemic with
increase in prevalence in India. 30% case per
day per dermat
‡ Increase in Resistant and recurrent fungal
infections
‡ Unique formulation helps in drug effectiveness
compared to existing brands
‡ Compliance / dose convenient pack for patients
‡ More number of me-too
products will be launched
with lesser price
‡ Generic variations of
Itraconazole could be sold
‡ Government regulations
like price barrier could be
introduced
SWOT Analysis: Itraconazole

19. Market size is big
and significant
market share can
be achieved with
correct product
strategy
It is must to
consider in
launching unique
formulation which
helps in drug
effectiveness
compared to
existing brands
Introducing
compliance and
dose convenient
pack for patients
will be an added
value for gaining
doctors attention
because most
brands are
introducing 10s
packing seen in the
market
Fungal infections in
Indian is becoming
epidemic, hence
opportunity in anti-
fungal segment will
be a growth driver
for a company,
hence Itraconazole
could be launched
GPs and Non-
MBBS should be
educated in
correct usage of
Itraconazole and
other anti-fungals
and investing in
their learning will
increase our
business
opportunity
‡ Itraconazole new product could be launched in considering the
following inferences:
Way forward from Inference

20. Itraconazole:
New Product Launch

21. Itraconazole 100 & 200 mg Capsules

22. Product Presentation
0
Itraconazole 100
mg Capsules
Itraconazole 200
mg Capsules
Itraconazole 100
mg Capsules
Itraconazole 200
mg Capsules
1 X 10s
10s X 1 Box
1 X 10s
10 X 1 Box
Bottle of 30
Capsules
Bottle of 30
Capsules
‡ BRINTRA… First time in India, Itraconazole is available in
Bottles of 30 Capsules for dosing convenience

23. Rationale for Packing
1
•Many Itraconazole brands are changing to 10s packing due to increase in dosing
regimen of fungal infections
2
•As resistance and recurrence are two major challenges in treating fungal infections,
dosage is increased clinically more than recommended duration of therapy
3
•10s packing strips is essential for treating Dermatophytosis & Candidiasis and
bottles will play a vital role in long term dosage schedules especially in resistant
fungal infections and onychomycosis
4
•Dermats are seeing patients with dermatophytosis do not respond to two weeks
therapy thus recommending to increase the days of treatment, where even in tinea
infections dermats prescribe till achieving mycological cure rate
5
•For onychomycosis bottle packing will be an value for patients which increases the
compliance and dosing convenience
Source: ims quintiles April MAT 2018

24. Suggested Positioning
SDP Technology
(Solid Dispersion of Itraconazole in Polymer)
For RESISTANT, REFRACTORY & RECURRENT Fungal Infections
Itraconazole, the broad-spectrum anti-fungal now in a new improved
pharmaceutical form ;
Super Bioavailability
3X Increase in Absorption
Reduces Intra / Inter-patient
Variability

25. Proof of Product Claim
BRINTRA Generic Itraconazole
Source: https://www.isdin.com/en/infections/itragerm/

26. Because of low solubility and high permeability Itraconazole suffer from poor aqueous
solubility which results in poor dissolution rate in the GI tract and may compromise oral
bioavailability.
Positioning Rationale
Enhancement of
dissolution rate of
Itraconazole after
oral administration
was one of the
most challenging
aspects in pellet
formulation.
Because of low
solubility and high
permeability
Itraconazole suffer
from poor aqueous
solubility which
results in poor
dissolution rate in
the GI tract and
may compromise
oral bioavailability.
Few strains of
dermatophytes
are resistant to
generic
Itraconazole due
to insufficient
bioavailability
because of poorly
soluble and highly
variability
Few clinical cases of
aspergillosis are
reported globally
were replacement
Sporanox with
generic itraconazole
resulted in
treatment failure
due to inadequate
plasma levels of
Itraconazole and
even development
of resistance
BRINTRA
reduces intra-
and inter-patient
variability and
enables more
predictable
clinical response.
SDP improves
bioavailability &
3X increase in
absorption
2 4 531
Super Bioavailable
Itraconazole with SDP Technology
Predictable Clinical Response in
3R Fungal Disease

27. Product Details
Composition:
•Itraconazole
100 mg & 200
mg Capsules
Development:
•Outsourcing
Delivery Form:
•Capsules Filled
With Pellets
Suggested Price:
•100 mg 10s: 180
•200 mg 10s: 300
•100 mg Bt: 540
•200 mg Bt: 900
Approximate
GC %::
•70%
Target Audience:
•Dermats
•GPs
•Non-MBBS
•Gynecs

28. Indications & Dosage
‡ Due to Resistant,
Refractory & Recurring
fungal infections the
recommended dosages
are not sufficient for
treatment.
‡ Inter/ intra-patient
variability makes
recommended dosage
unpredictable
‡ Dermats clinically in
practice recommend
Itraconazole with other
topical anti-fungals till
infection resolves.
‡ Dermats see more
refractory and recurring
cases in same patients
which clinically required
more days for resolution
of infection.

29. First Year
SKUs
PCPM (175
MRs)
PTD PCPM Value
Brintra 100 mg 10s 50 108 5400
Brintra 200 mg 10s 50 180 9000
Brintra 100 mg
Bottle
25 324 8100
Brintra 200 mg
Bottle
25 540 13500
PCPM Value / MR 36000
Sale in Value (Company) 75600000
Sales Forecast
BRINTRA First 3 Years Sales Forecast
Second Year
SKUs
PCPM (175
MRs)
PTD PCPM Value
Brintra 100 mg 10s 70 108 7560
Brintra 200 mg 10s 70 180 12600
Brintra 100 mg
Bottle
40 324 12960
Brintra 200 mg
Bottle
40 540 21600
PCPM Value / MR 54720
Sale in Value (Company) 114912000
Third Year
SKUs
PCPM (175
MRs)
PTD PCPM Value
Brintra 100 mg 10s 100 108 10800
Brintra 200 mg 10s 100 180 18000
Brintra 100 mg
Bottle
60 324 19440
Brintra 200 mg
Bottle
60 540 32400
PCPM Value / MR 80640
Sale in Value (Company) 169344000
‡ BRINTRA sale projected in first year is 7.56
Cr, second year 11.49 Cr & in third year 16.93
Cr. 50% growth is considered compared to
CAGR 74% of the market
‡ As a strong focus in derma PCPM of
CANDITRAL(100 mg-383/200 mg-456),
SYNTRAN (100 mg-385/200 mg-337) &
ITASPOR (100 mg-343/200 mg-352) is
considered for PCPM derivation.
Source: ims quintiles April MAT 2018

30. Brand Strategy
2 4 531
SDP Technology
Communication
‡Super
Bioavailability
‡3X Increase in
absorption
‡Reducing intra-
and inter-patient
variability to
enable predictable
clinical cure rate
3Rs Fungal Infections
Communication
‡Communication &
positioning on
Resistant, Refractory
& Recurrent Fungal
Infections
‡Special campaign on
BRINTRA against
Trichophyton in
diabetics
Bottles Compliance
Packing Focus
‡Communicating
bottle packing for
dosing & patient
compliance
‡Creating niche
space for dermats
to try new
packing variant
Non-Dermats
Education
‡GPs & Non-
MBBS activities
in educating on
rationale use of
anti-fungals
‡Activity to
reduce steroid
modified fugal
infections
Awareness
Activities
‡Patient
awareness
activities is
much needed as
insist by
dermats
‡Creating brand
awareness in
conferences
Sales promotional activities to be deployed in first year

31. Brand Strategy
For Qtr 1
No Conventional VAB
(Looks Usual)
• In 1st visit Detail
BRINTRA with big flyer
(Tabloid). Discussing all
USPs
VAB & LBLs: Main USPs
Communication
• 3X increase in
absorption & reducing
intra-and inter-patient
variability to enable
predictable clinical
cure rate in 3Rs fungal
infection (as suggested
by a dermat). Focus on
bottle pack
Sampling Strategy
• For derma introducing
Bottles is required with
sampling one bottles
each in 1st visit & not
required further visits
• For non-dermas 100
mg & 200 mg 2s
sampling can be
followed

32. Brand Strategy
For Qtr 2
VAB & LBLs: Main USPs
Communication
• 3X increase in
absorption & reducing
intra-and inter-patient
variability to enable
predictable clinical
cure rate in 3Rs fungal
infection (as suggested
by a dermat). Focus on
bottle pack
GPs, N0n-MBBS &
Gynec Focus
• Invest in potential GPs
to learn clinical aspects
of fungal disease & to
enhance their standard
in derma practice by
courses & CMEs
enrollment
Patient Awareness
• Organizing outdoor
patient awareness
activities in institutions
& colleges with
involving upcoming
dermat as occurrence
of fungal disease is
seen in students which
helps in brand
awareness with Rx

33. Brand Strategy
For Qtr 3
VAB & LBLs: Main USPs
Communication
• 3X increase in
absorption & reducing
intra-and inter-patient
variability to enable
predictable clinical
cure rate in 3Rs fungal
infection (as suggested
by a dermat). Focus on
bottle pack
LBLs: BRINTRA against
3RsTrichophyton
infection in Diabetics
• In diabetic patients
Trichophyton infection
treatment requires long
duration of treatment
with Itraonazole plus
Luliconazole (Co-
promotion).
Patient Awareness
• Organizing outdoor
patient awareness
activities in institutions
and colleges with
involving upcoming
dermats

34. Brand Strategy
For Qtr 4
VAB & LBLs: Main USPs
Communication
• 3X increase in
absorption & reducing
intra-and inter-patient
variability to enable
predictable clinical
cure rate in 3Rs fungal
infection (as suggested
by a dermat). Focus on
bottle pack
LBLs: BRINTRA against
3RsTrichophyton
infection in Diabetics
• In diabetic patients
Trichophyton infection
treatment requires long
duration of treatment
with Itraonazole plus
Luliconazole (Co-
promotion).
GPs, N0n-MBBS & Gynec
Focus
• Invest in potential GPs
to learn clinical aspects
of fungal disease & to
enhance their standard
in derma practice by
courses & CMEs
enrollment

35. Brand Strategy
Product launch to the field force need to be unique & KOLs should
be called during product launch to learn Rx behaviours
Inflatable ball to show
super bioavailable
Itraconazole
Palm Scanner to unveil the
product
Product launched
through drone

36. Execute…Brand Plan
Prepared By:
K. Varun Ramkumar
Brand Manager