Invest or Update on R&D Pipeline June 10, 2015
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Investor Update on
R&D Pipeline
June 10, 2015
8/21/2019 Investor Presentation - Update on NCE and NDDS programs [Company Update]
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6a)or 6ilestones
Investor Update on R&D Pipeline 7
ELEPSIA™ XR U+*D$ approval in 6arch 2015
XELPROS™
+i%ned licensin% & commerciali4ation a%reement !ith +un Pharma
$pproval in 7 8mer%in% 6ar'ets
Responded to the U+*D$ complete response letter
Salmeterol &FluticasoneDry Powder Inhaler
P9 stud" in erman" indicates comparale P9 parameters to +eretide: $ccuhaler:
Received %uidance from 7 re%ulator" a%encies in 8U for re%istrational studies
PIC
ompleted 8;P2< 6= meetin% !ith U+*D$
U+*D$ concurrence on Phase 7 6etastatic reast ancer protocol Promisin% data in holan%iocarcinoma
In a Pilot P9 stud", PI3 demonstrated encoura%in% results, compared to aluminound Paclita(el
A!use DeterrentFormulations
+P$R has developed a platform technolo%" for $use Deterrent *ormulations .$D*
ompleted preI3D meetin% to discuss the product concept
Accelerated Pro"ramDe#elo$ment
ompleted > meetin%s !ith re%ulator" a%encies in U+ and 8U to discussdevelopment plans of 'e" pro%rams
Patent Estate
2? patents %ranted since last update@ 1> more filed#
121 patents %ranted !orld!ide till date
< 8;P 2A 8nd of Phase II =6A hemistr", 6anufacturin%, and ontrols
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+trate%ic Initiatives
Investor Update on R&D Pipeline B
Au"mentin"Ca$a!ilities
Colla!orations& Partnershi$
Port%olioO$timiation
reast cancer pro%ram incollaoration !ith e(perts on
cancer iolo%"
Partnerin% !ith %loaluniversities on ne!technolo%ies and iolo%"
8valuation of developmental pipeline to identif" andprioriti4e hi%h potential pro%rams
Deprioriti4ed certain clinical sta%e pro%rams ased on
mar'et research
3e! additions to thesenior mana%ement team
iolo%" infrastructure
$DDC capailities
uildin% +cientific$dvisor" oard
Dedicated Pro%ram6ana%ement ;ffice
C $DDA omputer $ided Dru% Desi%n
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$u%mentin% +enior 6ana%ement Team
Investor Update on R&D Pipeline 5
Anil Ra"ha#an B.Tech
$nil Ra%havan, is 8; of +P$R# Prior to )oinin% +P$R, he served as the 6ana%in% Director of the India and+ri -an'a usiness of uintiles# Ee !as part of the uintiles %loal leadership team and an active memer ofthe $siaPac mana%ement oard#
In past, he spent a decade consultin% !ith leadin% firms such as $rthur $ndersen, 9P6 and amrid%eTechnolo%" Partners#
Dr' Siu(Lon" )ao* MD
Dr# +iu-on% Fao, +r# GP for linical Development & ;perations, oversees desi%n & e(ecution of clinical
research %loall"#+iu rin%s in 20 "ears of e(perience in clinical research# Prior to )oinin% +P$R, he held positions of increasin%responsiilit" in linical Pharmacolo%" & ;ncolo%" at 6erc', +anofi$ventis and +cherin%Plou%h# Eecompleted suspecialt" trainin% in hematolo%" & oncolo%" at Johns Eop'ins and is a oard certifiedInternist, Eematolo%ist and ;ncolo%ist#
Dr' itin +' Damle* PhD
Dr# 3itin Damle, +r# GP for Discover" iolo%" and Preclinical R&D, oversees desi%n and e(ecution of preclinicalresearch and development#
3itin rin%s in 70 "ears of e(perience in dru% discover" and preclinical development in ;ncolo%" andImmunoInflammator" therapeutic areas !ith foucs on oth small molecules and iolo%ics# Ee !as Directorof ;ncolo%" and ImmunoInflammator" diseases at H"eth, and +r# Director of Preclinical Research at 8ndo
Pharmaceuticals efore )oinin% +P$R#
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Deprioriti4ed Pro%rams
Investor Update on R&D Pipeline
Upon commercial assessment and portfolio reor%ani4ation,
follo!in% pro%rams !ere deprioriti4ed
+U3-?71 Genlafa(ine 8R 700m%
+U35>? 3asalInhalation
-atanoprost K Timolol in 8U aclofen R+ for $lcohol dependence in 8U
• +P$R is evaluatin% development of +U3-?71 and +U35>?
3asal Inhalation for India and other emer%in% mar'ets• Timolol ;D and -atanoprost K Timolol are ein% evaluated
for select emer%in% mar'ets
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Upcomin% 9e" 8vents
Investor Update on R&D Pipeline ?
Licensin" & Commercialiation o% Ele$sia™ XR
Xel$ros,- A$$ro#al !y .SFDA
PIC Launch in India
Initiation o% Pi#otal Clinical ,rial %or PIC
Filin" o% / IDs
Indicative timeline ased on the current estimates of the mana%ement and are su)ect to chan%e# The ompan" cannot assure that this indicative date !ill eachieved# The actual results, performance or achievements, could thus differ materiall" from those pro)ected herein#
8/21/2019 Investor Presentation - Update on NCE and NDDS programs [Company Update]
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+trate%ic Therap" $reas and Research Pro%rams
Investor Update on R&D Pipeline L
MelprosT6
rimonidine ;DO$hthalmolo"y
PI3
+U39?0Oncolo"y
8lepsiaT6 MR
aclofen R+
Ti4anidine 8R
CS
+U35>? Topical
6inoc"cline TopicalDermatolo"y
+almeterol K *luticasone DPIRes$iratory
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Investor Update on R&D Pipeline >
;phthalmolo%"
MelprosN
8/21/2019 Investor Presentation - Update on NCE and NDDS programs [Company Update]
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MelprosN ;phthalmic 8mulsion
Investor Update on R&D Pipeline 10
Re"ulatory .$date
Received omplete Response -etter.R- from U+*D$ in 3ovO1B
• han%e in nomenclature of dosa%e form
• 3o additional preclinical or clinical data
reuirement
+umitted the response to R-
8/21/2019 Investor Presentation - Update on NCE and NDDS programs [Company Update]
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MelprosN ;phthalmic 8mulsion
Investor Update on R&D Pipeline 11
Licensin" & Commercialiation
+P$R si%ned licensin% deal !ith a +un
Pharma susidiar" for U+ mar'et
• Q7 million as upfront and certain other
milestone pa"ments oth totalin% to Q1
million
• $dditionall", +P$R is eli%ile for certain
defined ro"alties and milestone pa"ments
lin'ed to actual sales performance
Indicative value ased on the current estimates of the mana%ement and are su)ect to chan%e# The actual results, performance or achievements, could differfrom those pro)ected herein#
8/21/2019 Investor Presentation - Update on NCE and NDDS programs [Company Update]
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Investor Update on R&D Pipeline 12
3+
8lepsiaN MR
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8lepsiaN MR
Investor Update on R&D Pipeline 17
U+*D$ approval in 6arch 2015
• 1st 3D$ approval for +P$R
omposition and dose specific patents%ranted in U+ !ith last patent e(pir" in 202?
8lepsiaN MR 1000m% & 1500m% patents are
listed in the ;ran%e oo'
0ra$ -atri1 T6
Use of -aser drill to achieve a
controlled release !ith minimale(cipients
A$$lication o Patent oPatent
E1$iration
320BB1? L1770 7+ep2?
320BB1? LB25>7L 22*e2
320BB1? LB7115 71;ct2?
320BB1? LB?07? 70Jun2B
320BB1? L575?1? 22*e2
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8lepsiaN MR
Investor Update on R&D Pipeline 1B
.S Commercial O$$ortunity-ar2et access studies in .S3
Pill urden in epileps" patients remains hi%h•
55S patients at pills per da"• L0S patients need dail" dosa%e of 1000m%
7000m%
8lepsiaN MR represents a ne! therapeutic
option to reduce pill urden in epileps"
patients
Ele$sia™ XR mar2et $otential
-evetiracetam mar'et in U+ is currentl" at
?20 million units and is %ro!in% at 5 "ear
$R of >SC
;pportunit" to mar'et 8lepsiaN MR at
si%nificant premium to %enerics
<
Le#etiracetam .se !y DailyDosa"e4
5676
8967:6
756
;6
500 6 D$F ?50 6 D$F
1000 6 D$F 1500 6 D$F
2000 6 D$F 2000 6 D$F
C I6+ 6$T $prO15< Primar" 6ar'et Research conducted throu%h 7rd Part"
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8lepsiaN MR
Investor Update on R&D Pipeline 15
Licensin" & Commercialiation
+P$R is at advanced sta%e of licensin% discussions
!ith potential partners
8lepsiaN MR commerciali4ation in U+ mar'et " 2
nd
half of 2015 201C
CIndicative timeline ased on the current estimates of the mana%ement and are su)ect to chan%e# The ompan" cannot assure that this indicative date !ill eachieved# The actual results, performance or achievements, could thus differ materiall" from those pro)ected herein#
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Investor Update on R&D Pipeline 1
;ncolo%"
PI3
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Paclita(el In)ection oncentrate for 3anodispersion
.PI3
Investor Update on R&D Pipeline 1?
o#el %ormulation o% Paclita1el usin" SPARC<s$ro$rietary anotecton™ $lat%orm technolo"y
PIC assu$$lied
PIC asadmi1ture
Electron microsco$eima"e o% nano $article
89 nm = 789 nmin sie
remophor: and $lumin free
formulation
70 minute infusion 3o standard Paclita(el premedications
reuired
$llo!s hi%her dose than Ta(ol:
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8ncoura%in% results in a P9 stud" comparin% PI3
!ith alumin ound Paclita(el
Investor Update on R&D Pipeline 1L
0 10 20 30 40 50 60 70 80
0.1
1
10
100
1000
10000
100000
PICN
Albumin bound Paclitaxel
Free
Total
P a c l i t a x e l ( n g . m
l - 1 )
Time (h)
+P$R conducted Pilot $8 stud"
in India
Data supports proailit" of 8
!ith alumin ound Paclita(el
$dditional patients are ein%
enrolled to %ain further confirmation
Pivotal 8 stud" planned in B,
2015201C ased on the outcomes
of the on%oin% Pilot stud"
CIndicative timeline ased on the current estimates of the mana%ement and are su)ect to chan%e# The ompan" cannot assure that this indicative date!ill e achieved# The actual results, performance or achievements, could thus differ materiall" from those pro)ected herein#
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8ncoura%in% PI3 data in holan%iocarcinoma
Investor Update on R&D Pipeline 1>
SPARC e#aluated PIC in > ?nd line treatment o% Cholan"iocarcinoma in ane1$anded cohort o% on"oin" $ro"ram in .S
Outcomes %rom Cholan"iocarcinoma Cohort
1>S
BBS
7?S
0S
25S
50S
Partial Response +tale disease Pro%ressiveDiseaseN=16
PI3 has demonstrated 1> S
response rate in su)ects !ith
metastatic holan%iocarcinoma
!ho have failed at least 1 line of chemotherap"
+P$R plans to discuss !ith
U+*D$ for approval path!a"
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PI3
Investor Update on R&D Pipeline 20
ompleted 8nd of Phase 2 6 meetin% !ith U+*D$
Received U+*D$ concurrence on Phase 7 6
protocol
Plan to initiate stud" " B, 20151C
CIndicative timeline ased on the current estimates of the mana%ement and are su)ect to chan%e# The ompan" cannot assure that this indicative date !ill eachieved# The actual results, performance or achievements, could thus differ materiall" from those pro)ected herein#
@reast Cancer Pro"ram .$date
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PI3 U+ ;pportunit"
Investor Update on R&D Pipeline 21
Paclita(el is still a standard of care in
6 and other solid tumors and its use
is %ro!in%
8stimated 15,000 patients receive
Paclita(el therap" ever" "ear<
• $out 25,000 metastatic reast cancer
patients are treated !ith Paclita(el<
Hith efficac" and safet" similar to
$ra(ane:, PI3 could address this
patient population
Paclita1el Sales -n'B
5/ /9 /98
;95:97
200
B00
00
L00
2010 2011 2012 2017 201B 2015
Paclita1el Sales Est' -n' .nits4
?' ?' ?'? ?'7
?'8?':
0
1
2
7
2010 2011 2012 2017 201B 2015
I6+ 6ar 6$T 2015# C 8st# Units euivalent to 100 m% paclita(el, < Primar" 6ar'et Research conductedthrou%h 7rd part"
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;verall PI3 appeal as second line 6 treatment
Investor Update on R&D Pipeline 22
Prior to an" mention of pricin%, appeal of /6ost -i'el" PI3 !as uite stron%@
even !ith /ase ase data 0S of oncolo%ists found it appealin%<
O#erall Im$ression o% PIC= All Physicians =
?6 786 56
Unappealin% .17 3either $ppealin% nor Unappealin% .B $ppealin% .5?
6 76 ;96
PI3 as efficacious utsafer than Paclita(el
n:8
PI3 as efficacious and
as safe as Paclita(el
< Primar" 6ar'et Research conducted throu%h 7rd part"
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Investor Update on R&D Pipeline 27
Respirator"
DPI
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Dr" Po!der Inhaler
Investor Update on R&D Pipeline 2B
SPARC<s DPI is a $re(metered* ;9 dose* !reath acti#ated de#ice %or administration o%com!ination o% inhaled steroids and !ronchodilator dru"s
Uniform dose deliver" independent of inspirator" flo! rate
onsistentl" delivers hi%her amount of dru% to lun%s
8liminates doule dosin% and dose !asta%e
Provides visual, audile and tactile feedac' upon dose
administration
lo!inthedar' feature for eas" ni%httime use
*eature for assistin% visuall" impaired, as reminder to refill
device, !hen L doses remain +mall and convenient, eas" to carr"
ompliant to the strin%ent U+*D$ and 8uropean
reuirements
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+almeterol & *luticasone DPI
Investor Update on R&D Pipeline 25
Com$ara!le P+ at hal% the dose o% SeretideG
AccuhalerG
Fluticasone Plasma Pro%ile
0
20
B0
0
L0
100
120
0 12 1L 2B 70 7 B2 BL
,ime Hrs
*luticasone propionate 250 V% .+un DPI
*luticasone propionate 500 V% .+eretide
$ccuhaler:
- e a n P l a s m a F l u t i c a s o n e C o n c ' $ " I m L
0
20
B0
0
L0
100
120
1B0
0 2 B L 10 12 1B 1
,ime Hrs
+almeterol 25 V% .+un DPI
+almeterol 50 V% .+eretide
$ccuhaler:
- e a n P l a s m a S a l m e t e
r o l C o n c ' $ " I m L
The pulmonar" deposition and s"stemic fluticasone and salmeterol
e(posure outcomes !ere comparale to +eretide: $ccuhaler:
::
Salmeterol Plasma Pro%ile
.+P$R DPI.+P$R DPI
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+almeterol & *luticasone DPI
Investor Update on R&D Pipeline 2
De#elo$ment Status .$date
CIndicative timeline ased on the current estimates of the mana%ement and are su)ect to chan%e# The ompan" cannot assure that this indicative date!ill e achieved# The actual results, performance or achievements, could thus differ materiall" from those pro)ected herein#
E.
Discussed the P9 stud" outcome and clinical development pro%ram!ith 7 8U re%ulator" a%encies
$chieved concurrence !ith re%ulator" a%encies on the +P$R
proposed clinical pro%ram
+P$R to accelerate recommended clinical studies
Tar%etin% 8U Re%ulator" filin% " B, 201?1LC
.S To otain re%ulator" advice and develop clinical strate%"
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+almeterol & *luticasone DPIE. -ar2et O$$ortunity
Investor Update on R&D Pipeline 2?
omparalepharmaco'inetics
at half the dose
8ase of use of device " the
patient
Dose freuenc" Device +hape &+i4e
6inimumInspirator" flo!
.efore device
activation
Device dosecounter
Device reductionof !asta%e
Device reathactivated
mechanism
-o! level of s"stemic effects
*rance erman"
Ital" +pain
United 9in%dom $vera%e
6uch !orsethan
Horsethan
+ameas
etterthan
6uch etterthan
;n all characteristics +P$R DPI is vie!ed as etter than +eretide: $ccuhaler:<
Com$arison to SeretideG AccuhalerG on De#ice Characteristics
< Primar" 6ar'et Research conducted throu%h 7rd part"
n789
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+P$R DPI Galue $nal"sisE. -ar2et O$$ortunity
Investor Update on R&D Pipeline 2L
20S elo! +eretide$ccuhaler
10S elo! +eretide$ccuhaler
8ual to +eretide$ccuhaler
10S aove +eretide$ccuhaler
20S aove +eretide$ccuhaler
70S aove +eretide$ccuhaler
Ph"sicians
Pa"ers
Ger" %ood value
ood value
Reasonale value
Poor value
Ger" poor value
Payers(:'86
PhysiciansJ776
Physicians n7:9Payers n78
Galue Point
oth ph"sicians and pa"ers su%%est price parit" to +eretide: $ccuhaler:<
< Primar" 6ar'et Research conducted throu%h 7rd part"
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Investor Update on R&D Pipeline 2>
3+
aclofen R+
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aclofen R+
Investor Update on R&D Pipeline 70
8(tended release formulation of aclofen !ith
Proprietar" astro Retentive Innovative
Device .RIDN technolo%"
;nce dail", recommended fed state dosin%
for optimal ioavailailit" and minimal
sedation
aclofen R+ !ill e availale in stren%thsi#e#, 10 20 70 B0 50 0 m%
Patent portfolio comprisin% of formulation,
onceada" therap" and indication patents
!ith last patent e(pirin% in 202?
KRID,- ,echnolo"y
@aclo%en KRS swells 5 = 79times u$on in"estion
f f
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aclofen is the standard of care in spasticit"
Investor Update on R&D Pipeline 71
Distri!ution o% $atients $rescri!edtreatment %or s$asticity4
:/6
8/6
:6
8/6
0S
B0S
L0S
120S
9;-s
.nW5
3euro
.nW11
9;-s
.nW7
3euro
.nW11aclofen Intrathecal aclofen oto( Ti4anidine ;ther
50S of multiple sclerosis and stro'e patients are
prescried aclofen as antispasticit" treatment<
Pro$ortion o% res$ondents< who a"ree that@aclo%en is the standard o% care in s$asticity
0S 25S 50S ?5S 100S
3euros .nW10
9;-s .nW5
aclofen Ti4anidine +oma
L0S of 9;-s and 3eurolo%ists a%ree that aclofen
is the standard of care for spasticit" treatment<
-ulti$le sclerosisStro2e
S h a r e o % l a s t
? 9 $ a t i e n t s r e u i r i n "
t r e a t m e
n t % o r s $ a s t i c i t y
* Values exceed 100% because of co-prescripio!
< Primar" 6ar'et Research conducted throu%h 7rd part"
l f i i d l d l 5 i U+
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Investor Update on R&D Pipeline
aclofen prescriptions douled over last 5 "ears in U+
72
@aclo%en Solid Oral -ar2et ,R14
/8
8
;
:
5
7
5
?
>
2010 2011 2012 2017 201B 2015
, R 1
m i l l i o n
@aclo%en Solid Oral -ar2et .nits4
/:?
89:
8/8 887
;
;:8
B00
00
L00
2010 2011 2012 2017 201B 2015
. n
i t s m i l l i o n
7BS prescriptions from spasticit" related neurolo%ical indicationsC
aclofen R+ ma" e priced at si%nificant premium over %enerics <
CI6+ 6$T 6$R 2015 < Primar" 6ar'et Research conducted throu%h 7rd part"
l f
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aclofen
Investor Update on R&D Pipeline 77
CIndicative timeline ased on the current estimates of the mana%ement and are su)ect to chan%e# The ompan" cannot assure that this indicative date !ill eachieved# The actual results, performance or achievements, could thus differ materiall" from those pro)ected herein#
< +P$W+pecial Protocol $ssessment
$ccelerated e(ecution of clinical studies under +P$< !ith *D$
•
Phase 7 efficac" stud"Ao B> sites recruitin% patients@ To add 25 more sites
o 12L patients enrolled as of 6a"O15
• ;pen lael safet" stud"A
o 1>7200 patients enrolled
• Duration of action stud"A
o 5>175 patients randomi4ed
Tar%eted 3D$ filin% " B, 201? 1LC
De#elo$ment Status .$date
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Investor Update on R&D Pipeline 7B
;ncolo%"
+U39?0
+U3 9?0 t t t t t i t t 6-
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+U39?0 tar%ets treatment resistant 6-
Investor Update on R&D Pipeline 75
+U39?0 is a potent, orall" active and
hi%hl" selective cr$l T"rosine 9inase
Inhiitor .T9I
+i%nificantl" inhiits 'e" Imatini resistant
mutants, includin% the T715I mutation
Unli'e Ponatini, !hich is a multi'inase
inhiitor, +U39?0 is selective for cr$l
'inase and its mutants
ein% selective, +U39?0 is less li'el" to
have offtar%et side effects
6-W hronic 6"eloid -eu'emia
@cr(A!l +inase
+U3 9?0 d t t d f l i i fil
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+U39?0 demonstrated favorale i!-"iro profile
Investor Update on R&D Pipeline 7
+inases
IC89 n-
S.(+:9;
Ponatini! Dasatini! Imatini!
$l 0#> 0#> 7#0 ?>0
$l.T715I 7 0#> 38 38
G8*R2 700 17 2000 38
Cell Lines
IC89 n-
S.(+:9;
Ponatini! Dasatini! Imatini!
9520#5 0#7 0#1 150
952IR 2# 0#B 0#L >L
U>7? 38 38 38 38
+U39?0 has potent
activit" a%ainst !ild t"pe
r$l and the difficult totreat mutation vi4# T715I
$rterial thromosis, a
serious safet" concern for
Ponatini, is attriuted toG8*R2 inhiition
+U39?0 ma" not e(hiit
similar safet" concern
38W 3ot effective .I50 W 10µ6
+U3 9?0 si%nificant efficac" in Imatini resistant
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+U39?0 si%nificant efficac" in Imatini resistant
leu'emia models
Investor Update on R&D Pipeline 7?
+i%nificantl" prolon%ed survival of mice
earin% patientderived leu'emia cell lines
carr"in% either the !ild t"pe or T715I
mutationearin% cr$l
auses re%ression of lar%e estalished
(eno%rafts of Imatini resistant 6- cells
;n oral administration sho!s consistents"stemic e(posure in different animal species
+afet" pharmacolo%" data indicates that +U3
9?0 has no adverse effect liailit" at
multiples of efficac" doses on hepatic,neurolo%ic, pulmonar" and cardiac functions
Antitumor acti#ity a"ainstImatini! Resistant +8;? Xeno"ra%t
S.(+:9;9 m"2"* o'd'
+U3 9?0
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+U39?0
Investor Update on R&D Pipeline 7L
+uitale formulation for clinical studies is optimi4ed
I3Denalin% efficac", safet", and to(icolo%" studies
completed I3D filin% " 7, 20151C
CIndicative timeline ased on the current estimates of the mana%ement and are su)ect to chan%e# The ompan" cannot assure that this indicative date
!ill e achieved# The actual results, performance or achievements, could thus differ materiall" from those pro)ected herein#
De#elo$ment Status .$date
+U3 9?0
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+U39?0
Investor Update on R&D Pipeline 7>
8stimated 500 ne! cases of 6- are
dia%nosed ever" "earC
The prescription trend su%%estsincrease in use of 2nd line T9I
inhiitors=
T715I mutations incidence is as hi%h asB0S in patients !ho failed secondline
T9I therap"<
Treatment %aps include etter dru%s totreat T715I mutation and dru%s that
treat advanced disease .accelerated
phase or last crisis Q
Sales B -n'M
?*;? */77/*;8/
8*7::*:/8
*987*;8
*?8
/*:5:
;*7;
:*955
:*97
9
9
9
7
8/7
7?
9
9
9
7:
88
/
2010 2011 2012 2017 201B 2015
Dasatini 3ilotini osutini Ponatini
?nd Keneration ,+INs $atients on thera$yMM
= I6+ 6$T 6ar 2015, == 8stimated from I6+ 6$T $pr 2015 sales dataC +88R +tat *act +heetsA6-# $li! $a!cer es &01'(1)+,&,-+,'. Pri/ar Mare esearch co!duced hrou2h 'rd Par.
.S O$$ortunity
2507?>L
25 B5
I6$TI3I D$+$TI3I 3I-;TI3I
;+UTI3I P;3$TI3I ;6$8T$MI38
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Investor Update on R&D Pipeline B0
;phthalmolo%"
rimonidine ;D
rimonidine ;D ;phthalmic +uspension
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rimonidine ;D ;phthalmic +uspension
Investor Update on R&D Pipeline B1
Im$ro#in" Patient Com$liance
rimonidine is one of the most commonl" used
secondline treatment in laucoma
Individual adherence to rimonidine TID is hi%hl"
variale and pharmacolo%icall" insufficient in more
than 27rd patientsC
+P$R is developin% a novel onceada" rimonidineusin% proprietar" 3T ;cular Technolo%"
• ontrolled and ma(imal availailit" of dru% to ocular
surface
• Reduces immediate e(posure of dru%
• *ree of %el formin% pol"mers
C J laucoma, 2011, 20, 50250L;DW ;nceada"# TID W Thrice a da"
3anoTemplate lusters .3T ;cular Technolo%"
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3anoTemplate lusters .3T ;cular Technolo%"
Investor Update on R&D Pipeline B2
rimonidine oundcluster micro particle
Disinte%ration toindividual particles "
dilution and shear
@lin2Sheer
Dru% release " tear saltsand corneal asorption
@lin2Sheer
3T technolo%" involves adsorption of !ater
solule dru%s onto the nano templates
3anoTemplate dru% is formulated as
microclusters
6icroclusters smear on ocular surface due to
lin' shear and emed in mucous la"er
Tear stimulus release permeale form of dru%from template in the corneal vicinit"
The deliver" and duration of dru% is controlled
and prolon%ed
oatin%retentionpenetration provides optimal
ocular dru% deliver" and enefit
rimonidine ;D ;phthalmic +uspension
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rimonidine ;D ;phthalmic +uspension
Investor Update on R&D Pipeline B7
Sustained IOP reductions achie#ed o#er ?/ hours
8ffect of rimonidine ;D on I;P of ;cular E"pertensive Raits
omparale pea' and trou%h I;P reduction
.mm E% !ith $lpha%an: P TID achieved
Ei%her e(posure in posterior se%ment
Pea24 IOP reduction ,rou"h4 IOP reduction
+P$R
;D
$lpha%an:
P TID
+P$R
;D
$lpha%an:
P TID
L#0 # B# 2#L
CPea' and trou%h I;P reduction are measured at 27 h and 272B h post Ist dose of the
da"
rimonidine ;D
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rimonidine ;D
Investor Update on R&D Pipeline BB
Patent filed
PreI3D meetin% completed
I3D filin% " B 20151C
CIndicative timeline ased on the current estimates of the mana%ement and are su)ect to chan%e# The ompan" cannot assure that this indicative date!ill e achieved# The actual results, performance or achievements, could thus differ materiall" from those pro)ected herein#
De#elo$ment Status .$date
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Investor Update on R&D Pipeline B5
Dermatolo%"
+U35>?Topical
+U35>? Topical
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+U3 5>? Topical
Investor Update on R&D Pipeline B
Topical steroids are the mainsta" in the treatment of steroidresponsive dermatoses
• B1 million prescriptions %enerated in U+ durin% 201B
-on% term use of topical steroids often results in severe &partiall" irreversile cutaneous adverse effects li'e s'in
atroph"<
+U35>? topical is a novel corticosteroid !ith improved
safet" profile
• In preclinical models, demonstrated lo! potential for
induction of s'in atroph"
•
+ho!ed etter efficac" compared to lo! to mid potenc"steroids such as Triamcinolone
• 8fficac" !as comparale !ith potent steroids such as
*luticasone and loetasol
< 8(p Dermatol 200A15A B0B20@ J $m $cad Dermatol 201BA?1.1A1172
+U35>? Topical
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+U3 5>? Topical
Investor Update on R&D Pipeline B?
Su$erior E%%icacy in Psoriasis Animal -odel
0
1
2
7
B
5
Da" 7 Da" 5 Da"
Imiuimod
Placeo
+05>?
E$ .1S
T$ .0#01S*P .0#05S
P .0#05S
E$A E"drocortisone acetate T$A Triamcinolone acetonide*PA *luticasone propionate PA loetasol propionate
Statistically si"ni%icant as com$ared to Imiuimod3 and Place!o4"rou$s
, o t a l P s o r i a s i s S y m $ t o m S c o r e
e r y t h e m a J s c
a l i n " J s 2 i n t h i c 2 n e s
s
Reduction o% $soriasis
sym$tom score+uperior to
E"drocortisone acetate
Triamcinolone acetonide
omparale to
*luticasone propionate loetasol propionate
3
3
4
3
4
+U35>? Topical
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+U3 5>? Topical
Investor Update on R&D Pipeline BL
F o l d " e n e e 1 $ r e s s i o n o % i n t e r l e u
2 i n s
n o r m a l i &
e d w i t h K A P D H
E$A E"drocortisone acetate T$A Triamcinolone acetonide*PA *luticasone propionate PA loetasol propionate
0
50
100
150
200
250
700
I-1? I-27
Imiuimod
Placeo
+05>?
E$ .1S
T$.0#01S*P .0#05S
P .0#05S
Statistically si"ni%icant as com$ared to Imiuimod4 andPlace!o3 "rou$s
Inhi!ition o% in%lammatory
interleu2ins
+uperior to
E"drocortisone acetate
Triamcinolone acetonide
omparale to
*luticasone propionate loetasol propionate
Si"ni%icant Reduction o% In%lammatory -ediators
3
43
+U35>? Topical
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CIndicative timeline ased on the current estimates of the mana%ement and are su)ect to chan%e# The ompan" cannot assure that this indicative date
!ill e achieved# The actual results, performance or achievements, could thus differ materiall" from those pro)ected herein#
p
Investor Update on R&D Pipeline B>
PreI3D meetin% !ith U+*D$ completed
I3D filin% " 2, 20151C
Phase 1 stud" to e initiated " 7, 20151C
De#elo$ment Status .$date
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Investor Update on R&D Pipeline 50
Dermatolo%"
6inoc"clineTopical
6inoc"cline Topical
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" p
Investor Update on R&D Pipeline 51
6inoc"cline is one of the lar%est sellin% oral antiiotics in U+
for inflammator" $cne
• In 201B, estimated 7 million prescriptions !ere
%enerated for oral 6inoc"cline in U+$ for $cne<
;ral 6inoc"cline is associated !ith various s"stemic side
effects li'e, I upset, candidiasis, eni%n intracranial
h"pertension, hepatoto(icit", di44iness etc#C
+P$ROs novel topical 6inoc"cline provides an effective &
safer alternative for $cne
• etter Dermato'inetics
• Reduced s"stemic e(posure
• Potentiall" active in oth inflammator" and non
inflammator" $cne lesions
Cochrane Dataase +"st Rev# 2012A15@LAD0020L@ J Dru%s Dermatol# 2010A>.11A1B0?11# < I6+ 6$T 6$R 2015
o#el ,reatment O$tion %or Acne
6inoc"cline Topical
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" p
Investor Update on R&D Pipeline 52
0
1
2
0 1 7 5 ? > 11 17 15
Untreated ontrol
Placeo
6inoc"cline Topical
E a r , h i c 2 n e s s m m
Days
CWpX0#001
CC C
In P# $cne +D rat model Y2LS reduction in ear thic'ness compared to
placeo at da" 15
Patents filed for the novel composition
Pre(clinical POC esta!lished in Acne model
P;WProof of oncept
6inoc"cline Topical
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C Indicative timeline ased on the current estimates of the mana%ement and are su)ect to chan%e# The ompan" cannot assure that this indicative date
!ill e achieved# The actual results, performance or achievements, could thus differ materiall" from those pro)ected herein
" p
Investor Update on R&D Pipeline 57
PreI3D meetin% planned in 7 20151C
I3D filin% " 1 2011?C
De#elo$ment Status .$date
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Investor Update on R&D Pipeline 5B
3+
Ti4anidine 8R
Ti4anidine 8R for 6usculos'eletal Pain
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Investor Update on R&D Pipeline 55
Schematic Re$resentation o% Com$arati#emean Plasma ,ianidine Concentration (
,ime Pro%iles
9 hour ; hour 7? hour
,ime hours
P l a s m a c o n c e n
t r a t i o n
?/ hour
Reference IR, T.I.D.
Tizanidine ER, Once-a-day
Ti4anidine IR is used in mana%ement of
spasticit" and Pain
8stimated B#B million Ti4anidine prescriptions%enerated in U+ for 6usculos'eletal painC
Ti4anidine has a short duration of action hence
reuires 7 to B times dosin% per da"#
Ti4anidine use is limited due to side effects li'eorthostatic h"potension, somnolence, co%nitive
function impairment
+P$R is developin% a novel e(tended release
formulation to tar%et• Patient convenience and etter compliance
• $n improved side effect profile
O$timiin" P+ to im$ro#e sa%ety $ro%ile
C I6+ 6$T 6$R 2015
Ti4anidine 8R
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CIndicative timeline ased on the current estimates of the mana%ement and are su)ect to chan%e# The ompan" cannot assure that this indicative date
!ill e achieved# The actual results, performance or achievements, could thus differ materiall" from those pro)ected herein#
Investor Update on R&D Pipeline 5
PreI3D meetin% !ith *D$ completed
Pilot P9 stud" completed
Phase 2 studies are planned in 2015 1C
De#elo$ment Status .$date
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Investor Update on R&D Pipeline 5?
$use
Deterrent*ormulations
.$D*
$use Deterrent *ormulationsO i
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O$$ortunity
Investor Update on R&D Pipeline 5L
O$ioid a!use an e$idemic in the .nited States *D$ considers the development of ause deterrent opioid
anal%esics a hi%h pulic health priorit"
;pioid anal%esics !ere involved in aout 7BL,000 8D visits in 2011 in
the U+$Z
Deaths from prescription pain'iller overdose have risen " 700S
over the past decade from 1>>> to 2012C
Re%ulator" environment stron%l" indicates future development of controlled sustance formulations to e ausedeterrent
O$ioids -ar2et in .S
Prescription opioids hold Y50S mar'et share in the U+ anal%esic
mar'et# Total opioids mar'et is estimated to e Q> illion=
6ar'eted $D* constitute 7S of unit sales ut command 72S of
value share
.SA O$ioid mar2etADF O$$ortunity
$D*,
2#L7
3on
$D*,
5#>?
Qalue in !illion B
$D*,
B02
3on
$D*,
1B,01B
.nits millions
ZDru% $use Harnin% 3et!or', 2011A 3ational 8stimates of Dru%Related 8D Gisits, U+ Dept of Eealth &Euman +ervices# CEealth 8+tats, Tends in Dru%Poisonin% Deaths Involvin% ;pioid anal%esics& Eeroin, D,,D8 201B# = I6+ 6$T $PR 2015
$use Deterrent *ormulationsD l t St t d Pl
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De#elo$ment Strate"y and Plan
Investor Update on R&D Pipeline 5>
+P$R identified an interestin% opportunit" in $D*
Preliminar" proofofconcept results encoura%in%
onceptual meetin% !ith *D$ completed
Patents filed
+P$R R&D Pipeline
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Investor Update on R&D Pipeline 0
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Investor Update on R&D Pipeline 1
*or updates and specific ueries,
please visit !!!#sunpharma#in or
contact
-ira Desai
Tel A K>1 22 B5 5B5, 8(t 50
Tel Direct A K>1 22 B550
6oile A K>1 >L21> 27?>?mira#desaiZsparcmail#com
[ 2017 +un Pharma $dvanced Research ompan" -imited#, $ll Ri%hts Reserved#
+un Pharma $dvanced Research ompan" -td# -o%o is trademar's of +un Pharma $dvanced Research ompan" -td # In addition to ompan" data, data from mar'et research a%encies, +toc' 8(chan%es and industr" pulications has een
used for this presentation# This material !as used durin% an oral presentation@ it is not a complete record of the discussion# This !or' ma" not e used, sold, transferred, adapted, arid%ed, copied or reproduced in !hole on or in part
in an" manner or form or in an" media !ithout the prior !ritten consent# $ll product names and compan" names and lo%os mentioned herein are the trademar's or re%istered trademar's of their respective o!ners#