Investor Presentation - Update on NCE and NDDS programs [Company Update]

8/21/2019 Investor Presentation - Update on NCE and NDDS programs [Company Update]

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Investor Update on

R&D Pipeline

June 10, 2015





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



+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



$u%mentin% +enior 6ana%ement Team


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#



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



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#



+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



Investor Update on R&D Pipeline >

;phthalmolo%"

MelprosN



MelprosN ;phthalmic 8mulsion


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-



MelprosN ;phthalmic 8mulsion


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#




3+

8lepsiaN MR



8lepsiaN MR


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



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"



8lepsiaN MR


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#




;ncolo%"

PI3



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:



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#



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"



PI3


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


@reast Cancer Pro"ram .$date



PI3 U+ ;pportunit"


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"



;verall PI3 appeal as second line 6 treatment


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"




Respirator"

DPI



Dr" Po!der Inhaler


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



+almeterol & *luticasone DPI


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



+almeterol & *luticasone DPI


De#elo$ment Status .$date


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%"



+almeterol & *luticasone DPIE. -ar2et O$$ortunity


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


n789



+P$R DPI Galue $nal"sisE. -ar2et O$$ortunity


20S elo! +eretide$ccuhaler

10S elo! +eretide$ccuhaler

8ual to +eretide$ccuhaler

10S 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:<





3+

aclofen R+



aclofen R+


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



aclofen is the standard of care in spasticit"


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!


l f i i d l d l 5 i U+



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



aclofen



< +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





;ncolo%"

+U39?0

+U3 9?0 t t t t t i t t 6-



+U39?0 tar%ets treatment resistant 6-


+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



+U39?0 demonstrated favorale i!-"iro profile


+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



+U39?0 si%nificant efficac" in Imatini resistant

leu'emia models


+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



+U39?0


+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#


+U3 9?0



+U39?0


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



Investor Update on R&D Pipeline B0

;phthalmolo%"

rimonidine ;D

rimonidine ;D ;phthalmic +uspension





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%"



3anoTemplate lusters .3T ;cular Technolo%"


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






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



rimonidine ;D

Investor Update on R&D Pipeline BB

Patent filed

PreI3D meetin% completed

I3D filin% " B 20151C






Dermatolo%"

+U35>?Topical

+U35>? Topical



+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



+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



+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





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





Dermatolo%"

6inoc"clineTopical

6inoc"cline Topical



" p


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



" p


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



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


PreI3D meetin% planned in 7 20151C

I3D filin% " 1 2011?C





3+

Ti4anidine 8R

Ti4anidine 8R for 6usculos'eletal Pain




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






PreI3D meetin% !ith *D$ completed

Pilot P9 stud" completed

Phase 2 studies are planned in 2015 1C





$use

Deterrent*ormulations

.$D*

$use Deterrent *ormulationsO i



O$$ortunity


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



De#elo$ment Strate"y and Plan


+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







*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#

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