Investor Update On R&D Pipeline 24th August Final
Investor Update On R&D Pipeline 24th August Final
Investor Update On R&D Pipeline 24th August Final
R&D Pipeline
24th August 2017
Except for the historical information contained herein, statements in this presentation and the
subsequent discussions, which include words or phrases such as will, aim, will likely
result,would, believe, may, expect, will continue, anticipate, estimate, intend, plan,
contemplate, seek to, future, objective, goal, likely, project, should, potential, will
pursue and similar expressions or variations of such expressions may constitute "forward-
looking statements". These forward-looking statements involve a number of risks, uncertainties
and other factors that could cause actual results to differ materially from those suggested by the
forward-looking statements. These risks and uncertainties include, but are not limited to our
ability to successfully implement our strategy, our growth and expansion plans, obtain regulatory
approvals, our provisioning policies, technological changes, investment and business income,
cash flow projections, our exposure to market risks as well as other risks. Sun Pharma Advanced
Research Company Limited does not undertake any obligation to update forward-looking
statements to reflect events or circumstances after the date thereof.
2017 SPARC 2
Agenda
1 Upcoming Milestones
Anil Raghavan CEO 5 Programs
Narendra Lakkad V.P. Business Development
2017 SPARC 3
Agenda
1 Upcoming Milestones
Anil Raghavan CEO 5 Programs
Narendra Lakkad V.P. Business Development
2017 SPARC 4
SPARCs R&D strategy
Innovation with balanced risk
2017 SPARC 5
Our short to medium term focus
Execute well while building competencies for the future
2017 SPARC 6
Focus on near term priorities
SPARC portfolio is gathering momentum
Key Milestones
Taclantis is provisionally approved trade name for PICN by USFDA; S1PR1 = Sphingosine 1-phosphate Receptor 1 2017 SPARC 7
Our operating model is evolving
Substantial investments to make SPARC future ready
2017 SPARC 8
Long-term portfolio strategy
Focused approach and translational discipline
2017 SPARC 9
Setting expectations
Upcoming milestones for SPARC
HAL = Human Abuse Liability; PD = Parkinsons Disease; CML = Chronic Myelogenous Leukemia; MAA = Marketing Authorization Application 2017 SPARC 10
Agenda
1 Upcoming Milestones
Anil Raghavan CEO 5 Programs
Narendra Lakkad V.P. Business Development
2017 SPARC 11
Baclofen GRS
Development on track as planned
Duration of Action
Efficacy Study Safety Study
Study
Number of
285 135 375
Subjects
Status Recruitment Studies completed
completed Data under review
LPO Aug17
2017 SPARC 13
Salmeterol Fluticasone Dry Powder Inhaler
Next steps
100000
Mean Plasma Concentration
ng/ml
No unanticipated safety findings
100
1
Planned NDA filing by Q3FY19
0 2 4 6 8 10 12
Time (Hours)
Taclantis nab-paclitaxel Taclantis nab-paclitaxel
2017 SPARC 15
SUN K0706 CML
Highly selective BCRABL Inhibitor
2017 SPARC 16
SUN K0706 CML
Development status update
2017 SPARC 17
Brimonidine OD
Improving Glaucoma patient compliance and adherence
* J Glaucoma. 2011 Oct;20(8):502-8; OD = Once-a-Day, TID = Three times a day 2017 SPARC 18
Brimonidine OD
Achieves similar IOP reduction as Alphagan P TID
26
24 Brimonidine OD
Alphagan P
22
IOP (mm Hg)
20
18
16
14
12
10
0 14 28 42 56 84
Days
2017 SPARC 21
Agenda
1 Upcoming Milestones
Anil Raghavan CEO 5 Programs
Narendra Lakkad V.P. Business Development
2017 SPARC 22
Parkinsons Disease
Growing evidence of c-Abl kinase involvement
^Parkinsons Disease Foundation - http://www.pdf.org/parkinson_statistics; Image adapted Nature Reviews Drug Discovery16, 371373:2017 2017 SPARC 23
SUN K0706 PD
Promising neuroprotective activity in mouse model of PD
Representative photomicrographs showing TH-immunoreactive neurons in SNPc
14
Integrated Density of TH-Immunoreactivity 25
% Area of TH-Positive Neurons
12
10 20
Int Density
8
15
% Area
6
10
4
5
2
0 0
Nave Placebo of K0706 (1 mpk) K0706 (3 mpk) K0706 (10 mpk) Nave Placebo of K0706 (1 mpk) K0706 (3 mpk) K0706 (10 mpk)
K0706 K0706
Phase 1
Assessment of PK, safety and
tolerability in patients
Phase 2
Proof of efficacy study in Parkinsons
Disease patients to be initiated
2017 SPARC 25
SCD 044
Novel highly selective S1P Receptor 1 agonist for
auto-immune disorders
*Evaluatepharma; 1. JMC, 2005, 48,5373-77; Nature 510,5867, June 2014 2017 SPARC 26
SCD 044
Comparable pre-clinical efficacy to Fingolimod
2017 SPARC 27
SCD 044
Development status update
1 Upcoming Milestones
Anil Raghavan CEO 5 Programs
Narendra Lakkad V.P. Business Development
2017 SPARC 29
Prescription Opioids Abuse
IR opioids are most vulnerable
% abusers
preference for IR dosage forms
50%
Oral ingestion of multiple pills is the 40%
most common form of abuse^ 30%
20%
10 ADFs approved by USFDA till date 10%
* Underlying Cause of Death 1999-2015 on CDC WONDER Online Database, released December 2016; ^Postgraduate Medicine, 2016, 128:1, 85-96
# Researched Abuse, Diversion and Addiction-Related Surveillance System technical report Q3 2015. 2017 SPARC 30
SDN 021
Designed to deter multi-pill oral abuse
2017 SPARC 31
SDN 021
Lead formulation demonstrated acceptable PK characteristics
SDN-021 fasted Ref fasted SDN-021fed Ref fed Ref fasted SDN-021 fed SDN-021 fasted
2017 SPARC 32
SDN 021
Development status update
2017 SPARC 33
Minocycline Topical
Development status update
Mean+SD
1.6
ongoing Oral
1.5 Minocycline
1.2
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Days
2017 SPARC 34
SDP 037
Novel BID steroid for Ocular pain and inflammation
2017 SPARC 36
SDP 037
Comparable pre-clinical efficacy at BID dosing and lower
drug concentration
70 3
60
2.5
Total Cell count
50
PGE2 (ng/ml)
2
40
1.5
30
20 1
*** ***
10 *** 0.5 ***
0
0
PBS LPS LPS + LPS + LPS +
Disease Control SDP-037 BID Reference
Treated (Disease Vehicle SDP-037 Reference
Steroid QID
Control) BID Steroid
QID
Data were analyzed using one way ANOVA followed by Dunnetts multiple comparison testversus Disease Control, ***= p<0.001 .
2017 SPARC 38
Agenda
1 Upcoming Milestones
Anil Raghavan CEO 5 Programs
Narendra Lakkad V.P. Business Development
39
Baclofen GRS
Significant commercial opportunity for once-a-day formulation
16
USA Baclofen Solid Oral Market* 900
789
Majority of physicians believe that 14 713 800
664
steady blood levels and once-a-day 12 628 700
Baclofen^ 8 9
10 500
8 400
6 7
IR Baclofen highly genericised; unit 4 5
6
300
200
volume in USA growing at 11% 2
TRx (millions) Number of tablets (millions) 100
- -
Prescription volume at 10 mn, dispensed 2012 2013 2014 2015 2016 2017
by wide spectrum of specialties
* IMS MAT May 2017 ^ Primary research conducted through 3rd party in USA 2017 SPARC 40
TaclantisTM
Cremophor and Albumin free paclitaxel formulation
reactions observed in clinical studies 0% 1-4% 5-9% 10-14% 15-19% 20-29% 30% or
with TaclantisTM higher
*Primary market research conducted through 3rd party in USA. 2017 SPARC 41
TaclantisTM
Market Opportunity
No. of patients
37000
~ 65% paclitaxel treated patients
prescribed Cremophor based 2500
formulation* 16500
17000
Significant opportunity for conversion to 7000 7000
novel formulations like TaclantisTM Metastatic Breast Lung Cancer Pancreatic Cancer
Cancer
Total ICS/LABA Dry Powder Inhaler ICS+LABA DPI sales (US$Mn) in Europe*
market in Europe is estimated to be ~
US$ 2.5 bn* 199 133
Accuhaler
*IMS MAT Jun 2017; **National Eye Institute, US ; FDCs = Fixed dose combinations, CAIs = Carbonic anhydrase inhibitors 2017 SPARC 44
Brimonidine OD
Market acceptance of improved Brimonidine products
Brimonidine USA Sales (Mn)*
$500 $15
$422
$400 $13
$374
$400
Brimonidine initially approved as $301
$333
$8
$11
$8
Brimonidie 0.2% eye drops $300 $7 $7 $7 $9
$7
$200
Tolerability issues with 0.2% strength $5
$3
led to development of 0.15% and 0.1% $100
$1
products $ -$1
2013 2014 2016 2016 2017
Brimonidine 0.15% and 0.1% continue
0.1% / 0.15% 0.2%
to dominate market in both value and
volumes inspite of genericization of
Brimonidine 0.2% Brimonidine USA Rx (Mn)*
2.5
Differentiated once-a-day Brimonidine
2.0
formulation expected to take
TRx (Million)
1.5
meaningful market share
1.0
.5
.0
2013 2014 2016 2016 2017
` 000
150
patients who fail two lines of
treatment 91 91
100 76
Low physician satisfaction for 62
50 63 67
available 3rd line and beyond
4 7 9 9
treatment# 1
0
2013 2014 2015 2016 2017
SUN K0706 has demonstrated Imatinib Dasatinib Nilotinib Bosutinib Ponatinib
efficacy and safety in treatment
resistant CML preclinical models
and toxicology studies
# Primary market research conducted through 3rd party. * IMS MAT June 2017. ^Internal Estimates 2017 SPARC 46
Agenda
1 Upcoming Milestones
Anil Raghavan CEO 5 Programs
Narendra Lakkad V.P. Business Development
47
Financial Summary
Liquidity Status
Cash and equivalents INR 282 mn as on 30th June 17
2017 SPARC 48
Financial Summary
2017 SPARC 49
Agenda
1 Upcoming Milestones
Anil Raghavan CEO 5 Programs
Narendra Lakkad V.P. Business Development
50
R&D Pipeline
Pre- Approved
Product Indication Discovery Preclinical Phase 1 Phase 2 Phase 3
registration / Market
ElepsiaTM XR
Epilepsy
(Levetiracetam ER)
XelprosTM
Glaucoma
(Latanoprost BAK Free)
Salmeterol-Fluticasone
Asthma / COPD
DPI
TaclantisTM
Cancer
(PICN)
Brimonidine OD Glaucoma
Autoimmune
SCD 044
Disorders
2017 SPARC 51
For updates and specific queries,
please visit www.sparc.life or contact
Narendra Lakkad
Tel : +91 22 6645 5645, Ext 5607
Tel Direct : +91 22 66455607
Mobile : +91 9821510498
[email protected]
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