Sun Pharma Advanced Research Co. Ltd. · NSE:SPARC
Sun Pharma Advanced Research — Investor Presentation (September 2019)
60 slides from Sun Pharma Advanced Research's investor presentation, Sep 19, 2019
Slide 1: Update on R&D Pipeline
Update on R&D Pipeline 19 Sep, 2019 BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L73100GJ2006PLC047837 SPARC © 2019
Slide 2: Disclaimer
Disclaimer This presentation and its contents are confidential and should not be distributed, published or reproduced, in whole or part, or disclosed by recipients directly or indirectly to any other person. Any failure to comply with these restrictions may constitute a violation of applicable laws.
Slide 3: Agenda
1. Strategy & Growth Drivers 6. Anil Raghavan – CEO Update on Clinical Programs 2. SiuLong Yao – Sr. V.P. Clinical Development & Operations Click to edit Master text styles Second level 3. Early Stage Program Update AgendaThird level Vikram Ramanathan – V.P. Translational Development Fourth level Co
Slide 4: Agenda
Strategy & Growth Drivers 1. 6. Anil Raghavan – CEO Update on Clinical Programs 2. SiuLong Yao – Sr. V.P. Clinical Development & Operations Click to edit Master text styles Second level 3. Early Stage Program Update AgendaThird level Vikram Ramanathan – V.P. Translational Development Fourth level Co
Slide 5: Strategy & Growth Drivers
Click to edit Master text styles Second level Third level Strategy & Growth Drivers Fourth level
Slide 6: Early programs reach the finish line
Early programs reach the finish line ...offering validation and key lessons for the future SPARC received USFDA approvals for Xelpros® and Elepsia® XR Click USFDA toaccepted edit Master textNDA SPARC’s styles for Taclantis® (PICS) Second level Third level Xelpros® BAK Free Fourth level Elepsia® XR 1
Slide 7: Our external environment is reshaping our strategy
Our external environment is reshaping our strategy Forces redefining the reimbursement environment are real and here to stay Click Society andtoregulatory edit Master text styles agencies continue Second to encourage level breakthrough innovation Third level First in class, Multiple Artificial Intel
Slide 8: Key strategic priorities
Key strategic priorities SCO-088 registration study and SCC-138 PoCs Accelerate prioritized SCD-044 Phase 2 study for Psoriasis clinical Click programs to edit Master text styles SCO-120 in ER+, HER2- metastatic Breast Cancer Second level Third level Obtain PoC for novel targets & complex platforms
Slide 9: Key portfolio reprioritizations
Key portfolio reprioritizations SPARC is committed to rigorous gating for resource allocations We have reprioritized the following programs after successful completion of early proof of concept studies Click to edit Master text styles ADF Second Platform level SDE-124 SDD-098 Third level Pilot HAL t
Slide 10: Setting expectations for 2020-21
Setting expectations for 2020-21 Ensure US commercial launch of Elepsia® XR and Taclantis® Stay on track for FY23 NDA submission for SCO-088 and FY22 Clinical PoCs for Click to edit SCC-138 andMaster text styles SCD-044 Secondthe Complete level Phase 1 trials of SCO-120, initiate patient trial Third
Slide 11: Agenda
1. Strategy & Growth Drivers 6. Anil Raghavan – CEO Update on Clinical Programs 2. SiuLong Yao – Sr. V.P. Clinical Development & Operations Click to edit Master text styles Second level 3. Early Stage Program Update AgendaThird level Vikram Ramanathan – V.P. Translational Development Fourth level Co
Slide 12: PDP-716
Click to edit Master text styles Second level Third level Fourth level PDP-716 Once-a-day formulation of Brimonidine for treatment of Glaucoma
Slide 13: PDP-716
PDP-716 Development status update Phase 2 completed with IOP reduction Patient recruitment status equivalent to Alphagan Click to edit ® P Master text styles Phase 3 study initiated Second level in Q1 FY19 45% PDP-716Third OD vs Alphagan® P TID level 3% Fourth Primary endpoint oflevel mean IOP at 8
Slide 14: SDN-037
Click to edit Master text styles Second level Third level Fourth level SDN-037 Novel formulation for Ocular Pain and Inflammation
Slide 15: SDN-037
SDN-037 Development status update Vehicle controlled single Phase 3 study Patient recruitment status to support NDA submission initiated in Click to edit Master text styles 21% Q1 FY19 Second level Number of sites recruiting ~15 Third level Last subject out planned by Q4 FY21 Fourth level Futility a
Slide 16: SCO-088
Click to edit Master text styles Second level Third level Fourth level SCO-088 Highly selective BCR-ABL inhibitor for treatment resistant Chronic Myeloid Leukemia
Slide 17: SCO-088 Clinical development plan: Umbrella protocol
SCO-088 Clinical development plan: Umbrella protocol Orphan Drug Designation approved Click to edit 7 years Master US market text styles exclusivity Second USFDA level user fee waiver Third Completing level Part B, starting Part C Fourth level Part A Single Ascending Dose study (SAD) in volunteers W
Slide 18: SCO-088 Promising clinical activity - Phase 1b study
SCO-088 Promising clinical activity - Phase 1b study Hematological response Heterogeneous population CML - CP Click to edit Master text styles 80% failed ≥ 3 TKI therapies Second level 32% had at least 1 baseline mutation Third level 56% had refractory disease 0 10 20 30 40 50 60 70 80 90 100 Fourth
Slide 19: SCO-088 Durable responses
SCO-088 Durable responses with about 70% patients continuing on treatment 6 months 18 months 2 years 37 Click 35 to edit Master text styles 33 31 Second level 29 27 Third level Number of subjects 25 * Fourth level * 23 * 21 * 19 17 15 * 13 * 11 * * 9 * 7 5 * 3 * * 1 0 3 6 9 12 15 18 21 24 27 30 33 D
Slide 20: SCO-088 Promising activity in accelerated approval population
SCO-088 Promising activity in accelerated approval population Dosing Cohort Click to (mg) edit Master 12 text24styles48 66 90 126 174 204 240 Total Second level N N N N N N N N N N Third level Subjects refractory to ≥3Fourth level 0 0 2 1 3 2 2 2 0 12 TKIs including Ponatinib Responders on SCO-088 0
Slide 21: SCO-088 Well tolerated in heavily pre-treated population
SCO-088 Well tolerated in heavily pre-treated population with refractory disease Click to edit Master text styles Second level 2 serious adverse events related to use of SCO-088 Third level Mild to moderate FourthGI disturbances and complaints of the musculoskeletal system level were most commonly o
Slide 22: SCO-088 Development status update
SCO-088 Development status update End to Click of Phase 1 meeting edit Master textwith USFDA completed styles Agreement on study design and approval requirements Second level Third Single armlevel study in refractory subjects Fourth level Site startup in progress FPI Q4 FY20 USFDA = United States Fo
Slide 23: SCC-138
Click to edit Master text styles Second level Third level SCC-138 Fourth level For treatment of Parkinson’s disease
Slide 24: SCC-138 1st in class disease modifying treatment
SCC-138 1st in class disease modifying treatment Potent, orally active, brain-penetrating, small molecule inhibitor of c-Abl with potential for neuroprotection Click to edit Master text styles Pre-clinical development Clinical development Second level Role of SCC-138 in in human iPSC- Phase 1 Third
Slide 25: SCC-138 Augmented autophagic flux
SCC-138 Augmented autophagic flux in human iPSC-derived neurons* Autophagy markers Augments autophagic flux BAF / DMSO Click to edit Master text styles LC3 II Can remove endogenous cABL-mediated interference in autophagy and augment autophagic Second level flux in a sustained manner Third level Sust
Slide 26: SCC-138 Dose dependent improvement in behavioral assessment
SCC-138 Dose dependent improvement in behavioral assessment in the PFF-induced mouse model* Click to edit Master text styles Second level Third level Fourth level Improves PFF-induced deficits in behavioral parameters; maximum improvement at 45 mg/kg dose Turning time and Descending time in pole tes
Slide 27: SCC-138 Neuroprotective effect in PFF-induced mouse model
SCC-138 Neuroprotective effect in the PFF-induced mouse model* 12000 PBS + Placebo Click to edit Master text styles α-Syn PFF + Placebo PFF synuclein model experiment Number of positive neurons in SNpc 10000 α-Syn PFF + SCC-138 (45 mg/kg) Second level completed. Thirdthat Result confirms levelSCC-13
Slide 28: SCC-138 Neuroprotective effect in AAV rat model
SCC-138 Neuroprotective effect in the AAV driven rat A53T α-synuclein model* Click to edit Master text styles 8000 Second level Third level Nigral TH+ve cell number 6000 Fourth level 4000 2000 0 1-way-RM-ANOVA with Fisher’s LSD test NS / * / ** / *** represents P>0.05, P<0.05 P<0.01 or P<0.001 cf. E
Slide 29: SCC-138 Phase 1 study update
SCC-138 Phase 1 study update Click to edit Master text styles Phase 1 trial (14 Day study) in Parkinson’s subjects completed Second level Doses up to 384 mg studied Third level Well tolerated-no severe adverse events. Fourth level Phase 1 trial in healthy controls completed up to 384 mg x 7 days. CS
Slide 30: Phase 2 study of Abl tyrosine kinase inhibition with K0706
Phase 2 study of Abl tyrosine kinase inhibition with K0706 (SCC-138) Placebo (N=168) Click to edit Master text styles SCC–138 Second level Screening Randomization 96 mg (N=168) Follow up Third level SCC–138 Fourth level 192 mg (N=168) 504 subjects randomized to placebo, 96 mg or 192 mg Early stage s
Slide 31: SCC-138 Broader application in Dementia with Lewy Bodies
SCC-138 Broader application in other synucleinopathies – Dementia with Lewy Bodies (DLB) DLB, a neurodegenerative condition with progressive cognitive impairment, Click to edit Master text styles hallucinations and Parkinsonism Second level Estimated to affect about 1.4 million people in the USA Thi
Slide 32: SCD-044
Click to edit Master text styles Second level Third level SCD-044 Fourth level For treatment of Autoimmune disorders
Slide 33: SCD-044 Selective S1PR1 modulator
SCD-044 Selective S1PR1 modulator for autoimmune diseases Click to edit SPARC Master text is developing styles a novel orally bioavailable, potent and selective S1PR1 modulator Second level in collaboration with Bioprojet, France Preclinical Thirdstudies level completed with promising results in var
Slide 34: SCD-044 Safety established in Phase 1 study
SCD-044 Safety established in Phase 1 study Multi-part Phase 1 study completed in healthy volunteers PartClick 1: Single ascending to edit Masterdose text styles Six dose levels Second in males and one dose level in females level ~55% lymphocyte Third levelcount decrease following 1 mg dose Part 2:
Slide 35: SCD-044 Heart rate and lymphocyte count relationship
SCD-044 Heart rate and lymphocyte count relationship Lymphocyte reduction Vs Heart Rate (HR) 90 18 Click to edit Master text styles 79 % decrease in lymphocyte count Heart rate change from baseline (bpm) 80 16 70 Second 70 level 57 59 14 60 12 50 Third level 10 17 40 Fourth level 8 30 13.0 6 10.4 20
Slide 36: SCD-044 Development status update
SCD-044 Development status update Click to edit Master text styles Second level IND filing by Q3 FY20 Third level Phase 2 study initiation by H2 FY20 Fourth level IND = Investigational New Drug SPARC © 2019 36
Slide 37: SDN-021
Click to edit Master text styles Second level Third level SDN-021 Fourth level For prevention of multi pill oral abuse
Slide 38: SDN-021 Abuse deterrent opioid
SDN-021 Abuse deterrent opioid Designed to deliver clinically effective dose at prescribed dose Drug plasma profile in recreational, oral multi-pill abusers Click to edit Master text styles Upon ingestion of multiple pills the 160 Secondreduces technology level peak drug levels and Norco Ref 140 slo
Slide 39: SDN-021 Trend indicating potential to deter oral multi-pill abuse
SDN-021 Trend indicating potential to deter oral multi-pill abuse Click to edit Master text styles Drug Liking Emax (linear model)* Encouraging results Second levelin Category 1 in 90 88.38 vitro tamperability evaluation Third level Reduction in drugFourth likinglevel was 85 observed in favour of SD
Slide 40: SDN-118
Click to edit Master text styles Second level Third level SDN-118 Fourth level Overdose prevention
Slide 41: SDN-118 Addressing intentional / accidental drug overdose
SDN-118 Addressing intentional / accidental drug overdose Targets the population at risk of suicidal ideation Click to edit Master text styles 18 Single capsule PK, SDN-118 Vs Reference Multi-component Second levelsystem employs pH dependent solubility of existing anti- 15 Test A SDN-118 Reference B
Slide 42: Agenda
SPARC Strategy & Growth Drivers 1. 6. Anil Raghavan – CEO Update on Clinical Programs 2. SiuLong Yao– Sr. V.P. Clinical Development & Operations Click to edit Master text styles Second level 3. Early Stage Program Update AgendaThird level Vikram Ramanathan – V.P. Translational Development Fourth lev
Slide 43: SCO-120
Click to edit Master text styles Second level Third level SCO-120 Fourth level Targeting ESR1 mutations
Slide 44: SCO-120 Orally bioavailable SERD
SCO-120 Orally bioavailable SERD Anti-estrogen therapy is mainstay of treatment for women with breast cancer whose tumors express ERα Click to edit Master text styles Degradation of ERα is deemed a superior therapeutic approach Second level in the treatment of ER +ve breast cancer Third level 20-50%
Slide 45: SCO-120 Efficacy established in preclinical assessments
SCO-120 Efficacy established in preclinical assessments* Tumor Growth Inhibition – MCF-7 cell xenografts expressing mutant ERα Y537S Clickinto Potent edit vitro Master SERD text activity in styles breast Vehicle cancer MCF-7 cells expressing ERα wild 800 SCO-120 (5 mg/kg) Fulvestrant (50 mg/kg) Seco
Slide 46: SCO-120 Combination with CDK 4/6 inhibitor: xenograft studies
SCO-120 Combination with CDK 4/6 inhibitor: xenograft studies* Wild Type Y537S mutant Vehicle Vehicle SCO-120 (25 mg/kg) 1100 Click to edit Master text styles SCO-120 (25 mg/kg) 1400 Palbociclib (45 mg/kg) Fulvestrant (50 & 25 mg/kg) Palbociclib (45 mg/kg) SCO-120 (25 mg/kg) + Palbociclib (45 mg/kg)
Slide 47: SCO-120 Encouraging preclinical toxicity results
SCO-120 Encouraging preclinical toxicity results IND enabling toxicity studies have been completed Click toand Acute edit Master text sub-chronic styles toxicity evaluated in mice, rats, dogs and monkeys. No Observed Adverse Effect Levels (NOAEL) established Second level Non-mutagenic and non-genoto
Slide 48: SCO-120 Development status update
SCO-120 Development status update Click to editpre-IND Completed Mastermeeting text styles with USFDA Second Phase level 1 study will be initiated in Q4 FY20 Third level Fourth level USFDA = United States Food and Drug Administration; IND = Investigational New Drug SPARC © 2019 48
Slide 49: Agenda
SPARC Strategy & Growth Drivers 1. 6. Anil Raghavan – CEO Update on Clinical Programs 2. SiuLong Yao– Sr. V.P. Clinical Development & Operations Click to edit Master text styles Second level 3. Early Stage Program Update AgendaThird level Vikram Ramanathan – V.P. Translational Development Fourth lev
Slide 50: Collaborations & Partnerships
Click to edit Master text styles Second level Third level Collaborations & Partnerships Fourth level
Slide 51: Build diversified drug pipeline
Build diversified drug pipeline …by complementing in-house expertise with strategic external partnerships Collaborations with external innovators Click to edit Master text styles Partnerships with leading global researchers to source Oncology promising early stage innovative science/biology Second l
Slide 52: Developing external innovation network
Developing external innovation network …to tap novel science early on Scale-up Click to editstrategic Masterpartnerships text styles with global academic centres as well as leading research service providers Second level SPARC – Washington University collaboration Third level SPARC is evaluating and
Slide 53: Update on external innovation: SPARC-HitGen collaboration
Update on external innovation SPARC–HitGen collaboration SPARC and HitGen have entered in to a research collaboration to identify novel small molecule leads for targets of interest to SPARC Under this collaboration, HitGen will apply its proprietary technology platform, Click to edit based Master te
Slide 54: Update on external innovation: SPARC-University of Arizona
Update on external innovation SPARC–University of Arizona collaboration SPARC has collaborated with University of Arizona, Tucson to develop novel molecule(s) derived from natural sources for treatment resistant cancer Click to edit Master text styles SPARC is currently conducting in vitro and in vi
Slide 55: Agenda
SPARC Strategy & Growth Drivers 1. 6. Anil Raghavan – CEO Update on Clinical Programs 2. SiuLong Yao– Sr. V.P. Clinical Development & Operations Click to edit Master text styles Second level 3. Early Stage Program Update AgendaThird level Vikram Ramanathan – V.P. Translational Development Fourth lev
Slide 56: Financial Summary
Click to edit Master text styles Second level Third level Financial Summary Fourth level
Slide 57: Financial Summary
Financial Summary (INR mn) FY19 FY18 FY17 FY16 FY15 Click to edit Master text1,964 Total Income styles 832 1,947 1,642 1,588 Second level Total Expenses 3,418 3,292 3,137 2,342 1,983 Third level Exceptional Item - 490 - - - Fourth level Profit / (Loss) after Tax (1,454) (1,970) (1,190) (700) (395) T
Slide 58: Pipeline
Click to edit Master text styles Second level Third level Pipeline Fourth level
Slide 59: R&D Pipeline
R&D Pipeline Pre- Approved Product Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 registration / Market Elepsia® XR Epilepsy Xelpros® Glaucoma Click to edit Master Taclantis® Cancer text styles Baclofen GRS Second level Spasticity PDP–716 Third level Glaucoma Fourth level SDN–037 Ocular Pa
Slide 60: Thank You
Click to edit Master text styles Second level Third level THANK YOU Fourth level For updates and specific queries, please visit www.sparc.life or write to us at bus.dev@sparcmail.com The SPARC Logo is a trademarks of Sun Pharma Advanced Research Company Ltd . In addition to Company data, data from m
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