Sun Pharma Advanced Research Co. Ltd. · NSE:SPARC
Sun Pharma Advanced Research — Corporate Update (August 2016)
50 slides from Sun Pharma Advanced Research's corporate update, Aug 4, 2016
Slide 1: Investor Update on R&D Pipeline
Investor Update on R&D Pipeline August 4, 2016 Investor Update on R&D Pipeline 13 BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO • CIN:L24230GJ1993PLC019050 © 2016 - Sun Pharma Advanced Research Company Limited (SPARC). All Rights Reserved
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: SPARC Portfolio – An Overview
SPARC Portfolio – An Overview Development Pipeline 2014 o Growing Clinical Portfolio • 2 NDAs submitted 19% • 3 Late stage clinical programs • 5 programs under early clinical development 81% • Multiple opportunities for revenue growth o Robust early stage discovery pipeline NDDS NCE • Transitioning
Slide 4: Delivering on Commitments
Delivering on Commitments Licensing & Commercialization of Signed licensing deal with Sun Pharma Elepsia™ XR Awaiting approval, pending site XelprosTM approval by USFDA clearance by USFDA PICN launch in India Bevetex® launched Approval strategy with BE study being Initiation of pivotal clinical tria
Slide 5: Strategic Roadmap for Sustainable Growth
Strategic Roadmap for Sustainable Growth • Oncology – Next generation agents targeting treatment resistance • Ophthalmology – Solving complex delivery challenges Smart Portfolio Growth • CNS – New pathways in Neuro-degeneration, Abuse Deterrence • Beyond Small Molecules – New treatment modalities Dr
Slide 6: Financial Summary
Financial Summary FY16 FY15 FY14 FY13 Total Income 1,613 1,557 1,670 873 Total Expenses 2,321 1,981 1,371 1,074 Net Profit / (Loss) (700) (395) 303 (225) INR Mn o Raised INR 2500 Mn. through Rights Issue o Cash and equivalents INR 2120 Mn. as on June ’16 Investor Update on R&D Pipeline o Development
Slide 7: Upcoming Key Events
Upcoming Key Events Baclofen GRS ElepsiaTM XR and XelprosTM Completion of patient USFDA Approval & recruitment in Pivotal Phase III Commercialization study Salmeterol – Fluticasone SUN – K706 DPI Establish Recommended Phase 2 Completion of Pivotal studies Dose PICN Brimonidine OD Investor Update on
Slide 8: Licensing and Commercialization Update
Licensing and Commercialization Update o ElepsiaTM XR • Licensed ElepsiaTM XR to a subsidiary of Sun Pharma for the US market • Up-front payment of US$10 million, additional milestones and sales based royalties • Sun Pharma to create a dedicated CNS sales team to commercialize ElepsiaTM XR in US o X
Slide 9: Elepsia XR US Commercial Opportunity
ElepsiaTM XR US Commercial Opportunity Levetiracetam Prescriptions o Healthy Rx growth despite no promotion 10.0M 9.3 M 9.5M Prescription Volume 9.0M 8.6 M 8.5M 7.9 M o For the majority of Epilepsy patients, pill burden remains high 8.0M 7.5M 7.2 M 7.0M 6.5 M 6.5M 5.8 M • Over 50% patients need >6 p
Slide 10: Commercial Opportunity for BAK-free Latanoprost
Commercial Opportunity for BAK-free Latanoprost o Prostaglandin analogues for Glaucoma is 20 Glaucoma-Prostaglandins Rx Trend* US$ 1.4 Bn. market in US* 18.4 17.6 18 15.8 16.7 o Latanoprost is the most widely prescribed 16 14.9 Prostaglandin for Glaucoma with ~67% share of prescriptions Prescription
Slide 11: Baclofen GRS
Investor Update on R&D Pipeline 11 Baclofen GRS CNS
Slide 12: Baclofen GRS
Baclofen GRS Designed to improve compliance in patients with Spasticity o Once-a-Day Baclofen with Proprietary Gastro Retentive Innovative Device (GRID™) Baclofen GRS PK Profile technology 440 400 Baclofen GRS 60 mg - 360 Fed 320 Baclofen IR Tablets 20 o Combination of mechanisms leads to successful
Slide 13: Baclofen GRS: Physicians favorably respond to product attributes
Baclofen GRS Physicians favorably respond to the distinct product attributes o In primary research, the majority of physicians responded that steady blood levels and once-a- Share of last 20 patients requiring treatment for spasticity * day dosing are key benefits over IR Baclofen Before# After # 12
Slide 14: Baclofen GRS Development Status Update
Baclofen GRS Development Status Update o Clinical studies under SPA* with FDA o Phase 3 efficacy study • 45 active sites, opened new sites in Europe • 161/214 patients completed study o Open label safety study • 200 subject enrolment completed o Duration of action study Investor Update on R&D Pipeli
Slide 15: PICN
Investor Update on R&D Pipeline 15 PICN Oncology
Slide 16: Paclitaxel Injection Concentrate for Nanodispersion (Taclantis)
Paclitaxel Injection Concentrate for Nanodispersion (TaclantisTM) o Novel formulation of paclitaxel using SPARC’s proprietary Nanotecton™ platform technology • Cremophor® and albumin free formulation • Short infusion time • No standard paclitaxel pre-medications required Investor Update on R&D Pipel
Slide 17: Pursuing PK strategy to compare Taclantis with albumin bound Paclitaxel
Pursuing PK strategy to compare TaclantisTM with albumin bound Paclitaxel o Completed pilot BA/BE study with 10000 PICN additional patients Albumin Bound Paclitaxel 1000 Paclitaxel (ng.ml-1) o SPARC is evaluating PK data for optimizing 100 study design in consultation with USFDA Total 10 o To initia
Slide 18: Taclantis: Opportunity for Cremophor free paclitaxel formulations
TaclantisTM Significant opportunity for Cremophor® free paclitaxel formulations o Albumin bound paclitaxel generated sales of ~ US$ 668 Mn in the US^^ 2.50 Paclitaxel Unit Sales# o Over 70% marketed units are Cremophor® based 2.00 paclitaxel formulations^^ 1.50 Units (Mn) o ~150,000 patients being t
Slide 19: DPI
Investor Update on R&D Pipeline 19 Respiratory DPI
Slide 20: Dry Powder Inhaler
Dry Powder Inhaler SPARC’s DPI is a pre-metered, 60 dose, breath activated device for administration of combination of inhaled steroids and bronchodilator drugs o High efficiency device, delivers more to the lung o Comparable PK profile to Seretide® Accuhaler® at half the dose o Uniform dose deliver
Slide 21: Salmeterol – Fluticasone DPI Development status update – Europe
Salmeterol – Fluticasone DPI Development status update – Europe o 120 subject Peak Inspiratory Flow rate study initiated in Europe • 20 subjects completed • Additional 20 subjects enrolled o Low dose PK study awaiting Regulatory Approval in Europe • Plan to initiate study by Q2FY17 o High dose PK st
Slide 22: Physicians responded favourably to SPARC DPI's device characteristics
Physicians responded favourably to SPARC DPI’s device characteristics* Device Characteristics Importance vs Product Performance 5-Point Scale 5 Ease of use of device by the patient Dose frequency 4 Device Characteristics importance Device Shape & Size 3 Minimum Inspiratory flow (before device activa
Slide 23: Physicians across Europe value SPARC device better than Seretide Accuhaler
Physicians across Europe value SPARC device better than Seretide® Accuhaler®* Value Analysis Very good value France Germany Italy Good value Spain UK Average Reasonable value Investor Update on R&D Pipeline Poor value Physicians n=170 combining interviews and online survey Very poor value 20% below
Slide 24: ICS/LABA DPI market dynamics in Europe
Salmeterol – Fluticasone DPI ICS/LABA DPI market dynamics in Europe ICS/LABA DPI sales ($Mn.)* 113 94 44 , 4% 1,154 1,222 1,110 , 96% Fluticasone P/Salmeterol Budesonoide/Formoterol Fluticasone F/Vilanterol Beclomethasone/Formoterol Fluticasone P/Salmeterol-Brand Investor Update on R&D Pipeline Flut
Slide 25: CML Program
Investor Update on R&D Pipeline 25 Program CML Oncology
Slide 26: SPARC program targets treatment-resistant CML
SPARC program targets treatment-resistant CML SUN-K706 Kinome Analysis SUN-K954 Kinome Analysis Investor Update on R&D Pipeline IC50 < 10 nM o SUN-K706 and SUN-K954 IC50 10-50 nM • Potent, orally available and BCR-ABL Tyrosine Kinase Inhibitors (TKIs) • Effective against BCR-ABL and most of its muta
Slide 27: SUN-K706 and SUN-K954 demonstrated efficacy in Imatinib resistant CML
SUN-K706 and SUN-K954 demonstrated efficacy in Imatinib resistant CML 3500 Efficacy in Large Tumor Volume K562 Xenograft Model 3000 o In pre-clinical studies both K0706 SUN-K706 and SUN-K954 2500 K0954 Tumor volume (mm3) 2000 Ponatinib • Cause tumor regressions in an Vehicle imatinib resistant xenog
Slide 28: CML Program Development Status Update
CML Program Development Status Update o SUN-K706 • US IND opened • Phase I dose escalation study ongoing in USA • Expecting indicative efficacy data by Q4FY17 o SUN-K954 • IND enabling toxicology studies ongoing Investor Update on R&D Pipeline • Plan to file IND by Q4FY17 28
Slide 29: CML Treatment: treatments inadequate for 3rd line
CML Treatment Physicians believe available treatments are inadequate for 3rd line of CML treatment* o Physician satisfaction score decreases for treatment choices when proceeding from 1st to 3rd line treatment options* o KOLs acknowledged the need for an agent with a reasonable toxicity profile for
Slide 30: SPARC CML Program: Niche yet commercially attractive market
SPARC CML Program Treatment resistant CML – Niche market, yet commercially attractive Sales $ Mn.^ TRx^ 88014 96 106 71,192 674 59,115 46,880 72428 38,158 64,563 58,830 2426 27,659 49,290 1025 37,320 2864 3589 6301 22,280 1033 6527 8570 872 3636 Imatinib Dasatinib Nilotinib 2011 2012 2013 2014 2015
Slide 31: SUN-597 Topical
Investor Update on R&D Pipeline 31 SUN-597 Topical Dermatology
Slide 32: SUN-597 Topical
SUN-597 Topical A novel topically active steroid with low systemic bio-availability o Prolonged continuous use of topical steroids often results in systemic side-effects as well as cutaneous adverse effects like skin atrophy# o SUN-597 is a novel steroid designed for topical use with an improved saf
Slide 33: SUN-597 Topical Development Status Update
SUN-597 Topical Development Status Update o IND opened in US o Phase 1 vasoconstrictor assay study completed o Phase 1 healthy volunteer safety/tolerability study is planned in Q4FY17 o Phase 1 study to evaluate SUN-597 potency in Psoriasis patients is planned in Q1FY18 Investor Update on R&D Pipeli
Slide 34: Minocycline Topical
Dermatology Minocycline Topical Investor Update on R&D Pipeline 34
Slide 35: Minocycline Topical: Pre-clinical PoC established in Acne model
Minocycline Topical Pre-clinical PoC established in Acne model o Minocycline is a commonly prescribed 2.2 antibiotic for inflammatory lesions of moderate to severe Acne 2.0 Untreated Control o Currently, minocycline has to be administered Right Ear Thickness (mm) Placebo 1.8 orally potentially resul
Slide 36: Brimonidine OD
Investor Update on R&D Pipeline 36 Brimonidine Ophthalmology OD
Slide 37: Brimonidine OD: Once daily formulation with TearAct Technology
Brimonidine OD Novel Once daily formulation with TearActTM Technology o Key Features • Fine resin particles act as a template on Brimonidine which the drug particle is adsorbed bound cluster micro particle • Drug-resin clusters disintegrate into individual drug bound resin particles due to eye blink
Slide 38: Brimonidine OD: Once daily dosing to improve patient compliance
Brimonidine OD Once daily dosing to significantly help improve overall patient compliance Initial reaction to Brimonidine OD versus Alphagan P# % Ophthalmologists Mean Rank 1 – extremely unfavorable 2 - unfavorable 3 –neutral 4 - favorable 5 – extremely favorable Overall Patient compliance 4.6 Overa
Slide 39: Brimonidine OD Regulatory Update
Brimonidine OD Regulatory Update o IND enabling toxicology studies completed o CTA approved o Phase 2 Proof-of-Concept study initiated Investor Update on R&D Pipeline 39
Slide 40: SDN-021 Abuse Deterrent Formulations
Abuse Deterrent Formulations SDN-021 Investor Update on R&D Pipeline
Slide 41: Prescription opioid drug abuse: a growing epidemic in USA
Prescription opioid drug abuse A growing epidemic in USA 19,000 deaths occurred in 2014 due to prescription opioid overdose 1 46/day people die due to prescription opioid overdose 2 ~1.9 million people abused prescription opioid in 2013 3 >420,000 ED visits involved abuse or misuse of prescription o
Slide 42: Prescription opioid drug abuse: IR formulations are most vulnerable
Prescription opioid drug abuse IR formulations are most vulnerable o 221 million prescriptions were written for IR opioid IR opioids Units* (Mn) – US analgesics in 2015-16* 1,812 o 66% of abusers prefer IR opioid formulations^ 2,067 6,174 o Currently no approved IR opioid with abuse- deterrent label
Slide 43: Abuse deterrent technology platform
Abuse deterrent technology platform Designed to deter multi-pill abuse o Designed to deliver clinically effective dose at Schematic presentation of prescribed dose Technology o Upon ingestion of multiple pills the technology reduces and delays the release of drug o Formulation could be modified to m
Slide 44: SDN-021: Proof of concept established for oral multi-pill abuse
SDN-021 Proof of concept established for oral multi-pill abuse Comparative Dissolution Profile of SDN-021 Multiple tablet PK data 120 1tablet (Ref) vs 5 tablets (SDN-021) 150 Plasma concentration (ng/ml) 100 120 SDN-021 5 tabs Ref 5 tabs* % Drug Release 80 90 60 60 40 30 20 0 1 tablet 5 tablets 0 0
Slide 45: SDN-021 Development Status Update
SDN-021 Development Status Update o IND filed in Q3FY16, PoC completed o Product optimization underway o Additional PK studies planned in FY17 Investor Update on R&D Pipeline 45
Slide 46: Tizanidine
Investor Update on R&D Pipeline Tizanidine CNS
Slide 47: Tizanidine ER for Musculoskeletal Pain
Tizanidine ER for Musculoskeletal Pain Optimizing PK to improve safety profile Schematic Representation of Comparative o Tizanidine market in USA is estimated at mean Plasma Tizanidine Concentration - 725 million tablets growing at 11%* Time Profiles o About 60% Tizanidine usage is in musculo- skele
Slide 48: Tizanidine ER Development Status Update
Tizanidine ER Development Status Update o Simulated driving study initiated in Q1FY17 o Topline results expected in Q2FY17 o IND filing planned in Q2FY17 Investor Update on R&D Pipeline 48
Slide 49: SPARC R&D Pipeline
SPARC R&D Pipeline Pre- Approved Product Indication Research Preclinical Phase 1 Phase 2 Phase 3 registration / Market Elepsia TM XR Epilepsy (Levetiracetam ER) Xelpros TM Glaucoma (Latanoprost BAK Free) TaclantisTM Cancer (PICN) Baclofen GRS Spasticity Fluticasone + Asthma / COPD Salmeterol DPI (EU
Slide 50: For updates and specific queries, please contact
For updates and specific queries, please visit www.sunpharma.in or contact Narendra Lakkad Tel : +91 22 6645 5645, Ext 5607 Tel Direct : +91 22 66455607 Mobile : +91 9821510498 narendra.lakkad@sparcmail.com Investor Update on R&D Pipeline © 2016 Sun Pharma Advanced Research Company Limited., All Rig
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