Sun Pharma Advanced Research Co. Ltd. · NSE:SPARC
Sun Pharma Advanced Research — Investor Presentation (June 2015)
61 slides from Sun Pharma Advanced Research's investor presentation, Jun 10, 2015
Slide 1: Investor Update on R&D Pipeline
Investor Update on June 10, 2015 R&D Pipeline
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: Major Milestones
Major Milestones ELEPSIA™ XR USFDA approval in March 2015 Signed licensing & commercialization agreement with Sun Pharma XELPROS™ Approval in 3 Emerging Markets Responded to the USFDA complete response letter Salmeterol & PK study in Germany indicates comparable PK parameters to Seretide® Accuhaler®
Slide 4: Strategic Initiatives
Strategic Initiatives Collaborations New additions to the & Partnership Breast cancer program in senior management team collaboration with experts on cancer biology Biology infrastructure Partnering with global CADD* capabilities universities on new Augmenting Building Scientific Capabilities techno
Slide 5: Augmenting Senior Management Team
Augmenting Senior Management Team Anil Raghavan B.Tech Anil Raghavan, is CEO of SPARC. Prior to joining SPARC, he served as the Managing Director of the India and Sri Lanka business of Quintiles. He was part of the Quintiles global leadership team and an active member of the AsiaPac management board
Slide 6: Deprioritized Programs
Deprioritized Programs Upon commercial assessment and portfolio reorganization, following programs were deprioritized SUN-L731 Venlafaxine ER 300mg SUN-597 Nasal/Inhalation Latanoprost + Timolol in EU Baclofen GRS for Alcohol dependence in EU • SPARC is evaluating development of SUN-L731 and SUN-597
Slide 7: Upcoming Key Events
Upcoming Key Events Licensing & Commercialization of Elepsia™ XR XelprosTM Approval by USFDA PICN Launch in India Initiation of Pivotal Clinical Trial for PICN Filing of 4 INDs Indicative timeline based on the current estimates of the management and are subject to change. The Company cannot assure t
Slide 8: Strategic Therapy Areas and Research Programs
Strategic Therapy Areas and Research Programs XelprosTM Ophthalmology Brimonidine OD PICN Oncology SUN-K706 ElepsiaTM XR CNS Baclofen GRS Tizanidine ER SUN-597 Topical Dermatology Minocycline Topical Respiratory Salmeterol + Fluticasone DPI Investor Update on R&D Pipeline 8
Slide 9: Xelpros™
Ophthalmology Xelpros™ Investor Update on R&D Pipeline 9
Slide 10: Xelpros™ Ophthalmic Emulsion
Xelpros™ Ophthalmic Emulsion Regulatory Update Received Complete Response Letter (CRL) from USFDA in Nov’14 • Change in nomenclature of dosage form • No additional pre-clinical or clinical data requirement Submitted the response to CRL Investor Update on R&D Pipeline 10
Slide 11: Xelpros™ Ophthalmic Emulsion
Xelpros™ Ophthalmic Emulsion Licensing & Commercialization SPARC signed licensing deal with a Sun Pharma subsidiary for US market • $3 million as upfront and certain other milestone payments both totaling to $16 million • Additionally, SPARC is eligible for certain defined royalties and milestone pa
Slide 12: Elepsia™ XR
CNS Elepsia™ XR Investor Update on R&D Pipeline 12
Slide 13: Elepsia™ XR
Elepsia™ XR USFDA approval in March 2015 • 1st NDA approval for SPARC Composition and dose specific patents granted in US with last patent expiry in 2027 Elepsia™ XR 1000mg & 1500mg patents are listed in the Orange Book Patent Application No Patent No Wrap Matrix TM Expiration Use of Laser drill to
Slide 14: Elepsia™ XR
Elepsia™ XR US Commercial Opportunity Levetiracetam Use by Daily Market access studies in US# Dosage* Pill burden in epilepsy patients remains high 6% 8% • >55% patients at >6 pills per day 1% • >80% patients need daily dosage of 1000mg- 18% 3000mg Elepsia™ XR represents a new therapeutic option to
Slide 15: Elepsia™ XR
Elepsia™ XR Licensing & Commercialization SPARC is at advanced stage of licensing discussions with potential partners Elepsia™ XR commercialization in US market by 2nd half of 2015 – 2016* *Indicative timeline based on the current estimates of the management and are subject to change. The Company ca
Slide 16: PICN
Oncology PICN Investor Update on R&D Pipeline 16
Slide 17: Paclitaxel Injection Concentrate for Nanodispersion (PICN)
Paclitaxel Injection Concentrate for Nanodispersion (PICN) Novel formulation of Paclitaxel using SPARC’s proprietary Nanotecton™ platform technology PICN as supplied Cremophor® and Albumin free formulation 30 minute infusion PICN as No standard Paclitaxel pre-medications admixture required Allows hi
Slide 18: Encouraging results in a PK study comparing PICN with albumin bound Paclitaxel
Encouraging results in a PK study comparing PICN with albumin bound Paclitaxel 100000 SPARC conducted Pilot BA/BE study PICN in India 10000 Albumin bound Paclitaxel Data supports probability of BE Paclitaxel (ng.ml ) -1 1000 with albumin bound Paclitaxel 100 Total Additional patients are being 10 en
Slide 19: Encouraging PICN data in Cholangiocarcinoma
Encouraging PICN data in Cholangiocarcinoma SPARC evaluated PICN in ≥ 2nd line treatment of Cholangiocarcinoma in an expanded cohort of ongoing program in US Outcomes from Cholangiocarcinoma Cohort PICN has demonstrated 19 % 50% 44% response rate in subjects with 37% metastatic Cholangiocarcinoma 25
Slide 20: PICN Breast Cancer Program Update
PICN Breast Cancer Program Update Completed End of Phase 2 CMC meeting with USFDA Received USFDA concurrence on Phase 3 MBC protocol Plan to initiate study by Q4, 2015-16* *Indicative timeline based on the current estimates of the management and are subject to change. The Company cannot assure that
Slide 21: PICN US Opportunity
PICN US Opportunity Paclitaxel Sales (Mn.$) Paclitaxel is still a standard of care in MBC and other solid tumors and its use 800 is growing 600 701 608 Estimated 165,000 patients receive 400 393 403 405 Paclitaxel therapy every year# 200 384 2010 2011 2012 2013 2014 2015 • About 25,000 metastatic br
Slide 22: Overall PICN appeal as second line MBC treatment
Overall PICN appeal as second line MBC treatment Prior to any mention of pricing, appeal of “Most Likely” PICN was quite strong; even with “Base Case” data 60% of oncologists found it appealing# Overall Impression of PICN – All Physicians – PICN as efficacious but 2% 15% 83% safer than Paclitaxel Un
Slide 23: DPI
Respiratory DPI Investor Update on R&D Pipeline 23
Slide 24: 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 Uniform dose delivery independent of inspiratory flow rate Consistently delivers higher amount of drug to lungs Eliminates double dosing an
Slide 25: Salmeterol & Fluticasone DPI
Salmeterol & Fluticasone DPI Comparable PK at half the dose of Seretide® Accuhaler® Fluticasone Plasma Profile Salmeterol Plasma Profile 140 120 Salmeterol 25 µg (Sun DPI)DPI) (SPARC Mean Plasma Fluticasone Conc. pg/mL Mean Plasma Salmeterol Conc. pg/mL Fluticasone propionate 250 µg (Sun DPI)DPI) (S
Slide 26: Salmeterol & Fluticasone DPI Development Status Update
Salmeterol & Fluticasone DPI Development Status Update EU Discussed the PK study outcome and clinical development program with 3 EU regulatory agencies Achieved concurrence with regulatory agencies on the SPARC proposed clinical program SPARC to accelerate recommended clinical studies Targeting EU R
Slide 27: Salmeterol & Fluticasone DPI EU Market Opportunity
Salmeterol & Fluticasone DPI EU Market Opportunity Comparison to Seretide® Accuhaler® on Device Characteristics Much better than Better than Same as France Germany Worse than Italy Spain United Kingdom Average Much worse than Comparable Ease of use of Dose frequency Device Shape & Minimum Device dos
Slide 28: SPARC DPI Value Analysis
SPARC DPI Value Analysis EU Market Opportunity Very good value Physicians n=170 Physicians Payers n=15 Payers Value Point Good value Physicians +11% Reasonable value Payers -7.5% Poor value Very poor value 20% below Seretide 10% below Seretide Equal to Seretide 10% above Seretide 20% above Seretide
Slide 29: Baclofen GRS
CNS Baclofen GRS Investor Update on R&D Pipeline 29
Slide 30: Baclofen GRS
Baclofen GRS Extended release formulation of Baclofen with GRIDTM Technology Proprietary Gastro Retentive Innovative Device (GRID™) technology Once daily, recommended fed state dosing for optimal bioavailability and minimal sedation Baclofen GRS will be available in 6 strengths i.e., 10 / 20 / 30 /
Slide 31: Baclofen is the standard of care in spasticity
Baclofen is the standard of care in spasticity Distribution of patients prescribed Proportion of respondents’ who agree that treatment for spasticity* Baclofen is the standard of care in spasticity Multiple sclerosis 120% Share of last 20 patients requiring Stroke treatment for spasticity KOLs (n=5)
Slide 32: Baclofen prescriptions doubled over last years in US
Baclofen prescriptions doubled over last 5 years in US Baclofen Solid Oral Market (TRx)* Baclofen Solid Oral Market (Units)* 9 800 8 675 7 7 639 Units (million) 6 TRx (million) 600 5 545 551 5 5 507 4 472 3 400 2010 2011 2012 2013 2014 2015 2010 2011 2012 2013 2014 2015 34% prescriptions from spasti
Slide 33: Baclofen Development Status Update
Baclofen Development Status Update Accelerated execution of clinical studies under SPA# with FDA • Phase 3 efficacy study: o 49 sites recruiting patients; To add 25 more sites o 128 patients enrolled as of May’15 • Open label safety study: o 193/200 patients enrolled • Duration of action study: o 59
Slide 34: SUN–K706
Oncology SUN–K706 Investor Update on R&D Pipeline 34
Slide 35: SUN-K706 targets treatment resistant CML
SUN-K706 targets treatment resistant CML SUN-K706 is a potent, orally active and highly selective Bcr-Abl Tyrosine Kinase Inhibitor (TKI) Significantly inhibits key Imatinib resistant mutants, including the T315I mutation Unlike Ponatinib, which is a multikinase inhibitor, SUN-K706 is selective for
Slide 36: SUN-K706 demonstrated favorable in-vitro profile
SUN-K706 demonstrated favorable in-vitro profile IC50 (nM) Kinases SUN-K706 has potent SUN- Ponatinib Dasatinib Imatinib activity against wild type K706 Abl 0.9 0.9 3.0 790 BCr-Abl and the difficult to treat mutation viz. T315I Abl(T315I) 3 0.9 NE NE VEGFR2 >300 13 >2000 NE Arterial thrombosis, a se
Slide 37: SUN-K706 - significant efficacy in Imatinib resistant leukemia models
SUN-K706 - significant efficacy in Imatinib resistant leukemia models Antitumor activity against Significantly prolonged survival of mice Imatinib Resistant K562 Xenograft bearing patient-derived leukemia cell lines carrying either the wild type or T315I mutation-bearing Bcr-Abl SUN-K706 Causes regr
Slide 38: SUN-K706 Development Status Update
SUN-K706 Development Status Update Suitable formulation for clinical studies is optimized IND-enabling efficacy, safety, and toxicology studies completed IND filing by Q3, 2015-16* *Indicative timeline based on the current estimates of the management and are subject to change. The Company cannot ass
Slide 39: SUN-K706 US Opportunity
SUN-K706 Sales $ Mn.^ US Opportunity 65 45 6 662 Estimated 6500 new cases of CML are diagnosed every year* 798 2503 The prescription trend suggests increase in use of 2nd line TKI IMATINIB DASATINIB NILOTINIB inhibitors^ BOSUTINIB PONATINIB OMACETAXINE T315I mutations incidence is as high as 2nd Gen
Slide 40: Brimonidine OD
Ophthalmology Brimonidine OD Investor Update on R&D Pipeline 40
Slide 41: Brimonidine OD Ophthalmic Suspension
Brimonidine OD Ophthalmic Suspension Improving Patient Compliance Brimonidine is one of the most commonly used second-line treatment in Glaucoma Individual adherence to Brimonidine TID is highly variable and pharmacologically insufficient in more than 2/3rd patients* SPARC is developing a novel once
Slide 42: NanoTemplate Clusters (NTC) Ocular Technology
NanoTemplate Clusters (NTC) Ocular Technology NTC technology involves adsorption of water Brimonidine bound cluster micro particle soluble drugs onto the nano templates NanoTemplate drug is formulated as microclusters Blink Sheer Microclusters smear on ocular surface due to blink shear and embed in
Slide 43: Sustained IOP reductions achieved over 24 hours
Brimonidine OD Ophthalmic Suspension Sustained IOP reductions achieved over 24 hours Effect of Brimonidine OD on IOP of Ocular Hypertensive Rabbits Peak* IOP reduction Trough* IOP reduction SPARC Alphagan® SPARC Alphagan® OD P TID OD P TID 8.0 6.6 4.6 2.8 *Peak and trough IOP reduction are measured
Slide 44: Brimonidine OD Development Status Update
Brimonidine OD Development Status Update Patent filed Pre-IND meeting completed IND filing by Q4 2015-16* *Indicative timeline based on the current estimates of the management and are subject to change. The Company cannot assure that this indicative date will be achieved. The actual results, perform
Slide 45: SUN-597 Topical
Dermatology SUN-597 Topical Investor Update on R&D Pipeline 45
Slide 46: SUN-597 Topical
SUN-597 Topical Topical steroids are the mainstay in the treatment of steroid-responsive dermatoses • 41 million prescriptions generated in US during 2014 Long term use of topical steroids often results in severe & partially irreversible cutaneous adverse effects like skin atrophy# SUN-597 topical i
Slide 47: Superior Efficacy in Psoriasis Animal Model
SUN-597 Topical Superior Efficacy in Psoriasis Animal Model 5 Reduction of psoriasis (erythema+scaling+skin thickness) 4 symptom score Total Psoriasis Symptom Score Imiquimod Superior to 3 Placebo S0597 Hydrocortisone acetate HCA (1%) 2 Triamcinolone acetonide TCA (0.01%) # FP (0.05%) * CP (0.05%) 1
Slide 48: Significant Reduction of Inflammatory Mediators
SUN-597 Topical Significant Reduction of Inflammatory Mediators 300 Inhibition of inflammatory Fold gene expression of interleukins 250 interleukins normalized with GAPDH Imiquimod 200 Superior to Placebo S0597 Hydrocortisone acetate 150 HCA (1%) TCA(0.01%) Triamcinolone acetonide 100 FP (0.05%) # C
Slide 49: SUN-597 Topical Development Status Update
SUN-597 Topical Development Status Update Pre-IND meeting with USFDA completed IND filing by Q2, 2015-16* Phase 1 study to be initiated by Q3, 2015-16* *Indicative timeline based on the current estimates of the management and are subject to change. The Company cannot assure that this indicative date
Slide 50: Minocycline Topical
Dermatology Minocycline Topical Investor Update on R&D Pipeline 50
Slide 51: Minocycline Topical: Novel Treatment Option for Acne
Minocycline Topical Novel Treatment Option for Acne Minocycline is one of the largest selling oral antibiotics in US for inflammatory Acne • In 2014, estimated 3 million prescriptions were generated for oral Minocycline in USA for Acne# Oral Minocycline is associated with various systemic side effec
Slide 52: Pre-clinical POC established in Acne model
Minocycline Topical Pre-clinical POC established in Acne model In P. Acne SD rat model ~28% reduction in ear thickness compared to placebo at day 15 Patents filed for the novel composition 2 * Ear Thickness (mm) * * Untreated Control 1 Placebo Minocycline Topical *=p<0.001 0 0 1 3 5 7 9 11 13 15 Day
Slide 53: Minocycline Topical Development Status Update
Minocycline Topical Development Status Update Pre-IND meeting planned in Q3 2015-16* IND filing by Q1 2016-17* * Indicative timeline based on the current estimates of the management and are subject to change. The Company cannot assure that this indicative date will be achieved. The actual results, p
Slide 54: Tizanidine ER
CNS Tizanidine ER Investor Update on R&D Pipeline 54
Slide 55: Tizanidine ER for Musculoskeletal Pain
Tizanidine ER for Musculoskeletal Pain Optimizing PK to improve safety profile Tizanidine IR is used in management of Schematic Representation of Comparative spasticity and Pain mean Plasma Tizanidine Concentration - Time Profiles Estimated 4.4 million Tizanidine prescriptions generated in US for Mu
Slide 56: Tizanidine ER Development Status Update
Tizanidine ER Development Status Update Pre-IND meeting with FDA completed Pilot PK study completed Phase 2 studies are planned in 2015 – 16* *Indicative timeline based on the current estimates of the management and are subject to change. The Company cannot assure that this indicative date will be a
Slide 57: Abuse Deterrent Formulations (ADF)
Abuse Deterrent Formulations (ADF) Investor Update on R&D Pipeline 57
Slide 58: Abuse Deterrent Formulations Opportunity
Abuse Deterrent Formulations Opportunity USA Opioid market Opioid abuse: an epidemic in the United States… ADF Opportunity FDA considers the development of abuse deterrent opioid Value in billion ($) analgesics a high public health priority ADF, 2.83 Opioid analgesics were involved in about 348,000
Slide 59: Abuse Deterrent Formulations Development Strategy and Plan
Abuse Deterrent Formulations Development Strategy and Plan SPARC identified an interesting opportunity in ADF Preliminary proof-of-concept results encouraging Conceptual meeting with FDA completed Patents filed Investor Update on R&D Pipeline 59
Slide 60: SPARC R&D Pipeline
SPARC R&D Pipeline Investor Update on R&D Pipeline 60
Slide 61: For updates and specific queries, please visit www.sunpharma.in or contact
For updates and specific queries, please visit www.sunpharma.in or contact Mira Desai Tel : +91 22 6645 5645, Ext 5606 Tel Direct : +91 22 66455606 Mobile : +91 98219 23797 mira.desai@sparcmail.com © 2013 Sun Pharma Advanced Research Company Limited., All Rights Reserved. Sun Pharma Advanced Researc
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