Sun Pharma Advanced Research Co. Ltd. · NSE:SPARC
Sun Pharma Advanced Research — Investor Presentation (February 2014)
47 slides from Sun Pharma Advanced Research's investor presentation, Feb 26, 2014
Slide 1: Investor Update on R&D Pipeline
Investor Update on R&D Pipeline February 26, 2014 February 26th, 2014 BSE:532872 • NSE: SPARC • BLOOMBERG: SPADV@IN • REUTERS: SPRC.BO © 2014 - Sun Pharma Advanced Research Company Limited (SPARC). All Rights Reserved
Slide 2: Disclaimer
Disclaimer 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”, “pl
Slide 3: FY 2013-14 Major Milestones
FY 2013 -14 Major Milestones PICN Marketing approval in India EOP2 meeting with USFDA Grant of US Patent Latanoprost “BAK free” Ophthalmic Solution - First NDA filing in US based on Phase III clinical program Latanoprost and Timolol Ophthalmic Solution marketing approval in India SUN -597 DPI first
Slide 4: Key Therapy Area and Research Programs
Key Therapy Area and Research Programs Swollen Micelle Microemulsion (SMM) OPHTHALMOLOGY Gel Free Reservoir Technology (GFR) NanotectonTM ONCOLOGY Liposomal Drug Delivery Biodegradable depot Tyrosine kinase inhibitor GRID TM CNS Wrap Matrix TM DPI RESPIRATORY Soft steroid LTD4 antagonist Investor Up
Slide 5: Ophthalmology
OPHTHALMOLOGY Latanoprost Latanoprost + Timolol Investor Update on R&D Pipeline 5
Slide 6: Latanoprost "BAK Free" Ophthalmic Solution
Latanoprost “BAK Free” Ophthalmic Solution Reduced risk of ocular surface damage on chronic use Potentially beneficial in chronic glaucoma patients with dry eyes Stable at room temperature; ease of storage and transportation in distribution channels “Swollen Micelle Microemulsion” Investor Update on
Slide 7: Latanoprost "BAK Free" - Glaucoma opportunity
Latanoprost “BAK Free” - Glaucoma opportunity Glaucoma is largest segment in ophthalmic market. 2.2 million patients are diagnosed in US ; estimated to reach 3 million by 2020; 74 % are Open Angle Glaucoma (OAG) 1 48%-59% of OAG patients show concurrent ocular surface disease (OSD) , 27% show severe
Slide 8: Latanoprost "BAK Free" US Commercial opportunity
Latanoprost “BAK Free” US Commercial opportunity US Glaucoma Market - 2013 (US$2 Bn) Glaucoma Market 14% Gluacoma products sales in US at ~ US$2 Bn 1% Prostaglandin products constitute 55% of sales 16% Prostaglandins market was growing at 6% in 2013 55% 7% 6% Prostaglandines Beta Blockers Carbonic a
Slide 9: Latanoprost "BAK Free" US Commercial opportunity
Latanoprost “BAK Free” US Commercial opportunity Latanoprost “BAK Free” market US Prostaglandin Market - 2013 potential (22 Mn. Units) Latanoprost is the largest selling PG 1% with 63% volume share 18% Market access studies suggest that 10% - 16% patients on Xalatan® and other BAK containing product
Slide 10: Regulatory status update
Regulatory status update NDA Filed Q4 FY 2013-14 US –505(b)(2) route Evaluating various options for commercialization 4 EM filing completed ; 5 more markets planned ROW in FY 2014-15 Investor Update on R&D Pipeline 10
Slide 11: Latanoprost and Timolol OD Ophthalmic Solution
Latanoprost and Timolol OD Ophthalmic Solution Combination of essential elements of the SMM into GFR platform P1 Once a day dosing Product with characteristics similar to P1/P2 P1/P2 Solution network natural tears P2 Storage at room temperature Efficacy of FDC met NI criteria of +/- 1.5 mm Hg with c
Slide 12: Regulatory status update
Regulatory status update Launched in India : Q4 FY 2013-14 Select ROW markets filing planned in FY 2014 -15 Advice obtained from regulatory consultants for potential EU filing; Evaluating commercial potential for EU Investor Update on R&D Pipeline 12
Slide 13: Oncology
ONCOLOGY PICN SUN-K706 Investor Update on R&D Pipeline 13
Slide 14: Paclitaxel Injection Concentrate for Nanodispersion (PICN)
Paclitaxel Injection Concentrate for Nanodispersion (PICN) Novel formulation of Paclitaxel using SPARC’s proprietary NanotectonTM platform technology Cremophor® and Albumin free formulation 30 min infusion No standard paclitaxel pre-medications required Allows higher dose than TAXOL® Electron micros
Slide 15: FDA feedback for regulatory pathway in US
FDA feedback for regulatory pathway in US SPARC completed End of Phase II meeting with FDA in December 2013 Single Phase III clinical study required for approval in metastatic breast cancer Next Steps Submit the Phase III study protocol to FDA by Q2 FY 2014-15 Initiate study in Q3 FY 2014-15 Investo
Slide 16: Update on ongoing phase I studies
Update on ongoing phase I studies In Phase I studies, clinical benefit was observed in various tumor types with patients exposed to several lines of treatment Biliary carcinoma Melanoma Ovarian cancer Anal canal cancer Cervical cancer Bladder cancer MTD reached in the ongoing Phase I clinical study
Slide 17: PICN – US Commercial opportunity in breast cancer
PICN – US Commercial opportunity in breast cancer Paclitaxel and ABRAXANE® are not approved in weekly dosing schedule for breast cancer As per market research 85%- 90% of Paclitaxel and ABRAXANE ® are used in weekly dosing schedule Estimated 30,000 breast cancer patients are on Paclitaxel therapy ev
Slide 18: Regulatory status update
Regulatory status update Received FDA guidance for registration of PICN in metastatic breast cancer indication in weekly dosing US –505(b)(2) route regimen Phase III trial planned Q3 FY 2014-15 Obtained marketing approval for India in Q4 FY 2013-14 India Expected launch in Q1 FY 2014-15 Investor Upd
Slide 19: SUN-K706 Excellent preclinical profile
SUN–K706 Excellent preclinical profile Potent and highly selective Bcr-Abl Tyrosine Kinase Inhibitor Significantly inhibits the key Imatinib resistant mutants, including the T315I mutation Unlike Ponatinib, the only approved TKI for T315I mutation , SUN-K706 is not a pan Bcr-Abl kinase inhibitor Bei
Slide 20: SUN-K706 In vivo efficacy in tumor xenograft model
SUN–K706 In vivo efficacy in tumor xenograft model with optimized formulation SUN-K706 formulation shows dose dependent anti-tumor activity in tumor xenograft in mice model Investor Update on R&D Pipeline 20
Slide 21: SUN-K706 Excellent in vivo safety profile
SUN–K706 Excellent in vivo safety profile Low potential for cardiac side effects No significant effect seen on heart rate, arterial blood pressure and “rate corrected” QT intervals in telemetered Beagle dogs Low potential for hemostasis Unlike Dasatinib therapy, where thrombocytopenia and platelet f
Slide 22: SUN-K706 Future development plan
SUN-K706 Future development plan Complete Safety pharmacology studies by Q2 FY 2014- 15 Complete Toxicity studies for IND by Q3 FY 2014-15 File IND in Q4 FY 2014-15 Investor Update on R&D Pipeline 22
Slide 23: CNS
CNS Levetiracetam Baclofen Venlafaxine Investor Update on R&D Pipeline 23
Slide 24: Levetiracetam ER – Wrap Matrix TM
Levetiracetam ER 1000mg / 1500mg NDA for Levetiracetam ER was filed in US in Q1 FY 2012-13 SPARC received complete response letter in May 2013 Interaction with USFDA was completed and FDA is in agreement with SPARC’s proposal to conduct 1 additional pharmacokinetic study Response to FDA planned by Q
Slide 25: Levetiracetam ER - US Commercial opportunity
Levetiracetam ER - US Commercial opportunity Levetiracetam Daily Dosage Market access studies in US 10% 9% Epilepsy patients in US: Pill burden remains high (>55%) at >6 pills required per day 10% >80% of patients need daily dosage of 1000mg-3000mg 17% Patients may pay a higher co-pay ( Tier 2) comp
Slide 26: Venlafaxine ER 300mg – Wrap Matrix TM
Venlafaxine ER 300mg Venlafaxine ER employs SPARC’s proprietary TM Wrap Matrix technology NDA was filed in US in Q4 FY 2012-13 Post complete response letter, discussion for additional requirements with FDA completed in Feb 2014 The FDA requested additional clinical data supporting safety and efficac
Slide 27: Baclofen GRS
Baclofen GRS Extended release formulation of Baclofen with Proprietary Gastro Retentive Innovative Device (GRID TM) technology GRIDTM Technology Once daily and recommended fed state dosing for optimal bioavailability and minimal sedation Inner coat – reactive Controlled gas generating coat release c
Slide 28: Baclofen GRS - US Commercial opportunity
Baclofen GRS - US Commercial opportunity Market access studies in US More than half million people in US suffer from spasticity associated with neurological conditions 79 %of Patients Treated for Spasticity* Baclofen is considered as ‘Gold Standard’ for treatment of spasticity associated with neurol
Slide 29: Regulatory status update
Regulatory status update Phase III, randomized, placebo-controlled efficacy study in 300 patients : 28 sites actively recruiting patients Plan to increase no. of sites to speed up study completion US –505(b)(2) route Open label safety study is ongoing 135 patients PD study to start in Q1 FY 2014-15
Slide 30: Baclofen GRS for Alcohol Dependence
Baclofen GRS for Alcohol Dependence 180 patients Phase II clinical study completed in India Although Baclofen GRS was found to be numerically better on certain study endpoints, overall statistical significance was not achieved Seeking expert opinion on clinical study design for Europe We are conduct
Slide 31: Respiratory
RESPIRATORY DPI SUN-L731 SUN-597 Investor Update on R&D Pipeline 31
Slide 32: Dry Powder Inhaler
Dry Powder Inhaler SPARC’s DPI is a pre-metered, 60 dose, inhalation 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 dosin
Slide 33: Regulatory status update
Regulatory status update US IND filing in Q3 FY 2014 -15 CTA submitted to BfARM-Q4 FY 2013-14 EU Study to be initiated in Q4 FY 2013-14 ROW In one market, CTA submission planned in Q1 FY 2014-15 Investor Update on R&D Pipeline 33
Slide 34: SUN-597 – Superior pre-clinical profile
SUN-597 – Superior pre-clinical profile SUN-597 has optimal in vitro potency for glucocorticoid receptors (GR) In a high-throughput safety screen, SUN-597 had no significant activity against a battery of 85 receptors, ion channels, enzymes and transporters at clinically relevant concentrations, esta
Slide 35: SUN-597 Nasal – Clinical proof of concept established
SUN-597 Nasal – Clinical proof of concept established Phase I studies of SUN-597 nasal have been completed in India with excellent safety profile Phase II proof-of- concept study completed in Germany At all dose levels SUN-597 demonstrated encouraging efficacy in relieving nasal symptoms No signific
Slide 36: SUN-597 Nasal – Regulatory status update
SUN-597 Nasal – Regulatory status update Pre-IND meeting with the USFDA with proposed Phase 2 study for identification of optimum dosage and dosing regimen – Completed in Q2 FY 2013-14 IND accepted by the USFDA Phase II study initiated in Q4 FY 2013- 14 and completion expected in Q1 FY 2015-16 Inves
Slide 37: SUN-597 - Nasal Commercial opportunity
SUN -597 - Nasal Commercial opportunity Allergic rhinitis in US 1 Prevalence between 24-28% of total population 2 million missed school days and 100 million missed work days annually US Nasal Corticosteroid Market Intranasal corticosteroids are recommended as first-line treatment for moderate/severe
Slide 38: SUN-597 Inhalation - Regulatory status update
SUN-597 Inhalation- Regulatory status update CTA approved by UK MHRA- Q3 FY 2013-14 Phase I/IIa Study initiated in Q4 FY 2013-14 Phase Ia-Single dose in healthy for tolerance, safety and PK Phase Ib-Multiple dosing in mild asthmatics to assess safety, PK and pharmacodynamics Phase IIa- Multiple dosi
Slide 39: SUN-597 Inhalation - Future development plan
SUN-597 Inhalation - Future development plan File IND in the US – Q2 FY 2015-16 Initiate Phase 2 program in the US –Q2 FY 2015-16 Investor Update on R&D Pipeline 39
Slide 40: SUN-L731 – A highly selective and potent LTD4 antagonist
SUN-L731 – A highly selective and potent LTD4 antagonist LTD4 receptor antagonists (CysLT1 receptor antagonists), are a class of effective anti-allergic therapies for mild asthma and rhinitis Pre-clinical profile Potent and selective LTD4 antagonist; selective to other isoforms by 1000 fold Good ora
Slide 41: SUN-L731 Development status update and plan
SUN-L731 Development status update and plan CNS and respiratory safety pharmacology studies for IND completed Toxicity studies for IND by Q4 FY 2014-15 File CTA in the UK by Q1 FY 2015-16 Investor Update on R&D Pipeline 41
Slide 42: Discontinued Programs
DISCONTINUED PROGRAMS Upon commercial assessment and portfolio reorganization, following programs were discontinued SUN 1334 ORAL SUN 1334 OPHTHALMIC DROPS B 09 G 44 Investor Update on R&D Pipeline 42
Slide 43: Robust clinical stage program pipeline
Robust clinical stage program pipeline Initiated 135 patients PD study to establish once a dosing in parallel to the Baclofen GRS ongoing Phase III program Successfully completed EOP2 meeting with USFDA. Clear pathway for PICN registration in metastatic breast cancer obtained from FDA Established MT
Slide 44: Cash flow opportunity – Out-licensing candidates
Cash flow opportunity – Out-licensing candidates Peak sales potential in US~ US$ 25Mn - 50 Mn Latanoprost “ BAK free” Filed patent application with 2028 expiry Ophthalmic Solution Peak sales potential in US ~ US$30 Mn – 50 Mn Product and dose specific granted patents in US -last patent Levetiracetam
Slide 45: Cash flow opportunity – Out-licensing candidates
Cash flow opportunity – Out-licensing candidates Target US filing in 2018 Peak sales potential ~ US$ 100 Mn - 250 Mn PICN Granted patents in US with 2029 expiry Potential upsides for SPARC Upfront , milestones and royalty income on out- licensing Investor Update on R&D Pipeline 45
Slide 46: SPARC Pipeline Summary
SPARC Pipeline Summary Investor Update on R&D Pipeline 46
Slide 47: For updates and specific queries, please visit www.sunpharma.in
For updates and specific queries, please visit www.sunpharma.in or feel free to contact Nimish Desai Mira Desai Tel : +91 22 6645 5645, Ext 5717 Tel : +91 22 6645 5645, Ext 5606 Tel Direct : +91 22 66455717 Tel Direct : +91 22 66455606 Mobile : +91 98203 30182 Mobile : +91 98219 23797 nimish.desai@s
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