Sun Pharmaceutical Industries Limited · NSE:SUNPHARMA
Sun Pharmaceutical Industries — Investor Presentation (March 2007)
33 slides from Sun Pharmaceutical Industries's investor presentation, Mar 16, 2007
Slide 1: NCE & NDDS Development Pipeline
NCE & NDDS Development Pipeline March 2007
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: Content
Content ¾ NCE projects ¾ NDDS Technology platforms Projects ¾ Summary of milestones NCE & NDDS Development Pipeline / 3
Slide 4: SUN-1334H
SUN-1334H ¾ Route of administration : Oral ¾ Broad therapeutic area : Anti-allergic disorder ¾ Treatment of Seasonal allergic rhinitis Perennial allergic rhinitis Urticaria ¾ Current status Phase I completed in India and Europe 127 human exposure Phase II ongoing in US Chronic toxicity
Slide 5: SUN-1334H
SUN-1334H ¾ Mechanism of action Selective histamine H-1 receptor antagonist Poor or no affinity for other relevant receptors ¾ Summary of findings from clinical studies Once-a-day dosing Faster onset of action (within 30 minutes) Efficacy comparable to Cetrizine over a period of 24 hours o
Slide 6: SUN-1334H
SUN-1334H ¾ Current global market size : USD 5.5 billion ¾ Opportunity : Patents expiring on competing products ¾ Challenge : Justify premium on competing generic products Will need significant investment in studies to prove superiority NCE & NDDS Development Pipeline / 6
Slide 7: SUN-461
SUN-461 ¾ Route of administration : Inhaler ¾ Broad therapeutic area : Anti-inflammatory ¾ Indications Asthma COPD ¾ Mechanism of action Glucocorticoid receptor agonist Suppresses inflammatory response with significantly reduced systemic side effects ¾ Current status Pre-clinical studies o
Slide 8: SUN-461
SUN-461 Inactive Metabolite Approach Classical “Soft” Corticosteroid Local Antiinflammatory Corticosteroid Activity Anti-inflammatory Anti-inflammatory Activity Activity Systemic Systemic Inactivation Side Effects Reduced Systemic Inactive Side Effects Metabolite & Excretion Inactive Metabolite & Ex
Slide 9: SUN-461
SUN-461 ¾ Summary findings / data from studies completed * Anti-inflammatory activity comparable to marketed corticosteriods Side-effect profile superior In Sephadex-induced lung edema model, therapeutic index significantly superior to marketed corticosteroid including budesonide, fluticasone a
Slide 10: SUN-461
SUN-461 Metabolic side effect profile superior to marketed corticosteroid * In liver glycogen deposition screen, deposition of glycogen in liver significantly lower compared to fluticasone and budesonide Glycogen content Comp No. (mg/100g liver) % Inhibition of thymus at 3mg/kg, i.t. SUN-S0461 16
Slide 11: SUN-44
SUN-44 ¾ Prodrug of Gabapentin ¾ Route of administration : Oral ¾ Broad therapeutic area : Anti-convulsant / Neuropathy ¾ Indications : Seizure / CNS related disorders ¾ Development rationale SUN-44 developed to offer higher bioavailability, enhanced absorption and reduced dosing frequency ¾ Curre
Slide 12: SUN-44
SUN-44 ¾ Summary findings from animal studies completed * On equivalent dosage, drug concentration 2-3 times higher compared to existing product in the market Drug levels in plasma Modified drug (SUN 44) dosed and XP13512 reported dosed and drug exposure drug exposure levels in plasma levels in pl
Slide 13: SUN-44
SUN-44 ¾ Clinical advantages Possible to achieve higher blood level Once-a-day dosing ¾ Current global market size : USD 1.2 billion (gabapentin is a generic product across most markets) ¾ Estimated IND filing : 2008 ¾ Phase I human studies exposure likely to begin in 2008 NCE & NDDS Development
Slide 14: SUN-09
SUN-09 ¾ Pro-drug of a marketed drug ¾ Route of administration : Oral / Injectable ¾ Broad therapeutic area : Skeletal muscle relaxants ¾ Indications : Muscle spasticity ¾ Development rationale SUN-09 offers quick and improved absorption during entire gastro-intestinal tract ¾ Current status Stu
Slide 15: SUN-09
SUN-09 ¾ Summary findings from animal studies completed * Drug as is dosed and drug levels in Modified drug (SUN 09) dosed and drug plasma exposure levels in plasma Dose Cmax Drug Equivalent Cmax Drug mg/kg, mg/mL Concentration, Dose mcg/mL Concentration, p.o AUC(0-t) mg/kg, AUC(0-t) mcg.hr/mL p.o m
Slide 16: NDDS Technology Platforms
NDDS Technology Platforms ¾ Dry powder inhalers ¾ Controlled release systems Gastric retention systems (GRID) Matrix system (Wrap-matrix) ¾ Targeted drug delivery Nanoemulsion ¾ Biodegradable injections/implants NCE & NDDS Development Pipeline / 16
Slide 17: DPI
DPI ¾ Inhalers used for Asthma and COPD ¾ Device can be modified for systemic delivery of drugs to lungs ¾ Easy to use Simple operating sequence of 3 steps : Open-inhale-close ¾ Small and convenient to carry ¾ Multiple dose device ¾ Being developed to comply with US FDA and European requirements f
Slide 18: DPI
DPI ¾ Device engineered to Give visual, audible and tactile feedback Deliver uniform dose over a range of patient effort (flow rates/patient inhalation effort) Eliminate double dosing and dose wastages Deliver multiple doses in one device with fail-safe dose counter Deliver consistently hi
Slide 19: DPI based product
DPI based product ¾ Developing a combination of steroid and bronchodilator with improved formulation ¾ Current status Semi-regulated markets Design and validation : 2008 Human exposure : 2007 Expected launch in semi-regulated markets : 2009 Regulated markets Expected NDA filing : 2011 NCE &
Slide 20: Gastro Retentive Innovative Device (GRID)
Gastro Retentive Innovative Device (GRID) ¾ Development Rationale Some drugs have narrow zones of absorption in GI tract Poor solubility and degradation in alkaline media of small intestine Carrier mediated transport mechanism Relatively short residence time in stomach and small intestine Decr
Slide 21: GRID
GRID ¾ Key features of GRID Coated multilayered dosage form Floats instantaneously Swells upto 8 times its initial volume Maintains physical integrity Flexible and soft ¾ Clinical advantages Once-a-day dosing improves patient compliance Reduced side effects Different types of release
Slide 22: Baclofen GRS Capsule
Baclofen GRS Capsule ¾ Once-a-day dosing against 3 to 4 times of marketed product ¾ Indications : Muscle spasticity ¾ Current status India Completed Phase I, II & III clinical studies Approved Completed pre-IND meeting with US FDA IND filing : 2007 NCE & NDDS Development Pipeline / 22
Slide 23: Baclofen GRS Capsule
Baclofen GRS Capsule ¾ Clinical outcome Once-a-day rated better by patients than three-times-a-day Ease of switchover from IR (3 times / day) to GRS (once-a- day) As effective (non-statistically superior) Reduced sedation (statistically superior) No unanticipated significant adverse event
Slide 24: Wrap Matrix System
Wrap Matrix System ¾ Key features Controlled release of drug for once-a-day administration Controlled release of drug for high dose – high solubility drugs pH independent performance Capable of different types of release profiles (IR + SR) Disease Specific Drug Release Patterns IR + SR (usef
Slide 25: Wrap Matrix System
Wrap Matrix System ¾ Clinical advantage Once-a-day dosing Reduces the side effects, leading to patient compliance Relatively smaller size of dosage form No residual drug in dosage form on evacuation Minimal effect of food Reproducing similar bio-equivalence difficult for products based o
Slide 26: Wrap Matrix System based products
Wrap Matrix System based products ¾ Proven technology : Commercially validated and scaled-up ¾ Metoprolol XL Once-a-day dosing against 2 to 3 times of marketed product Indications : Hypertension / Angina Current status India : Approved ¾ Based on this technology, a few ANDAs for controlled re
Slide 27: Nanoemulsion
Nanoemulsion ¾ Key features of technology for cytotoxic substances Avoids toxic excipients Better safety index as proven in animal model Increases circulation half life and improved efficacy More drugs can be delivered at target site Avoids hypersensitivity reaction to toxic excipients U
Slide 28: Biodegradable implants / injections
Biodegradable implants / injections ¾ Key Features of technology developed Can produce controlled particle size for facile injection through conventional needle to reduce patient trauma and pain No local anaesthetic required while delivering the drug Closed semi-automatic process to give kilog
Slide 29: Biodegradable implants / injections
Biodegradable implants / injections ¾ GnRH analogue Comparable to marketed products Achieved comparable profile in animals Injection less painful Easy to use No need of local anaesthesia Current status Preclinical studies ongoing Clinical studies planned in India : 2008 ¾ Somatostatin anal
Slide 30: Tobra + Dexa Ophthalmic Solution
Tobra + Dexa Ophthalmic Solution ¾ Development rationale Marketed product available as suspension form SUN product a clear solution, a preferred dosage form ¾ Indication Prophylaxis of bacterial infection following cataract surgery ¾ Completed formulation development ¾ Completed Pre-IND meetin
Slide 31: NCE Milestones
NCE Milestones New Chemical Entity Therapy IND Pre- Phase I Phase II Phase III filing clinical SUN-1334H Allergic rhinitis Filed Perennial rhinitis 2007 2008 Urticaria SUN-461 Asthma 2008 2008 2009 COPD SUN-44 Seizure 2008 2008 2009 CNS Related Diorders SUN-09 Muscle spasticity 2008 2009 Completed O
Slide 32: NDDS Milestones
NDDS Milestones Novel Drug Delivery Systems IND Pre- Phase I Phase II Phase III NDA Approved Launch filing clinical filing DPI Semi-regulated markets 2007 2008 2009 Regulated markets 2011 Baclofen GRS India US 2007 2008 2009 Biodegradable implants / injections GnRH analogue India 2008 Somatostatin a
Slide 33: Sun Pharma Advanced Research Company Ltd.
SUN PHARMA ADVANCED RESEARCH COMPANY LTD.
Sun Pharmaceutical Industries — Investor Presentation (March 2007) on 6ix