September 2008 INVESTOR PRESENTATION. Investor Presentation / 2 Disclaimer Except for the historical information contained herein, statements in this.

  • Published on
    18-Jan-2016

  • View
    212

  • Download
    0

Transcript

<ul><li><p>INVESTOR PRESENTATIONSeptember 2008</p></li><li><p>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, plan, contemplate, seek to, future, objective, goal, likely, project, should, potential, will pursue and similar expressions or variations of such expressions may constitute "forward-looking statements". These forward-looking statements involve a number of risks, uncertainties and other factors that could cause actual results to differ materially from those suggested by the forward-looking statements. These risks and uncertainties include, but are not limited to our ability to successfully implement our strategy, our growth and expansion plans, obtain regulatory approvals, our provisioning policies, technological changes, investment and business income, cash flow projections, our exposure to market risks as well as other risks. Sun Pharma Advanced Research Company Limited does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date thereof.</p></li><li><p>BOARD OF DIRECTORS Mr. Dilip S. Shanghvi, Chairman &amp; Managing Director Dr. T. Rajamannar, Director &amp; Executive VP (R&amp;D) Mr. Sudhir V. Valia, Director</p><p>Independent Directors Prof. Dr. Andrea Vasella Prof. Dr. Goverdhan Mehta Mr. S. Mohanchand Dadha</p></li><li><p>NCE PipelineSun-1334H : An anti-allergicSun-461 : An anti-inflammatory molecule for use in the treatment of asthma and COPDSun-44 : A prodrug of gabapentinSun-09 : A prodrug of marketed muscle relaxant</p></li><li><p> Route of administration : Oral Broad therapeutic area : Anti-allergic disorder Treatment of Seasonal allergic rhinitisPerennial allergic rhinitisUrticaria Current statusPhase I completed in India and Europe 127 human exposure Phase II ongoing in USChronic toxicity studies ongoingSUN-1334H</p></li><li><p>SUN-1334HMechanism of actionSelective histamine H-1 receptor antagonistPoor or no affinity for other relevant receptorsSummary of findings from clinical studiesOnce-a-day dosingFaster onset of action (within 30 minutes)Efficacy comparable to Cetrizine over a period of 24 hours on wheal and flare modelNon-sedatingNo cardio toxicity seenEstimated Phase III beginning : 2008</p></li><li><p>SUN-1334HCurrent global market size : USD 5.5 billionOpportunity : Patents expiring on competing productsChallenge : Justify premium on competing generic productsWill need significant investment in studies to prove superiority</p></li><li><p>SUN-461Route of administration : InhalerBroad therapeutic area : Anti-inflammatoryIndicationsAsthmaCOPDMechanism of actionGlucocorticoid receptor agonistSuppresses inflammatory response with significantly reduced systemic side effectsCurrent statusPre-clinical studies ongoingAcute toxicity studies ongoingPhase I human studies exposure likely to begin in 2008</p></li><li><p>SUN-461Inactive Metabolite ApproachLocalAnti-inflammatory ActivityClassicalCorticosteroidSoftCorticosteroidInactiveMetabolite&amp; ExcretionSystemicSide EffectsReduced SystemicSide EffectsAnti-inflammatoryActivitySystemicInactivationAnti-inflammatoryActivityInactiveMetabolite&amp; Excretion</p></li><li><p>SUN-461Summary findings / data from studies completed *Anti-inflammatory activity comparable to marketed corticosteriodsSide-effect profile superiorIn Sephadex-induced lung edema model, therapeutic index significantly superior to marketed corticosteroid including budesonide, fluticasone and ciclesonide* Data on file</p></li><li><p>SUN-461Metabolic side effect profile superior to marketed corticosteroid *In liver glycogen deposition screen, deposition of glycogen in liver significantly lower compared to fluticasone and budesonide</p><p>Current global market data : USD 8 billionEstimated IND filing : 2008* Data on file</p></li><li><p>SUN-44Prodrug of GabapentinRoute of administration : OralBroad therapeutic area : Anti-convulsant / NeuropathyIndications : Seizure / CNS related disordersDevelopment rationaleSUN-44 developed to offer higher bioavailability, enhanced absorption and reduced dosing frequencyCurrent statusStudies ongoingPre-clinicalAcute toxicity</p></li><li><p>SUN-44Summary findings from animal studies completed *On equivalent dosage, drug concentration 2-3 times higher compared to existing product in the market</p><p>LD50 2.5 times higher than competing product under development in Phase III (XP13512 #)</p><p>Found to be safer than XP13512 in animal studies* Data on file# XP13512 is a gabapentin prodrug from Xenoport Inc, currently in Phase III</p></li><li><p>SUN-44Clinical advantagesPossible to achieve higher blood levelOnce-a-day dosingCurrent global market size : USD 1.2 billion (gabapentin is a generic product across most markets)Estimated IND filing : 2008Phase I human studies exposure likely to begin in 2008</p></li><li><p>SUN-09Pro-drug of a marketed drugRoute of administration : Oral / InjectableBroad therapeutic area : Skeletal muscle relaxantsIndications : Muscle spasticityDevelopment rationaleSUN-09 offers quick and improved absorption during entire gastro-intestinal tractCurrent statusStudies ongoingPre-clinicalAcute toxicity</p></li><li><p>SUN-09Summary findings from animal studies completed *</p><p>At equivalent dosage, AUC 1.6 times higher than existing marketed productsSubstantially improved efficacy seen in muscle coordination in animal modelCurrent global market size : USD 200 million (all existing products are generic)No. of spastic patients under treatment (US+Europe) : 1.5 millionLikely IND filing : 2008* Data on file</p></li><li><p>NDDS Technology PlatformsDry powder inhalersControlled release systemsGastric retention systems (GRID)Matrix system (Wrap-matrix)Targeted drug deliveryNanoemulsionBiodegradable injections/implants</p></li><li><p>DPIInhalers used for Asthma and COPDDevice can be modified for systemic delivery of drugs to lungsEasy to useSimple operating sequence of 3 steps : Open-inhale-closeSmall and convenient to carryMultiple dose deviceBeing developed to comply with US FDA and European requirements for inhalation device</p></li><li><p>DPIDevice engineered toGive visual, audible and tactile feedbackDeliver uniform dose over a range of patient effort (flow rates/patient inhalation effort)Eliminate double dosing and dose wastagesDeliver multiple doses in one device with fail-safe dose counterDeliver consistently higher drug to lungsEasy use by children, adults and elderlyCan be used in delivery ofExisting combinations of steroid and bronchodilatorsNCE steroid</p></li><li><p>DPI based productDeveloping a combination of steroid and bronchodilator with improved formulationCurrent statusSemi-regulated marketsExpected launch : 2009Regulated marketsExpected NDA filing : 2011</p></li><li><p>Gastro Retentive Innovative Device (GRID)Development RationaleSome drugs have narrow zones of absorption in GI tractPoor solubility and degradation in alkaline media of small intestineCarrier mediated transport mechanismRelatively short residence time in stomach and small intestineDecreased absorption hence unsuitable for once a day administrationGastro Retentive systemsDesigned for retention in the stomach for longer time than usual (~about 8 hours)Mechanisms involvedFlotationSize expansionMucoadhesion</p></li><li><p>GRIDKey features of GRIDCoated multilayered dosage formFloats instantaneouslySwells upto 8 times its initial volumeMaintains physical integrityFlexible and softClinical advantagesOnce-a-day dosing improves patient complianceReduced side effectsDifferent types of release profiles possible (IR + SR)</p></li><li><p>Baclofen GRS CapsuleOnce-a-day dosing against 3 to 4 times of marketed productIndications : Muscle spasticityCurrent statusIndiaCompleted Phase I, II &amp; III clinical studiesApprovedCompleted pre-IND meeting with US FDAIND filing : 2008</p></li><li><p>Baclofen GRS CapsuleClinical outcomeOnce-a-day rated better by patients than three-times-a-dayEase 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</p></li><li><p>Key featuresControlled release of drug for once-a-day administrationControlled release of drug for high dose high solubility drugspH independent performanceCapable of different types of release profiles (IR + SR)</p><p>High drug to excipient ratioWrap Matrix SystemDisease Specific Drug Release Patterns </p></li><li><p>Wrap Matrix SystemClinical advantageOnce-a-day dosingReduces the side effects, leading to patient complianceRelatively smaller size of dosage formNo residual drug in dosage form on evacuationMinimal effect of foodReproducing similar bio-equivalence difficult for products based on other competing technologyLow risk of genericsDetailed presentation made to US FDA</p></li><li><p>Wrap Matrix System based productsProven technology : Commercially validated and scaled-upMetoprolol XLOnce-a-day dosing against 2 to 3 times of marketed productIndications : Hypertension / AnginaCurrent statusIndia : ApprovedBased on this technology, a few ANDAs for controlled release dosage form filed with US FDA</p></li><li><p>NanoemulsionKey features of technology for cytotoxic substancesAvoids toxic excipientsBetter safety index as proven in animal modelIncreases circulation half life and improved efficacyMore drugs can be delivered at target siteAvoids hypersensitivity reaction to toxic excipientsUses all approved excipients in injectable productsNanoparticle platform technology at preclinical development stage with demonstrated proof of conceptBased on this technology, 2 cytotoxic products are being developed</p></li><li><p>Biodegradable implants / injections Key Features of technology developedCan produce controlled particle size for facile injection through conventional needle to reduce patient trauma and painNo local anaesthetic required while delivering the drugClosed semi-automatic process to give kilogram scale, reproducible, consistent and uniform microsphere productTechnology can be applied to peptidesQuantity of the drug product required to be injected is less to get similar profile.No toxic solvents used in the formulationEasy for reconstitution and mixing</p></li><li><p>Biodegradable implants / injectionsGnRH analogueComparable to marketed productsAchieved comparable profile in animalsInjection less painfulEasy to useNo need of local anaesthesiaCurrent statusPreclinical studies ongoingClinical studies planned in India : 2008Somatostatin analogueComparable to marketed productsAchieved comparable profile in animalsEasy to useCurrent statusClinical studies in India ongoing</p></li><li><p> SUN-1334H : IND filed in 2006, Phase III in 2008 SUN-461 : IND filing 2008 SUN-44 (Prodrug of Gabapentin): IND filing 2008 SUN-09 (Prodrug of a marketed drug) : IND filing 2008 NCE Next Milestones</p></li><li><p> DPISemi-regulated marketsExpected launch : 2009Regulated marketsExpected NDA filing : 2011 Baclofen GRSApproved in IndiaIND filing 2008Biodegradable Implements / Injections GnRH Analogue (For India) : Phase I in 2008Somatostatin Analogue (For India) : Phase I ongoing</p><p>NDDS Next Milestones</p></li><li><p>Financial Summary Fully diluted no of equity shares : 207 million Market capitalisation : MINR 19,500 (MUSD 450)</p></li><li><p>Thank you</p><p>****</p></li></ul>

Recommended

View more >