3rd India-Russia Trade & Investment Forum Pravin TripathiVice President - InternationalEmail: pravin.tripathi@cadilapharma.co.inMoscow 29th Sept 2009

SnapshotObjectives: The areas of collaboration in pharmaceutical segments between Russia and India through leveraging each others strengths and weaknesses. Exploring the areas such as JVs in Greenfield projects, Offering quality Formulations & APIs at affordable prices, Collaborative R&Ds and innovations, Sharing the knowledge base & talent pool and enhancing medical tourism

Market Insights

Generics market hits $64.5B, with growth of 11%, compared to 5% total market growth

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World Full of Opportunities!!!

Global Emerging Markets# Trends# - Emerging markets include countries in Asia, LatAm & Eastern Europe & key countries with double digit growth are China, India, Russia & TurkeyEmerging markets growing @11.4%Global markets growing @ 7%Source: IMS Health: MIDAS

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Sales US$Bn

Sales US$ Bn

Global Emerging Markets Trend

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Year20012002200320042005200620072008

Sales US$Bn43465060718093102

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Global Emerging Markets# Trends# - Emerging markets include countries in Asia, LatAm & Eastern Europe & key countries with double digit growth are China, India, Russia & TurkeyUSD 83 Bn11.4%7%Source: IMS Health: MIDAS

Want to be in Generics?: BRIC is the market to Be!Russia39614.2

Indian Pharmaceutical MktCurrent ScenarioLocal Pharma market: $12bn; Growth rate: 9%Pharma Exports $8bn; Export growth rate 25% (Graph)Second largest API manufacturing & R&D hub~15000 mfg facilities & ~100 big & organized manufacturersCore to the expansion of Indian pharmaceutical industry is availability of high quality generic products at affordable pricesIs becoming a global pharmaceutical back office for Clinical research & trials has grown to $1bnR&D Expenditure USD 495 mn.Excellent education system & talent pool75+ US FDA Approved plantsSource: IMS Health: MIDAS & IMS World Review; Analyst projections; McKinsey India Pharmaceutical Demand Model, India Includes institutional sales

Indian Pharmaceutical MarketAspirationsTo become one of the top 10 marketsStimulating development & production of innovative drugsOne of the biggest exporters of Pharmaceutical products & APIsHub for CRAMS & Generic drugsLeader in back-end for Global Clinical Research & TrialsPreferred Medical tourism destination by providing world class treatment at affordable prices Epicenter for global pharmaceutical brainwave and talent poolChallenges Translate initial R&D development into end product Increasing healthcare cost to make high end drugs available to allLack of public health resources and infrastructureUnutilized manufacturing capacities

Source: IMS Health,*DSM Group

Russian Pharmaceutical MktCurrent ScenarioPharma market: $17bnGrowth rate: 31%Pharmacy sales increased by 26% Industry dominated by pharmaceutical importsEconomic growth & stability have increased the market attractivenessState run healthcare program DLO have increased 60% financing but the number of entitled patients dipped by 60%Out of pocket spending is 65%

Russian Pharmaceutical MktAspirationsIncrease in local manufacturingHarmonization of Russian drugs as per international requirementStimulating development & production of innovative drugsPromote exports by providing additional funding for originator projectsProtect local market & make market access conditions smoothUpgrade technologies, equipmentsTrain specialists in production areas

ChallengesUnder developed legislationInability to innovate & inadequate budget for R&D Lack of API industry (2%)Low local manufacturing baseHigh credit interest ratesPoor Liquidity & incapability of sponsoring long-term risky projects for innovative pharmaceuticalsLow talent pool for the sector with lack of skilled labors

Indo-Russia Pharmaceutical Trade Opportunities

What India Can offer?High quality, Affordable Formulations & APIs (Cost Effective)JVs for manufacturing, R&D & Clinical Trials (Greenfield projects)Offering CRAMS (Contract Research & Manufacturing) (CRAMS)R&D services and Clinical Trials at CROs in India (Overview)Advanced medical treatment at affordable cost (Medical Tourism)Skilled scientists for innovative researchExtensive Practical training and world class education Special Economic Zones for manufacturing

CRAM - OpportunityUS Pharmacoepia India office opened at Hyderabad -first outside USASource: CYGNUS Business Consulting & ResearchBackIndia could potentially capture 10% of the global CRAMS market of almost US$ 168 billion by 2009. Overall, the CRAMS segment is expected to have grown at 40-50 percent in the last few years.

World class educationNo of Higher education institutes including medical, Science & pharmacy: 18,000 348 Universities 299 Medical colleges 10.48 Mio. Students gradate every year 460,000 registered pharmacist 668,131 Doctors

Expectations from RussiaSuitable investment climate for Greenfield projects in terms of tax benefits, soft loans, easier processes, land & other resourcesCredit worthiness and insurance coverageFaster & More Cost-Effective registration processEncouragement for speedy registration for launch of innovative products from IndiaSending patients to India for advanced treatmentStudent exchange programs for advanced studies in pharmaceutical researchPreferred Visa process and issuance of long-time visa

Cadila Pharmaceuticals Ltd

I A Modi-ChairmanDr. R I Modi-MD

OverviewActively present in Entire Life Sciences Value Chain from Research and Development to API to Finished Formulations to Marketing and Distribution.State-of-the-Art Manufacturing facilities conforming to most stringent global cGMP Standards.Dedicated world class Research and Development Centre focusing on Formulation / Biotechnology / API.Committed Contract Research Organization conforming to International Regulatory Framework.International presence in 5 Continents and 50+ Countries.Amongst the largest healthcare manufacturing groups (Global Sales -2008 US$ 1.5 Bn. at US Price Parity).

Sterile FormsAmpoulesMulti dose vialsSuspensionsDry powdersEye & Ear dropsNon-Sterile FormsTablets-Coated / Uncoated Hard Gelatin Capsules Soft Gelatin Capsules GranulesDry SyrupsOral Liquids & Susp.Range of Dosage FormsManufacturing CapabilitiesDec 08

Tablets 18300 Million NosFinished FormulationsCapsules1500 Million NosInjections 151.2 Kilo litresLiquids 15 000 Kilo litresDry Powder injections240 Tonnes (PA)Granules35 Mn Sachets* Manufacturing Capacity/Annum on single shift basisPlant Manufacturing CapacityDedicated facilities for production of Cephalosporins, Rifampicin and Lyophilised productsAnkleshwar API:Bulk Drug 700 Tonnes

Dedicated facilities for - Innovative Research - Generics ResearchFormulation Development - Novel Dosage Form Development - Novel Drug Delivery systemsBiotechnology - Vaccines, Diagnostics, Bio TherapeuticsChemical Research (API) - Anti-Hypertensive, Anti-Histaminic, Anti-Diabetic, - Anti-Ulcerants, Anti-Depressant, Anti-TBResearch and Development

Innovation at CadilaWorlds First 5 in 1 wonder pillReduces the Cardiovascular risk by 62 % and Stroke by 48 % with ease of taking medicine

Tuesday, March 31, 2009. USA Today

30th Mar09 ACC, Orlando, US TIPS Study Presentation (World Thrilled)18th Apr09TIPS Study Published (Cover of Lancet)9th May Polycap TIPS Symposium at Delhi by Prof.S.Yusuf 20th Jul First time in World POLYCAP got Regulatory (DCGI) approval6th Aug09 POLYCAP Launch

Innovation at CadilaRisorin Rifampicin 200mg + Isoniazid 300mg + PipeRine 10mgA product that will revolutionize the treatment for TB by reducing the dose of rifampicin and increasing the patient complianceRisorine is bioequivalent to Rifampicin 450mgFaster absorption, Lesser doseBetter & earlier clinical improvement Rapid improvement in radiological signs, and clinical signs and symptoms

Entered into JV with Novovax, USA

To develop innovative vaccinesBased on Virus Like Particles (VLP Technology)Currently developing H1N1 vaccines (Clinical trial stage)

CPL CROServices Offered:Pre-clinical and toxicology studies.Bio-availability / Bio-equivalence studies.Bio-analysisClinical Trial Management [Up to Phase IV]Data Management.Medical WritingBiostatisticsExpertise in the areas of Vaccine, TB & Cancer

Medical TourismHealth Insurance and Third Party AdministrationPrimary Care ClinicsHealth Education & e-LearningRetail PharmaciesGlobal Projects ConsultingOwned & ManagedHospitalsCADILA-APOLLOAhmedabadClinical Research & Site ManagementTechnology Services& Solutions

CPL Group CompaniesCPL Infrastructure Pvt. Ltd. Established with an objective to develop world class, state-of-the-art pharmaceutical infrastructure. PhaEZ Park, developed by CPL Infrastructure Pvt. Ltd. is one of the largest private sector Life Sciences SEZ promoted in India.

Casil Industries Limited (CIL) Established to cater to the requirements of the medical profession, drugs and pharmaceuticals.- Four major divisions: Sofgel, Hospicon, Diacon and Kemicon

Karnavati Engineering Ltd. (KEL)- The engineering arm of Cadila, Karnavati Engineering Ltd (KEL), is a well-established manufacturer of "Rimek" precision pharmaceutical machinery and allied equipment.

Total healthcare solutions Dec 08

CPLs International The ReachEUROPE & CIS (12 Countries)AMERICAS(8 Countries)AFRICA(13 Countries)ASIA (14 Countries)MIDDLEEAST(5 Countries)Over 1000 marketing authorizations / products registrations in 52 countriesInternational Distribution Network of 65 distributorsMultinational, multicultural and multilingual work force internationally

CPLs Russia PresenceCPL Operation since last 25yrsRegional office in Moscow20 product RegistrationVision:To have JVs in the areas of manufacturing and R&DIntroducing innovative products such as Polycap, Resorine and Vaccines

Photo Gallery

Thanks

Back-up slides

Brand Building Initiatives - Therapeutic AreasCARDIOVASCULAR & DIABETICSAnti-hypertensives Anti-anginalsLipid LoweringAnti-arrythmicsOHA & InsulinGASTROINTESTINALAnti-ulcerantsAnti-spasmodics Gastrointestinal anti-infectivesAnti-emeticsAnthelminticsNEUROPSYCHIATRICAnti-depressantsAnxiolyticsANTI-INFECTIVEAnti-bacterialsAnti-viralsAnti-fungalsNSAIDs

ANTI-HISTAMINICS

CORTICOSTEROIDS

VITAMINS / HAEMATINICS

Marketing - International

What India Can offer?Economy on a boomRevolutionary wealth creation (Special Economic Zones for manufacturing created for tax benefits)Share of wealth for everyoneIncreasing urbanizationLife-style changesHealthcare infrastructureInsurance & reimbursementGreater spread of patient baseBuoyant pharma industry growth

Indian Export Trend

Indias Export to Top 5 Countries Back

Demand Outlook Economic Play GDP Growth %Real GDP $ BnSource: Goldman Sachs, Dreaming with BRICs : The Path to 2050Indias GDP will exceed Italys in 2016, Frances in 2019, Germanys in 2023 and Japans in 2032

INDIA TO BECOME THE 3RD LARGEST ECONOMY IN THE WORLD BY 2032

There is India Advantage Back

CRAMs - OpportunityUS Pharmacoepia India office opened at Hyderabad -first outside USASource: Competitiveness of Indian Pharma Industry in the new Product Patent Regime, FICCIBack2b

Clinical Trial an OverviewGlobal Clinical Trial Market: US$15BnIndian Clinical Trial Market: US$350Mn (2008)Total CROs in India: 100Indias Clinical Trial Market is projected to be US$1Bn by 2010Back

Russia Pharmaceutical IndustryBusiness Cooperation

Demographic & Economic ParametersSource: Gov. Stats

Russian General StatisticsSource: PharmaExpert

Leading Pharma Corporation in Russia

Leading Pharma Importers in Russia

Leading Pharma Importers in RussiaSource:*Pharmexpert (2007)

Shares of drug importers in Russia

Shares of Drug Importers In Russia

Drug Importers to Russia

Drug Import to Russia

Structure of Russianpharma market imported/local, %

Leading Pharma Medicine SalesSource: IMS Health

Leading Therapy class in RussiaSource: PharmaExpert

Russian Pharmaceutical Market StructurePrescriptionGenericRetail PharmacyOut of PocketOTCOriginalHospitalBudget Sate Financing

OTC & Rx Segment, in USD

Top Pharmacy Chains in Russia

Regulatory Structure & Process

Drug Import Process

Regulatory Necessary documents for the product registration in MOH . 1. GMP certificate (ISO certificate) 2. COPP (certificate of pharma products ) a. MFG. license b. Free Pharm Sales Certificate(FSC)3.DOSSIER a. Application for registration (subject of power of attorney from the manufacture ) b. Normative documents (ND) i. Specification of the product ii. Method of analysis c. Pharmacology of the product d. Pharmokinetics e. Bio equivalency or clinical trials (Russia) f. Preclinical studies. g. Stability data (min. three batches ) + instruction of use h. COA (certificate of analysis ) 4. Art work 5.Barcode registration6.Samples of the product+Standards(impurities)7.Pharm expertise (Lab testing)Note: Documents 1,2,3 must be notarized and legalized by Russian Embassy.

Investment in Russian Pharma Market

Global trends in health careMedical tourism on the rise >*Cost Advantage for Medical Tourism is 20 % of US cost . Deloitte Center for Health SolutionsBack

A World-Class Healthcare Organization Apollo Hospitals Chennai, 650 bedsApollo Hospitals New Delhi, 650 bedsApollo Hospitals Hyderabad, 540 beds

Medical MilestonesOver 18 million patients touchedOver 1.6 million preventive health checks doneOver 98K cardiac surgeriesOver 3,00,000 angiograms, 25,000 angioplasties (PTCA) and 3,500 mitral balloon valvuloplasties. Over 2K renal transplantsOver 240 Bone Marrow Transplants (BMT)Over 100 liver transplantsPioneered several procedures in Orthopaedics, Neuro Sciences, Cardiology, Gastroenterology, Nephrology and othersFirst successful cord blood transplant for treatment of leukaemiaFirst successful liver transplant in the country

Typical Day at ApolloHigh Volumes with International Standard Success Rates14000 patient visits1000 admissions150 MRI scans300 CT scans12-20 cardiac surgeries40,000 laboratory tests

Single-largest healthcare employer in the private sector 4,000 doctors across more than 50 specialties : Proven strength to attract clinical talent across continents70% of consultants qualified / trained / worked in UK / USA Our nurses qualify for international placements with a fair degree of easeHuman Capital

Apollo Health StreetLargest process focused healthcare off-shore company.Among the top 5 revenue cycle vendors in the US handling $1.5 billion in ARProvider clients include 3 top academic health systems, 40 hospitals and others.Payer clients include 3 of the top 5 commercial payers.IT clients include 2 of top 5 PMS companies, 2 of the top 10 EMR companies.Processes over 3 Mn claims per annum

http://www.deloitte.com/dtt/cda/doc/content/us_chs_MedicalTourismStudy%283%29.pdf***