Gvk Bio Corporate Presentation

Corporate PresentationJanuary 2009

GVK BIO: Asia’s Leading CRO

GVK BIOGVK BIOAsia’s leading Contract Research Organization

Promoted by US$1.5 billion GVK Group and

Mr D S Brar (ex CEO and MD Ranbaxy)Mr. D S Brar (ex CEO and MD Ranbaxy)

Vision:Be a global leader in life‐sciences services

Mission:Deliver value‐added scientific services with Speed and Q litQuality

Values: Customer Focus: Change “expected” to “exceptional”Customer Focus: Change expected to exceptionalIntegrity: Integrity is IntegralRespect: Give to get Commit to Excel: In every act and deedLeadership and Teamwork: Team first p

3/6/2009 GVK BIO Confidential 2

History

InformaticsClinical Pharmacology

Established Inogent

Private Equity

2001 2002 2003 2004 2005 2006 2007 2008

Informatics Pharmacology Inogent

Medicinal Chemistry

• Clinical Research• Biology

DiscoveryResearch

GVK BIO becomes a JV between GVK Group and Mr. Brar


Locations and Activities

Gurgaon: Clinical Research

2

2

H d b d1

ca esea c

14

Hyderabad: • Corporate Office• Medicinal Chemistry• Informatics• Clinical PharmacologyMumbai:

Cli i l R h

46 61

3

gy• Clinical Research• Biology• Discovery Research• Custom Chemical Synthesis

Clinical Research

5

6

Bangalore: 5

Vishakhapatnam:Land for expansion

6

Synthesis• Process Research• Custom Manufacturing

Chennai:InformaticsClinical Research

3g

Land for expansion


Business Portfolio

Discovery Development

HitValidation

LeadOptimization

TargetId. & Pre

ClinicalPhase

II IIIPhase I

PoCPhase

IVValidation OptimizationValidation Clinical II-IIIPoC IV

Development

•Clinical Research•Clinical Pharmacology

Discovery

•Medicinal Chemistry•Biology Clinical Pharmacology

•Process R&D•CMC•Custom Chemical Synthesis• Contract Manufacturing

Biology•Discovery Research

Informatics and Scientific Applications Development


Discovery: Medicinal Chemistry

CapabilitiesSynthesis of

• Intermediates & Building Blocks

• Reference Standards

• Analogue Compounds for Lead Optimization

Design & Parallel Synthesis of Focused & Large Librariesg

Hit Validation & Lead Optimization

Specialty Chemistry• Chiral Synthesis, Synthesis of Dendrimers, Nucleotides Peptides PEGylation LipidNucleotides, Peptides, PEGylation, Lipid Chemisty, Metabolite Synthesis

Resources600 fume‐hoods

State of the art analytical chemistry facilities

2,00,000 sq.ft. of lab space

810 employees across four locations

Technical and project management training


Discovery: Biology

CapabilitiesIn vitro Pharmacology

• Panel of GPCR and Kinase – Binding and Functional

• Cellular assays in inflammation and cancer

Drug Metabolism and Pharmacokinetics• Physicochemical properties• Absorption, Metabolism• In vivo PK – Bioavailability and Blood Brain Barrier Studies

Animal Models • Pain• Inflammation• CNS

Toxicology (exploratory in rodents)ResourcesState‐of‐the‐art laboratory with animal house Approved Type III radioactive labClass‐II cell culture lab


Hi h

Continuous Upgrading of Services

High

Value Co‐creatorsDiscovery Research

ality

ts

Strategic Advisors

Integrated* Service

ess Technica

ue fo

r Client

Problem Solvers

Integrated Service Offerings (2 to 3

disciplines)

Busine

Valu

Order Takers

Commodity

Standalone Chemistry, Biology

Client SpecificityLow High

Low


Discovery Research

I ili Hit G tiIn silico Hit Generation

Hit Validation

Lead Generation (identification of potent and selective compounds with adequate ( p p qPK features)

Lead optimization (process of optimizing efficacy, PK and safety profile to deliver a clinical candidate)

Drug Candidate IND Phase 1/ PoCLeadProgramSetup

Hit

• Med. Chemistry• Informatics

Optimization Regulatory Studies Clinical Studies

• GLP/GMP Synth.• PK & Metabolism

• Safety• Clinical PK

Validation

• Project feasibility • Ref compound

• Med. Chemistry• Informatics

• In vitro potency• Selectivity• In vivo efficacy• PK‐ADME studies• Exploratory Tox.• Patent ‐ IP

• Met. Character.• Regulatory Tox.• Safety Pharmacol.• Pharma. Technol.• IND filing

• Dose prediction• First indication of efficacy in man

pSynthesis• Assay dev.

• Potency/ADMEprofiling of ref compounds• Virtual library

• In vitro potency• Selectivity• Limited in vivo• Limited PK


Virtual library design

Informatics

CapabilitiesDatabases

• Reference Centric

Astra Zeneca paper on GVK BIO Database

• Medhcem Database

• Target Inhibitor Database

• Molecule Centric• Clinical Candidate Database

D D t b• Drug Database

• Toxicity Database

• Mechanism‐based Toxicity Database

• Biomarker Database

Curation ServicesCuration Services

Training

Scientific Applications Development

ResourcesResourcesFacilities in Hyderabad & Chennai

~ 32,000 sq.ft.

~300 employeesp y


Development: Clinical Research

CapabilitiesPhase II to Phase IV clinical trials: Oncology, CNS, Infectious Diseases, Pain Management and Vaccines

Clinical Data Management (Phase I to Phase IV)

Medical AffairsMedical Affairs

Biostatistics

Quality Assurance

ResourcesGVK BIO Sites: 143 sitesResources

Pan India coverage

Oracle Clinical, Thesaurus Management System

SAS 9.1.3

~75 professionals; Past work experience in Pharma companies and CROs

20,000 sq. ft. facility20,000 sq. ft. facility


Development: Clinical Pharmacology

CapabilitiesBioavailability/Bioequivalence studies

Stand alone services • Clinical

• Bioanalytical Services

• PK & Statistical Analysis

• Report writingp g

ResourcesF li i ith 144 b dFour clinics with 144 beds

72,000 sq ft.

222 employees

Dedicated Analytical FacilityDedicated Analytical Facility

State‐of‐the‐art HPLC and LCMS machines –13 LCMS/MS machines

Pathological Laboratory


Process R&D and Contract Manufacturing

CapabilitiesCapabilitiesProcess Development & Custom Synthesis

• Route Identification

• Process Feasibility, Optimization & Validation Discovery Services

Process R&D

Mfg. of Adv.Inters for

Mfg. of NCEs &

Contract Mfg.

Generic APIs

• Laboratory Scale Up, Engg. Studies including Hazard Evaluation

• Polymorph and Salt Screening

Analytical Development

Services R&DNCEs & APIs

APIsg

From Discovery to Commercial Quantities

• Method Development & Validation

• Impurity Profiling

• Stability Studies (ICH)

• Documentation for Regulatory FilingsDocumentation for Regulatory Filings

Contract Manufacturing• Scale Up & Manufacturing

• Technology Transfer

• Commercial Supply contracts• Commercial Supply contracts

Resources267 employees

64 KL capacity (250L 3000L)64 KL capacity (250L‐3000L)

Kilo Lab, Pilot Plant, 2 Production Blocks


Industry Leading People Systems

General Development

Others, 10%

Others – 10%

Induction

On‐the‐job training

Competency Based Development

Domain

10%

PhD – 15%

M t 73%training

Quality & Safety

Domain Training

Customer interface

Leadership Development

Leadership Training Personalized Advanced Training

Others – 12% Masters – 73%Techno-Scientific – 90%

Soft SkillsManagerial

Employee Benefits

ESOPTransportati

/F d fInsurance/P id t Performance

Employee Engagement

Business Town B From the Value Coffee ith


ESOPs on/Food forweekends

Provident Fund BonusUpdates halls Buzzz President Awards with

President

Scientific & Management Strength

• The GVK BIO team is a mix of senior members with international experience Scientific Leadership and scientists who worked extensively in domestic pharma and CROs.

Scientific Leadership

• The top management has the expertise and experience to make the Company a d i t f i th t

Professional Managementdominant force in the sector.

• The GVK BIO board bring together business and scientific visionaries who provide direction to the GVK BIO Management in the fast growing Life‐sciences segment

World Class Board


the fast growing Life sciences segment.

Growth Strategy & Investments

Growth Strategy• Establish a leadership position in core business areas (Discovery Services)• Offer new and integrated services to enable GVK BIO be a preferred supplier of

contract research services (Collaborative Research, Phase I, Formulations)• Grow through Acquisitions • Explore new opportunities in other Life-Sciences domainsExplore new opportunities in other Life-Sciences domains

Investments• Capital Expenditure of approximately US$ 50 Million over the next three yearsCapital Expenditure of approximately US$ 50 Million over the next three years

o Private Equity invested US$ 25 Million into GVK BIO (Sequoia Capital)• Invested in land bank for growth and scale

o Hyderabad – 25 AcresB l B d 10o Bangalore – Bomasandra – 10 acres

o Vizag – Ramky Pharma City – 10 acres


Campus

25 acres of land500,000 sq. ft of built up space

M di i l Ch i t• Medicinal Chemistry• Biology & Animal House• Kilo Lab• Administrative Block• Training• Informatics • Ancillary & Auxiliary services

3 phasesp• Each phase: 250,000 sft• Phase I – 2009• Ultimate Phase - 2011

2 Blocks for Medicinal Chemistry2 Blocks for Medicinal Chemistry• Each block with 500 fume hoods

Preliminary civil works commenced


Summary

Integrated Offerings across the R&D Value Chain

No Conflict Model with focus on Value-added Services

P T k R d ith Abilit t S l

Accele

Proven Track Record with Ability to Scale

Industry Leading People Systems

erating R

Strong Scientific and Professional Management

esearch

Passionate about Science


THANK YOU

Gvk Bio Corporate Presentation

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