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Gvk Bio Corporate Presentation

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Gvk Bio Corporate Presentation

  1. 1. Corporate Presentation January 2009
  2. 2. GVK BIO: Asia’s Leading CRO GVK BIO GVK BIO Asia’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  Quality Q lit Values:  Customer Focus: Change  expected to exceptional Customer Focus: Change “expected” to “exceptional” Integrity: Integrity is Integral Respect: Give to get  Commit to Excel: In every act and deed Leadership and Teamwork: Team first  p 3/6/2009 GVK BIO Confidential 2
  3. 3. History Clinical Established Private Equity Pharmacology Inogent Informatics 2001 2002 2003 2004 2005 2006 2007 2008 Medicinal GVK BIO becomes • Clinical Research Discovery Chemistry a JV between GVK • Biology Research Group and Mr. Brar 3/6/2009 GVK BIO Confidential 3
  4. 4. Locations and Activities 2 Gurgaon:  Clinical Research ca esea c 2 1 Hyderabad:  Hd bd • Corporate Office • Medicinal Chemistry 4 4 • Informatics Mumbai:  6 • Clinical Pharmacology gy 6 1 Clinical Research Cli i l R h • Clinical Research Vishakhapatnam: • Biology Land for expansion • Discovery Research 5 5 3 • Custom Chemical  Bangalore:  g Synthesis 3 Land for expansion • Process Research Chennai: • Custom Manufacturing  Informatics Clinical Research 3/6/2009 GVK BIO Confidential 4
  5. 5. Business Portfolio Development Discovery Target Hit Lead Pre Phase I Phase Phase Id. & Validation Optimization Clinical PoC II-III II III IV Validation Discovery Development • Medicinal Chemistry • Clinical Research • Biology • Clinical Pharmacology Clinical Pharmacology • Discovery Research • Process R&D • CMC • Custom Chemical Synthesis • Contract Manufacturing Informatics and Scientific Applications Development 3/6/2009 GVK BIO Confidential 5
  6. 6. Discovery: Medicinal Chemistry Capabilities Synthesis of  • Intermediates & Building Blocks • Reference Standards • Analogue Compounds for Lead Optimization Design & Parallel Synthesis of Focused &  Large Libraries g Hit Validation & Lead Optimization Specialty Chemistry • Chiral Synthesis, Synthesis of Dendrimers,  Nucleotides, Peptides, PEGylation, Lipid  Nucleotides Peptides PEGylation Lipid Chemisty, Metabolite Synthesis Resources 600 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 3/6/2009 GVK BIO Confidential 6
  7. 7. Discovery: Biology Capabilities In 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) Resources State‐of‐the‐art laboratory with animal house  Approved Type III radioactive lab Class‐II cell culture lab 3/6/2009 GVK BIO Confidential 7
  8. 8. Continuous Upgrading of Services High Hi h Value Co‐creators Discovery Research Strategic Advisors  ality  ts Integrated Service Integrated* Service  ue for Client ess Technica Offerings (2 to 3  Problem  disciplines) Solvers Valu Busine Order Takers Standalone  Chemistry,  Biology Commodity Low Low High Client Specificity 3/6/2009 GVK BIO Confidential 8
  9. 9. Discovery Research In silico Hit Generation I ili Hit G ti Hit Validation  Lead Generation (identification of potent and selective compounds with adequate  ( p p q PK features)   Lead optimization (process of optimizing efficacy, PK and safety profile to deliver a  clinical candidate) Program Lead Drug Candidate IND Phase 1/ PoC Hit Setup Validation Optimization Regulatory Studies Clinical Studies • Project feasibility  • Med. Chemistry • GLP/GMP Synth. • Safety • Med. Chemistry • Informatics • PK & Metabolism • Clinical PK • Informatics • Ref compound p • In vitro potency • Met. Character. • Dose prediction Synthesis • In vitro potency • Selectivity • Regulatory Tox. • First indication of  • Selectivity • Assay dev. • In vivo efficacy • Safety Pharmacol. efficacy in man • Limited in vivo • Potency/ADME • PK‐ADME studies • Pharma. Technol. • Limited PK profiling of  • Exploratory Tox. • IND filing ref compounds • Patent ‐ IP  • Virtual library Virtual library  design  3/6/2009 GVK BIO Confidential 9
  10. 10. Informatics Capabilities Astra Zeneca paper on GVK BIO Database Databases • Reference Centric • Medhcem Database • Target Inhibitor Database • Molecule Centric Clinical Candidate Database • Drug Database D Dtb • Toxicity Database • Mechanism‐based Toxicity Database • • Biomarker Database Curation Services Training Scientific Applications Development Resources Facilities in Hyderabad & Chennai ~ 32,000 sq.ft.  ~300 employees py 3/6/2009 GVK BIO Confidential 10
  11. 11. Development: Clinical Research Capabilities Phase II to Phase IV clinical trials: Oncology,  CNS, Infectious Diseases, Pain Management  and Vaccines  Clinical Data Management (Phase I to Phase  IV) Medical Affairs  Medical Affairs Biostatistics Quality Assurance GVK BIO Sites: Resources 143 sites 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. facility 20,000 sq. ft. facility 3/6/2009 GVK BIO Confidential 11
  12. 12. Development: Clinical Pharmacology Capabilities Bioavailability/Bioequivalence studies Stand alone services  Clinical • Bioanalytical Services • PK & Statistical Analysis • Report writing p g • Resources Four clinics with 144 beds F li i ith 144 b d 72,000 sq ft. 222 employees Dedicated Analytical Facility  Dedicated Analytical Facility State‐of‐the‐art HPLC and LCMS machines – 13 LCMS/MS machines Pathological Laboratory 3/6/2009 GVK BIO Confidential 12
  13. 13. Process R&D and Contract Manufacturing Capabilities Process Development & Custom Synthesis Mfg. of   • Route Identification Adv. Generic  Inters  Contract  Mfg. of  • Process Feasibility, Optimization & Validation Discovery  Process  APIs for  Mfg. g NCEs &  Services R&D NCEs &  • Laboratory Scale Up, Engg. Studies including  APIs APIs Hazard Evaluation • Polymorph and Salt Screening Analytical Development   From Discovery to Commercial Quantities Method Development & Validation  • Impurity Profiling • Stability Studies (ICH) • Documentation for Regulatory Filings Documentation for Regulatory Filings • Contract Manufacturing • Scale Up & Manufacturing  • Technology Transfer • Commercial Supply contracts Commercial Supply contracts  Resources 267 employees 64 KL capacity (250L‐3000L) 64 KL capacity (250L 3000L) Kilo Lab, Pilot Plant, 2 Production Blocks 3/6/2009 GVK BIO Confidential 13
  14. 14. Industry Leading People Systems General Development Others,  – 10% Others 10% Competency Based Development Induction PhD – 15% On‐the‐job  training Domain  Domain Masters – 73% Mt Leadership Development Others – 12% Training Techno-Scientific – 90% Quality &  Customer  Safety interface Personalized  Leadership Training Advanced Training Managerial Soft Skills Employee Engagement Employee Benefits Coffee  Transportati Insurance/ Business  Town  From the  Value  Performance Buzzz B ESOPs ESOP with  ith on/Food for /F d f Provident  P id t Updates halls President Awards Bonus President weekends Fund 3/6/2009 GVK BIO Confidential 14
  15. 15. Scientific & Management Strength • The GVK BIO team is a mix of senior  members with international experience  Scientific Leadership Scientific Leadership and scientists who worked extensively in  domestic pharma and CROs. • The top management has the expertise  Professional Management and experience to make the Company a  dominant force in the sector. di tf i th t • The GVK BIO board bring together business  and scientific visionaries who provide  World Class Board direction to the GVK BIO Management in  the fast growing  Life sciences segment. the fast growing Life‐sciences segment 3/6/2009 GVK BIO Confidential 15
  16. 16. 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 domains Investments • Capital 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 Acres oBBangalore – B l Bomasandra – 10 acres d o Vizag – Ramky Pharma City – 10 acres 3/6/2009 GVK BIO Confidential 16
  17. 17. Campus 25 acres of land 500,000 sq. ft of built up space • Medicinal Chemistry M di i l Ch i t • Biology & Animal House • Kilo Lab • Administrative Block • Training • Informatics • Ancillary & Auxiliary services 3 phases p • Each phase: 250,000 sft • Phase I – 2009 • Ultimate Phase - 2011 2 Blocks for Medicinal Chemistry • Each block with 500 fume hoods Preliminary civil works commenced 3/6/2009 GVK BIO Confidential 17
  18. 18. Summary Integrated Offerings across the R&D Value Chain Accele No Conflict Model with focus on Value-added Services erating Research Proven Track Record with Abilit t S l P T kR d ith Ability to Scale Industry Leading People Systems Strong Scientific and Professional Management Passionate about Science 3/6/2009 GVK BIO Confidential 18
  19. 19. THANK YOU

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