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SK Life Science Introduction

SK Life Science Introduction. 2008. June. Life Science in SK Group. Life Science Business is outset for the growth drive in the future. SK Group. Revenue: $ 848 MM Employee > 300. Revenue: $ 1.2 B. Employee > 1,150. SK holdings. SK Chemicals. Holding company in SK Croup .

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SK Life Science Introduction

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  1. SK Life Science Introduction 2008. June

  2. Life Science in SK Group Life Science Business is outset for the growth drive in the future SK Group Revenue: $ 848 MM Employee > 300 Revenue: $ 1.2 B. Employee > 1,150 SK holdings SK Chemicals Holding company in SK Croup Fine Chemicals, Life Science Life Science Biz Life Science Division New Drug Development Custom Manufacturing Service Drug development & Marketing (Korean and Asian Market) 1) E&P: Exploration & Production

  3. SK Life Science As of July 1st 2007, SK Corporation was divided into two companies, SK Energy and SK Holdings Ltd, and Life Science biz becomes a part of SK Holdings Purpose ofReorganization Solidifying Corporate Governance Enhancing OverallShareholder Value Maximizing Management Efficiency Resolving the Issue of Under-valuation Previous Structure New Structure • SK Corporation had various operating divisions and held many subsidiary companies • Reorganize as a holding company and 8 operating companies • SK Life Science stays with holding company as one operating division Chemicals E&P Lubri-cants SK Holdings Life Science Oil Refinery Life Science SK Corp. SKEnergy SKTelecom SKNetworks OtherSubsidiaries SKTelecom SKNetworks OtherSubsidiaries

  4. Organization SK Life Science Biz. Seoul, Korea Life Science Strategy Team Process R&D Lab. Daejeon, Korea Drug Development Center(신약개발사업부) CMS Business(CMS사업부) Discovery Lab. CMS Production Team Drug Preclinical Research Lab. Marketing Team(New Jersey) New Jersey, USA R&D Planning Team New Jersey R&D Center Shanghai R&D Center * CMS: Custom Manufacturing Service Shanghai, China

  5. Drug Development Center

  6. Role & Responsibility Drug Development Center USA CHINA KOREA [New Jersey] Advanced Preclinical Studies Clinical Studies in USA Regulatory Affairs in USA [Seoul] Strategic Planning Licensing Out [LSRDP 1)] R&D Planning Licensing In Drug Discovery Early Preclinical Studies Formulation Studies Intellectual Properties [Shanghai] Drug discovery Market research in China 1) LSRDP: Life Science R&D Park

  7. History The first Korean company to obtain IND approval from U.S. FDA Licensing Out to Johnson & Johnson (CNS field) Developing globally competitive new drug pipeline Licensing Out to J&J (YKP10A) Start Pharmaceutical research in New Jersey, US and Daejeon, Korea focusing on CNS area Licensing Out to J&J (YKP509) Establish Shanghai Drug Dev. Center 1998 1996 2005 2003 2007 1993 2000 2002 1999 IND Approval for YKP10A,an antidepressant, from U.S. FDA IND Approval for YKP1358,an Antipsychotic, from U.S. FDA New IND expected IND Approval for YKP509,an anticonvulsant, from U.S. FDA IND Approval for YKP3089,an anxiolytic, from U.S. FDA (currently at POC entering)

  8. R&D Areas • Successful track records in CNS drug discovery • Epilepsy, Depression, Schizophrenia, Neuropathic pain and Parkinson etc. • Expansion toward Metabolic diseases • Obesity, Diabetes and Osteoporosis • Transdermal • Controlled release • Intranasal Technology DDS CV • Restenosis • Epilepsy • Depression • Schizophrenia CNS Metabolic diseases • Neuropathic Pain • Parkinson • Obesity • Diabetes

  9. Pipeline Status CNS By J&J Narcolepsy, Drug addiction (Ready to IND) on-going Preclinical studies w/ active enantiomer (YKP1447) Planning IND & Phase I in 2008 Partnering Alliance- Clinical Study expected in May, 2008 DDS Metabolic CV

  10. CMS Business

  11. Role & Responsibility CMS Business USA CHINA KOREA [Seoul] Planning [LSRDP 1)] Production Process Development QC/QA [New Jersey] Marketing Market Research CustomerRelationship [Shanghai] Process Development Biz Development Raw Material Purchasing 1) LSRDP: Life Science R&D Park

  12. Overview SK CMS provides custom manufacturing service to the global major pharma companies based on the innovative technological and production capabilities with a cGMP complied quality system • Operation since 2000 based on R&D capabilities • Production Plants and R&D in Daejeon, Korea • Marketing in NJ, USA History & Location • GlobalMajor Pharmaceutical Companies Pfizer, Roche, Bristol-Meyers-Squibb, Schering Plough, Novartis, GSK, J&J, etc. Customers Technology • Catalytic Processes, Continuous Reaction Technologies • Enzymatic technology • Conventional Organic Synthesis Products & Services • GMP Intermediates and API (End of 2007) • Process development and DMF support for customers • Catalytic and Continuous Processes • Co-Work and DMF support • GMP (Good Manufacturing Practice)

  13. Quality System • Plant Operation based upon cGMP & ICH Q7A • Quality Assurance based on Quality Management Systems • Quality Management System • Material Control System • Facilities & Equipment System • Production & In-Process Control System • Laboratory Control System • Audits and Approval by Many Customers • ’98 ~’01 GSK • ’02 ~’03 Roche, Novartis, Pfizer • ’04 ~’05 Pfizer, GSK, BMS, Lonza • ’06 Pfizer, BMS (Approved for cGMP Intermediate Production) • Current Preparation of API Production and DMF Filing for New Drug

  14. `08년 하반기 신입 사원 채용

  15. Thank you

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