Holding company in SK Croup

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Presentation transcript:

SK Life Science Introduction 2008. June

Holding company in SK Croup 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

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 of Reorganization Solidifying Corporate Governance Enhancing Overall Shareholder 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 SK Corp. SK Telecom SK Networks Other Subsidiaries Life Science SK Energy SK Telecom SK Networks Other Subsidiaries

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

Drug Development Center

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

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 1996 1998 2003 2005 2007 1993 1999 2000 2002 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)

R&D Areas CNS 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

Planning IND & Phase I in 2008 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 Discovery Lead Preclinical Phase I Phase II Phase III

CMS Business

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

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 History & Location Operation since 2000 based on R&D capabilities Production Plants and R&D in Daejeon, Korea Marketing in NJ, USA Customers Global Major Pharmaceutical Companies Pfizer, Roche, Bristol-Meyers-Squibb, Schering Plough, Novartis, GSK, J&J, etc. Technology Catalytic Processes, Continuous Reaction Technologies Enzymatic technology Conventional Organic Synthesis 박준구 박사께 CMS의 자료를 받아서 소개에 어울리는 내용으로 바꿀 것!!! 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)

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

`08년 하반기 신입 사원 채용 모집분야 주요업무 모집인원 Process Chemist 유기합성 기술을 활용한 신약 후보물질 및 관련 중간체 제조 공정 개발 연구 0명 Process Engineer 신규 촉매 개발, 신규 연속공정 개발 업무

Thank you