Transcript SK Life Science

SK Life Science
Introduction
2008. June
0
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
Drug development & Marketing
Custom Manufacturing Service
(Korean and Asian Market)
1) E&P: Exploration & Production
1
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
Solidifying Corporate Governance
Purpose of
Reorganization
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
E&P
Oil
Refinery
SK
Telecom
Chemicals
• Reorganize as a holding company and 8
operating companies
• SK Life Science stays with holding
company as one operating division
Lubricants
SK Corp.
Life
Science
SK
Networks
Other
Subsidiaries
SK Holdings
SK
Energy
SK
Telecom
SK
Networks
Life
Science
Other
Subsidiaries
2
Organization
SK Life Science Biz.
Life Science Strategy Team
Seoul, Korea
Process R&D Lab.
Drug Development Center
(신약개발사업부)
CMS Business
(CMS사업부)
Discovery Lab.
CMS Production Team
Drug Preclinical Research Lab.
Marketing Team(New Jersey)
Daejeon, Korea
New Jersey, USA
R&D Planning Team
New Jersey R&D Center
Shanghai R&D Center
* CMS: Custom Manufacturing Service
Shanghai, China
3
Drug Development Center
Role & Responsibility
Drug Development Center
KOREA
[Seoul]
Strategic Planning
Licensing Out
[LSRDP 1)]
USA
[New Jersey]
Advanced Preclinical Studies
Clinical Studies in USA
Regulatory Affairs in USA
CHINA
[Shanghai]
Drug discovery
Market research in China
R&D Planning
Licensing In
Drug Discovery
Early Preclinical Studies
Formulation Studies
Intellectual Properties
1) LSRDP: Life Science R&D Park
5
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
1996
1993
Licensing Out
to J&J (YKP509)
Establish Shanghai
Drug Dev. Center
1998
2003
1999
IND Approval for YKP10A,
an antidepressant,
from U.S. FDA
IND Approval for YKP509,
an anticonvulsant, from U.S. FDA
2000
2005
2007
2002
IND Approval for YKP1358,
an Antipsychotic, from U.S. FDA
New IND expected
IND Approval for YKP3089,
an anxiolytic, from U.S. FDA
(currently at POC entering)
6
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
DDS • Intranasal Technology
CV
• Epilepsy
• Depression
• Schizophrenia
CNS
• Neuropathic Pain
• Parkinson
• Restenosis
Metabolic
diseases
• Obesity
• Diabetes
7
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
8
CMS Business
Role & Responsibility
CMS Business
KOREA
[Seoul]
Planning
[LSRDP 1)]
USA
CHINA
[New Jersey]
[Shanghai]
Marketing
Market Research
Customer Relationship
Process Development
Biz Development
Raw Material Purchasing
Production
Process Development
QC/QA
1) LSRDP: Life Science R&D Park
10
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
Technology
Products &
Services
Pfizer, Roche, Bristol-Meyers-Squibb, Schering Plough, Novartis, GSK, J&J, etc.
• Catalytic Processes, Continuous Reaction Technologies
• Enzymatic technology
• Conventional Organic Synthesis
• GMP Intermediates and API (End of 2007)
• Process development and DMF support for customers
– Catalytic and Continuous Processes
– Co-Work and DMF support
1) GMP (Good Manufacturing Practice)
11
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
’02 ~’03
’04 ~’05
’06
Current
GSK
Roche, Novartis, Pfizer
Pfizer, GSK, BMS, Lonza
Pfizer, BMS (Approved for cGMP Intermediate Production)
Preparation of API Production and DMF Filing for New Drug
12
`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
0명
13
Thank you