BioSocialism as Causality of Drug Lag

1
Bio-Socialismas Causality of Drug Lag Role of
Ventures Against It

• Jin Shiomura, CEO
• Nobelpharma Co., Ltd., Japan

2

• Drug Lag Status Analysis
• Bio-Venture
• Solution and Role of Ventures

3
Two Types of Drug Lag

• Drug Lag 1 Unapproved in Japan While Approved in
  US/EU
• Drug Lag 2 No Effort in Japan While Under
  Clinical Development in US/EU

4
Classification of Drug Lag 1
Necessary Drugs for Global Practice Standards
5
Example of Drug Lag 2
No Effort in Japan While Under Clinical
Development in US/EU
6
Causality of Drug Lag

• Tangible Barriers
• Intangible Barriers
• Intangible gt Tangible

7
Tangible Barriers

• Regulatory and Approval Systems
• Mostly Well-Recognized
• Being Solved or Attempting to Solve
• Some NOT Very Much Recognized
• Non-Clinical Issues in VERY Thick TSUCHI
• Dose Finding Study
• SHINRAISEI HOSHO Over-Quality Comparing with
  US/EU
• Causing Higher Cost of Clinical Trials in Japan

8
Intangible Barriers

• Bio-Socialism
• No Walk-out from, Nor New Entry to the Japanese
  Drug Industry for 30 years
• No Bio-Innovation from Ventures in Japan
• ? Conservative Mentality among Japanese
  Industries
• Lack of Entrepreneurship
• Risk Averse Attitude
• Bio-Socialism ? NHI Pricing System

9
Bio-Socialism ? NHI Price System

• Existing Price Cut Down ? Convoy System
• Reflection of Market Prices??
• Basket Pricing Practice between WS and HP
• Interim Supply Prices
• Arbitrary, but Equal Price Cut
• Price Cut of Main Products of Big Pharmas Mostly
  4 8
• Patented Products
• E.g. TOKUREI (Special) 8, TSUIKA (Additional) 2

10
Bio-Socialism ? NHI Price System

• New Drug Pricing
• Very Rigid Despite Transparency
• No Good Pricing System for Super, Innovative
  Drugs, Including Orphans, Except Originated from
  US/EU
• Unfair to the Japanese Original Super Drugs
• Extremely Low Prices for Drug Category w/o New
  Drug for Many Years

11
Bio-Socialism ? NHI Price System

• KONGO SHINRYO Payment Mixture Treatment
• Payment Mixture Medication Listed in NHI
  Reimbursed from NHI, and Non-Listed (Free
  Treatment) Paid by Patients
• Since It Is Prohibited, If Any Free Treatment
  Practiced Even in Tiny Part, All Cost Shall be
  Paid by Patients with No Reimbursement from NHI.
• Practical Ban of Free Prices

12

• Drug Lag Status Analysis
• Bio-Venture
• Solution and Role of Ventures

13
Classification of Bio-Venture

• Discoverers
• Seeds Oriented
• Basic Research
• E.g. Anges MG
• Developers
• Needs Oriented
• Applied/Clinical Development
• E.g. Sosei, Nobelpharma

14
Venture Opportunities

• Light Fixed Cost
• Out-Sourcing
• Research Institutes
• Manufacturing
• Non-Core Parts of Development
• Administration
• Small Sales Force

15
Organization of Developer
40 ? 60
Difference from Existing Pharmas
16
Venture Opportunities

• Speedy Decision Making
• Faster Development
• E.g. Developer Established June, 2003
• As of Sep., 2006
• 6 Clinical Trials Including a Placebo DBT
• 1 Orphan Drug (NCE) NDA in May, 2006
• 1 New Combination NDA in Oct, 2006
• 1 Orphan, Dr-Oriented NDA in 2007

17
Venture Opportunities

• Lighter Fixed Cost
• Faster Development
• ? Inexpensive Development

18
Weakness of Ventures

• Insufficient
• Experience
• Funds
• Human Resources
• Etc

19
Nature of Venture Management

• Venture Risky Business
• Born Risk Takers
• Idealists and/or Strong Money Seekers
• Rather International

20

• Drug Lag Status Analysis
• Bio-Venture
• Solution and Role of Ventures

21
Tactical Solution of Drug Lag 1 Role
of Ventures
22
To Support Ventures

• ?Developing Small, but Important Drugs
• Poor Fund Orphan Drug Subsidy a
• Personnel Cost
• Equally Subsidized between Pfizer Nobelpharma?
• Poor Experience of Ventures
• Pmda
• Broader Perspectives
• Positive, Constructive Advisory Meeting
  Inquiries

23
Tactical Solution of Drug Lag 2
Participation in Multi-National Clinical Trial
24
Tactical Solution of Drug Lag 2
Role of Ventures
Break Through by Ventures
25
Multi-National Clinical Trials
Tangible Barriers Remaining

• PI
• PII Dose Finding
• Some Not-Global Non-Clinical Requirements
  Remaining
• SHINRAISEI-HOSHO

26
Strategic Solution Shift to
Bio-Liberalism

• Abolition of KONGO SHINRYO
• Lift the Ban of Free Drug Prices
• Consumer Decides Prices
• ? Adjust NHI
  Accordingly
• ? Market Economy
• Venture as Starter of Entrepreneurship
• Risk Averse ? Risk Taking Attitude

? Drug Lag in US/EU
27
Conclusion

• Two Types of Drug Lag
• Causality Tangible lt Intangible Bio-Socialism
• Venture Risk-Takers, Inexpensive, Speedy, but
  Inexperienced, Lack of Fund HR
• Tactical Solutions
• Ventures for Small, but Important Drugs Needs
  Help
• Multi-National Clin Trial Tangible Barriers
  Remaining
• Strategic Solution? Bio-Liberalism
• Abolition of KONGO SHINRYO
• Role of Ventures

28
Acknowledgement

• Yasuo Ohasi, Ph.D., Tokyo University
• Yuichi Kubo, Daiichi Sankyo
• Hiroshi Matsumori, Pfizer Japan
• Gordon Marsh, Japanese-English Translater
• Eiji Suzuki, Nobelpharma
• Hiroyuki Kosuge, Nobelpharma