欧州製薬団体連合会
加藤会長記者会見

Chairman
Press Conference
4 March 2010

EFPIA Japan
EFPIA Press Conference
4 March 2010
EFPIA Japan

EFPIA Japan Organization(as of March 2010)

ChairmanPress Conference
4 March 2010

Board Members
Chairman:
Masuhiro Kato
(AstraZeneca K.K.)
Vice Chairman:
Marc Dunoyer(GlaxoSmithKline K.K.)
Vice Chairman:
Patrick Chocat(sanofi-aventis K.K.)
Board of Director: Hiroyuki Mitani(Novartis Pharma K.K.)
Board of Director: Jean-Luc Lowinski(Bayer Yakuhin, Ltd.)Board of Director: Claus Eilersen(Novo Nordisk Pharma Ltd. )Board of Director: Wayne Paterson(Merck Serono Co., Ltd.)
Director General: Takahiro Maehama(EFPIA Japan)
Controller
Mitsuru Kikuchi
CHUGAI PHARMACEUTICAL CO., LTD.

Pricing &Economics
Committee

TechnicalCommittee

PublicRelations
Committee

Intellectual Property,
Legal & Corporate Ethics
Committee

VaccineCommittee

ChairmanKuniyuki Hara

ChairmanMizuho Inazu

Chairman
Hideto Kita

Chairman
Muneki Natani

ChairmanShunjiro Sugimoto

sanofi-aventis K.K.

Novartis Pharma K.K.

Novartis Pharma K.K.

Sanofi-aventis K.K.

GlaxoSmithKline K.K.

EFPIA Japan Member Companies List
（Total 22 Companies)

ChairmanPress Conference
4 March 2010

• Actelion Pharmaceuticals Japan Ltd.

• JANSSEN PHARMACEUTICAL K.K.

• Amersham K.K.

• Lundbeck Japan K.K.

• AstraZeneca K.K.

• Merck Serono Co., Ltd.

• Bayer Yakuhin, Ltd.

• NIHON SERVIER COMPANY LIMITED• Bracco-Eisai Co., Ltd.

• Nippon Boehringer Ingelheim Co., Ltd.

• CHUGAI PHARMACEUTICAL CO., LTD. • Novartis Pharma K.K.
• CSL Behring K.K.

• Novo Nordisk Pharma Ltd.

• Ferring Pharmaceuticals Co., Ltd.

• Pierre Fabre Japon Co., LTD• GALDERMA K.K.

• sanofi-aventis K.K.

• GlaxoSmithKline K.K.

• SOLVAY SEIYAKU K.K.

• Guerbet Japan KK• UCB Japan Co., Ltd.
As of March 2010

EFPIA Japan Member Companies

ChairmanPress Conference
4 March 2010

New drug approvals(2007 - 2009)

Sales (2009)
2.1 trillion yen
EFPIA member
companies

24.2%
その他

75.8%

Market total: 8.9 trillion yen (IMS)

EFPIA member
companies

Japan
その他
44%

(28)

28.9%

71.1%

Approvals total : 342(PMDA Homepage)# of employees： ~28,000 people (EFPIA Japan companies)

EFPIA Japan Presence in the Japanese Market

ChairmanPress Conference
4 March 2010

“2.1trillion yen (24.2%)”
Our total ethical pharmaceutical sales were 2.1 trillion yen based on NHI
price or 24% of the total market (8.9 trillion yen)
Source: JPM, Jan –Dec 2009
Copyright : IMS Japan K.K.

“4 & 3”
4 EFPIA J member companies were included in the top 10 companies
3 EFPIA J member companies in the top 11- 20 companies

Source: JPM, Jan –Dec 2009
Copyright : IMS Japan K.K.

“7 (50%)*”In terms of growth, 7 EFPIA Japan member companies (50% of the relevantmembers) showed a higher growth rate than the market growth rate of7.2%※ 14 EFPIA member companies are included in the IMS Data.

Source: JPM, Jan –Dec 2009
Copyright : IMS Japan K.K.

“ 30%”
Our member companies obtained 30% of the new drug approvals inSource: PMDA Homepage
the past three years (2007-2009)

Mission

ChairmanPress Conference
4 March 2010

“Contribute to healthcare and patientsin Japan by early introduction ofinnovative medicines and vaccines”

Vision

ChairmanPress Conference
4 March 2010

• Realize the best access to innovative
medicines and vaccines for patients in Japanby contributing to the establishment ofsystems to promote their development anddelivery• Build strong credibility with society with ourmember companies united

2010 Policy Objectives

ChairmanPress Conference
4 March 2010

1. Expedite the access of Japanese patients toinnovations
2. Acquire reward for innovation with the new pricing
system
3. Pursue better balance between prevention andtreatment
4. Make Japan a dynamic and attractive place to invest infor pharmaceutical companies
5. Increase credibility of the pharmaceutical industry
further

2010 Policy Objectives

ChairmanPress Conference
4 March 2010

1. Expedite access for Japanese patients to innovations
Promote further efficiency improvement of Japaneseclinical trials

Realize a more efficient review process by PMDA.



Expand the scope of MRA for GMP beyond oral solid
preparations

Trend of Global Joint Clinical Trials
in the past 6 years

ChairmanPress Conference
4 March 2010

The ratio of global joint clinical trials was 55% in 2008
(試験数)
No.
of clinical trials
020

40

60

80

1001202003年度
2004年度Global joint CT
国際共同治験
Total CT
治験全体

2005年度
2006年度
2007年度
2008年度0%
2003年度
2004年度
2005年度
2006年度
2007年度
2008年度

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

7.1%
5.6%
4.9%
5.6%
28.6%
55.2%
Source: EFPIA-J2010 Policy Objectives

ChairmanPress Conference
4 March 2010

2. Acquire reward for innovation with the new pricing systemSustain the new pricing system with no price decrease
for new products until generic entry

Obtain price premium for innovation

Eliminate systems and rules to hinder innovation

Enlarge price premium by additional scientific dataobtained during re-examination

Premium for acceleration of new drug development

ChairmanPress Conference
4 March 2010

In respect of premium obtaining drugs for acceleration and requests for development,
EFPIA member companies’ products account for about 30% of the total obtaining drugs

Premium obtaining Drugs
EFPIA
Membercompanies

32%

Requests for development ofUnapproved Drugs and UnapprovedIndications

EFPIA
Membercompanies

30%

2010 Policy Objectives

ChairmanPress Conference
4 March 2010

3. Pursue better balance between prevention and treatment

Promote disease prevention by vaccines
Insist on global harmonization of Biological standards



Recommend the introduction of EpidemiologyExpand the scope of public funding for vaccination.

Vaccine Gap

ChairmanPress Conference
4 March 2010

MMR and polio vaccines have not been approved yet
米国
US

欧州連合
EU

日本上市時期
Launched
in Japan（ranking)（国別上市順位）

Hib
インフルエンザ菌b型
（Hib）

✔1987

✔

Dec.
2008 (132nd)
2008年12月（132番目）

Human papilomavirus(HPV)(HPV)
ヒトパピローマウイルス

✔2006

✔

th )
2009年12月
Dec.
2009 (99（99番目）

肺炎球菌
PCV-7 (7価)

✔2000

✔

Feb. 24, 2010 (98th)

MMR*
MMR*

✔1971

✔

未
Not launched

Inactivated polio
不活化ポリオ✔1987✔

Not launched
未Rotavirus
ロタウイルス✔2006✔

未
Not launched

ワクチン
Vaccine2010年2月24日 （98番目）*MMR=はしか、おたふく風邪、風疹の3種混合の予防接種.
* Vaccinationof combination of 3 vaccines, namely,measles (M), mumps (M) and rubella (R)As of February 2010

Chairman
Press Conference
4 March 2010

Preventable Diseases by Vaccine
Japan vs. USA
Rubella, measles and mumps have almost vanished in the West
Incidence by year (no. of people)
Voluntary Vaccination*(Low vaccination rate）
Mumps
Epidemic parotitis
YearJapan

2000

132,877

2001

Chickenpox

Periodic Vaccination*(High vaccination rate）
Rubella

Japan

USA

338

275,036

27,382

3,123

176

22,552

86

254,711266

271,40922,5362,561

2333,812

116

2002

180,827270

263,308

22,8412,971

18

12,47344

2003

84,735231

250,561

20,948

2,795

7

8,285

6

2004

127,592258

245,941

32,931

4,239

10

1,547

37

2005

187,837314

242,296

32,242

895

11

537

66

2006

200,639

6,584

265,453

48,445

509

11

516

55

2007

67,803800

245,880

40,146

463

12

3,133

43

USA

reference：
Population in Japan： 127 million
Population in USA： 280 million

JapanMeasles
JapanUSAUSA* Recommended in JapanAll but chickenpox required in USA
when entering elementary school
Sourece：
Japan: (Infectious Disease Surveillance Center: Infectious Disease Data)
USA： （CDC: MMWR annual report）

欧州製薬団体連合会
加藤会長記者会見