roche in japan – a challenging and rewarding …...1993 - cefyl tablets introduced, an oral...
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Roche in Japan – A Challenging and Rewarding Experience of a Major Swiss Pharmaceutical Company
Dr. Eduard E. HoldenerChief Medical OfficerF. Hoffmann – La Roche AG
23 October 2007
Roche and Japan – Brief historical review: 1899 to 2001
Roche – Global player in pharmaceutical industry
Growing challenges in pharmaceutical industry
The Chugai-Roche response: Meeting high medical needs in Japan
Outlook
Agenda
Roche in Japan - 1A rich history of successful collaboration
1899: Roche establishes network of sales representatives in Japan as first western pharmaceutical company
1904 Karl Rhode Company distributesRoche products in Japan
1912 Dr. E.C. Barell visits Japan; first Medical Representative system
in Japan1924 Roche opens its own company inJapan on July 7 under name of Roche Gomeikaisha
1932 Nippon Roche K.K. founded
Dr Alice KellerTalented and determined
Dr. Alice Keller, Head of Roche in Japan from 1924 to 1939
“I liked it in Japan from the beginning. The people were friendly, the country I found beautiful…”
“I arrived in Kobe on August first in 1926 after a journey of 35 days”
Roche in Japan - 2A rich history of successful collaboration
1950 First import licences for Roche products regained, e.g. for Saridon
1967 Kamakura factory completed
1972 Research center opened in Kamakura
1986 Rocaltrol in osteoporosis
1987 Furtulon anticancer drug
1992 Roferon-A alpha interferon as first treatment for HCV in Japan
1993 - Cefyl tablets introduced, an oral antibiotic
- Bactramin injection introduced, acarini pneumonia drug
1995 Vesanoid for acute promyelocyticleukemia
1996- Four new drugs for HIV/AIDS, e.g. HIVID,2000 Saquinivir
1999 CellCept for rejection reactions in patients with organ transplants
2001 - Promotion of Kytril for anti-nausea - Tamiflu for A-Type/B-Type influenza - Herceptin, a monoclonal antibody in metastatic breast cancer
- Mabthera/Rituxan, a monoclonal antibody, in B-cell non-Hodgkin's lymphoma
2002 Roche acquires 50.1% of Chugai and merges its Japanese business with Chugai
Roche in Japan - 3A rich history of successful collaboration
Global Reach of Pharma DevelopmentBenefiting from top-class expertise from around world
United Kingdom(Welwyn)
Chugai (Japan)
Genentech (USA)
USA(NJ)
Switzerland(Basel)USA
(CA)
China (Shanghai)
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Roche PD Staff Total: ~3,500, excluding contractors, Genentech and Chugai
Delivering Clinically Differentiated MedicinesSucceeding across all 3 strategic objectives
Avastin in cancer
Fuzeon in HIV
Invirase in HIV
Herceptin in BC
Mabthera in NHL
First-in-Class Best-in-Class
Pegasys in HCV and HBV
Xeloda in cancer
Boniva in osteoporosis
Tarceva in cancer
CERA in anemia
Mabthera
Xeloda
Avastin
Tarceva
Herceptin
Pegasys
Boniva
Lifecycle Development
Completed In Phase III Additional indicationsin Phase III
Actemra in RA
Mabthera in RA
Ocreclizumab in RA
Roche Group’s Successful Track RecordMajor progress in key disease areas
From 2002Number 2 in oncologyNumber 2 in renal anemia*Number 2 in transplantationNumber 5 in hepatitisNumber 1 in obesityNumber 4 in influenzaNumber 5 in HIV/Aids
• We have achieved the Winning for the Future financial target of doublingTotal Shareholder Return (TSR) value of Roche from 2002–2007
• We are market leaders in disease areas where we want to play:
To 2007Number 1 in oncologyNumber 1 in renal anemia*Number 1 in transplantationNumber 1 in hepatitisNumber 1 in obesityNumber 1 in influenzaNumber 5 in HIV/Aids
Source: Extended Wood Mackenzie's Pharmaview, Jan 2007 * NeoRecormon territories
1. Pfizer2. GlaxoSmithKline3. Sanofi-Aventis4. Novartis5. Roche6. AstraZeneca7. Johnson & Johnson8. Merck & Co.9. Wyeth10. Eli Lilly
Pharmaceutical Industry Ranking in 2006Roche moves up to #5 from #8
Source: Extended Wood Mackenzie's Pharmaview, August 2007
Roche and Japan – Brief historical review: 1899 to 2001
Roche – Global player in pharmaceutical industry
Growing challenges in pharmaceutical industry
The Chugai-Roche response: Meeting high medical needs in Japan
Outlook
Agenda
• Global pharmaceutical market will more than double to $1.3 trillion by 2020
• Drugmakers‘ R&D spending in the US reached $55.2 billion in 2006
• FDA approved about half as many new treatments that year as a decade earlier
• Up to 45 percent of late-stage drugs currently fail
• Industry‘s core problem is lack of innovation in making effective new therapies for the world‘s unmet medical needs while R&D costs as well as marketing costs are increasing
by Daniel Beaulieu
2007 Pharma Business Model “Unsustainable”PWC report – June 13, 2007
„Industry‘s current business model is botheconomically
unsustainable and operationally incapable of actingquickly
enough to produce the types of innovative treatmentsthat will be
d d d b l b l k t “
40
60
80
100
120
140
160
180
200
220
240
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004*Year
Inde
xed
to 1
994
R&D expenditure Development times NME output Sales
Source: CMR International & IMS Health
Innovation ChallengeA gap in R&D productivity
The Gap
Cost Challenge of Developing New DrugsSignificant increase in investment needed
$138
$318
$802
$0
$100
$200
$300
$400
$500
$600
$700
$800
$900
1975 1987 2000
Expe
nditu
res
per R
x D
rug
(M
illion
s of
200
0 D
olla
rs)
Source: J. A. DiMasi, R. W. Hansen, and H. G. Grabowski, “The Price of Innovation: New Estimates of Drug Development Costs,”Journal of Health Economics 22 (2003):151-185.
R&D Productivity ChallengeDecreasing in USA
020406080100120140160180200
2005
2003
2001
1999
1997
1995
1993
1991
1989
1987
1985
1983
1981
Ann
ual N
ME
appr
oval
s
0
5
10
15
20
25
30
35
40
Indu
stry
R&
D E
xpen
ses
($B
illio
ns)
R&D InvestmentNME Approvals
Source: BioExecutive International April 2007
Japan - Market ChallengePositive and negative factors impacting the market
Factors Negatively Impacting Market Factors Positively Impacting Market
• April 2007 NHI Price revisions • Aging population driving growth in • -6.7% on annual basis geriatric related therapies • -4.9% impact Q2-Q4 2007 • including Alzheimer’s, Parkinson’s
and dementia • Slowed volume growth
• +3.2% in 2006 vs +6.2% in 2005 • Continued growth in oncology• +11.7% volume growth
• Influenza season back to normal • est. 28% of all deaths • -7.4% change in related Rx
• Expanding diabetes market • Less severe pollinosis / allergy season • +8.9% volume increase
• -10.1% change in related Rx • MHLW est. 5.8% of population having and 6.9% at high risk
• Increased use of generics • including Cephalosporins, Statins, • Growth in cardiovascular franchiseAntifungals, and Oral Antidiabetics
Japan Market Review 2006 – Chasing Growth in a Challenging Market , IMS
• +8.4% volume increase
Japan: Availability of Recently Launched NCEs25% of top 100 global products and 75% of NCEs not available in Japan
Of 142 NCEs launched globally Of top 100 products by global between 2002 and 2006 sales in 2006, 73 are available
only 32 launched in Japan in Japan
Not launched
Launched in Japan
in Japan
Source: IMS Health, IMS World Review 2005 and IMSMIDAS Quantum
IMS Japan Market Review 2006 – Chasing Growth in a Challenging Market
32
110
Available in Japan
73
Not available in Japan
27
Japan: Launch Lag between First Country of Launch and Japan Launch Approval times hover around 17-18 months
1st Japan Months Product Corp Average Approval Time in Japan
Launch Launch Lag Blopress TAK 10/1997 6/1999 20 33.5 months for the 58 products Aricept EIS 1/1997 11/1999 34 approved in 1999 Diovan NVR 7/1996 11/2000 52 28.3 months for the 67 products Lipitor PFZ 1/1997 5/2000 40 approved in 2000
Zithromac PFZ 9/1991 6/2000 105 Tamiflu CHG 10/1999 2/2001 16 Glivec NVR 5/2001 12/2001 7 16.8 months for the 39 products
Zyprexa LLY 10/1996 6/2001 56 approved in 2001 Fosamac BAN 11/1993 8/2001 93 Micardis B.I 11/1998 12/2002 49 17.7 months for the 43 products Iressa AZN 7/2002 7/2002 0 approved in 2002 Claritin SHC 2/1988 9/2002 175 Maxalt EIS 6/1998 9/2003 63 19.1 months for the 29 products
Pegasys CHU 9/2001 12/2003 27 approved in 2003 Lantus S.A. 6/2000 12/2003 42 Evista CHG 1/1998 5/2004 76 17.9 months for the 31 products
Bi Sifrol B.I 7/1997 1/2004 78 approved in 2004 Spiriva B.I 6/2002 12/2004 30 Enbrel WYE 11/1998 3/2005 76 Crestor AZN 2/2003 4/2005 26 Propecia BAN 6/1992 12/2005 162 Abilify OTS 11/2002 6/2006 43
Vesicare AST 9/2004 6/2006 21 Zoloft PFZ 12/1990 7/2006 187
Source: IMS Health, IMS MIDAS Quantum IMS JAPAN MARKET REVIEW 2006 - CHASING GROWTH IN A CHALLENGING MARKET 43
Roche and Japan – Brief historical review: 1899 to 2001
Roche – Global player in pharmaceutical industry
Growing challenges in pharmaceutical industry
The Chugai-Roche response: Meeting high medical needs in Japan
Outlook
Agenda
December, 2001: Signing of Basic Agreement October, 2002: Completion of merger with Nippon Roche and full--fledged start of the Alliancefledged start of the Alliance
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Chugai-Roche Strategic AllianceHigh-visibility partnership benefits both companies
Chugai-Roche “Unique” AllianceWin-win opportunity for both partners
• Roche acquired 50.1% of Chugai shares • Chugai and Nippon Roche merged • Chugai maintained autonomous management
Win for Chugai Win for Roche • Secures foundation for drug • Acquires local management that
discovery technology related to bio- understands the Japanese business pharmaceuticals environment
• Acquires more chances to produce • Strengthens its presence in Japan -innovative products through R&D the world’s second largest market synergies • Increases opportunities to acquire
• Strengthens total resources, including Japan-originated innovative drugs product/pipeline portfolios • Establishes a “Global Management
• Gains an option to the global market Network” infrastructure (Hub & through Roche’s infrastructure Spokes) 9
Copyright 2007 IMS Health or its affiliates. All rights reserve
2000 Rank 2006 Rank Estimated RankSankyo Pfizer Daiichi-SankyoTakeda Takeda PfizerDaiichi Chugai Takeda
Yamanouchi Astellas Mitsubishi-TanabeEisai Novartis ChugaiPfizer Eisai Astellas
Shionogi Daiichi NovartisBanyu Sankyo EisaiOtsuka GSK GSK
Novartis Dainippon Sumitomo Dainippon SumitomoChugai Otsuka OtsukaTanabe Mitsubishi AstraZeneca
Ono AZ BanyuFujisawa Banyu Shionogi
Sumitomo Shionogi OnoGlaxo Wellcome Tanabe Bayer-Schering
Aventis Ono Nippon BoehringerWelfide Nippon Boehringer sanofi-aventis
Kyowa Hakko Sanofi-Aventis TaihoBayer Taiho Kyowa Hakko
< Co's Outside Top 20 >
Source: IMS Japan K.K., Japan Pharmaceutical Market (JPM)
Japan: Ongoing M&A Shakes Up Top 10 in JapanDaiichi - Sankyo set to be new #1
Copyright 2007 IMS Health or its affiliates. All rights reserve
Franchise 2006 Growth (%) and 2001-2005 CAGR (%)
-14
-12
-10
-8
-6
-4
-2
0
2
4
6
8
10
-4 -3 -2 -1 0 1 2 3 4 5 6 7 8 9 10 11 12CAGR 2001-2005 % (Total Market = 3.2%)
2006 G
row
th %
(Tota
l M
arke
t =
-0.6
%)
Gastro / Metabolism
Respiratory
Anti-Infectives & Anti-Virals
Cardiovascular
Arthritis & Pain
CNS
Diabetes
Oncology
Source: IMS Japan K.K., Japan Pharmaceutical Market
Growth Performance across Franchises in JapanOncology continues strong growth in 2006
Areas of Focus and Products in Japan MarketStrong Chugai and Roche partnership
Others ¥326 billion in 2006 Rohypnol (consolidated net sales) AmobanUlcerlmin Cancer Euglucon
FurtulonOthers Infection/ Transp Xeloda9.3% NeutroginImmunology
Cancer KytrilTamiflu Immunology RituxanPegasys 28.2%
Copegus* & Infection HerceptinRocephin Avastin* 16.4% Cardio/Cerebro
Vascular CV SigmartRythmodan Renal 9.9% Preran
Renal EpoginBone 23.4% OxarolBone/Joint 12.8% RenagelAlfarol
RocaltrolSuvenylEvista * Copegus and Avastin were launched in 2007 12
Actemra
Roche R&D Pipeline TodayA promising flow of new medicines, also available to JapanPhase I
(30 NMEs + 1 Al)Phase II
(20 NMEs + 15 Als)Phase III
(3 NMEs + 34 Als)
Status as of September 7, 2007
Registration(2 NMEs + 8 Als)
NMEAdditional Indication
DBA OncologyDBA InflammationDBA VirologyDBA MetabolicDBA CNSOthers
R-No Roche managedGEN Genentech managedCHU Chugai managedARQ ArQule opt-inMEM Memory opt-inISO Isotechnika opt-in
Avastin NSCLC 1stlineR435
Avastin mCRC 1st combooxalipatinR435
Antevas subarach haemorrCHU
Sigmart acute heartfailCHU
Mircera renal anemiaR744
Avastin mBC combo Taxol1stR435
Epogin chemo inducedanaemiaCHU
Xeloda mCRC combo 1stR340Xeloda mCRC combo 2ndR340
Avastin NSCLC squamousR435
Avastin adj BC HER2-R435Avastin NSCLC mCNS treatR435solid tumorsR1507
malignant melanomaR7204
solid tumorsR¥547
RAR7277
solid tumorsR1645solid tumorsR1530
Apo2L/TRAIL - cancerGEN
DM1 - mBCGENPARP inh - malignant melanomaGEN
CRCCHUCD40 Ab - NHL/MM/rel large B-CLGEN
Apomab - cancerGENhedgehog ant - cancerGEN
HCVR7025
schizophreniaR1678
autoimmune diseasesR3477
type 2 diabetesR1511
HCVR7128HCVR7227
IFN-alpha Ab - SLEGEN
Avastin RCCR435Avastin ovarian cancer 1st lineR435
Avastin adj CCR435Avastin pancreatic cancerR435Avastin prostate caR435
Avastin mBC combo Taxotere 1stR435Avastin BC combo nonTaxanes 1stR435Avastin mBC combo Herceptin 1stR435
Xeloda adj CC combo oxaliplatinR340
MabThera CLL 1st lineR105
Tarceva+Avastin NSCLC 2nd lineR1415+R435
MabThera CLL relapseR105
Tarceva NSCLC maint 1stR1415
Tarceva+Avastin NSCLC 1st line maintR1415+R435
MabThera iNHL maint 1st lineR105
Tarceva adj NSCLCR1415
Herceptin gastric caR597
Avastin GIST recurrGENAvastin adj rectal cancerGENAvastin mBC 2nd lineGEN
ocrelizumab RAR1594
MabThera RA DMARD IRR105
Actemra RAR1569Actemra sJIAR1569
Xolair pediatric asthmaGEN
MabThera SLEGEN
MabThera PPMSGEN
MabThera ANCA ass vasculGENMabThera lupus nephritisGEN
Xeloda adj BCR340Xeloda adj CC combo AvastinR340
TNKase catherter clearanceGEN
Valcyte CMV extensionR127
ED-71 osteoporosisCHU
pamapimod - RAR1503
HCV pol - HCVR1626
RAR gamma - emphysemaR667
pertuzumab ovarian cancerR1273
solid tumorsARQ
renal transplantISO
pertuzumab mBCR1273
Avastin ovarian cancer 2nd lineGEN
CD40 Ab – diff large B-Cell lymphGEN
PNP inh - AI / transplantR3421
Avastin glioblastoma recurrGENAvastin malignant melanomaGEN
Avastin adj NSCLC* R435
MabThera+Avastin NHL aggr* R105
painR1646
HPV16 - cervical neoplasiaR3484
GLP-1 - type 2 diabetesR1583CETP inh - dyslipidemiaR1658
gastroparesis/IBSCHUpost-hepatectomy/cirrhosisCHU
topical VEGF - diabetic foot ulcersGEN
aleglitazar - type 2 diabetesR1439
Lucentis diabetic macular edemaGEN
ocrelizumabRRMSR1594
ALTU-238 - growth hormone defGEN
Alzheimer's/schizophreniaMEMCERA cancer anemiaR744
Alzheimer‘sR1450depressionR1647
Alzheimer‘sR4996
anticoagulantR1663
schizophreniaR7118
MSR1295
CellCept lupus nephritisR99CellCept pemphigus vulgarisR99
anti-CD20 3rd gen – hem maligGENIAP antag – cancer therapyGEN
MEK inh – cancer therapyGENABT-263 – sol tumors & hem maligGEN
ABT-869 – sol tumorsGEN
Apomab - sarcomaGEN
Avastin extensive SCLCGEN
Avastin 1st line BC+sunitinibGENAvastin 1st line mNSCLC+sunitinibGENAvastin relapse MMGEN
type 2 diabetesR1579
Roche and Japan – Brief historical review: 1899 to 2001
Roche – Global player in pharmaceutical industry
Roche and Chugai – Bold strategic move toward a leadership position
in Japan
The Roche/Chugai response to high medical needs in Japan – Astrong portfolio
Outlook
Agenda
Unless stated otherwise, submissions will occur in US and EU
pertuzumab (R1273)solid tumors (EU)
MabTheraCLL (EU)
Xeloda+Avastinadj. CC (EU)
CERA (R744 ) cancer anaemia
Avastinprostate Ca (EU)
ocrelizumab (R1594 )RA (EU)
AvastinNSCLC squamous (EU)
Major Roche-Managed Projected SubmissionsPortfolio variety expands over coming years
Tarcevaadj. NSCLC (EU)
GLP-1 (R1583)type II diabetes
Avastin+HerceptinmBC 1st line (EU)
Status as of September 30, 2007
MabTheraiNHL maint 1st line (EU)
RAR gamma (R667)emphysema
Phas
e 3
MabThera+Avastinaggressive NHL (EU)
Avastinadj. NSCLC (EU)
HCV pol.inhib. (R1626)HCV
HPV 16 (R3484)cervical neoplasia
2007 2008 2009 2010 post 2010
Avastinovarian Ca (EU)
PNP inhibitor (R3421)AI/transplant
Phas
e 2
ActemraRA
TarcevaNSCLC 1st line maint (EU)
MabTheraRA DMARD IR (EU)
Tarceva+AvastinNSCLC 2nd line (EU)
AvastinmBC + Taxotere (EU)
Avastinpancreatic Ca (EU)
Herceptingastric Ca (EU)
Xeloda adj. CC combo oxaliplatin
Xelodaadj. BC
CETP inhibitor (R1658)dyslipidemia
aleglitazar (R1439)type II diabetes
AvastinHER2- adj. BC (EU)
AvastinRCC (EU)
√XelodamCRC 1st & 2nd line combo
AvastinmCRC 1st line combo
oxaliplatin (EU)
Avastinadj. CC (EU)
AvastinmBC + standard chem (EU)
Avastingastric Ca metastatic(EU)
DPP-IV (3) (R1579)type II diabetes
Tarceva+AvastinNSCLC 1st line (EU)DBA Oncology
DBA InflammationDBA VirologyDBA MetabolicDBA CNSOthers
Tarceva + AvastinNSCLC 1st line maint (EU)
• File for approval of NMEs and additional indications every year • Secure safety and proper market introduction of new drugs
AVASTINAVASTINBC CRC Launched
in 2007 COPEGUS HERCEPTIN MIRCERA* HCV GC CIA
TARCEVA* AVASTINEPOGIN XELODA PC Adj.CCCIA Adj.CC
MIRCERA* PEG/COPE EPOGIN HERCEPTIN AVASTINRenal Anemia Liver Cirrhosis Renal Anemia Adj.BC NSCLC
ACTEMRA TARCEVA* ACTEMRA XELODA ED-71 BONVIVA* RA, sJIA NSCLC RA/Overseas CRC Osteoporosis Osteoporosis
~2006 2007 2008 2009 2010~2012 * overseas product name New Molecular Additional In-licensed Entity Indication etc. from Roche
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Future Regulatory Submissions in Japan Filings reflect increasing global harmonization
Thank you