Takeda R&D Strategy
Tadataka Yamada, M.D.
Chief Medical & Scientific Officer
Deborah Dunsire, M.D.
President and CEO, Millennium: The Takeda Oncology Company
Nikko Hotel, , San Francisco January 8, 2013
Takeda R&D Value
Takeda is a p pharmaceutical company p y committed to the discovery and development of innovative solutions addressing unmet medical needs of patients ti t through th h R&D i investment t t
1 | R&D Meeting | January 8, 2013
Takeda R&D Mission
Meet the future promise of Takeda as a leader l d i in th the pharmaceutical h ti l industry by providing solutions to patients ti t with ith unmet t medical di l needs d Transform the R&D organization to be an engine of growth that is an industry leader in R&D productivity
2 | R&D Meeting | January 8, 2013
Takeda R&D Principles
URGENCY
INNOVATION
Focus on Patients
PARTNERSHIP
MEASUREMENT
3 R&D Meeting | January 8, 2013
Takeda R&D Principles
URGENCY
4 | R&D Meeting | January 8, 2013
Takeda R&D Principles
INNOVATION
New Frontier Science
Novel New Molecular Entity
TAK-875 TAK-438 438 TAK MLN0002 TAK-375SL AD-4833/TOMM40 4833/TOMM40 AD Lupron 6M Depot
Novel Life Cycle Management
Drug Discovery Unit CMC Center
5 | R&D Meeting | January 8, 2013
Takeda R&D Principles
MEASUREMENT
POC&C C Concept t
Value Creation
POC&C: Proof of Concept & Competitiveness
6 | R&D Meeting | January 8, 2013
Takeda R&D Principles
Why y POC&C?
Valid surrogate of value - 50% success to market More proximate measure of value creation Focus measurement on peak year sales Better tool to predict future corporate performance Set targets g for therapeutic p area units
7 | R&D Meeting | January 8, 2013
Takeda R&D Principles
PARTNERSHIP
In license In-license
Di Discovery
(formerly Syrrx)
Takeda California
Mill Millennium i
N Nycomed d
Affymax, y Lundbeck, Orexigen, Novartis, Seattle Genetics, etc.
• REVESTIVE • ADCETRIS • OMONTYS • RIENSO • CONTRAVE • LOTRIGA • BRINTELLIX* • Lurasidone • ATL-962 • AMG 386 • AMG 706 • TAK-816 • TAK-361S • ITI-214
• Advinus • Envoy • LigoCyte • Intracellular Therapies
• NESINA • SYR-472
• MLN0002 • MLN9708 • MLN8237 • MLN0264
• DAXAS • REVESTIVE • Veltuzumab • Namilumab • Alvesco • Omnaris
*Proposed brand name of Lu AA21004
8
| R&D Meeting | January 8, 2013
6 Therapeutic Areas
Pipeline Assets in Phase 2 or Beyond Metabolic / CV
• • • • BLOPRESS EDARBI AZILVA NESINA • • • • • CONTRAVE ATL-962 TAK-875 SYR-472 TAK-428
Oncology
• VELCADE • LUPRON • ADCETRIS • • • • • MLN9708 MLN8237 TAK-700 AMG 706 AMG 386
CNS
• BRINTELLIX* • Lurasidone TAK 375SL • TAK-375SL • SOVRIMA
Respiratory & Inflammatory f
• DAXAS • Veltuzumab • • • • • •
General Medicine
TAKEPRON DEXILANT REVESTIVE OMONTYS RIENSO AMITIZA • MLN0002 • TAK-438 • TAK TAK-385 385
Vaccine
• TAK-816 • TAK-361S • Norovirus vaccine
*Proposed brand name of Lu AA21004
9
| R&D Meeting | January 8, 2013
R&D Budget in FY2012-2014 (average)
Cardiovascular & Metabolic Oncology
31%
27%
Vaccine
4% 12% 14%
12%
Respiratory & Immunology
General Medicine Central Nervous System
10
| R&D Meeting | January 8, 2013
NESINA / SYR-322 (alogliptin)
First DPP-4 inhibitor with prospective CV outcome data
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status First DPP-4 inhibitor to have prospective CV outcome data in a high CV risk population (EXAMINE trial) Treatment as monotherapy and in fixed-dose combination with pioglitazone or metformin PDUFA dates of alogliptin and alogliptin/pioglitazone FDC in late January 2013
Mechanism of Action A1 1c change fro om baseline at Wk k 26
0 ‐0.1 ‐0.2 ‐0.3 ‐0.4 ‐0.5 ‐0.6 ‐0.7 ‐0.8 ‐0.9
Key Data – Phase 3
Incretin (GLP‐1 or GIP) deactivated
*** ***
momo therapy ‐0.02 ‐0.56 ‐0.59
***
***
******
Met add‐on ‐0.1 ‐0.61 ‐0.59
***
*** ***
***
Active site
Placbo
SU add‐on 0 ‐0.38 ‐0.52
TZD add‐on ‐0.19 ‐0.66 ‐0.8
Ins add‐on ‐0.13 ‐0.63 ‐0.71
DPP‐4 enzyme y
*** P
g Alo 12.5mg Alo 25mg
11 | R&D Meeting | January 8, 2013
Contrave
First obesity agent with prospective CV outcome data
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status Fixed-dose, sustained-release combination of naltrexone-HCl and bupropion-HCl CV outcome “LIGHT STUDY” underway to meet FDA requirement. The first obesity agent to be supported by prospective cardiovascular outcome data Due to fast enrollment into LIGHT STUDY, accrual of events needed for interim analysis could occur as early as second quarter of calendar 2013. Partnership with Orexigen Therapeutics, Inc.
Mechanism of Action
LS Mean % change fro om BL
Key Data – Phase 3
***p
12 | R&D Meeting | January 8, 2013
TAK-875
First-in-class GPR40 agonist for type 2 diabetes
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status
Once-daily insulin-secretagogue with clear differentiation from competitors: In Phase 2 trials, all doses had a markedly lower incidence of hypoglycemia compared to glimepiride (TAK-875 2.0%, glimepiride 16.1%) Phase 3 studies (including CV outcome study) ongoing in the US, EU & Japan Head to head and concomitant trials with DPP4 inhibitor ongoing Projected launch in FY2015 Mechanism of Action
Gl Glucose TAK-875
Key Data – Phase 2
Change e in HbA1c (% %)
0 -0.2 02 -0.4 -0.6 -0.8 -1 -1.2 -1.4
K+/ATP Channel GLUT2 GK Mitochondria
↑ ATP ↓K
X
+
Insulin Granule Exocytosis
Gq PLC
Insulin Granules DAG PKC
*#
GPR40 IP3 Free Fatty Acid
* *
*
-Cell C ll
↑Ca2+ Endoplasmic
R ti l Reticulum
*
*
Ca2+ Channel * p p
# p
13 | R&D Meeting | January 8, 2013
DAXAS (roflumilast)
The first oral drug in new class of treatment for COPD
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status Once daily oral selective phosphodiesterase 4 (PDE4) enzyme inhibitor for COPD Approved in the EU for maintenance treatment of severe COPD and currently filed or approved in several emerging markets. Out-licensed to Forest in the US. Clinical POM study ongoing for new combination with alogliptin for type 2 diabetes diabetes.
Mechanism of Action Intestine
DPP4
Key Data - preclinical
Combination of PDE4 inhibitors and DPP4 inhibitors increases active plasma GLP-1 levels (db/db mice)
Vehicle PDE4 inhibitor (10 mg/kg) Januvia (100 mg/kg) PDE4 inhibitor + Januvia Mean+SE (n=10)
–
DPP4‐i
Pancreas
GLP‐1 ↑
GLP‐1R
↑
Insulin
+
PDE4 – PDE4i AMP
cAMP
+
GLP‐1↑
PDE4 – PDE4i
cAMP
+
AMP
Beta cells
Intestinal L cells
14 | R&D Meeting | January 8, 2013
BRINTELLIX* / Lu AA21004 (vortioxetine)
Novel multimodal antidepressant for major depressive disorder
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status The US NDA includes data from 6 global Phase 3 trials (including a study in elderly patients) that demonstrated significant efficacy in dose range of 5 to 20mg/day Potential for favorable short and long term safety and tolerability and improvement of cognitive dysfunction of depression p
Lower incidence of treatment emergent sexual dysfunction No impact on sleep and weight neutrality Absence of discontinuation symptoms
US NDA filed by y Takeda in October 2012, ,& Japan NDA filing expected in mid-FY2013 Partnership with H. Lundbeck A/S
Key Data – Phase 3
0.7 06 0.6 0.5 0.4 0.3 0.2 0.1 ‐0.1 0.07 DSST RAVLT Acquisition RAVLT Delayed Recall * 0.25 * * 0.33 0.27 * 0.24 ** 0.32
Standardized d Effect Size Ve ersus Placebo P
Acute Major Depression in Elderly Patients
Vortioxetine Duloxetine
*p
6E‐16
*Proposed brand name of Lu AA21004
15 | R&D Meeting | January 8, 2013
Lurasidone
Atypical antipsychotic for schizophrenia & bipolar depression
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status Demonstrated robust schizophrenia maintenance efficacy in a 52 week study against Seroquel XR (QXR: atypical antipsychotic)
27% improved reduction in relapse compared to Seroquel XR p reduction in the risk of hospitalization p compared p to Seroquel q XR 57% improved
Lack of significant effects on metabolic parameters including body weight Met primary and key secondary Key Data - Phase 3 endpoints in two phase 3 trials in 52 week double-blind extended study y bipolar I depression EU MAA filed by Takeda in September 2012 for schizophrenia Partnership with D i i Dainippon S Sumitomo it Ph Pharma
Favorable F
16 | R&D Meeting | January 8, 2013
MLN0002 (vedolizumab)
A precision-based strike on inflammatory bowel disease
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status A novel class of gut-selective monoclonal antibody targets α4β7 integrin on leukocytes involved in ulcerative colitis (UC) and Crohn’s disease (CD): Phase III UC study GEMINI I met primary endpoints of response (induction) and remission (maintenance) Phase III CD study GEMINI II met primary endpoints of remission (both induction and maintenance) MLN0002 has demonstrated efficacy in patients who are TNF naïve and those with prior anti-TNF failure in both UC and CD
Key Data – Phase 2
UC
CD
17 | R&D Meeting | January 8, 2013
TAK-438 (vonoprazan)
Longer, g faster, better acid suppression pp
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status First-in-class potassium competitive acid blocker (PCAB) More rapid onset of action as compared with a PPI (lansoprazole) High accumulation in parietal cells – potent/prolonged acid suppression No food effect effect, a limitation of PPIs No interaction with CYP2C19 Phase III ongoing in Japan Mechanism of Action Key Data – Phase 1
Intragastric pH from MRD Study (comparison with lansoprazole)
18 | R&D Meeting | January 8, 2013
Acquisition of LigoCyte
Gains First-in-Class Norovirus Vaccine Candidate & Virus-Like Particle Platform
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
A major step forward in the expansion of Takeda’s global Vaccine Business Unit Enhances Takeda’s R&D capacity with the acquisition of VLP* technology Expands Takeda s development Takeda’s pipeline with first-in-class norovirus vaccine (P-I/II) and pre-clinical assets , influenza and rotavirus for RS virus,
19 | R&D Meeting | January 8, 2013
*Virus-Like Particles (VLPs) mimic the external protein structure of a virus without including the genetic material (DNA or RNA). The human immune system responds as if encountering e cou te g a live e virus, us, a allowing o g it t to bu build d immune defenses
LigoCyte’s norovirus VLP Credit: LigoCyte Ph Pharmaceuticals, ti l Inc. I
40
| R&D Meeting | January 8, 2013
Forward-Looking Statements
This presentation contains forward-looking statements regarding the Company's plans, outlook, strategies, and results for the future. All forward-looking statements are based on judgments derived from the information available to the Company at this time. Forward looking statements can sometimes be identified by the use of forwardlooking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "continue," "seek," "pro forma," "potential," "target, " "forecast," or "intend" or other similar words or expressions of the negative thereof thereof. Certain risks and uncertainties could cause the Company's actual results to differ materially from any forward looking statements contained in this presentation. These risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding the Company's business, including general economic conditions in the US and worldwide; (2) competitive pressures; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) decisions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates; and (8) integration activities with acquired companies companies. We assume no obligation to update or revise any forward-looking statements or other information contained in this presentation, whether as a result of new information, future events, or otherwise.
2013/1/10
Takeda R&D Strategy
Tadataka Yamada, M.D.
Chief Medical & Scientific Officer
Deborah Dunsire, M.D.
President and CEO, Millennium: The Takeda Oncology Company
Nikko Hotel, , San Francisco January 8, 2013
Takeda R&D Value
Takeda is a p pharmaceutical company p y committed to the discovery and development of innovative solutions addressing unmet medical needs of patients ti t through th h R&D i investment t t
1 | R&D Meeting | January 8, 2013
Takeda R&D Mission
Meet the future promise of Takeda as a leader l d i in th the pharmaceutical h ti l industry by providing solutions to patients ti t with ith unmet t medical di l needs d Transform the R&D organization to be an engine of growth that is an industry leader in R&D productivity
2 | R&D Meeting | January 8, 2013
Takeda R&D Principles
URGENCY
INNOVATION
Focus on Patients
PARTNERSHIP
MEASUREMENT
3 R&D Meeting | January 8, 2013
Takeda R&D Principles
URGENCY
4 | R&D Meeting | January 8, 2013
Takeda R&D Principles
INNOVATION
New Frontier Science
Novel New Molecular Entity
TAK-875 TAK-438 438 TAK MLN0002 TAK-375SL AD-4833/TOMM40 4833/TOMM40 AD Lupron 6M Depot
Novel Life Cycle Management
Drug Discovery Unit CMC Center
5 | R&D Meeting | January 8, 2013
Takeda R&D Principles
MEASUREMENT
POC&C C Concept t
Value Creation
POC&C: Proof of Concept & Competitiveness
6 | R&D Meeting | January 8, 2013
Takeda R&D Principles
Why y POC&C?
Valid surrogate of value - 50% success to market More proximate measure of value creation Focus measurement on peak year sales Better tool to predict future corporate performance Set targets g for therapeutic p area units
7 | R&D Meeting | January 8, 2013
Takeda R&D Principles
PARTNERSHIP
In license In-license
Di Discovery
(formerly Syrrx)
Takeda California
Mill Millennium i
N Nycomed d
Affymax, y Lundbeck, Orexigen, Novartis, Seattle Genetics, etc.
• REVESTIVE • ADCETRIS • OMONTYS • RIENSO • CONTRAVE • LOTRIGA • BRINTELLIX* • Lurasidone • ATL-962 • AMG 386 • AMG 706 • TAK-816 • TAK-361S • ITI-214
• Advinus • Envoy • LigoCyte • Intracellular Therapies
• NESINA • SYR-472
• MLN0002 • MLN9708 • MLN8237 • MLN0264
• DAXAS • REVESTIVE • Veltuzumab • Namilumab • Alvesco • Omnaris
*Proposed brand name of Lu AA21004
8
| R&D Meeting | January 8, 2013
6 Therapeutic Areas
Pipeline Assets in Phase 2 or Beyond Metabolic / CV
• • • • BLOPRESS EDARBI AZILVA NESINA • • • • • CONTRAVE ATL-962 TAK-875 SYR-472 TAK-428
Oncology
• VELCADE • LUPRON • ADCETRIS • • • • • MLN9708 MLN8237 TAK-700 AMG 706 AMG 386
CNS
• BRINTELLIX* • Lurasidone TAK 375SL • TAK-375SL • SOVRIMA
Respiratory & Inflammatory f
• DAXAS • Veltuzumab • • • • • •
General Medicine
TAKEPRON DEXILANT REVESTIVE OMONTYS RIENSO AMITIZA • MLN0002 • TAK-438 • TAK TAK-385 385
Vaccine
• TAK-816 • TAK-361S • Norovirus vaccine
*Proposed brand name of Lu AA21004
9
| R&D Meeting | January 8, 2013
R&D Budget in FY2012-2014 (average)
Cardiovascular & Metabolic Oncology
31%
27%
Vaccine
4% 12% 14%
12%
Respiratory & Immunology
General Medicine Central Nervous System
10
| R&D Meeting | January 8, 2013
NESINA / SYR-322 (alogliptin)
First DPP-4 inhibitor with prospective CV outcome data
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status First DPP-4 inhibitor to have prospective CV outcome data in a high CV risk population (EXAMINE trial) Treatment as monotherapy and in fixed-dose combination with pioglitazone or metformin PDUFA dates of alogliptin and alogliptin/pioglitazone FDC in late January 2013
Mechanism of Action A1 1c change fro om baseline at Wk k 26
0 ‐0.1 ‐0.2 ‐0.3 ‐0.4 ‐0.5 ‐0.6 ‐0.7 ‐0.8 ‐0.9
Key Data – Phase 3
Incretin (GLP‐1 or GIP) deactivated
*** ***
momo therapy ‐0.02 ‐0.56 ‐0.59
***
***
******
Met add‐on ‐0.1 ‐0.61 ‐0.59
***
*** ***
***
Active site
Placbo
SU add‐on 0 ‐0.38 ‐0.52
TZD add‐on ‐0.19 ‐0.66 ‐0.8
Ins add‐on ‐0.13 ‐0.63 ‐0.71
DPP‐4 enzyme y
*** P
g Alo 12.5mg Alo 25mg
11 | R&D Meeting | January 8, 2013
Contrave
First obesity agent with prospective CV outcome data
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status Fixed-dose, sustained-release combination of naltrexone-HCl and bupropion-HCl CV outcome “LIGHT STUDY” underway to meet FDA requirement. The first obesity agent to be supported by prospective cardiovascular outcome data Due to fast enrollment into LIGHT STUDY, accrual of events needed for interim analysis could occur as early as second quarter of calendar 2013. Partnership with Orexigen Therapeutics, Inc.
Mechanism of Action
LS Mean % change fro om BL
Key Data – Phase 3
***p
12 | R&D Meeting | January 8, 2013
TAK-875
First-in-class GPR40 agonist for type 2 diabetes
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status
Once-daily insulin-secretagogue with clear differentiation from competitors: In Phase 2 trials, all doses had a markedly lower incidence of hypoglycemia compared to glimepiride (TAK-875 2.0%, glimepiride 16.1%) Phase 3 studies (including CV outcome study) ongoing in the US, EU & Japan Head to head and concomitant trials with DPP4 inhibitor ongoing Projected launch in FY2015 Mechanism of Action
Gl Glucose TAK-875
Key Data – Phase 2
Change e in HbA1c (% %)
0 -0.2 02 -0.4 -0.6 -0.8 -1 -1.2 -1.4
K+/ATP Channel GLUT2 GK Mitochondria
↑ ATP ↓K
X
+
Insulin Granule Exocytosis
Gq PLC
Insulin Granules DAG PKC
*#
GPR40 IP3 Free Fatty Acid
* *
*
-Cell C ll
↑Ca2+ Endoplasmic
R ti l Reticulum
*
*
Ca2+ Channel * p p
# p
13 | R&D Meeting | January 8, 2013
DAXAS (roflumilast)
The first oral drug in new class of treatment for COPD
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status Once daily oral selective phosphodiesterase 4 (PDE4) enzyme inhibitor for COPD Approved in the EU for maintenance treatment of severe COPD and currently filed or approved in several emerging markets. Out-licensed to Forest in the US. Clinical POM study ongoing for new combination with alogliptin for type 2 diabetes diabetes.
Mechanism of Action Intestine
DPP4
Key Data - preclinical
Combination of PDE4 inhibitors and DPP4 inhibitors increases active plasma GLP-1 levels (db/db mice)
Vehicle PDE4 inhibitor (10 mg/kg) Januvia (100 mg/kg) PDE4 inhibitor + Januvia Mean+SE (n=10)
–
DPP4‐i
Pancreas
GLP‐1 ↑
GLP‐1R
↑
Insulin
+
PDE4 – PDE4i AMP
cAMP
+
GLP‐1↑
PDE4 – PDE4i
cAMP
+
AMP
Beta cells
Intestinal L cells
14 | R&D Meeting | January 8, 2013
BRINTELLIX* / Lu AA21004 (vortioxetine)
Novel multimodal antidepressant for major depressive disorder
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status The US NDA includes data from 6 global Phase 3 trials (including a study in elderly patients) that demonstrated significant efficacy in dose range of 5 to 20mg/day Potential for favorable short and long term safety and tolerability and improvement of cognitive dysfunction of depression p
Lower incidence of treatment emergent sexual dysfunction No impact on sleep and weight neutrality Absence of discontinuation symptoms
US NDA filed by y Takeda in October 2012, ,& Japan NDA filing expected in mid-FY2013 Partnership with H. Lundbeck A/S
Key Data – Phase 3
0.7 06 0.6 0.5 0.4 0.3 0.2 0.1 ‐0.1 0.07 DSST RAVLT Acquisition RAVLT Delayed Recall * 0.25 * * 0.33 0.27 * 0.24 ** 0.32
Standardized d Effect Size Ve ersus Placebo P
Acute Major Depression in Elderly Patients
Vortioxetine Duloxetine
*p
6E‐16
*Proposed brand name of Lu AA21004
15 | R&D Meeting | January 8, 2013
Lurasidone
Atypical antipsychotic for schizophrenia & bipolar depression
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status Demonstrated robust schizophrenia maintenance efficacy in a 52 week study against Seroquel XR (QXR: atypical antipsychotic)
27% improved reduction in relapse compared to Seroquel XR p reduction in the risk of hospitalization p compared p to Seroquel q XR 57% improved
Lack of significant effects on metabolic parameters including body weight Met primary and key secondary Key Data - Phase 3 endpoints in two phase 3 trials in 52 week double-blind extended study y bipolar I depression EU MAA filed by Takeda in September 2012 for schizophrenia Partnership with D i i Dainippon S Sumitomo it Ph Pharma
Favorable F
16 | R&D Meeting | January 8, 2013
MLN0002 (vedolizumab)
A precision-based strike on inflammatory bowel disease
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status A novel class of gut-selective monoclonal antibody targets α4β7 integrin on leukocytes involved in ulcerative colitis (UC) and Crohn’s disease (CD): Phase III UC study GEMINI I met primary endpoints of response (induction) and remission (maintenance) Phase III CD study GEMINI II met primary endpoints of remission (both induction and maintenance) MLN0002 has demonstrated efficacy in patients who are TNF naïve and those with prior anti-TNF failure in both UC and CD
Key Data – Phase 2
UC
CD
17 | R&D Meeting | January 8, 2013
TAK-438 (vonoprazan)
Longer, g faster, better acid suppression pp
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
Program Status First-in-class potassium competitive acid blocker (PCAB) More rapid onset of action as compared with a PPI (lansoprazole) High accumulation in parietal cells – potent/prolonged acid suppression No food effect effect, a limitation of PPIs No interaction with CYP2C19 Phase III ongoing in Japan Mechanism of Action Key Data – Phase 1
Intragastric pH from MRD Study (comparison with lansoprazole)
18 | R&D Meeting | January 8, 2013
Acquisition of LigoCyte
Gains First-in-Class Norovirus Vaccine Candidate & Virus-Like Particle Platform
Cardiovascular & Metabolic Respiratory & Inflammatory Central Nervous System General Medicine Vaccine Oncology
A major step forward in the expansion of Takeda’s global Vaccine Business Unit Enhances Takeda’s R&D capacity with the acquisition of VLP* technology Expands Takeda s development Takeda’s pipeline with first-in-class norovirus vaccine (P-I/II) and pre-clinical assets , influenza and rotavirus for RS virus,
19 | R&D Meeting | January 8, 2013
*Virus-Like Particles (VLPs) mimic the external protein structure of a virus without including the genetic material (DNA or RNA). The human immune system responds as if encountering e cou te g a live e virus, us, a allowing o g it t to bu build d immune defenses
LigoCyte’s norovirus VLP Credit: LigoCyte Ph Pharmaceuticals, ti l Inc. I
40
| R&D Meeting | January 8, 2013
Forward-Looking Statements
This presentation contains forward-looking statements regarding the Company's plans, outlook, strategies, and results for the future. All forward-looking statements are based on judgments derived from the information available to the Company at this time. Forward looking statements can sometimes be identified by the use of forwardlooking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "continue," "seek," "pro forma," "potential," "target, " "forecast," or "intend" or other similar words or expressions of the negative thereof thereof. Certain risks and uncertainties could cause the Company's actual results to differ materially from any forward looking statements contained in this presentation. These risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding the Company's business, including general economic conditions in the US and worldwide; (2) competitive pressures; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) decisions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates; and (8) integration activities with acquired companies companies. We assume no obligation to update or revise any forward-looking statements or other information contained in this presentation, whether as a result of new information, future events, or otherwise.
2013/1/10