SlideShare a Scribd company logo
1 of 18
Download to read offline
1
The Future of Anti-Infectives
ESTABLISH 2 Top Line Data Release
March 25, 2013
2
Forward Looking Statements
Statements contained in this data release regarding matters that are not
historical facts are “forward-looking statements” within the meaning of
the Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such forward-looking
statements. Risks that contribute to the uncertain nature of the forward-
looking statements include: the accuracy of Trius’ estimates regarding
expenses, future revenues and capital requirements; the success and
timing of Trius’ preclinical studies and clinical trials; regulatory
developments in the United States and foreign countries; changes in
Trius’ plans to develop and commercialize its product candidates; Trius’
ability to obtain additional financing; Trius’ ability to obtain and maintain
intellectual property protection for its product candidates; and the loss of
key scientific or management personnel. These and other risks and
uncertainties are described more fully in Trius’ most recently filed SEC
documents, including its Form 10-K, Forms 10-Q and other documents
filed with the United States Securities and Exchange Commission,
including those factors discussed under the caption “Risk Factors” in
such filings. All forward-looking statements contained in this press
release speak only as of the date on which they were made. Trius
undertakes no obligation to update such statements to reflect events that
occur or circumstances that exist after the date on which they were
made.
3
ESTABLISH 2 (IV/PO) Phase 3 Trial Design
2o
EMA
1o
EMA
Tedizolid
Linezolid
1x 200mg
2x 600mg
n=666
1o
FDA
2o
FDA
Placebo
Post-Treatment Evaluations
END-POINTS FOR GLOBAL REGISTRATION
Safety Analysis
Non-inferiority trial design vs Linezolid
4
ESTABLISH 2 Primary & Secondary Endpoints
Primary Endpoint:
• 20% or greater reduction in lesion area at 48-72 hours after first dose of drug
Secondary Endpoints:
• Programmatic clinical response at end of therapy (EOT)
• Investigator’s assessment of clinical response at post treatment evaluation (PTE)
5
ESTABLISH 2 Demographics and Baseline Characteristics
Tedizolid, %
n = 332
Linezolid, %
n = 334
Male, % 67.8 64.1
Age, mean 45.6 45.6
Geographic Region, %
North America (US) 47.0 47.3
Ex-U.S. 53.0 52.7
Clinical Syndrome, %
Cellulitis/erysipelas 50.0 50.3
Major abscess 20.5 20.4
Wound infection 29.5 29.3
MRSA (MITT), % 27.2 26.9
MSSA (MITT), % 52.8 53.0
Lymphadenopathy, % 70.8 70.4
WBC < 4,000 or > 10,000, % 53.0 45.2
Immature neutrophils, % 16.2 12.2
Fever, % 31.0 29.0
6
ESTABLISH 2 Efficacy
ITT Analysis Set Endpoint
Tedizolid
6 days
treatment, %
n = 332
Linezolid
10 days
treatment, %
n = 334
Treatment
Difference
(95% CI), %
Primary Endpoint
≥20% decrease from
baseline in lesion
area at 48-72 hours
85.2 82.6 2.6 (-3.0 to 8.2)
Key Secondary
Endpoints
Sustained clinical
response at end of
therapy
87.0 88.0 -1.0 (-6.1 to 4.1)
Investigators
assessment of
clinical response at
7-14 days after end
of therapy
88.0 87.7 0.3 (-4.8 to 5.3)
Sensitivity
analysis
(2010 Guidance)
Cessation of lesion
spread and absence
of fever at 48-72 hrs
85.8 81.4 4.4 (-1.2 to 10.1)
7
ESTABLISH 2 Efficacy by Infection Type
ITT Analysis Set
Tedizolid
6 days
treatment, %
n = 332
Linezolid
10 days
treatment, %
n = 334
Treatment
Difference
(95% CI), %
Cellulitis/erysipelas
80.7
n = 166
80.4
n = 168
0.37 (-8.2 to 8.9)
Major cutaneous
abscess
86.8
n = 68
89.7
n = 68
-2.9 (-14.5 to 8.4)
Wound infection
91.8
n = 98
81.6
n = 98
10.2 (0.71 to 20.1)
8
ESTABLISH 2 Safety: Tedizolid was Safe and Well
Tolerated with a Favorable AE Profile vs Linezolid
Safety Analysis Set
Tedizolid
6 days treatment, %
Linezolid
10 days treatment, %
Any Treatment Emergent
Adverse Event (TEAE)
45.3 43.7
Any Drug Related TEAE 20.5 24.8
Gastrointestinal Disorders 16.0 20.5
No Safety Signals
9
ESTABLISH 2 Incidence of TEAEs >2%
System Organ Class
Tedizolid, (%)
n = 331
Linezolid, (%)
n =327
Gastrointestinal disorders 53 (16.0) 67 (20.5)
General disorders and
administration site conditions
23 (6.9) 24 (7.3)
Infections and infestations 40 (12.1) 40 (12.2)
Metabolism and nutrition
disorders
9 (2.7) 7 (2.1)
Musculoskeletal and connective
tissue disorders
9 (2.7) 9 (2.8)
Nervous system disorders 29 (8.8) 36 (11.0)
Psychiatric disorders 10 (3.0) 4 (1.2)
Respiratory, thoracic and
mediastinal disorders
6 (1.8) 13 (4.0)
Skin and subcutaneous tissue
disorders
21 (6.3) 24 (7.3)
Vascular disorders 7 (2.1) 4 (1.2)
10
ESTABLISH 2 Post-Baseline Substantially Abnormal
Hematology Values
Tedizolid, (%)
n = 331
Linezolid, (%)
n =327
Hemoglobin 292 287
Below LLN 147 (50.3) 148 (51.6)
Substantially abnormal 4 (1.4) 2 (0.7)
White blood cells 272 258
Below LLN 16 (5.9) 20 (7.8)
Substantially abnormal 3 (1.1) 5 (1.9)
Platelets 275 269
Below LLN 37 (13.5) 35 (13.0)
Substantially abnormal 9 (3.3) 5 (1.9)
11
Differences Between ESTABLISH 1 and 2
ESTABLISH 2 ESTABLISH 1
Dosing
IV to oral
(minimum 1st day’s dosing IV)
Oral
Demographics US 47%, x-US 53% US 80%, x-US 20%
MRSA, % 27.1 42.6
Primary
Endpoint*
> 20% reduction in lesion
area @ 48 to 72 hrs
Cessation of lesion spread,
absence of fever @ 48 to 72 hrs
*ESTABLISH 2 SPA amended under agreement with FDA to reflect expected new primary endpoint. Both endpoints
prospectively captured as sensitivity analyses in respective studies. Integrated summary of efficacy will reflect the
ESTABLISH 2 primary endpoint under the amended SPAs
12
ESTABLISH Program Comparison
Endpoint Study
Tedizolid
6 days
treatment, %
Linezolid
10 days
treatment, %
Treatment
Difference
(95% CI), %
≥20% decrease from
baseline in lesion area at
48-72 hours
ESTABLISH 2
ESTABLISH 1
85.2
78.0
82.6
76.1
2.6 (-3.0 to 8.2)
1.9 (-4.5 to 8.3)
Sustained clinical
response at end of
therapy
ESTABLISH 2
ESTABLISH 1
87.0
87.0
88.0
87.8
-1.0 (-6.1 to 4.1)
-0.8 (-5.8 to 4.4)
Investigators assessment
of clinical response at 7-
14 days after end of
therapy
ESTABLISH 2
ESTABLISH 1
88.0
85.5
87.7
86.0
0.3 (-4.8 to 5.3)
-0.5 (-5.8 to 4.9)
Cessation of lesion
spread and absence of
fever at 48-72 hrs
ESTABLISH 2
ESTABLISH 1
85.8
79.5
81.4
79.4
4.4 (-1.2 to 10.1)
0.1 (-6.1 to 6.2)
13
ESTABLISH Program Safety Comparison
Safety Analysis Set Study Tedizolid % Linezolid %
Any Treatment
Emergent Adverse
Event (TEAE)
ESTABLISH 2 45.3 43.7
ESTABLISH 1 40.8 43.3
Any Drug Related
TEAE
ESTABLISH 2 20.5 24.8
ESTABLISH 1 24.2 31.0
Gastrointestinal
Disorders
ESTABLISH 2 16.0 20.5
ESTABLISH 1 16.3 25.4
14
Summary
• All primary and secondary efficacy endpoints were met for FDA and EMA
• Safety profile indicated that tedizolid was safe and well tolerated
• Results are consistent with those from ESTABLISH 1 and support filings for
global regulatory approval
• Combined results of all clinical studies support tedizolid differentiation:
– Safe, well tolerated, fast acting drug for resistant gram positive infections
– Convenient once daily IV or oral administration over short course of therapy
– Fewer drug-drug interactions
– Active against key linezolid resistant strains
15
*Efficacy performance ratings among those aware of brand
Tedizolid ATU Study, Wave 1 – USA Report, conducted by CMI on behalf of Trius, November 2012, N=505
Strong Response to Tedizolid Efficacy, Dosing and
Administration*
Tedizolid, 65%
Tedizolid, 52%
Zyvox, 62%
Zyvox, 42%
Cubicin, 54%
Cubicin, 37%
Vancomycin, 25%
Vancomycin, 27%
Offers simple dosing and
administration
Has a lower potential for
resistance development
KeyDriversof
MarketShare
KeyDriversof
Preference
Tedizolid, 45%
Tedizolid, 42%
Zyvox, 45%
Zyvox, 38%
Cubicin, 42%
Cubicin, 37%
Vancomycin, 30%
Vancomycin, 30%
Has superior efficacy vs.
other products
Is effective for all patient
types
16
Strong Response to Tedizolid Safety & TolerabilityKeyDriversof
MarketShare
Tedizolid, 48%
Tedizolid, 53%
Tedizolid, 59%
Zyvox, 27%
Zyvox, 45%
Zyvox, 31%
Cubicin, 48%
Cubicin, 42%
Cubicin, 44%
Vancomycin, 39%
Vanco., 14%
Vancomycin, 25%
Has a low frequency of
DDI (drug-drug
interaction)
Does not cause renal
and hepatic impairment
Has a low frequency of
safety/adverse events
*Efficacy performance ratings among those aware of brand
Tedizolid ATU Study, Wave 1 – USA Report, conducted by CMI on behalf of Trius, November 2012, N=505
17
80%
69% 74% 72% 76%
92%
83%
19%
31% 25% 27% 23%
7%
17%
High Interest (8-10)
Neutral (4-7)
Low Interest (1-3)
Tedizolid ATU Study, Wave 1 – USA Report, conducted by CMI on behalf of Trius, November 2012, N=505
Base: Total respondents
Q8.1 How interesting is tedizolid to you for suspected or confirmed MRSA ABSSSI patients overall? Use a 1 to 10 scale where “1” means “Not at all Interesting”
and “10” means “Very Interesting,” to indicate your level of interest.
Interest in Tedizolid, by Specialty
(0 = Not Interested, 10 = Very Interested)
Physician Interest in Tedizolid Strong Across Specialties
Total
(N = 505)
Critical Care,
Pulmonologist
(n = 120)
Internist
(n = 137)
General
Surgeon
(n = 86)
Hospitalist
(n = 175)
Infectious
Disease
Specialist
(n = 101)
Infusion Clinic
Specialist
(n = 75)
18
Upcoming Milestones
• Late breaker presentations at ECCMID conference (submitted for April)
• Detailed data presentations at ICAAC conference (September)
• Advance EU partnership discussions
• NDA Filing (H2 2013)
• Implement pre-commercial activities for potential U.S. launch (H2 2013)
• Initiation of Phase 3 ventilated nosocomial pneumonia study (H2 2013)
• EMA Filing (H1 2014)
• Potential PDUFA date for ABSSSI (mid 2014)

More Related Content

What's hot

Feasibility study outline (final)
Feasibility study outline (final)Feasibility study outline (final)
Feasibility study outline (final)Neeraj Mahajan
 
YM BioSciences 2012 Annual Meeting of Shareholders
YM BioSciences 2012 Annual Meeting of ShareholdersYM BioSciences 2012 Annual Meeting of Shareholders
YM BioSciences 2012 Annual Meeting of ShareholdersYMBioSciences
 
Regenozene Capstone Project Slidedeck
Regenozene Capstone Project SlidedeckRegenozene Capstone Project Slidedeck
Regenozene Capstone Project SlidedeckKawin Koh
 
Topical WBI - 1001 is effective in the treatment of mild to moderate psoriasi...
Topical WBI - 1001 is effective in the treatment of mild to moderate psoriasi...Topical WBI - 1001 is effective in the treatment of mild to moderate psoriasi...
Topical WBI - 1001 is effective in the treatment of mild to moderate psoriasi...innovaderm
 
Pharma IQ's 2nd Annual Innovation in Phase I Clinical Development
Pharma IQ's 2nd Annual Innovation in Phase I Clinical DevelopmentPharma IQ's 2nd Annual Innovation in Phase I Clinical Development
Pharma IQ's 2nd Annual Innovation in Phase I Clinical DevelopmentNicola Abbott
 
Gary Franklin
Gary FranklinGary Franklin
Gary FranklinOPUNITE
 
Economic evaluation, reimbursement and context. How to assess personalised me...
Economic evaluation, reimbursement and context. How to assess personalised me...Economic evaluation, reimbursement and context. How to assess personalised me...
Economic evaluation, reimbursement and context. How to assess personalised me...HTAi Bilbao 2012
 

What's hot (9)

Feasibility study outline (final)
Feasibility study outline (final)Feasibility study outline (final)
Feasibility study outline (final)
 
YM BioSciences 2012 Annual Meeting of Shareholders
YM BioSciences 2012 Annual Meeting of ShareholdersYM BioSciences 2012 Annual Meeting of Shareholders
YM BioSciences 2012 Annual Meeting of Shareholders
 
Regenozene Capstone Project Slidedeck
Regenozene Capstone Project SlidedeckRegenozene Capstone Project Slidedeck
Regenozene Capstone Project Slidedeck
 
COVID SITUATION IN INDIA 09.01.2022
COVID SITUATION IN INDIA 09.01.2022COVID SITUATION IN INDIA 09.01.2022
COVID SITUATION IN INDIA 09.01.2022
 
Gadobutrol presentation
Gadobutrol presentationGadobutrol presentation
Gadobutrol presentation
 
Topical WBI - 1001 is effective in the treatment of mild to moderate psoriasi...
Topical WBI - 1001 is effective in the treatment of mild to moderate psoriasi...Topical WBI - 1001 is effective in the treatment of mild to moderate psoriasi...
Topical WBI - 1001 is effective in the treatment of mild to moderate psoriasi...
 
Pharma IQ's 2nd Annual Innovation in Phase I Clinical Development
Pharma IQ's 2nd Annual Innovation in Phase I Clinical DevelopmentPharma IQ's 2nd Annual Innovation in Phase I Clinical Development
Pharma IQ's 2nd Annual Innovation in Phase I Clinical Development
 
Gary Franklin
Gary FranklinGary Franklin
Gary Franklin
 
Economic evaluation, reimbursement and context. How to assess personalised me...
Economic evaluation, reimbursement and context. How to assess personalised me...Economic evaluation, reimbursement and context. How to assess personalised me...
Economic evaluation, reimbursement and context. How to assess personalised me...
 

Viewers also liked

Viewers also liked (7)

Trius sept12confpresentation
Trius sept12confpresentationTrius sept12confpresentation
Trius sept12confpresentation
 
Portfolio
PortfolioPortfolio
Portfolio
 
Kempt and Cowan Gold Mines
Kempt and Cowan Gold MinesKempt and Cowan Gold Mines
Kempt and Cowan Gold Mines
 
Top Recruitment Trends Of 2011
Top Recruitment Trends Of 2011Top Recruitment Trends Of 2011
Top Recruitment Trends Of 2011
 
Keymet mine shaft and ore body
Keymet mine shaft and ore bodyKeymet mine shaft and ore body
Keymet mine shaft and ore body
 
Internet trends-2013
Internet trends-2013Internet trends-2013
Internet trends-2013
 
Fagan, a. an introduction to the petroleum industry
Fagan, a.   an introduction to the petroleum industryFagan, a.   an introduction to the petroleum industry
Fagan, a. an introduction to the petroleum industry
 

Similar to Trius mar13presentation

Treatment of Multidrug-resistant and Extensively Drug-Resistant Tuberculosis ...
Treatment of Multidrug-resistant and Extensively Drug-Resistant Tuberculosis ...Treatment of Multidrug-resistant and Extensively Drug-Resistant Tuberculosis ...
Treatment of Multidrug-resistant and Extensively Drug-Resistant Tuberculosis ...WAidid
 
Targovax Next generation immune activators for solid tumors
Targovax Next generation immune activators for solid tumorsTargovax Next generation immune activators for solid tumors
Targovax Next generation immune activators for solid tumorsRoarFredriksen1
 
Investor Call
Investor CallInvestor Call
Investor Callmerckir
 
barrett's esophagus in SOT patients [1440].pptx
barrett's esophagus in SOT patients [1440].pptxbarrett's esophagus in SOT patients [1440].pptx
barrett's esophagus in SOT patients [1440].pptxdrpatel5794
 
Merck asco-briefing-slides
Merck asco-briefing-slidesMerck asco-briefing-slides
Merck asco-briefing-slidesThe ScientifiK
 
ACC 2013 what did we learn
ACC 2013 what did we learnACC 2013 what did we learn
ACC 2013 what did we learnhospital
 
Remdesivir RCT in patients with severe Covid-19 (Wuhan). The Lancet
Remdesivir RCT in patients with severe Covid-19 (Wuhan). The LancetRemdesivir RCT in patients with severe Covid-19 (Wuhan). The Lancet
Remdesivir RCT in patients with severe Covid-19 (Wuhan). The LancetPROANTIBIOTICOS
 
Early phase drug development and the fda roadmap final version 2ax
Early phase drug development and the fda roadmap final version 2axEarly phase drug development and the fda roadmap final version 2ax
Early phase drug development and the fda roadmap final version 2axE. Dennis Bashaw
 
SciTech Development Company Presentation
SciTech Development Company PresentationSciTech Development Company Presentation
SciTech Development Company PresentationSciTech Development
 
HIV Alert- Novel Strategies and Agents for HIV Management.2016
HIV Alert- Novel Strategies and Agents for HIV Management.2016HIV Alert- Novel Strategies and Agents for HIV Management.2016
HIV Alert- Novel Strategies and Agents for HIV Management.2016hivlifeinfo
 
Greenwich LifeSciences (GLSI) January 2021
Greenwich LifeSciences (GLSI) January 2021Greenwich LifeSciences (GLSI) January 2021
Greenwich LifeSciences (GLSI) January 2021RedChip Companies, Inc.
 
Newer management techniques for glioblastoma
Newer management techniques for glioblastomaNewer management techniques for glioblastoma
Newer management techniques for glioblastomaabhitux
 
Beating the Beast: Best Current Pharmacological Modalities for Treating Covid...
Beating the Beast: Best Current Pharmacological Modalities for Treating Covid...Beating the Beast: Best Current Pharmacological Modalities for Treating Covid...
Beating the Beast: Best Current Pharmacological Modalities for Treating Covid...Imad Hassan
 
New perspectives in the treatment of multidrug-resistant tuberculosis - Profe...
New perspectives in the treatment of multidrug-resistant tuberculosis - Profe...New perspectives in the treatment of multidrug-resistant tuberculosis - Profe...
New perspectives in the treatment of multidrug-resistant tuberculosis - Profe...WAidid
 
Best techniques to control Genotoxities and impact of ICH M7 guideline
Best techniques to control Genotoxities and impact of ICH M7 guidelineBest techniques to control Genotoxities and impact of ICH M7 guideline
Best techniques to control Genotoxities and impact of ICH M7 guidelineBhaswat Chakraborty
 
Ctxr presentation mid-size_02.22.2019_spring.final
Ctxr presentation mid-size_02.22.2019_spring.finalCtxr presentation mid-size_02.22.2019_spring.final
Ctxr presentation mid-size_02.22.2019_spring.finalScott Martin
 

Similar to Trius mar13presentation (20)

Trius apr13presentation
Trius apr13presentationTrius apr13presentation
Trius apr13presentation
 
Treatment of Multidrug-resistant and Extensively Drug-Resistant Tuberculosis ...
Treatment of Multidrug-resistant and Extensively Drug-Resistant Tuberculosis ...Treatment of Multidrug-resistant and Extensively Drug-Resistant Tuberculosis ...
Treatment of Multidrug-resistant and Extensively Drug-Resistant Tuberculosis ...
 
Targovax Next generation immune activators for solid tumors
Targovax Next generation immune activators for solid tumorsTargovax Next generation immune activators for solid tumors
Targovax Next generation immune activators for solid tumors
 
Investor Call
Investor CallInvestor Call
Investor Call
 
barrett's esophagus in SOT patients [1440].pptx
barrett's esophagus in SOT patients [1440].pptxbarrett's esophagus in SOT patients [1440].pptx
barrett's esophagus in SOT patients [1440].pptx
 
Merck asco-briefing-slides
Merck asco-briefing-slidesMerck asco-briefing-slides
Merck asco-briefing-slides
 
ACC 2013 what did we learn
ACC 2013 what did we learnACC 2013 what did we learn
ACC 2013 what did we learn
 
Remdesivir RCT in patients with severe Covid-19 (Wuhan). The Lancet
Remdesivir RCT in patients with severe Covid-19 (Wuhan). The LancetRemdesivir RCT in patients with severe Covid-19 (Wuhan). The Lancet
Remdesivir RCT in patients with severe Covid-19 (Wuhan). The Lancet
 
Early phase drug development and the fda roadmap final version 2ax
Early phase drug development and the fda roadmap final version 2axEarly phase drug development and the fda roadmap final version 2ax
Early phase drug development and the fda roadmap final version 2ax
 
SciTech Development Company Presentation
SciTech Development Company PresentationSciTech Development Company Presentation
SciTech Development Company Presentation
 
HIV Alert- Novel Strategies and Agents for HIV Management.2016
HIV Alert- Novel Strategies and Agents for HIV Management.2016HIV Alert- Novel Strategies and Agents for HIV Management.2016
HIV Alert- Novel Strategies and Agents for HIV Management.2016
 
Greenwich LifeSciences (GLSI) January 2021
Greenwich LifeSciences (GLSI) January 2021Greenwich LifeSciences (GLSI) January 2021
Greenwich LifeSciences (GLSI) January 2021
 
Cypher Stent - SIRIUS Trial
Cypher Stent - SIRIUS TrialCypher Stent - SIRIUS Trial
Cypher Stent - SIRIUS Trial
 
Newer management techniques for glioblastoma
Newer management techniques for glioblastomaNewer management techniques for glioblastoma
Newer management techniques for glioblastoma
 
Effortles Trial
Effortles TrialEffortles Trial
Effortles Trial
 
M crpc
M crpcM crpc
M crpc
 
Beating the Beast: Best Current Pharmacological Modalities for Treating Covid...
Beating the Beast: Best Current Pharmacological Modalities for Treating Covid...Beating the Beast: Best Current Pharmacological Modalities for Treating Covid...
Beating the Beast: Best Current Pharmacological Modalities for Treating Covid...
 
New perspectives in the treatment of multidrug-resistant tuberculosis - Profe...
New perspectives in the treatment of multidrug-resistant tuberculosis - Profe...New perspectives in the treatment of multidrug-resistant tuberculosis - Profe...
New perspectives in the treatment of multidrug-resistant tuberculosis - Profe...
 
Best techniques to control Genotoxities and impact of ICH M7 guideline
Best techniques to control Genotoxities and impact of ICH M7 guidelineBest techniques to control Genotoxities and impact of ICH M7 guideline
Best techniques to control Genotoxities and impact of ICH M7 guideline
 
Ctxr presentation mid-size_02.22.2019_spring.final
Ctxr presentation mid-size_02.22.2019_spring.finalCtxr presentation mid-size_02.22.2019_spring.final
Ctxr presentation mid-size_02.22.2019_spring.final
 

More from Company Spotlight

Presentation Clayton Valley, NevadaFrom Drilling to PEA in under 2 Years
Presentation Clayton Valley, NevadaFrom Drilling to PEA in under 2 YearsPresentation Clayton Valley, NevadaFrom Drilling to PEA in under 2 Years
Presentation Clayton Valley, NevadaFrom Drilling to PEA in under 2 YearsCompany Spotlight
 
Cypress Development Corp. Investor Presentation
Cypress Development Corp. Investor PresentationCypress Development Corp. Investor Presentation
Cypress Development Corp. Investor PresentationCompany Spotlight
 
Aben Resources Ltd. Corporate Presentation
Aben Resources Ltd. Corporate PresentationAben Resources Ltd. Corporate Presentation
Aben Resources Ltd. Corporate PresentationCompany Spotlight
 
Cypress Development Corp. Corporate Presentation
Cypress Development Corp. Corporate PresentationCypress Development Corp. Corporate Presentation
Cypress Development Corp. Corporate PresentationCompany Spotlight
 
Cypress Development Corp. Presentation
Cypress Development Corp. PresentationCypress Development Corp. Presentation
Cypress Development Corp. PresentationCompany Spotlight
 
Aben Resources Ltd. Presentation
Aben Resources Ltd. PresentationAben Resources Ltd. Presentation
Aben Resources Ltd. PresentationCompany Spotlight
 
Aben Resources Ltd. Corporate Presentation
Aben Resources Ltd. Corporate PresentationAben Resources Ltd. Corporate Presentation
Aben Resources Ltd. Corporate PresentationCompany Spotlight
 
Cypress Development Corp. Presentation
Cypress Development Corp. PresentationCypress Development Corp. Presentation
Cypress Development Corp. PresentationCompany Spotlight
 
Aben Resources Ltd. Presentation
Aben Resources Ltd. PresentationAben Resources Ltd. Presentation
Aben Resources Ltd. PresentationCompany Spotlight
 
Cypress Development Corp. Corporate Presentation
Cypress Development Corp. Corporate PresentationCypress Development Corp. Corporate Presentation
Cypress Development Corp. Corporate PresentationCompany Spotlight
 
TerraX Minerals - Corporate Presentation
TerraX Minerals - Corporate PresentationTerraX Minerals - Corporate Presentation
TerraX Minerals - Corporate PresentationCompany Spotlight
 
Aben Resources Ltd. Corporate Presentation
Aben Resources Ltd. Corporate PresentationAben Resources Ltd. Corporate Presentation
Aben Resources Ltd. Corporate PresentationCompany Spotlight
 
TerraX Minerals, Inc. Corporate Presentation
TerraX Minerals, Inc. Corporate PresentationTerraX Minerals, Inc. Corporate Presentation
TerraX Minerals, Inc. Corporate PresentationCompany Spotlight
 
Cypress Development Corp. Presentation
Cypress Development Corp. PresentationCypress Development Corp. Presentation
Cypress Development Corp. PresentationCompany Spotlight
 
Cypress Development Corp. Corporate Presentation
Cypress Development Corp. Corporate PresentationCypress Development Corp. Corporate Presentation
Cypress Development Corp. Corporate PresentationCompany Spotlight
 

More from Company Spotlight (20)

Presentation Clayton Valley, NevadaFrom Drilling to PEA in under 2 Years
Presentation Clayton Valley, NevadaFrom Drilling to PEA in under 2 YearsPresentation Clayton Valley, NevadaFrom Drilling to PEA in under 2 Years
Presentation Clayton Valley, NevadaFrom Drilling to PEA in under 2 Years
 
Aben resources presentation
Aben resources presentationAben resources presentation
Aben resources presentation
 
Aben Resources Ltd.
Aben Resources Ltd.Aben Resources Ltd.
Aben Resources Ltd.
 
Cypress Development Corp. Investor Presentation
Cypress Development Corp. Investor PresentationCypress Development Corp. Investor Presentation
Cypress Development Corp. Investor Presentation
 
Aben Resources Ltd. Corporate Presentation
Aben Resources Ltd. Corporate PresentationAben Resources Ltd. Corporate Presentation
Aben Resources Ltd. Corporate Presentation
 
Cypress Development Corp. Corporate Presentation
Cypress Development Corp. Corporate PresentationCypress Development Corp. Corporate Presentation
Cypress Development Corp. Corporate Presentation
 
Aben Resources Ltd.
Aben Resources Ltd.Aben Resources Ltd.
Aben Resources Ltd.
 
Cypress Development Corp. Presentation
Cypress Development Corp. PresentationCypress Development Corp. Presentation
Cypress Development Corp. Presentation
 
Aben Resources Ltd. Presentation
Aben Resources Ltd. PresentationAben Resources Ltd. Presentation
Aben Resources Ltd. Presentation
 
Aben Resources Ltd. Corporate Presentation
Aben Resources Ltd. Corporate PresentationAben Resources Ltd. Corporate Presentation
Aben Resources Ltd. Corporate Presentation
 
Cypress Development Corp. Presentation
Cypress Development Corp. PresentationCypress Development Corp. Presentation
Cypress Development Corp. Presentation
 
Aben Resources Ltd. Presentation
Aben Resources Ltd. PresentationAben Resources Ltd. Presentation
Aben Resources Ltd. Presentation
 
Cypress Development Corp. Corporate Presentation
Cypress Development Corp. Corporate PresentationCypress Development Corp. Corporate Presentation
Cypress Development Corp. Corporate Presentation
 
TerraX Minerals - Corporate Presentation
TerraX Minerals - Corporate PresentationTerraX Minerals - Corporate Presentation
TerraX Minerals - Corporate Presentation
 
Aben Resources Ltd. Corporate Presentation
Aben Resources Ltd. Corporate PresentationAben Resources Ltd. Corporate Presentation
Aben Resources Ltd. Corporate Presentation
 
Cypress Development Corp
Cypress Development CorpCypress Development Corp
Cypress Development Corp
 
TerraX Minerals, Inc. Corporate Presentation
TerraX Minerals, Inc. Corporate PresentationTerraX Minerals, Inc. Corporate Presentation
TerraX Minerals, Inc. Corporate Presentation
 
Cypress Development Corp. Presentation
Cypress Development Corp. PresentationCypress Development Corp. Presentation
Cypress Development Corp. Presentation
 
Cypress Development Corp
Cypress Development CorpCypress Development Corp
Cypress Development Corp
 
Cypress Development Corp. Corporate Presentation
Cypress Development Corp. Corporate PresentationCypress Development Corp. Corporate Presentation
Cypress Development Corp. Corporate Presentation
 

Recently uploaded

Independent Call Girls Andheri Nightlaila 9967584737
Independent Call Girls Andheri Nightlaila 9967584737Independent Call Girls Andheri Nightlaila 9967584737
Independent Call Girls Andheri Nightlaila 9967584737Riya Pathan
 
Darshan Hiranandani [News About Next CEO].pdf
Darshan Hiranandani [News About Next CEO].pdfDarshan Hiranandani [News About Next CEO].pdf
Darshan Hiranandani [News About Next CEO].pdfShashank Mehta
 
PSCC - Capability Statement Presentation
PSCC - Capability Statement PresentationPSCC - Capability Statement Presentation
PSCC - Capability Statement PresentationAnamaria Contreras
 
Entrepreneurship lessons in Philippines
Entrepreneurship lessons in  PhilippinesEntrepreneurship lessons in  Philippines
Entrepreneurship lessons in PhilippinesDavidSamuel525586
 
APRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdfAPRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdfRbc Rbcua
 
TriStar Gold Corporate Presentation - April 2024
TriStar Gold Corporate Presentation - April 2024TriStar Gold Corporate Presentation - April 2024
TriStar Gold Corporate Presentation - April 2024Adnet Communications
 
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptxThe-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptxmbikashkanyari
 
(Best) ENJOY Call Girls in Faridabad Ex | 8377087607
(Best) ENJOY Call Girls in Faridabad Ex | 8377087607(Best) ENJOY Call Girls in Faridabad Ex | 8377087607
(Best) ENJOY Call Girls in Faridabad Ex | 8377087607dollysharma2066
 
Investment in The Coconut Industry by Nancy Cheruiyot
Investment in The Coconut Industry by Nancy CheruiyotInvestment in The Coconut Industry by Nancy Cheruiyot
Investment in The Coconut Industry by Nancy Cheruiyotictsugar
 
FULL ENJOY Call girls in Paharganj Delhi | 8377087607
FULL ENJOY Call girls in Paharganj Delhi | 8377087607FULL ENJOY Call girls in Paharganj Delhi | 8377087607
FULL ENJOY Call girls in Paharganj Delhi | 8377087607dollysharma2066
 
International Business Environments and Operations 16th Global Edition test b...
International Business Environments and Operations 16th Global Edition test b...International Business Environments and Operations 16th Global Edition test b...
International Business Environments and Operations 16th Global Edition test b...ssuserf63bd7
 
Call Us 📲8800102216📞 Call Girls In DLF City Gurgaon
Call Us 📲8800102216📞 Call Girls In DLF City GurgaonCall Us 📲8800102216📞 Call Girls In DLF City Gurgaon
Call Us 📲8800102216📞 Call Girls In DLF City Gurgaoncallgirls2057
 
Call Girls Contact Number Andheri 9920874524
Call Girls Contact Number Andheri 9920874524Call Girls Contact Number Andheri 9920874524
Call Girls Contact Number Andheri 9920874524najka9823
 
PB Project 1: Exploring Your Personal Brand
PB Project 1: Exploring Your Personal BrandPB Project 1: Exploring Your Personal Brand
PB Project 1: Exploring Your Personal BrandSharisaBethune
 
8447779800, Low rate Call girls in Saket Delhi NCR
8447779800, Low rate Call girls in Saket Delhi NCR8447779800, Low rate Call girls in Saket Delhi NCR
8447779800, Low rate Call girls in Saket Delhi NCRashishs7044
 
8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCR
8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCR8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCR
8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCRashishs7044
 

Recently uploaded (20)

Call Us ➥9319373153▻Call Girls In North Goa
Call Us ➥9319373153▻Call Girls In North GoaCall Us ➥9319373153▻Call Girls In North Goa
Call Us ➥9319373153▻Call Girls In North Goa
 
Independent Call Girls Andheri Nightlaila 9967584737
Independent Call Girls Andheri Nightlaila 9967584737Independent Call Girls Andheri Nightlaila 9967584737
Independent Call Girls Andheri Nightlaila 9967584737
 
Corporate Profile 47Billion Information Technology
Corporate Profile 47Billion Information TechnologyCorporate Profile 47Billion Information Technology
Corporate Profile 47Billion Information Technology
 
Japan IT Week 2024 Brochure by 47Billion (English)
Japan IT Week 2024 Brochure by 47Billion (English)Japan IT Week 2024 Brochure by 47Billion (English)
Japan IT Week 2024 Brochure by 47Billion (English)
 
Darshan Hiranandani [News About Next CEO].pdf
Darshan Hiranandani [News About Next CEO].pdfDarshan Hiranandani [News About Next CEO].pdf
Darshan Hiranandani [News About Next CEO].pdf
 
PSCC - Capability Statement Presentation
PSCC - Capability Statement PresentationPSCC - Capability Statement Presentation
PSCC - Capability Statement Presentation
 
Entrepreneurship lessons in Philippines
Entrepreneurship lessons in  PhilippinesEntrepreneurship lessons in  Philippines
Entrepreneurship lessons in Philippines
 
APRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdfAPRIL2024_UKRAINE_xml_0000000000000 .pdf
APRIL2024_UKRAINE_xml_0000000000000 .pdf
 
TriStar Gold Corporate Presentation - April 2024
TriStar Gold Corporate Presentation - April 2024TriStar Gold Corporate Presentation - April 2024
TriStar Gold Corporate Presentation - April 2024
 
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptxThe-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
The-Ethical-issues-ghhhhhhhhjof-Byjus.pptx
 
(Best) ENJOY Call Girls in Faridabad Ex | 8377087607
(Best) ENJOY Call Girls in Faridabad Ex | 8377087607(Best) ENJOY Call Girls in Faridabad Ex | 8377087607
(Best) ENJOY Call Girls in Faridabad Ex | 8377087607
 
Investment in The Coconut Industry by Nancy Cheruiyot
Investment in The Coconut Industry by Nancy CheruiyotInvestment in The Coconut Industry by Nancy Cheruiyot
Investment in The Coconut Industry by Nancy Cheruiyot
 
FULL ENJOY Call girls in Paharganj Delhi | 8377087607
FULL ENJOY Call girls in Paharganj Delhi | 8377087607FULL ENJOY Call girls in Paharganj Delhi | 8377087607
FULL ENJOY Call girls in Paharganj Delhi | 8377087607
 
International Business Environments and Operations 16th Global Edition test b...
International Business Environments and Operations 16th Global Edition test b...International Business Environments and Operations 16th Global Edition test b...
International Business Environments and Operations 16th Global Edition test b...
 
Call Us 📲8800102216📞 Call Girls In DLF City Gurgaon
Call Us 📲8800102216📞 Call Girls In DLF City GurgaonCall Us 📲8800102216📞 Call Girls In DLF City Gurgaon
Call Us 📲8800102216📞 Call Girls In DLF City Gurgaon
 
Call Girls Contact Number Andheri 9920874524
Call Girls Contact Number Andheri 9920874524Call Girls Contact Number Andheri 9920874524
Call Girls Contact Number Andheri 9920874524
 
PB Project 1: Exploring Your Personal Brand
PB Project 1: Exploring Your Personal BrandPB Project 1: Exploring Your Personal Brand
PB Project 1: Exploring Your Personal Brand
 
8447779800, Low rate Call girls in Saket Delhi NCR
8447779800, Low rate Call girls in Saket Delhi NCR8447779800, Low rate Call girls in Saket Delhi NCR
8447779800, Low rate Call girls in Saket Delhi NCR
 
Enjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCR
Enjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCREnjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCR
Enjoy ➥8448380779▻ Call Girls In Sector 18 Noida Escorts Delhi NCR
 
8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCR
8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCR8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCR
8447779800, Low rate Call girls in Kotla Mubarakpur Delhi NCR
 

Trius mar13presentation

  • 1. 1 The Future of Anti-Infectives ESTABLISH 2 Top Line Data Release March 25, 2013
  • 2. 2 Forward Looking Statements Statements contained in this data release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward- looking statements include: the accuracy of Trius’ estimates regarding expenses, future revenues and capital requirements; the success and timing of Trius’ preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; changes in Trius’ plans to develop and commercialize its product candidates; Trius’ ability to obtain additional financing; Trius’ ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Trius’ most recently filed SEC documents, including its Form 10-K, Forms 10-Q and other documents filed with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in such filings. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trius undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
  • 3. 3 ESTABLISH 2 (IV/PO) Phase 3 Trial Design 2o EMA 1o EMA Tedizolid Linezolid 1x 200mg 2x 600mg n=666 1o FDA 2o FDA Placebo Post-Treatment Evaluations END-POINTS FOR GLOBAL REGISTRATION Safety Analysis Non-inferiority trial design vs Linezolid
  • 4. 4 ESTABLISH 2 Primary & Secondary Endpoints Primary Endpoint: • 20% or greater reduction in lesion area at 48-72 hours after first dose of drug Secondary Endpoints: • Programmatic clinical response at end of therapy (EOT) • Investigator’s assessment of clinical response at post treatment evaluation (PTE)
  • 5. 5 ESTABLISH 2 Demographics and Baseline Characteristics Tedizolid, % n = 332 Linezolid, % n = 334 Male, % 67.8 64.1 Age, mean 45.6 45.6 Geographic Region, % North America (US) 47.0 47.3 Ex-U.S. 53.0 52.7 Clinical Syndrome, % Cellulitis/erysipelas 50.0 50.3 Major abscess 20.5 20.4 Wound infection 29.5 29.3 MRSA (MITT), % 27.2 26.9 MSSA (MITT), % 52.8 53.0 Lymphadenopathy, % 70.8 70.4 WBC < 4,000 or > 10,000, % 53.0 45.2 Immature neutrophils, % 16.2 12.2 Fever, % 31.0 29.0
  • 6. 6 ESTABLISH 2 Efficacy ITT Analysis Set Endpoint Tedizolid 6 days treatment, % n = 332 Linezolid 10 days treatment, % n = 334 Treatment Difference (95% CI), % Primary Endpoint ≥20% decrease from baseline in lesion area at 48-72 hours 85.2 82.6 2.6 (-3.0 to 8.2) Key Secondary Endpoints Sustained clinical response at end of therapy 87.0 88.0 -1.0 (-6.1 to 4.1) Investigators assessment of clinical response at 7-14 days after end of therapy 88.0 87.7 0.3 (-4.8 to 5.3) Sensitivity analysis (2010 Guidance) Cessation of lesion spread and absence of fever at 48-72 hrs 85.8 81.4 4.4 (-1.2 to 10.1)
  • 7. 7 ESTABLISH 2 Efficacy by Infection Type ITT Analysis Set Tedizolid 6 days treatment, % n = 332 Linezolid 10 days treatment, % n = 334 Treatment Difference (95% CI), % Cellulitis/erysipelas 80.7 n = 166 80.4 n = 168 0.37 (-8.2 to 8.9) Major cutaneous abscess 86.8 n = 68 89.7 n = 68 -2.9 (-14.5 to 8.4) Wound infection 91.8 n = 98 81.6 n = 98 10.2 (0.71 to 20.1)
  • 8. 8 ESTABLISH 2 Safety: Tedizolid was Safe and Well Tolerated with a Favorable AE Profile vs Linezolid Safety Analysis Set Tedizolid 6 days treatment, % Linezolid 10 days treatment, % Any Treatment Emergent Adverse Event (TEAE) 45.3 43.7 Any Drug Related TEAE 20.5 24.8 Gastrointestinal Disorders 16.0 20.5 No Safety Signals
  • 9. 9 ESTABLISH 2 Incidence of TEAEs >2% System Organ Class Tedizolid, (%) n = 331 Linezolid, (%) n =327 Gastrointestinal disorders 53 (16.0) 67 (20.5) General disorders and administration site conditions 23 (6.9) 24 (7.3) Infections and infestations 40 (12.1) 40 (12.2) Metabolism and nutrition disorders 9 (2.7) 7 (2.1) Musculoskeletal and connective tissue disorders 9 (2.7) 9 (2.8) Nervous system disorders 29 (8.8) 36 (11.0) Psychiatric disorders 10 (3.0) 4 (1.2) Respiratory, thoracic and mediastinal disorders 6 (1.8) 13 (4.0) Skin and subcutaneous tissue disorders 21 (6.3) 24 (7.3) Vascular disorders 7 (2.1) 4 (1.2)
  • 10. 10 ESTABLISH 2 Post-Baseline Substantially Abnormal Hematology Values Tedizolid, (%) n = 331 Linezolid, (%) n =327 Hemoglobin 292 287 Below LLN 147 (50.3) 148 (51.6) Substantially abnormal 4 (1.4) 2 (0.7) White blood cells 272 258 Below LLN 16 (5.9) 20 (7.8) Substantially abnormal 3 (1.1) 5 (1.9) Platelets 275 269 Below LLN 37 (13.5) 35 (13.0) Substantially abnormal 9 (3.3) 5 (1.9)
  • 11. 11 Differences Between ESTABLISH 1 and 2 ESTABLISH 2 ESTABLISH 1 Dosing IV to oral (minimum 1st day’s dosing IV) Oral Demographics US 47%, x-US 53% US 80%, x-US 20% MRSA, % 27.1 42.6 Primary Endpoint* > 20% reduction in lesion area @ 48 to 72 hrs Cessation of lesion spread, absence of fever @ 48 to 72 hrs *ESTABLISH 2 SPA amended under agreement with FDA to reflect expected new primary endpoint. Both endpoints prospectively captured as sensitivity analyses in respective studies. Integrated summary of efficacy will reflect the ESTABLISH 2 primary endpoint under the amended SPAs
  • 12. 12 ESTABLISH Program Comparison Endpoint Study Tedizolid 6 days treatment, % Linezolid 10 days treatment, % Treatment Difference (95% CI), % ≥20% decrease from baseline in lesion area at 48-72 hours ESTABLISH 2 ESTABLISH 1 85.2 78.0 82.6 76.1 2.6 (-3.0 to 8.2) 1.9 (-4.5 to 8.3) Sustained clinical response at end of therapy ESTABLISH 2 ESTABLISH 1 87.0 87.0 88.0 87.8 -1.0 (-6.1 to 4.1) -0.8 (-5.8 to 4.4) Investigators assessment of clinical response at 7- 14 days after end of therapy ESTABLISH 2 ESTABLISH 1 88.0 85.5 87.7 86.0 0.3 (-4.8 to 5.3) -0.5 (-5.8 to 4.9) Cessation of lesion spread and absence of fever at 48-72 hrs ESTABLISH 2 ESTABLISH 1 85.8 79.5 81.4 79.4 4.4 (-1.2 to 10.1) 0.1 (-6.1 to 6.2)
  • 13. 13 ESTABLISH Program Safety Comparison Safety Analysis Set Study Tedizolid % Linezolid % Any Treatment Emergent Adverse Event (TEAE) ESTABLISH 2 45.3 43.7 ESTABLISH 1 40.8 43.3 Any Drug Related TEAE ESTABLISH 2 20.5 24.8 ESTABLISH 1 24.2 31.0 Gastrointestinal Disorders ESTABLISH 2 16.0 20.5 ESTABLISH 1 16.3 25.4
  • 14. 14 Summary • All primary and secondary efficacy endpoints were met for FDA and EMA • Safety profile indicated that tedizolid was safe and well tolerated • Results are consistent with those from ESTABLISH 1 and support filings for global regulatory approval • Combined results of all clinical studies support tedizolid differentiation: – Safe, well tolerated, fast acting drug for resistant gram positive infections – Convenient once daily IV or oral administration over short course of therapy – Fewer drug-drug interactions – Active against key linezolid resistant strains
  • 15. 15 *Efficacy performance ratings among those aware of brand Tedizolid ATU Study, Wave 1 – USA Report, conducted by CMI on behalf of Trius, November 2012, N=505 Strong Response to Tedizolid Efficacy, Dosing and Administration* Tedizolid, 65% Tedizolid, 52% Zyvox, 62% Zyvox, 42% Cubicin, 54% Cubicin, 37% Vancomycin, 25% Vancomycin, 27% Offers simple dosing and administration Has a lower potential for resistance development KeyDriversof MarketShare KeyDriversof Preference Tedizolid, 45% Tedizolid, 42% Zyvox, 45% Zyvox, 38% Cubicin, 42% Cubicin, 37% Vancomycin, 30% Vancomycin, 30% Has superior efficacy vs. other products Is effective for all patient types
  • 16. 16 Strong Response to Tedizolid Safety & TolerabilityKeyDriversof MarketShare Tedizolid, 48% Tedizolid, 53% Tedizolid, 59% Zyvox, 27% Zyvox, 45% Zyvox, 31% Cubicin, 48% Cubicin, 42% Cubicin, 44% Vancomycin, 39% Vanco., 14% Vancomycin, 25% Has a low frequency of DDI (drug-drug interaction) Does not cause renal and hepatic impairment Has a low frequency of safety/adverse events *Efficacy performance ratings among those aware of brand Tedizolid ATU Study, Wave 1 – USA Report, conducted by CMI on behalf of Trius, November 2012, N=505
  • 17. 17 80% 69% 74% 72% 76% 92% 83% 19% 31% 25% 27% 23% 7% 17% High Interest (8-10) Neutral (4-7) Low Interest (1-3) Tedizolid ATU Study, Wave 1 – USA Report, conducted by CMI on behalf of Trius, November 2012, N=505 Base: Total respondents Q8.1 How interesting is tedizolid to you for suspected or confirmed MRSA ABSSSI patients overall? Use a 1 to 10 scale where “1” means “Not at all Interesting” and “10” means “Very Interesting,” to indicate your level of interest. Interest in Tedizolid, by Specialty (0 = Not Interested, 10 = Very Interested) Physician Interest in Tedizolid Strong Across Specialties Total (N = 505) Critical Care, Pulmonologist (n = 120) Internist (n = 137) General Surgeon (n = 86) Hospitalist (n = 175) Infectious Disease Specialist (n = 101) Infusion Clinic Specialist (n = 75)
  • 18. 18 Upcoming Milestones • Late breaker presentations at ECCMID conference (submitted for April) • Detailed data presentations at ICAAC conference (September) • Advance EU partnership discussions • NDA Filing (H2 2013) • Implement pre-commercial activities for potential U.S. launch (H2 2013) • Initiation of Phase 3 ventilated nosocomial pneumonia study (H2 2013) • EMA Filing (H1 2014) • Potential PDUFA date for ABSSSI (mid 2014)