credit suisse health care conference · asunaprevir (asv) potent ns3 inhibitor peginterferon lambda...
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Credit SuisseHealth Care Conference
Doug Manion
Senior Vice President, Development
Virology, Neuroscience and Japan
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November 14, 2012
NOT FOR PRODUCT PROMOTIONAL USE
Forward-Looking Information
During this meeting, we will make statements about the Company’s future plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995.Actual results may differ materially from those indicated as a result of various important factors, including those discussedin the company’s most recent annual report on Form 10-K and reports on Form 10-Q and Form 8-K. These documents are available from the SEC, the Bristol-Myers Squibb website orfrom Bristol-Myers Squibb Investor Relations.
In addition, any forward-looking statements represent our estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some pointin the future, we specifically disclaim any obligation to do so,even if our estimates change.
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NME Development Portfolio
ONC IMMMET VIR NSCV
NULOJIX ®YERVOYTM
Dapagliflozin
ELIQUISTM
***
Brivanib
ORENCIA®
ONGLYZA® /
KOMBIGLYZETM
XR
ABILIFY®
SUSTIVA® /ATRIPLA®
REYATAZ®
BARACLUDE®ERBITUX®
SPRYCEL®
CCR1
Antagonists
Anti-IP10
11βHSDInhibitor
PCSK9 Adnectin
CCR2 / 5 Antagonists
IKur Antagonists
IKACh Inhibitor
LXR Modulators
Triple Reuptake Inhibitor
Microtubule Stabilizer
Avagacestat(Gamma Secretase
Inhibitor)
NS5B Non Nuc
Peginterferonlambda-1a
HIV Attachment Inhibitor
Daclatasvir(NS5A Inhibitor)
Asunaprevir(NS3 Inhibitor)
IGF-1R
Antagonist
Urelumab(Anti-CD137)
SMO Antagonist
IL-21
Elotuzumab
Anti-PD1
Anti-CXCR4
JAK2 Inhibitor
Anti-PD-L1
Exploratory Development *Full
Development ^Marketed Product
Development †
* Post discovery through Phase II
^ Registrational program
† Approved in at least one major market
Anti-IL6
Anti-CD28
GPR119 Agonists
IL-23 Adnectin
Necitumumab
GABA/Nicotinic Modulator
CGRP Antagonist
Notch Inhibitor
a-7 Nicotinic Agonist
Ab Modulator
NS5B Primer Grip Inhibitor
NRT Inhibitor
Data as of June 30, 2012
HIV Maturation Inhibitor
Anti-IL31
PEG-FGF21
LPA1 Antagonist
Anti-CD40L
NS5A Second Generation
NS5B Site 1Inhibitor
Anti-LAG3
Anti-KIR
*** ELIQUIS is approved for VTE Prevention in the EU
Factor XIaParenteral
Anti- CD40
Anti-IL23
Anti-Fucosyl GM1
Metreleptin**
SYMLIN®**
BYETTA® /
BYDUREONTM
**
** Amylin compounds added on August 9, 2012
INX-189 was removed on August 23, 2012
AntidiabeticPeptide**
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NOT FOR PRODUCT PROMOTIONAL USE
Discontinuation of BMS-986094 disappointing
We believe we are well positioned with a broad portfolio designed to address needs across a number of patient populations and geographies
We continue to explore strategic partnerships to complement our internal portfolio
BMS Commitment to HCV
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BMS Strategy: A Multipronged Approach to Optimize Hepatitis C Opportunity
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Pegylated
Interferon-a
+
Ribavirin
+
Telaprevir or
Boceprevir
Direct Acting Antiviral(s)+/-
Ribavirin
Novel Lambda Interferon+/-
Direct Acting Antiviral(s) +/-Ribavirin
Pegylated Interferon-a + Ribavirin+
Direct Acting Antiviral(s)
Current Standard of Care Potential Future Treatment Options
NOT FOR PRODUCT PROMOTIONAL USE
Broad Late-Stage HCV Portfolio ProvidesMultiple Approaches to Possible New Treatments
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Asset Description
Daclatasvir (DCV) First-in-class NS5A inhibitor
Asunaprevir (ASV) Potent NS3 Inhibitor
Peginterferon
Lambda
Novel Type III interferon
from ZymoGenetics
BMS-791325Potent Non-Nucleos(t)ide
NS5B Inhibitor
Leveraging key partnerships to
complement our internal portfolio
NOT FOR PRODUCT PROMOTIONAL USE 7
PEG -IFNα/R =Pegylated-Interferon Alfa + ribavirin
Daclatasvir
(DCV)
Combinations with PEG-IFNα/R
– Ph III studies ongoing
Asunaprevir
(ASV)
Dual therapy (DCV + ASV)
– Ph III study ongoing in Japan
– Ph III initiated in US, EU
Quad therapy (DCV + ASV + PEG-IFNα/R)
to start in 2012
Peginterferon
Lambda
Ph III studies in HCV begun
Ph II ongoing in hepatitis B
NS5B Non-
Nuc Inhibitor
Triple therapy (DCV + ASV +’325 )
– Ph II study expanded to enable Phase III
start in first half 2014
Key HCV Development Programs: Using Different Combinations for Different Patient Segments
NOT FOR PRODUCT PROMOTIONAL USE
All-Oral Regimen for GT1b:Dual Therapy of Daclatasvir + Asunaprevir
Phase II data showed high rates of sustained virologicresponse in GT1b Japanese patients (null responders or ineligible/intolerant to PEG -IFNα/R)
Phase III registrational study in Japanese GT1b null responders and ineligible/intolerant patients
– Data expected in mid-2013 with potential filing at the
end of 2013
– Potential for first all-oral regimen to market in Japan
Exploring options to augment this program globally andto include additional studies in naïve GT1b patients
PEG -IFNα/R =Pegylated-Interferon Alfa + ribavirin
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NOT FOR PRODUCT PROMOTIONAL USE 9
Triple Therapy: Daclatasvir + Asunaprevir +BMS-791325 – Results of Phase II 12 Week Therapy
First company to study triple DAA regimen that is
interferon-, ritonavir-, and ribavirin-free
94% (15/16) subjects achieved SVR4
– 12/12 GT1a subjects achieved SVR4
– 1 Subject (GT1b) lost to follow-up (3/3 observed
achieved SVR4)
– No viral breakthrough in either group
– No viral relapse to date
Safety results consistent with favorable risk/benefit profile
Ph II ongoing; Ph III registrational program planned
for 1H 2014
HCV RNA Endpoints Modified Intention-to-Treat Analysis
a Includes 1 patient with HCV RNA 118 IU/mL at last on-treatment visit but < LLOQTND 2 and 4 weeks
posttreatment (SVR4).b EOT, end of treatment; includes patients who discontinued prior to the protocol-defined last treatment visit.
< LLOQTD or TND, HCV RNA below assay lower limit of quantitation (25 IU/mL) and target detected (LLOQTD) or target not detected
(LLOQTND); HCV RNA < LOD ≈ 10 IU/mL, previously reported as HCV RNA undetectable); PT, posttreatment.
Study Week
Pa
tie
nts
ach
ievin
g
end
po
int
(%)
0102030405060708090
100
4 12 EOT SVR SVR
0102030405060708090
100
4 12 EOT SVR4
Missing data
HCV RNA < LLOQTD or TND
24-Week TreatmentGroup 1, N = 16
Missing data
HCV RNA < LLOQTD or TND
12-Week TreatmentGroup 2, N = 16
100 88 100 94 94 % < LLOQTD or TND
bb
Everson GT, et al. AASLD 2012. Oral LB-310
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100 94 94a 94
NOT FOR PRODUCT PROMOTIONAL USE
Number of Patients (%)
24-Wk
Treatment
Group 1, N=16
12-Wk
Treatment
Group 2, N=16
Total
N = 32
Serious AEs a 0 1 (6) 1 (3)
AEs leading to discontinuation 0 0 0
Grade 3–4 AE b 0 1 (6) 1 (3)
Grade 3–4 laboratory abnormalities c
0 1 (6) 1 (3)
AE in > 10% of patients in combined treatment groups
Headache 4 (25) 6 (38) 10 (31)
Diarrhea 2 (13) 6 (38) 8 (25)
Asthenia 2 (13) 3 (19) 5 (16)
a Renal calculus, considered by the investigator to be unrelated to study therapy.b Grade 3 headache, resolved after 7 days with continued study treatment.c Lymphopenia at a single study visit concomitant with influenza; there were no grade 3–4 bilirubin
or transaminase elevations.
Safety, Adverse Events, and Laboratory Abnormalities On Treatment
Everson GT, et al. AASLD 2012. Oral LB-311
NOT FOR PRODUCT PROMOTIONAL USE
BMS in HCV – in Summary
Daclatasvir – potential first in class and key component of multiple regimens in late stage development
BMS potentially delivering first all oral therapyin Japan in GT1b patients
Promising Ph II data recently presented from triple DAA therapy (daclatasvir + asunaprevir + ‘325)
Lambda is an opportunity in both HCV and HBV
Partnerships to complement our internal portfolio
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Credit SuisseHealth Care Conference
Doug Manion
Senior Vice President, Development
Virology, Neuroscience and Japan
13
November 14, 2012