Investigational Direct-Acting Antiviral BMS-790052 Plus PEG-Interferon Alfa and Ribavirin Achieved Up to 92% Sustained Virologic Response in Phase II Dose-Ranging Study of Treatment-Naïve Hepatitis C Patients

[Guest guest]

http://www.therapeuticsdaily.com/news/article.cfm?contentValue=771711 & contentTyp\

e=newsarchive & channelID=26

Investigational Direct-Acting Antiviral BMS-790052 Plus PEG-Interferon Alfa and

Ribavirin Achieved Up to 92% Sustained Virologic Response in Phase II

Dose-Ranging Study of Treatment-Naïve Hepatitis C Patients

From the PharmaLive.com News Archive - Mar. 31, 2011

Adverse event profile of regimen containing BMS-790052 was consistent with that

of treatment with PEG-Interferon alfa and ribavirin alone

PRINCETON, N.J.--(BUSINESS WIRE)--Mar 31, 2011 - Bristol-Myers Squibb Company

(NYSE: BMY) today announced results from a Phase II clinical trial in which

treatment with the investigational direct-acting antiviral (DAA) BMS-790052, an

NS5A replication complex inhibitor, in combination with PEG-Interferon alfa and

ribavirin (RBV), achieved sustained virologic response 12 weeks post-treatment

(SVR12) in up to 92% of treatment-naïve patients chronically infected with

hepatitis C (HCV) genotype 1 (10 mg dose arm, n=12). Adverse events and serious

adverse events were consistent with those reported in the PEG-Interferon alfa

and ribavirin arm and were comparable across all doses of BMS-790052. These data

were reported today for the first time in a late-breaker poster session at the

International Liver Congress, the 46th annual meeting of the European

Association for the Study of the Liver (EASL) in Berlin, Germany.

“There currently exists a medical need for new medicines or new combinations of

medicines for hepatitis C patients as many hepatitis C patients have limited

success on the currently available treatments,” said Stanislas Pol, MD, PhD,

Professor of Hepatology at Université Paris V (René Descartes), Paris, France

and head of the Hepatology unit at Cochin Hospital, Paris, France. “The results

of this study warrant further clinical investigation of adding Bristol-Myers

Squibb's investigational compound BMS-790052 to the current medicines to

evaluate its potential to address this unmet treatment need.”

Study Results

The primary endpoint of the study was the proportion of patients with extended

rapid virologic response (eRVR) defined as undetectable viral load (HCV RNA < 10

IU/mL) at both Weeks 4 and 12. BMS-790052 plus PEG-interferon alfa and ribavirin

achieved higher rates of SVR12 compared to PEG-interferon alfa and ribavirin

alone, across all BMS-790052 treatment groups [bMS-790052: 60 mg: 83% (10/12

patients), 10 mg: 92% (11/12 patients), 3 mg: 42% (5/12 patients);

PEG-interferon alfa/RBV: 25% (3/12 patients)].

Adverse events (AEs) and serious adverse events (SAEs) were comparable across

study arms and were consistent with the safety profile of PEG-Interferon alfa

and ribavirin therapy. Four patients discontinued due to AEs in the BMS-790052

60 mg group for a diverse set of adverse events. All four patients had

undetectable viral load at the time of study discontinuation and three of these

patients achieved SVR12. No new on-treatment SAEs were reported beyond study

week 24.

Grade 3 to 4 adverse events for BMS-790052 treatment groups and placebo were

BMS-790052: 60 mg: 33.3%, 10 mg: 25%, 3 mg: 8.3%; PEG-interferon alfa/RBV:

41.7%. Two patients (one receiving 3 mg BMS-790052 and one receiving 60 mg

BMS-790052) experienced anemia (hemoglobin <9 g/dL). Erythropoietin use was

comparable between BMS-790052 treatment groups (one to three patients per arm)

and the placebo treatment group (two patients). The use of filgrastim (G-CSF) in

the study groups was: BMS-790052: 60 mg: 0%, 10 mg: 25%, 3 mg: 16.7%;

PEG-interferon alfa/RBV: 16.7%. Other adverse events, occurring in at least four

patients (33.3%) in any cohort include: fatigue (BMS-790052: 60 mg: 50%,10 mg:

50%, 3 mg: 58.3%; placebo: 75%), neutropenia (BMS-790052: 60 mg: 16.7%,10 mg:

33.3%, 3 mg: 25%; placebo: 41.7%), nausea (BMS-790052: 60 mg: 33.3%,10 mg:

33.3%, 3 mg: 41.7%; placebo: 50%), vomiting (BMS-790052 60 mg: 33.3%, 10 mg:

8.3%, 3 mg: 16.7%; placebo: 0%), and headache (BMS-790052: 60 mg: 25%, 10 mg:

75%, 3 mg: 58.3%; placebo: 25%).

About the Study

This double-blind study randomized 48 treatment-naïve HCV genotype 1-infected

patients 1:1:1:1 (n=12/arm) to receive one of three doses of BMS-790052 (3 mg,

10 mg, or 60 mg) or placebo once daily, in combination with PEG-interferon

alfa-2a and ribavirin for 48 weeks. The primary endpoint of the study was the

proportion of patients with extended rapid virologic response (eRVR) defined as

undetectable viral load (HCV RNA < 10 IU/mL) at both Weeks 4 and 12. Primary

endpoint data were previously reported at EASL 2010 in Vienna, Austria.

About BMS-790052

Discovered by Bristol-Myers Squibb through a genomics approach, BMS-790052 is

part of a portfolio of investigational compounds that the company is developing

for the treatment of hepatitis C. BMS-790052 is the first NS5A replication

complex inhibitor to be investigated in HCV clinical trials. BMS-790052 is

currently in Phase II development.

About Hepatitis C1

Hepatitis C is a virus that infects the liver and is transmitted through direct

contact with blood. An estimated 170 million people worldwide are infected with

hepatitis C. Twenty percent of people with chronic hepatitis C will develop

cirrhosis and, of those, 20 percent will progress to liver cancer. Although

there is no vaccine to prevent hepatitis C, it is a curable disease.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to

discover, develop and deliver innovative medicines that help patients prevail

over serious diseases. For more information, please visit http://www.bms.com or

follow us on Twitter at http://twitter.com/bmsnews.

Bristol-Myers Squibb Forward Looking Statement

This press release contains “forward-looking statements” as that term is defined

in the Private Securities Litigation Reform Act of 1995, regarding the research,

development and commercialization of pharmaceutical products. Such

forward-looking statements are based on current expectations and involve

inherent risks and uncertainties, including factors that could delay, divert or

change any of them, and could cause actual outcomes and results to differ

materially from current expectations. No forward-looking statement can be

guaranteed. Among other risks, there can be no guarantee that the compound

described in this release will move from exploratory development into full

product development, that clinical trials of this compound will support a

regulatory filing, or that the compound will receive regulatory approval or

become a commercially successful product. Forward-looking statements in this

press release should be evaluated together with the many uncertainties that

affect Bristol-Myers Squibb's business, particularly those identified in the

cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form

10-K for the year ended December 31, 2010, in our Quarterly Reports on Form

10-Q, and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no

obligation to publicly update any forward-looking statement, whether as a result

of new information, future events, or otherwise.

References

1 World Health Organization. Hepatitis C. Available at:

http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index1.html.

Accessed March 9, 2011.

Contact: Bristol-Myers Squibb Company

Media:

Cristi Barnett, 609-252-6028

cristi.barnett@...

or

Investors:

Elicker, 609-252-4611

john.elicker@...

[Guest guest]

http://www.therapeuticsdaily.com/news/article.cfm?contentValue=771711 & contentTyp\

e=newsarchive & channelID=26

Investigational Direct-Acting Antiviral BMS-790052 Plus PEG-Interferon Alfa and

Ribavirin Achieved Up to 92% Sustained Virologic Response in Phase II

Dose-Ranging Study of Treatment-Naïve Hepatitis C Patients

From the PharmaLive.com News Archive - Mar. 31, 2011

Adverse event profile of regimen containing BMS-790052 was consistent with that

of treatment with PEG-Interferon alfa and ribavirin alone

PRINCETON, N.J.--(BUSINESS WIRE)--Mar 31, 2011 - Bristol-Myers Squibb Company

(NYSE: BMY) today announced results from a Phase II clinical trial in which

treatment with the investigational direct-acting antiviral (DAA) BMS-790052, an

NS5A replication complex inhibitor, in combination with PEG-Interferon alfa and

ribavirin (RBV), achieved sustained virologic response 12 weeks post-treatment

(SVR12) in up to 92% of treatment-naïve patients chronically infected with

hepatitis C (HCV) genotype 1 (10 mg dose arm, n=12). Adverse events and serious

adverse events were consistent with those reported in the PEG-Interferon alfa

and ribavirin arm and were comparable across all doses of BMS-790052. These data

were reported today for the first time in a late-breaker poster session at the

International Liver Congress, the 46th annual meeting of the European

Association for the Study of the Liver (EASL) in Berlin, Germany.

“There currently exists a medical need for new medicines or new combinations of

medicines for hepatitis C patients as many hepatitis C patients have limited

success on the currently available treatments,” said Stanislas Pol, MD, PhD,

Professor of Hepatology at Université Paris V (René Descartes), Paris, France

and head of the Hepatology unit at Cochin Hospital, Paris, France. “The results

of this study warrant further clinical investigation of adding Bristol-Myers

Squibb's investigational compound BMS-790052 to the current medicines to

evaluate its potential to address this unmet treatment need.”

Study Results

The primary endpoint of the study was the proportion of patients with extended

rapid virologic response (eRVR) defined as undetectable viral load (HCV RNA < 10

IU/mL) at both Weeks 4 and 12. BMS-790052 plus PEG-interferon alfa and ribavirin

achieved higher rates of SVR12 compared to PEG-interferon alfa and ribavirin

alone, across all BMS-790052 treatment groups [bMS-790052: 60 mg: 83% (10/12

patients), 10 mg: 92% (11/12 patients), 3 mg: 42% (5/12 patients);

PEG-interferon alfa/RBV: 25% (3/12 patients)].

Adverse events (AEs) and serious adverse events (SAEs) were comparable across

study arms and were consistent with the safety profile of PEG-Interferon alfa

and ribavirin therapy. Four patients discontinued due to AEs in the BMS-790052

60 mg group for a diverse set of adverse events. All four patients had

undetectable viral load at the time of study discontinuation and three of these

patients achieved SVR12. No new on-treatment SAEs were reported beyond study

week 24.

Grade 3 to 4 adverse events for BMS-790052 treatment groups and placebo were

BMS-790052: 60 mg: 33.3%, 10 mg: 25%, 3 mg: 8.3%; PEG-interferon alfa/RBV:

41.7%. Two patients (one receiving 3 mg BMS-790052 and one receiving 60 mg

BMS-790052) experienced anemia (hemoglobin <9 g/dL). Erythropoietin use was

comparable between BMS-790052 treatment groups (one to three patients per arm)

and the placebo treatment group (two patients). The use of filgrastim (G-CSF) in

the study groups was: BMS-790052: 60 mg: 0%, 10 mg: 25%, 3 mg: 16.7%;

PEG-interferon alfa/RBV: 16.7%. Other adverse events, occurring in at least four

patients (33.3%) in any cohort include: fatigue (BMS-790052: 60 mg: 50%,10 mg:

50%, 3 mg: 58.3%; placebo: 75%), neutropenia (BMS-790052: 60 mg: 16.7%,10 mg:

33.3%, 3 mg: 25%; placebo: 41.7%), nausea (BMS-790052: 60 mg: 33.3%,10 mg:

33.3%, 3 mg: 41.7%; placebo: 50%), vomiting (BMS-790052 60 mg: 33.3%, 10 mg:

8.3%, 3 mg: 16.7%; placebo: 0%), and headache (BMS-790052: 60 mg: 25%, 10 mg:

75%, 3 mg: 58.3%; placebo: 25%).

About the Study

This double-blind study randomized 48 treatment-naïve HCV genotype 1-infected

patients 1:1:1:1 (n=12/arm) to receive one of three doses of BMS-790052 (3 mg,

10 mg, or 60 mg) or placebo once daily, in combination with PEG-interferon

alfa-2a and ribavirin for 48 weeks. The primary endpoint of the study was the

proportion of patients with extended rapid virologic response (eRVR) defined as

undetectable viral load (HCV RNA < 10 IU/mL) at both Weeks 4 and 12. Primary

endpoint data were previously reported at EASL 2010 in Vienna, Austria.

About BMS-790052

Discovered by Bristol-Myers Squibb through a genomics approach, BMS-790052 is

part of a portfolio of investigational compounds that the company is developing

for the treatment of hepatitis C. BMS-790052 is the first NS5A replication

complex inhibitor to be investigated in HCV clinical trials. BMS-790052 is

currently in Phase II development.

About Hepatitis C1

Hepatitis C is a virus that infects the liver and is transmitted through direct

contact with blood. An estimated 170 million people worldwide are infected with

hepatitis C. Twenty percent of people with chronic hepatitis C will develop

cirrhosis and, of those, 20 percent will progress to liver cancer. Although

there is no vaccine to prevent hepatitis C, it is a curable disease.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to

discover, develop and deliver innovative medicines that help patients prevail

over serious diseases. For more information, please visit http://www.bms.com or

follow us on Twitter at http://twitter.com/bmsnews.

Bristol-Myers Squibb Forward Looking Statement

This press release contains “forward-looking statements” as that term is defined

in the Private Securities Litigation Reform Act of 1995, regarding the research,

development and commercialization of pharmaceutical products. Such

forward-looking statements are based on current expectations and involve

inherent risks and uncertainties, including factors that could delay, divert or

change any of them, and could cause actual outcomes and results to differ

materially from current expectations. No forward-looking statement can be

guaranteed. Among other risks, there can be no guarantee that the compound

described in this release will move from exploratory development into full

product development, that clinical trials of this compound will support a

regulatory filing, or that the compound will receive regulatory approval or

become a commercially successful product. Forward-looking statements in this

press release should be evaluated together with the many uncertainties that

affect Bristol-Myers Squibb's business, particularly those identified in the

cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form

10-K for the year ended December 31, 2010, in our Quarterly Reports on Form

10-Q, and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no

obligation to publicly update any forward-looking statement, whether as a result

of new information, future events, or otherwise.

References

1 World Health Organization. Hepatitis C. Available at:

http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index1.html.

Accessed March 9, 2011.

Contact: Bristol-Myers Squibb Company

Media:

Cristi Barnett, 609-252-6028

cristi.barnett@...

or

Investors:

Elicker, 609-252-4611

john.elicker@...

[Guest guest]

http://www.therapeuticsdaily.com/news/article.cfm?contentValue=771711 & contentTyp\

e=newsarchive & channelID=26

Investigational Direct-Acting Antiviral BMS-790052 Plus PEG-Interferon Alfa and

Ribavirin Achieved Up to 92% Sustained Virologic Response in Phase II

Dose-Ranging Study of Treatment-Naïve Hepatitis C Patients

From the PharmaLive.com News Archive - Mar. 31, 2011

Adverse event profile of regimen containing BMS-790052 was consistent with that

of treatment with PEG-Interferon alfa and ribavirin alone

PRINCETON, N.J.--(BUSINESS WIRE)--Mar 31, 2011 - Bristol-Myers Squibb Company

(NYSE: BMY) today announced results from a Phase II clinical trial in which

treatment with the investigational direct-acting antiviral (DAA) BMS-790052, an

NS5A replication complex inhibitor, in combination with PEG-Interferon alfa and

ribavirin (RBV), achieved sustained virologic response 12 weeks post-treatment

(SVR12) in up to 92% of treatment-naïve patients chronically infected with

hepatitis C (HCV) genotype 1 (10 mg dose arm, n=12). Adverse events and serious

adverse events were consistent with those reported in the PEG-Interferon alfa

and ribavirin arm and were comparable across all doses of BMS-790052. These data

were reported today for the first time in a late-breaker poster session at the

International Liver Congress, the 46th annual meeting of the European

Association for the Study of the Liver (EASL) in Berlin, Germany.

“There currently exists a medical need for new medicines or new combinations of

medicines for hepatitis C patients as many hepatitis C patients have limited

success on the currently available treatments,” said Stanislas Pol, MD, PhD,

Professor of Hepatology at Université Paris V (René Descartes), Paris, France

and head of the Hepatology unit at Cochin Hospital, Paris, France. “The results

of this study warrant further clinical investigation of adding Bristol-Myers

Squibb's investigational compound BMS-790052 to the current medicines to

evaluate its potential to address this unmet treatment need.”

Study Results

The primary endpoint of the study was the proportion of patients with extended

rapid virologic response (eRVR) defined as undetectable viral load (HCV RNA < 10

IU/mL) at both Weeks 4 and 12. BMS-790052 plus PEG-interferon alfa and ribavirin

achieved higher rates of SVR12 compared to PEG-interferon alfa and ribavirin

alone, across all BMS-790052 treatment groups [bMS-790052: 60 mg: 83% (10/12

patients), 10 mg: 92% (11/12 patients), 3 mg: 42% (5/12 patients);

PEG-interferon alfa/RBV: 25% (3/12 patients)].

Adverse events (AEs) and serious adverse events (SAEs) were comparable across

study arms and were consistent with the safety profile of PEG-Interferon alfa

and ribavirin therapy. Four patients discontinued due to AEs in the BMS-790052

60 mg group for a diverse set of adverse events. All four patients had

undetectable viral load at the time of study discontinuation and three of these

patients achieved SVR12. No new on-treatment SAEs were reported beyond study

week 24.

Grade 3 to 4 adverse events for BMS-790052 treatment groups and placebo were

BMS-790052: 60 mg: 33.3%, 10 mg: 25%, 3 mg: 8.3%; PEG-interferon alfa/RBV:

41.7%. Two patients (one receiving 3 mg BMS-790052 and one receiving 60 mg

BMS-790052) experienced anemia (hemoglobin <9 g/dL). Erythropoietin use was

comparable between BMS-790052 treatment groups (one to three patients per arm)

and the placebo treatment group (two patients). The use of filgrastim (G-CSF) in

the study groups was: BMS-790052: 60 mg: 0%, 10 mg: 25%, 3 mg: 16.7%;

PEG-interferon alfa/RBV: 16.7%. Other adverse events, occurring in at least four

patients (33.3%) in any cohort include: fatigue (BMS-790052: 60 mg: 50%,10 mg:

50%, 3 mg: 58.3%; placebo: 75%), neutropenia (BMS-790052: 60 mg: 16.7%,10 mg:

33.3%, 3 mg: 25%; placebo: 41.7%), nausea (BMS-790052: 60 mg: 33.3%,10 mg:

33.3%, 3 mg: 41.7%; placebo: 50%), vomiting (BMS-790052 60 mg: 33.3%, 10 mg:

8.3%, 3 mg: 16.7%; placebo: 0%), and headache (BMS-790052: 60 mg: 25%, 10 mg:

75%, 3 mg: 58.3%; placebo: 25%).

About the Study

This double-blind study randomized 48 treatment-naïve HCV genotype 1-infected

patients 1:1:1:1 (n=12/arm) to receive one of three doses of BMS-790052 (3 mg,

10 mg, or 60 mg) or placebo once daily, in combination with PEG-interferon

alfa-2a and ribavirin for 48 weeks. The primary endpoint of the study was the

proportion of patients with extended rapid virologic response (eRVR) defined as

undetectable viral load (HCV RNA < 10 IU/mL) at both Weeks 4 and 12. Primary

endpoint data were previously reported at EASL 2010 in Vienna, Austria.

About BMS-790052

Discovered by Bristol-Myers Squibb through a genomics approach, BMS-790052 is

part of a portfolio of investigational compounds that the company is developing

for the treatment of hepatitis C. BMS-790052 is the first NS5A replication

complex inhibitor to be investigated in HCV clinical trials. BMS-790052 is

currently in Phase II development.

About Hepatitis C1

Hepatitis C is a virus that infects the liver and is transmitted through direct

contact with blood. An estimated 170 million people worldwide are infected with

hepatitis C. Twenty percent of people with chronic hepatitis C will develop

cirrhosis and, of those, 20 percent will progress to liver cancer. Although

there is no vaccine to prevent hepatitis C, it is a curable disease.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to

discover, develop and deliver innovative medicines that help patients prevail

over serious diseases. For more information, please visit http://www.bms.com or

follow us on Twitter at http://twitter.com/bmsnews.

Bristol-Myers Squibb Forward Looking Statement

This press release contains “forward-looking statements” as that term is defined

in the Private Securities Litigation Reform Act of 1995, regarding the research,

development and commercialization of pharmaceutical products. Such

forward-looking statements are based on current expectations and involve

inherent risks and uncertainties, including factors that could delay, divert or

change any of them, and could cause actual outcomes and results to differ

materially from current expectations. No forward-looking statement can be

guaranteed. Among other risks, there can be no guarantee that the compound

described in this release will move from exploratory development into full

product development, that clinical trials of this compound will support a

regulatory filing, or that the compound will receive regulatory approval or

become a commercially successful product. Forward-looking statements in this

press release should be evaluated together with the many uncertainties that

affect Bristol-Myers Squibb's business, particularly those identified in the

cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form

10-K for the year ended December 31, 2010, in our Quarterly Reports on Form

10-Q, and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no

obligation to publicly update any forward-looking statement, whether as a result

of new information, future events, or otherwise.

References

1 World Health Organization. Hepatitis C. Available at:

http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index1.html.

Accessed March 9, 2011.

Contact: Bristol-Myers Squibb Company

Media:

Cristi Barnett, 609-252-6028

cristi.barnett@...

or

Investors:

Elicker, 609-252-4611

john.elicker@...

[Guest guest]

http://www.therapeuticsdaily.com/news/article.cfm?contentValue=771711 & contentTyp\

e=newsarchive & channelID=26

Investigational Direct-Acting Antiviral BMS-790052 Plus PEG-Interferon Alfa and

Ribavirin Achieved Up to 92% Sustained Virologic Response in Phase II

Dose-Ranging Study of Treatment-Naïve Hepatitis C Patients

From the PharmaLive.com News Archive - Mar. 31, 2011

Adverse event profile of regimen containing BMS-790052 was consistent with that

of treatment with PEG-Interferon alfa and ribavirin alone

PRINCETON, N.J.--(BUSINESS WIRE)--Mar 31, 2011 - Bristol-Myers Squibb Company

(NYSE: BMY) today announced results from a Phase II clinical trial in which

treatment with the investigational direct-acting antiviral (DAA) BMS-790052, an

NS5A replication complex inhibitor, in combination with PEG-Interferon alfa and

ribavirin (RBV), achieved sustained virologic response 12 weeks post-treatment

(SVR12) in up to 92% of treatment-naïve patients chronically infected with

hepatitis C (HCV) genotype 1 (10 mg dose arm, n=12). Adverse events and serious

adverse events were consistent with those reported in the PEG-Interferon alfa

and ribavirin arm and were comparable across all doses of BMS-790052. These data

were reported today for the first time in a late-breaker poster session at the

International Liver Congress, the 46th annual meeting of the European

Association for the Study of the Liver (EASL) in Berlin, Germany.

“There currently exists a medical need for new medicines or new combinations of

medicines for hepatitis C patients as many hepatitis C patients have limited

success on the currently available treatments,” said Stanislas Pol, MD, PhD,

Professor of Hepatology at Université Paris V (René Descartes), Paris, France

and head of the Hepatology unit at Cochin Hospital, Paris, France. “The results

of this study warrant further clinical investigation of adding Bristol-Myers

Squibb's investigational compound BMS-790052 to the current medicines to

evaluate its potential to address this unmet treatment need.”

Study Results

The primary endpoint of the study was the proportion of patients with extended

rapid virologic response (eRVR) defined as undetectable viral load (HCV RNA < 10

IU/mL) at both Weeks 4 and 12. BMS-790052 plus PEG-interferon alfa and ribavirin

achieved higher rates of SVR12 compared to PEG-interferon alfa and ribavirin

alone, across all BMS-790052 treatment groups [bMS-790052: 60 mg: 83% (10/12

patients), 10 mg: 92% (11/12 patients), 3 mg: 42% (5/12 patients);

PEG-interferon alfa/RBV: 25% (3/12 patients)].

Adverse events (AEs) and serious adverse events (SAEs) were comparable across

study arms and were consistent with the safety profile of PEG-Interferon alfa

and ribavirin therapy. Four patients discontinued due to AEs in the BMS-790052

60 mg group for a diverse set of adverse events. All four patients had

undetectable viral load at the time of study discontinuation and three of these

patients achieved SVR12. No new on-treatment SAEs were reported beyond study

week 24.

Grade 3 to 4 adverse events for BMS-790052 treatment groups and placebo were

BMS-790052: 60 mg: 33.3%, 10 mg: 25%, 3 mg: 8.3%; PEG-interferon alfa/RBV:

41.7%. Two patients (one receiving 3 mg BMS-790052 and one receiving 60 mg

BMS-790052) experienced anemia (hemoglobin <9 g/dL). Erythropoietin use was

comparable between BMS-790052 treatment groups (one to three patients per arm)

and the placebo treatment group (two patients). The use of filgrastim (G-CSF) in

the study groups was: BMS-790052: 60 mg: 0%, 10 mg: 25%, 3 mg: 16.7%;

PEG-interferon alfa/RBV: 16.7%. Other adverse events, occurring in at least four

patients (33.3%) in any cohort include: fatigue (BMS-790052: 60 mg: 50%,10 mg:

50%, 3 mg: 58.3%; placebo: 75%), neutropenia (BMS-790052: 60 mg: 16.7%,10 mg:

33.3%, 3 mg: 25%; placebo: 41.7%), nausea (BMS-790052: 60 mg: 33.3%,10 mg:

33.3%, 3 mg: 41.7%; placebo: 50%), vomiting (BMS-790052 60 mg: 33.3%, 10 mg:

8.3%, 3 mg: 16.7%; placebo: 0%), and headache (BMS-790052: 60 mg: 25%, 10 mg:

75%, 3 mg: 58.3%; placebo: 25%).

About the Study

This double-blind study randomized 48 treatment-naïve HCV genotype 1-infected

patients 1:1:1:1 (n=12/arm) to receive one of three doses of BMS-790052 (3 mg,

10 mg, or 60 mg) or placebo once daily, in combination with PEG-interferon

alfa-2a and ribavirin for 48 weeks. The primary endpoint of the study was the

proportion of patients with extended rapid virologic response (eRVR) defined as

undetectable viral load (HCV RNA < 10 IU/mL) at both Weeks 4 and 12. Primary

endpoint data were previously reported at EASL 2010 in Vienna, Austria.

About BMS-790052

Discovered by Bristol-Myers Squibb through a genomics approach, BMS-790052 is

part of a portfolio of investigational compounds that the company is developing

for the treatment of hepatitis C. BMS-790052 is the first NS5A replication

complex inhibitor to be investigated in HCV clinical trials. BMS-790052 is

currently in Phase II development.

About Hepatitis C1

Hepatitis C is a virus that infects the liver and is transmitted through direct

contact with blood. An estimated 170 million people worldwide are infected with

hepatitis C. Twenty percent of people with chronic hepatitis C will develop

cirrhosis and, of those, 20 percent will progress to liver cancer. Although

there is no vaccine to prevent hepatitis C, it is a curable disease.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to

discover, develop and deliver innovative medicines that help patients prevail

over serious diseases. For more information, please visit http://www.bms.com or

follow us on Twitter at http://twitter.com/bmsnews.

Bristol-Myers Squibb Forward Looking Statement

This press release contains “forward-looking statements” as that term is defined

in the Private Securities Litigation Reform Act of 1995, regarding the research,

development and commercialization of pharmaceutical products. Such

forward-looking statements are based on current expectations and involve

inherent risks and uncertainties, including factors that could delay, divert or

change any of them, and could cause actual outcomes and results to differ

materially from current expectations. No forward-looking statement can be

guaranteed. Among other risks, there can be no guarantee that the compound

described in this release will move from exploratory development into full

product development, that clinical trials of this compound will support a

regulatory filing, or that the compound will receive regulatory approval or

become a commercially successful product. Forward-looking statements in this

press release should be evaluated together with the many uncertainties that

affect Bristol-Myers Squibb's business, particularly those identified in the

cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form

10-K for the year ended December 31, 2010, in our Quarterly Reports on Form

10-Q, and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no

obligation to publicly update any forward-looking statement, whether as a result

of new information, future events, or otherwise.

References

1 World Health Organization. Hepatitis C. Available at:

http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index1.html.

Accessed March 9, 2011.

Contact: Bristol-Myers Squibb Company

Media:

Cristi Barnett, 609-252-6028

cristi.barnett@...

or

Investors:

Elicker, 609-252-4611

john.elicker@...