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Continued Development of Investigational HIV Attachment
Inhibitor Underscores BMS' Commitment to HIV Research
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Efficacy, Safety, and Drug Interaction Profile of
Investigational NS5A replication inhibitor Daclatasvir Studied in
Multiple Hepatitis C Treatment Regimens and Patient Groups
PRINCETON, N.J.--(BUSINESS WIRE)--
Bristol-Myers
Squibb Company (NYSE:BMY) announced today that ten abstracts have
been accepted for presentation at IDWeek 2014(TM), which is taking place in
Philadelphia, PA, October 8-12, 2014. The breadth of data being
presented highlights Bristol-Myers Squibb's commitment to discover,
develop and deliver innovative medicines that help patients prevail over
chronic viral diseases.
Highlights include:
-- A 24 week sub-group analysis investigating the HIV-1 attachment
inhibitor prodrug BMS-663068 in treatment-experienced patients infected
with HIV-1; as well as a 24 week safety profile analysis in this group.
BMS-663068 is an investigational prodrug of an attachment inhibitor with
a unique mechanism of action that prevents initial viral attachment to
the host CD4+ T cell and entry into the host immune cell.
-- A series of data presentations investigating the use ofdaclatasvir in
multiple treatment regimens with other antiviral medicines and among
varied patient groups and HCV genotypes.
Daclatasvir is an investigational NS5A replication complex inhibitor
that has shown high antiviral potency and pan-genotypic activity across
HCV genotypes (in vitro).
"The compelling body of data presented at this year's IDWeek underscore
Bristol-Myers Squibb's ongoing commitment to pioneering scientific
innovation that investigates the significant unmet medical needs of
those living with chronic viral diseases including HIV and HCV," said
Douglas Manion, M.D., Head of Specialty Development, Bristol-Myers
Squibb. "We aim to bring to market treatment options that will improve
health outcomes for a diverse range of HIV and HCV patients, including
treatment-experienced HIV patients in search of new options, and HCV
patients with difficult-to-treat disease."
The complete list of Bristol-Myers Squibb data presentations is outlined
below. More information is available at http://www.idweek.org/.
Title Date/Time
HIV
Oral Presentation: HIV-1 Attachment Inhibitor Thursday, Oct 9, 2014
Prodrug BMS-663068 in Antiretroviral-Experienced
Subjects: Week 24 Subgroup Analysis
Oral Presentation: Using Real World Data to Assess Friday, October 10, 2014
the Risk of Suicidality among Patients Initiating
an Efavirenz-containing regimen versus an
Efavirenz-free Antiretroviral Regimen
Poster: Safety Profile of HIV-1 Attachment Saturday, October 11, 2014
Inhibitor Prodrug BMS-663068 in
Antiretroviral-Experienced Subjects: Week 24
Analysis
Poster: Impact of Hyperbilirubinemia on Persistence Saturday, October 11, 2014
and Adherence of Atazanavir Among HIV Patients
Hepatitis C
Poster: Evaluation of Drug-Drug Interaction between Friday, October 10, 2014
Daclatasvir and Methadone or Buprenorphine/Naloxone
Poster: Evaluation of Drug-Drug Interaction between Friday, October 10, 2014
Asunaprevir and Methadone or Buprenorphine/Naloxone
Poster: Effect of Steady State Daclatasvir Plus Friday, October 10, 2014
Asunaprevir on the Single Dose Pharmacokinetics of
the P-glycoprotein Substrate Digoxin in Healthy
Adult Subjects
Poster: Daclatasvir and Asunaprevir Plus Friday, October 10, 2014
Peginterferon Alfa-2a and Ribavirin in Patients
With HCV Genotype 1 or 4 Infection: Phase 3
HALLMARK-QUAD Results
Poster: Daclatasvir in Combination with Friday, October 10, 2014
Peginterferon Alfa-2a and Ribavirin for
Treatment-Naive Patients with HCV Genotype 4
Infection: Phase 3 COMMAND-4 Results
Poster: Triple Combination Treatment With Friday, October 10, 2014
Peginterferon Lambda-1a, Daclatasvir and Ribavirin
for 12 Weeks in Patients Infected With HCV Genotype
1b
Please note: All information is embargoed until 12:01 a.m. ET on
Wednesday, October 8.
About IDWeek
IDWeek 2014TM is an annual meeting of the Infectious Diseases
Society of America (IDSA), the Society for Healthcare Epidemiology of
America (SHEA), the HIV Medicine Association (HIVMA) and the Pediatric
Infectious Diseases Society (PIDS). With the theme "Advancing Science,
Improving Care," IDWeek features the latest science and bench-to-bedside
approaches in prevention, diagnosis, treatment, and epidemiology of
infectious diseases, including HIV, across the lifespan. IDWeek 2014
takes place October 8-12 at the Pennsylvania Convention Center in
Philadelphia, Pennsylvania. The full name of the meeting is IDWeek
2014(TM). For more information, visit www.idweek.org.
About Bristol-Myers Squibb's Virology Portfolio
Bristol-Myers Squibb is committed to research, education and support to
transform clinical outcomes for patients with chronic viral diseases,
through a portfolio of approved medicines and investigational compounds
that aim to address unmet medical needs in HIV and liver disease,
including hepatitis C (HCV) and hepatitis B (HBV).
At the core of its HCV pipeline is daclatasvir, a potent pan-genotypic
NS5A replication complex inhibitor (in vitro). Daclatasvir was
recently approved in Japan as Daklinza in combination with
asunaprevir, approved as Sunvepra, a NS3/4A protease inhibitor,
which together form Japan's first all-oral, interferon- and
ribavirin-free treatment regimen for patients with genotype 1 chronic
HCV infection. In addition, in the European Union (EU), once daily oral
daclatasvir was recently approved as Daklinza for use in
combination with other medicinal products for the treatment of HCV
infection in adults. Applications for daclatasvir and asunaprevir are
also under review by the U.S. Food and Drug Administration (FDA).
Additional studies continue to investigate daclatasvir in multiple
treatment regimens and in people with co-morbidities, including in
combination with sofosbuvir in pre- and post-transplant patients,
HIV/HCV co-infected patients and patients with genotype 3, as part of
the ongoing Phase III ALLY Program; and the investigational all-oral
fixed-dose-combination daclatasvir 3DAA Regimen
(daclatasvir/asunaprevir/BMS-791325), including in non-cirrhotic naive,
cirrhotic naive and previously treated patients.
In HIV, Bristol-Myers Squibb is focused on discovering, developing and
delivering innovative medicines to help meet the needs of patients
living with HIV/AIDS and continues to pursue advances in treatment, for
both children and adults with HIV. Studies are ongoing for new
treatments including an attachment inhibitor prodrug (BMS-663068), a
maturation inhibitor (BMS-955176) and an anti-PD-L1 (BMS-936559).
Bristol-Myers Squibb also continues to enhance its current product
offerings for patients living with HIV/AIDS, and an application is under
review by the FDA for a fixed-dose combination of atazanavir and
cobicistat, marketed by Gilead Sciences, Inc.
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 daclatasvir or
asunaprevir or any other compounds mentioned in this release will
receive regulatory approval in the United States or, if approved, that
they will become commercially successful products. 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, 2013, 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.

CONTACT: Bristol-Myers Squibb Company
Media:
Chris Clark, +1-609-252-6269
Cell: +1-215-421-4887
chris.clark@bms.com
or
Carrie Fernandez, +1-609-252-4831
Cell: +1-215-859-2605
carrie.fernandez@bms.com
or
Investors:
Ranya Dajani, +1-609-252-5330
ranya.dajani@bms.com
or
Ryan Asay, +1-609-252-5020
ryan.asay@bms.com
Source: Bristol-Myers Squibb Company
Bristol-Myers Squibb Company
Media:
Chris Clark, 1-609-252-6269
Cell: 1-215-421-4887
chris.clark@bms.com
or
Carrie Fernandez, 1-609-252-4831
Cell: 1-215-859-2605
carrie.fernandez@bms.com
or
Investors:
Ranya Dajani, 1-609-252-5330
ranya.dajani@bms.com
or
Ryan Asay, 1-609-252-5020
ryan.asay@bms.com