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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™, 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:
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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.
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A series of data presentations investigating the use of daclatasvir
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/.
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Title
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Date/Time
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HIV
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Oral Presentation: HIV-1 Attachment
Inhibitor Prodrug BMS-663068 in Antiretroviral-Experienced
Subjects: Week 24 Subgroup Analysis
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Thursday, Oct 9, 2014
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Oral Presentation: Using Real World
Data to Assess the Risk of Suicidality among Patients Initiating
an Efavirenz-containing regimen versus an Efavirenz-free
Antiretroviral Regimen
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Friday, October 10, 2014
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Poster: Safety Profile of HIV-1
Attachment Inhibitor Prodrug BMS-663068 in
Antiretroviral-Experienced Subjects: Week 24 Analysis
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Saturday, October 11, 2014
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Poster: Impact of Hyperbilirubinemia
on Persistence and Adherence of Atazanavir Among HIV Patients
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Saturday, October 11, 2014
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Hepatitis C
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Poster: Evaluation of Drug-Drug
Interaction between Daclatasvir and Methadone or
Buprenorphine/Naloxone
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Friday, October 10, 2014
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Poster: Evaluation of Drug-Drug
Interaction between Asunaprevir and Methadone or
Buprenorphine/Naloxone
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Friday, October 10, 2014
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Poster: Effect of Steady State
Daclatasvir Plus Asunaprevir on the Single Dose Pharmacokinetics
of the P-glycoprotein Substrate Digoxin in Healthy Adult Subjects
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Friday, October 10, 2014
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Poster: Daclatasvir and Asunaprevir
Plus Peginterferon Alfa-2a and Ribavirin in Patients With HCV
Genotype 1 or 4 Infection: Phase 3 HALLMARK-QUAD Results
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Friday, October 10, 2014
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Poster: Daclatasvir in Combination
with Peginterferon Alfa-2a and Ribavirin for Treatment-Naive
Patients with HCV Genotype 4 Infection: Phase 3 COMMAND-4 Results
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Friday, October 10, 2014
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Poster: Triple Combination Treatment
With Peginterferon Lambda-1a, Daclatasvir and Ribavirin for 12
Weeks in Patients Infected With HCV Genotype 1b
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Friday, October 10, 2014
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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™. 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 naïve,
cirrhotic naïve 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.

Source: Bristol-Myers Squibb Company