- Continued Development of
Investigational HIV Attachment Inhibitor Underscores BMS’
Commitment to HIV Research
- Efficacy, Safety, and Drug
Interaction Profile of Investigational NS5A replication inhibitor
Daclatasvir Studied in Multiple Hepatitis C Treatment Regimens and
Patient Groups
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:
- 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 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/.
Title Date/Time
HIV
Oral
Presentation: HIV-1 Attachment Inhibitor Prodrug BMS-663068
in Antiretroviral-Experienced Subjects: Week 24 Subgroup
Analysis
Thursday, Oct 9, 2014
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
Friday, October 10, 2014
Poster:
Safety Profile of HIV-1 Attachment Inhibitor Prodrug BMS-663068 in
Antiretroviral-Experienced Subjects: Week 24 Analysis
Saturday, October 11, 2014
Poster:
Impact of Hyperbilirubinemia on Persistence and Adherence of
Atazanavir Among HIV Patients
Saturday, October 11, 2014
Hepatitis C
Poster:
Evaluation of Drug-Drug Interaction between Daclatasvir and
Methadone or Buprenorphine/Naloxone
Friday, October 10, 2014
Poster:
Evaluation of Drug-Drug Interaction between Asunaprevir and
Methadone or Buprenorphine/Naloxone
Friday, October 10, 2014
Poster:
Effect of Steady State Daclatasvir Plus Asunaprevir on the Single
Dose Pharmacokinetics of the P-glycoprotein Substrate Digoxin in
Healthy Adult Subjects
Friday, October 10, 2014
Poster:
Daclatasvir and Asunaprevir Plus Peginterferon Alfa-2a and
Ribavirin in Patients With HCV Genotype 1 or 4 Infection: Phase 3
HALLMARK-QUAD Results
Friday, October 10, 2014
Poster:
Daclatasvir in Combination with Peginterferon Alfa-2a and Ribavirin
for Treatment-Naive Patients with HCV Genotype 4 Infection: Phase 3
COMMAND-4 Results
Friday, October 10, 2014
Poster:
Triple Combination Treatment With Peginterferon Lambda-1a,
Daclatasvir and Ribavirin for 12 Weeks in Patients Infected With
HCV Genotype 1b
Friday, October 10, 2014
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.
Bristol-Myers Squibb CompanyMedia:Chris Clark,
+1-609-252-6269Cell: +1-215-421-4887chris.clark@bms.comorCarrie
Fernandez, +1-609-252-4831Cell:
+1-215-859-2605carrie.fernandez@bms.comorInvestors:Ranya
Dajani, +1-609-252-5330ranya.dajani@bms.comorRyan Asay,
+1-609-252-5020ryan.asay@bms.com
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