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Bristol-Myers Squibb Presents Data from Multiple New Studies at IDWeek 2014TM Showcasing Continued Innovation in Virology

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Bristol-Myers Squibb Company (NYSE:BMY) announced today that ten abstracts have been accepted for presentation at IDWeek 2014TM, 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 2014TM. 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, HIVHCV 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 na”ive, cirrhotic na”ive 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.

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