Press Release
NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) will take part in Goldman Sachs 35th Annual Global Health Care Conference on Tuesday, June 10, 2014, in Rancho Palos Verdes, CA. Michael Giordano, senior vice president, Head of Development, Oncology & Immunosciences, will answer questions about the company at 1:40 p.m. EDT (10:40 a.m. PST).
Bristol-Myers Squibb
Media:
Laura Hortas; 609-252-4587; [email protected]
or
Investors:
Ranya Dajani; 609-252-5330, [email protected]
Ryan Asay, 609-252-5020, [email protected]
PRINCETON, N.J. & BANGALORE, India--(BUSINESS WIRE)--Bristol-Myers Squibb (NYSE:BMY) and Syngene International, India’s largest contract research organization, today announced a five-year extension of their drug discovery and development collaboration in India. Financial terms were not disclosed.
Biocon + Syngene
Media:
Seema Ahuja, +91 9972317792
[email protected]
or
Rumman Ahmed, +91 98451 04173
[email protected]
or
Investors:
Saurabh Paliwal, +91 9538380801
[email protected]
or
Sweta Pachlangiya, +91 96865 09372
[email protected]
or
Bristol-Myers Squibb
Media:
Frederick J. Egenolf, 609-252-4875
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
- Results demonstrate a significant improvement in recurrence-free survival for an investigational dose of Yervoy vs. placebo for patients with stage 3 melanoma at high risk of recurrence following surgical resection
- Types of adverse events were generally consistent with those observed using Yervoy in advanced melanoma, although a higher incidence of endocrinopathies was observed
- Third positive Phase 3 trial of Yervoy in melanoma, now with a study demonstrating efficacy in an earlier stage of the disease
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced results from a Phase 3 randomized, double blind study demonstrating that Yervoy (ipilimumab) 10 mg/kg (n=475) significantly improved recurrence-free survival (RFS, the length of time before recurrence or death) vs. placebo (n=476) for patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection, an adjuvant setting.
Media:
Melanie Brunner, 609-252-6338
[email protected]
or
Sarah Koenig, 609-252-4145
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced follow up results from Study -004, a multi-arm Phase 1b dose-ranging trial evaluating the safety and activity of the combination regimen of nivolumab, an investigational PD-1 immune checkpoint inhibitor, and Yervoy® (ipilimumab) given either concurrently or sequentially in patients with advanced melanoma (n=127).
Media:
Sarah Koenig, 609-252-4145
[email protected]
or
Chrissy Trank, 609-252-3418
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
Phase I/II study to evaluate nivolumab, Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor with Incyte’s investigational oral IDO1 inhibitor for multiple cancers
NEW YORK & WILMINGTON, Del.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Incyte Corporation (Nasdaq:INCY) announced today the establishment of a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, nivolumab, and Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360, in a Phase I/II study.
Bristol-Myers Squibb
Media:
Ken Dominski, 609-252-5251
[email protected]
Investors:
Ranya Dajani, 609-252-5330
[email protected]
Ryan Asay, 609-252-5020
[email protected]
Incyte
Pamela Murphy, 302-498-6944
[email protected]
NEW YORK & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and CytomX Therapeutics, Inc. today announced the companies have signed a worldwide research collaboration and license agreement to discover, develop and commercialize novel therapies against multiple immuno-oncology targets using CytomX’s proprietary Probody™ Platform.
Bristol-Myers Squibb
Media:
Ken Dominski, 609-252-5251
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
or
CytomX
Media:
Pure Communications, Inc.
Dan Budwick, 973-271-6085
[email protected]
- First presentation of results from the Phase IIIb AVERT study highlighting induction of remission with Orencia in patients with highly-active early rheumatoid arthritis (RA)
- New data from the two-year head-to-head AMPLE trial, evaluating Orencia vs. Humira® (adalimumab) in RA, also to be presented
- Presentation of 24-week efficacy, safety and MRI data from a Phase IIb trial of clazakizumab, an investigational selective IL-6 cytokine inhibitor for RA
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that 20 abstracts for Orencia® (abatacept), and clazakizumab have been accepted for presentation at the 2014 annual meeting of the European League Against Rheumatism (EULAR), to be held June 11-14 in Paris, France.
Bristol-Myers Squibb
Media:
Chris Clark, 609-252-6269
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
- Designation granted for investigational agent elotuzumab in combination with lenalidomide and dexamethasone for treatment of multiple myeloma in patients who have received one or more prior therapies
PRINCETON, N.J. & NORTH CHICAGO, Ill.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and AbbVie (NYSE:ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted elotuzumab, an investigational humanized monoclonal antibody, Breakthrough Therapy Designation for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies.
Bristol Myers Squibb
Media:
Melanie Brunner, 609-252-6338
[email protected]
or
Sarah Koenig, 609-252-4145
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
or
AbbVie
Media:
David Freundel, 847-937-4522
[email protected]
or
Investors:
Liz Shea, 847-935-2211
[email protected]
NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) will host a teleconference on Monday, June 2, 2014, at 8 a.m. EDT (7 a.m. CDT) to review data presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Company executives will provide an overview of data presented at the meeting, with a focus on the company’s immuno-oncology portfolio, and address inquiries from investors and analysts.
Bristol-Myers Squibb
Media:
Laura Hortas, 609-252-4587
[email protected]
or
Investors:
John Elicker, 609-252-4611
[email protected]
or
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
- In the Phase 2 dose-ranging trial, overall response rates for nivolumab as a single agent ranged from 20-22% and one-year survival rates ranged from 63-72% in patients who received prior anti-angiogenic treatment (CheckMate -010)
- In the Phase 1b trial, overall response rates for the investigational combination regimen of nivolumab and Yervoy ranged from 43-48% and 24-week progression free survival rates ranged from 64-65% in previously treated and treatment-naïve patients (CheckMate -016)
- The types of treatment-related serious adverse events were consistent with those in other nivolumab trials, with higher frequency for the combination regimen in CheckMate -016 (18%) than nivolumab as a single agent in CheckMate -010 (7.2%)
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced results from a Phase 2 and a Phase 1b study of its investigational PD-1 immune checkpoint inhibitor nivolumab in patients with advanced or metastatic renal cell carcinoma (RCC), commonly known as kidney cancer.
Media:
Sarah Koenig, 609-252-4145
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
- Across doses (n=107), 48% and 41% of this heavily pre-treated patient population that received nivolumab as a single agent was alive at two and three years, respectively
- Spectrum, frequency and severity of treatment-related adverse events from this study were consistent with those initially reported for these patients in prior publications
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced updated survival data from the advanced melanoma cohort (n=107) of the expanded Phase 1b dose-ranging study of nivolumab, an investigational PD-1 immune checkpoint inhibitor, administered as a single agent (Study -003). Results showed sustained activity in this heavily pre-treated patient population as defined by two- and three-year survival rates of 48% and 41%, respectively, across dose cohorts.
Bristol-Myers Squibb
Media:
Sarah Koenig, 609-252-4145, [email protected]
Chrissy Trank, 609-252-3418, [email protected]
or
Investors:
Ranya Dajani, 609-252-5330, [email protected]
Ryan Asay, 609-252-5020, [email protected]
- Longer-term data from study of previously treated patients who received nivolumab as a single agent showed a two-year survival rate of 24% across doses; results from 3 mg/kg dose also presented (Study -003)
- In chemotherapy-naïve patients who received nivolumab 3 mg/kg as a single agent, the overall response rate (ORR) was 50% in PD-L1 positive tumors and 0% in PD-L1 negative tumors (CheckMate -012)
- The types of treatment-related serious adverse events (SAEs) in CheckMate -012 were consistent with those in other nivolumab trials; of the chemotherapy-naïve patients who received nivolumab as a single agent, 15% experienced grade 3-4 treatment-related SAEs
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced results from a Phase1b study evaluating the safety and efficacy of its investigational PD-1 immune checkpoint inhibitor nivolumab as a single agent in patients with advanced non-small cell lung cancer (NSCLC) who were previously treated (Study -003) and a Phase 1b study evaluating nivolumab as a single agent in chemotherapy-naïve patients (CheckMate -012).
Bristol-Myers Squibb
Media:
Sarah Koenig, 609-252-4145, [email protected]
Chrissy Trank, 609-252-3418, [email protected]
or
Investors:
Ranya Dajani, 609-252-5330, [email protected]
Ryan Asay, 609-252-5020, [email protected]
- Designation granted for nivolumab for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant followed by brentuximab
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted the investigational PD-1 immune checkpoint inhibitor nivolumab Breakthrough Therapy Designation for the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant and brentuximab. The designation is based on data from a cohort of patients with HL in the company’s ongoing Phase 1b study of relapsed and refractory hematological malignancies.
Bristol-Myers Squibb
Media:
Sarah Koenig, 609-252-4145,
[email protected]
Chrissy Trank, 609-252-3418,
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330,
[email protected]
Ryan Asay, 609-252-5020,
[email protected]
NEW YORK & HAMPTON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that they have entered into a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of nivolumab, Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, and varlilumab, Celldex’s CD27 targeting investigational antibody in a Phase 1/2 study.
Bristol-Myers Squibb
Media:
Laura Hortas, 609-252-4587
[email protected]
or
Ken Dominski, 609-252-5251
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
or
Celldex
Media:
Dan Budwick, 973-271-6085
[email protected]
or
Investors & Company:
Sarah Cavanaugh, 508-864-8337
[email protected]
NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) will present at the UBS Global Health Care Conference on Monday, May 19, 2014, in New York. Giovanni Caforio, executive vice president and chief commercial officer, will make a formal presentation about the company at 3 p.m. EDT.
Bristol-Myers Squibb
Media:
Laura Hortas, 609-252-4587
[email protected]
or
Investors:
John Elicker, 609-252-4611
[email protected]
or
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that Brian Daniels, senior vice president, Global Development and Medical Affairs, will be retiring from the company, effective July 1, 2014.
Bristol-Myers Squibb
Media:
Laura Hortas, 609-252-4587
[email protected]
or
Ken Dominski, 609-252-5251
[email protected]
or
Investors:
John Elicker, 609-252-4611
[email protected]
or
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
- Data from company’s immuno-oncology clinical development programs to be presented in three tumor types across several lines of therapy
- Results for the investigational PD-1 immune-checkpoint inhibitor nivolumab to be highlighted in six oral presentations, including longer-term data from some trials
- Results for nivolumab and Yervoy® (ipilimumab) as a combination regimen in three tumor types to be presented, including melanoma and the first findings in non-small cell lung cancer and renal cell carcinoma
- Results from Yervoy Phase 3 trial in high-risk adjuvant melanoma to be presented for first time
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that new data from studies investigating its immunotherapies in adjuvant and advanced melanoma, non-small cell lung cancer (NSCLC) and metastatic renal cell carcinoma (mRCC) will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 30-June 3.
Bristol-Myers Squibb
Media
Melanie Brunner, 609-252-6338
[email protected]
or
Sarah Koenig, 609-252-4145
[email protected]
or
Investors
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
- Posts First Quarter GAAP EPS of $0.56 and Non-GAAP EPS of $0.46
- Announces Plans to Initiate a Rolling Submission for nivolumab in Third-Line Squamous Cell Non-Small Cell Lung Cancer Based on Study 063, to be Completed by Year-end
- Achieved Important Regulatory Milestones for Eliquis, daclatasvir/asunaprevir and Diabetes Franchise
- Acquires iPierian, Inc., a privately held biotechnology company
- Adjusts 2014 GAAP EPS and Non-GAAP EPS Guidance Ranges to $1.70 - $1.80
NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today reported financial results for the first quarter of 2014 and adjusted GAAP and non-GAAP guidance for 2014. The first quarter was highlighted by the achievement of important regulatory milestones for Eliquis, daclatasvir/asunaprevir and the diabetes franchise. The company also completed the sale of its diabetes business to AstraZeneca, receiving $3.3 billion in closing and milestone payments during the quarter.
Bristol-Myers Squibb Company
Communications:
Laura Hortas, 609-252-4587
[email protected]
or
Investor Relations:
John Elicker, 609-252-4611
[email protected]
or
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
- Advances Discovery Strategy to Pursue Therapeutics for Genetically Defined Diseases
- Gains Full Rights to IPN007, a Promising Preclinical Asset Targeting Tau Dysfunction for Certain Neurodegenerative Diseases
- Potential to Commence to Phase 1 Clinical Trials in Progressive Supranuclear Palsy (PSP) by early 2015
SOUTH SAN FRANCISCO, Calif. & NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and iPierian, Inc. announced today that Bristol-Myers Squibb has acquired iPierian, a privately held biotechnology company focused on the discovery and development of new treatments for Tauopathies, a class of neurodegenerative diseases associated with the pathological aggregation of Tau protein in the human brain.
Bristol-Myers Squibb
Media:
Laura Hortas, 609-252-4587
[email protected]
or
Ken Dominski, 609-252-5251
[email protected]
or
Investors:
John Elicker, 609-252-4611
[email protected]
or
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
or
iPierian, Inc.
Media:
Barbara Yates, 781-258-6153
[email protected]
Company secures top ranking for third time in six years
NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that it has been ranked No. 1 on Corporate Responsibility magazine’s 2014 list of the 100 Best Corporate Citizens, a leading benchmark for socially responsible investors and other stakeholders.
Bristol-Myers Squibb is the only company to achieve the No. 1 ranking three times, including 2009 and 2012, and has ranked among the top 10 each of the last six years.
Bristol-Myers Squibb Company
Media:
Frederick J. Egenolf, 609-252-4875
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
NEW YORK & SEOUL, South Korea--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Samsung BioLogics today announced the companies will increase the scope of their existing manufacturing agreement in which Samsung will manufacture commercial drug substances and drug product for several Bristol-Myers Squibb biologic medicines at its Incheon manufacturing site. Financial terms of the agreement are not disclosed.
Bristol-Myers Squibb
Media:
Laura Hortas, 609-252-4587
[email protected]
Ken Dominski, 609-252-5251
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
Ryan Asay, 609-252-5020
[email protected]
or
Samsung BioLogics
Media:
Changsik Park, 82-32-455-3710
[email protected]
Hoyeol (James) Yoon, 82-32-455-3700
[email protected]
Atazanavir sulfate capsules are available as Reyataz®
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today the submission of a new drug application (NDA) on April 4, 2014 to the U.S. Food and Drug Administration (FDA) for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz®, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective.
Bristol-Myers Squibb Company
Media:
Carrie Fernandez
Office: 609-252-4831; Cell: 215-859-2605
[email protected]
or
Julie Ferguson
Office: 609-252-5597; Cell: 312-385-0098
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330, [email protected]
Ryan Asay, 609-252-5020, [email protected]
- Results of the HALLMARK-Dual study include data among genotype 1b cirrhotic and non-cirrhotic, treatment-naïve, non-responder, and peginterferon/ribavirin ineligible and intolerant patients
- Study reinforces the potential of daclatasvir-based regimens to treat HCV patients with high unmet needs
- Data to be presented during late-breaker session at EASL The International Liver CongressTM
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced Phase III results from the global HALLMARK-Dual study investigating the all-oral, interferon- and ribavirin-free regimen of daclatasvir (DCV), a NS5A inhibitor, and asunaprevir (ASV), a NS3 inhibitor, among genotype 1b hepatitis C virus (HCV) infected patients.
Bristol-Myers Squibb
Media:
Jeff Smith,
Office: +33(0) 1 58 83 83 21
Cell: +33(0) 6 03 99 40 18
[email protected]
or
Carrie Fernandez
Office: +1-609-252-4831
Cell: +1-215-859-2605
[email protected]
or
Investors:
Ranya Dajani, +1-609-252-5330
[email protected]
or
Ryan Asay, +1-609-252-5020
[email protected]
U.S. application submission marks third major daclatasvir regulatory milestone globally, follows E.U. and Japan
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that they have submitted new drug applications (NDAs) with the U.S. Food and Drug Administration (FDA) for the investigational products daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), a NS3 protease inhibitor. The data submitted in the NDAs support the use of DCV+ASV in patients with genotype 1b hepatitis C (HCV).
Bristol-Myers Squibb
Media:
Carrie Fernandez,
Office: +1-609-252-4831; Cell: +1-215-859-2605
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330, [email protected]
Ryan Asay, 609-252-5020, [email protected]
NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) will announce results for the first quarter of 2014 on Tuesday, April 29, 2014. During a conference call at 9 a.m. EDT on April 29, company executives will review financial information and will address inquiries from investors and analysts.
Bristol-Myers Squibb Company
Media:
Laura Hortas, 609-252-4587
[email protected]
or
Investors:
John Elicker, 609-252-4611
[email protected]
or
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
R&D News
- Results demonstrate a significant improvement in recurrence-free survival for an investigational dose of Yervoy vs. placebo for patients with stage 3 melanoma at high risk of recurrence following surgical resection
- Types of adverse events were generally consistent with those observed using Yervoy in advanced melanoma, although a higher incidence of endocrinopathies was observed
- Third positive Phase 3 trial of Yervoy in melanoma, now with a study demonstrating efficacy in an earlier stage of the disease
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced results from a Phase 3 randomized, double blind study demonstrating that Yervoy (ipilimumab) 10 mg/kg (n=475) significantly improved recurrence-free survival (RFS, the length of time before recurrence or death) vs. placebo (n=476) for patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection, an adjuvant setting.
Media:
Melanie Brunner, 609-252-6338
[email protected]
or
Sarah Koenig, 609-252-4145
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced follow up results from Study -004, a multi-arm Phase 1b dose-ranging trial evaluating the safety and activity of the combination regimen of nivolumab, an investigational PD-1 immune checkpoint inhibitor, and Yervoy® (ipilimumab) given either concurrently or sequentially in patients with advanced melanoma (n=127).
Media:
Sarah Koenig, 609-252-4145
[email protected]
or
Chrissy Trank, 609-252-3418
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
- Designation granted for investigational agent elotuzumab in combination with lenalidomide and dexamethasone for treatment of multiple myeloma in patients who have received one or more prior therapies
PRINCETON, N.J. & NORTH CHICAGO, Ill.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and AbbVie (NYSE:ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted elotuzumab, an investigational humanized monoclonal antibody, Breakthrough Therapy Designation for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies.
Bristol Myers Squibb
Media:
Melanie Brunner, 609-252-6338
[email protected]
or
Sarah Koenig, 609-252-4145
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
or
AbbVie
Media:
David Freundel, 847-937-4522
[email protected]
or
Investors:
Liz Shea, 847-935-2211
[email protected]
- In the Phase 2 dose-ranging trial, overall response rates for nivolumab as a single agent ranged from 20-22% and one-year survival rates ranged from 63-72% in patients who received prior anti-angiogenic treatment (CheckMate -010)
- In the Phase 1b trial, overall response rates for the investigational combination regimen of nivolumab and Yervoy ranged from 43-48% and 24-week progression free survival rates ranged from 64-65% in previously treated and treatment-naïve patients (CheckMate -016)
- The types of treatment-related serious adverse events were consistent with those in other nivolumab trials, with higher frequency for the combination regimen in CheckMate -016 (18%) than nivolumab as a single agent in CheckMate -010 (7.2%)
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced results from a Phase 2 and a Phase 1b study of its investigational PD-1 immune checkpoint inhibitor nivolumab in patients with advanced or metastatic renal cell carcinoma (RCC), commonly known as kidney cancer.
Media:
Sarah Koenig, 609-252-4145
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
- Across doses (n=107), 48% and 41% of this heavily pre-treated patient population that received nivolumab as a single agent was alive at two and three years, respectively
- Spectrum, frequency and severity of treatment-related adverse events from this study were consistent with those initially reported for these patients in prior publications
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced updated survival data from the advanced melanoma cohort (n=107) of the expanded Phase 1b dose-ranging study of nivolumab, an investigational PD-1 immune checkpoint inhibitor, administered as a single agent (Study -003). Results showed sustained activity in this heavily pre-treated patient population as defined by two- and three-year survival rates of 48% and 41%, respectively, across dose cohorts.
Bristol-Myers Squibb
Media:
Sarah Koenig, 609-252-4145, [email protected]
Chrissy Trank, 609-252-3418, [email protected]
or
Investors:
Ranya Dajani, 609-252-5330, [email protected]
Ryan Asay, 609-252-5020, [email protected]
- Longer-term data from study of previously treated patients who received nivolumab as a single agent showed a two-year survival rate of 24% across doses; results from 3 mg/kg dose also presented (Study -003)
- In chemotherapy-naïve patients who received nivolumab 3 mg/kg as a single agent, the overall response rate (ORR) was 50% in PD-L1 positive tumors and 0% in PD-L1 negative tumors (CheckMate -012)
- The types of treatment-related serious adverse events (SAEs) in CheckMate -012 were consistent with those in other nivolumab trials; of the chemotherapy-naïve patients who received nivolumab as a single agent, 15% experienced grade 3-4 treatment-related SAEs
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced results from a Phase1b study evaluating the safety and efficacy of its investigational PD-1 immune checkpoint inhibitor nivolumab as a single agent in patients with advanced non-small cell lung cancer (NSCLC) who were previously treated (Study -003) and a Phase 1b study evaluating nivolumab as a single agent in chemotherapy-naïve patients (CheckMate -012).
Bristol-Myers Squibb
Media:
Sarah Koenig, 609-252-4145, [email protected]
Chrissy Trank, 609-252-3418, [email protected]
or
Investors:
Ranya Dajani, 609-252-5330, [email protected]
Ryan Asay, 609-252-5020, [email protected]
- Designation granted for nivolumab for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant followed by brentuximab
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted the investigational PD-1 immune checkpoint inhibitor nivolumab Breakthrough Therapy Designation for the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant and brentuximab. The designation is based on data from a cohort of patients with HL in the company’s ongoing Phase 1b study of relapsed and refractory hematological malignancies.
Bristol-Myers Squibb
Media:
Sarah Koenig, 609-252-4145,
[email protected]
Chrissy Trank, 609-252-3418,
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330,
[email protected]
Ryan Asay, 609-252-5020,
[email protected]
- Data from company’s immuno-oncology clinical development programs to be presented in three tumor types across several lines of therapy
- Results for the investigational PD-1 immune-checkpoint inhibitor nivolumab to be highlighted in six oral presentations, including longer-term data from some trials
- Results for nivolumab and Yervoy® (ipilimumab) as a combination regimen in three tumor types to be presented, including melanoma and the first findings in non-small cell lung cancer and renal cell carcinoma
- Results from Yervoy Phase 3 trial in high-risk adjuvant melanoma to be presented for first time
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that new data from studies investigating its immunotherapies in adjuvant and advanced melanoma, non-small cell lung cancer (NSCLC) and metastatic renal cell carcinoma (mRCC) will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 30-June 3.
Bristol-Myers Squibb
Media
Melanie Brunner, 609-252-6338
[email protected]
or
Sarah Koenig, 609-252-4145
[email protected]
or
Investors
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
- Results of the HALLMARK-Dual study include data among genotype 1b cirrhotic and non-cirrhotic, treatment-naïve, non-responder, and peginterferon/ribavirin ineligible and intolerant patients
- Study reinforces the potential of daclatasvir-based regimens to treat HCV patients with high unmet needs
- Data to be presented during late-breaker session at EASL The International Liver CongressTM
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced Phase III results from the global HALLMARK-Dual study investigating the all-oral, interferon- and ribavirin-free regimen of daclatasvir (DCV), a NS5A inhibitor, and asunaprevir (ASV), a NS3 inhibitor, among genotype 1b hepatitis C virus (HCV) infected patients.
Bristol-Myers Squibb
Media:
Jeff Smith,
Office: +33(0) 1 58 83 83 21
Cell: +33(0) 6 03 99 40 18
[email protected]
or
Carrie Fernandez
Office: +1-609-252-4831
Cell: +1-215-859-2605
[email protected]
or
Investors:
Ranya Dajani, +1-609-252-5330
[email protected]
or
Ryan Asay, +1-609-252-5020
[email protected]
Daclatasvir data demonstrates potential to address high unmet needs, including cirrhotic and treatment-experienced patients, and those with genotypes 1, 2, 3 and 4
Breadth of viral hepatitis data underscores Company’s commitment to advancing research of liver diseases
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that 12 abstracts have been accepted for presentation at The International Liver CongressTM, the 49th annual meeting of the European Association for the Study of the Liver (EASL), in London, April 9 – 13.
Key presentations include:
Bristol-Myers Squibb Company
Media:
Jeff Smith,
Office: +33(0)1 58 83 83 21; Cell: +33(0) 6 03 99 40 18
[email protected]
or
Carrie Fernandez,
Office: +1-609-252-4831; Cell: +1-215-859-2605
[email protected]
or
Julie Ferguson,
Office: +1-609-252-5597; Cell: +1-312-385-0098
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330, [email protected]
Ryan Asay, 609-252-5020, [email protected]
Data from Phase 3 ARISTOTLE trial pre-specified subanalysis published in the European Heart Journal
PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial in relation to patient age. ARISTOTLE was designed to evaluate the efficacy and safety of Eliquis compared to warfarin for reducing the risk of stroke or systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).
Bristol-Myers Squibb
Media:
Shelly Mittendorf, 609-252-5799
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
or
Pfizer Inc.
Media:
Jennifer Kokell, 212-733-2596
[email protected]
or
Investors:
Ryan Crowe, 212-733-8160
[email protected]
In clinical trials, new once-daily Farxiga, in addition to diet and exercise, improved glycemic control by removing glucose from the body
WILMINGTON, Del. & PRINCETON, N.J.--(BUSINESS WIRE)--AstraZeneca (NYSE:AZN) and Bristol-Myers Squibb Company (NYSE:BMY) announced the U.S. Food and Drug Administration (FDA) approved Farxiga™ [far-SEE-ga] (dapagliflozin), a once-daily oral treatment indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Farxiga should not be used for the treatment of patients with type 1 diabetes or diabetic ketoacidosis.
Media:
Bristol-Myers Squibb
Ken Dominski, 609-252-5251
[email protected]
or
AstraZeneca
Kristin Rogers, 302-885-8922
[email protected]
or
Investors:
Bristol-Myers Squibb
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
or
AstraZeneca
Karl Hard, 44-20-7604-8123
[email protected]
or
Anthony Brown, 44-20-7604-8067
[email protected]
or
Jens Lindberg, 44-20-7604-8414
[email protected]
or
Colleen Proctor, 302-886-1842
[email protected]
WILMINGTON, Del. & PRINCETON, N.J.--(BUSINESS WIRE)--AstraZeneca (NYSE:AZN) and Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Farxiga™ (dapagliflozin).
Please click here for US Full Prescribing Information for Farxiga.
The companies will provide additional details regarding the approval in a press release to follow.
About the AstraZeneca/Bristol-Myers Squibb Diabetes Alliance
Media:
Bristol-Myers Squibb
Ken Dominski, 609-252-5251
[email protected]
or
AstraZeneca
Kristin Rogers, 302-885-8922
[email protected]
or
Investors:
Bristol-Myers Squibb
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
or
AstraZeneca
Karl Hard, 44-20-7604-8123
[email protected]
or
Anthony Brown, 44-20-7604-8067
[email protected]
or
Jens Lindberg, 44-20-7604-8414
[email protected]
or
Colleen Proctor, 302-886-1842
[email protected]
WILMINGTON, Del. & PRINCETON, N.J.--(BUSINESS WIRE)--AstraZeneca (NYSE:AZN) and Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13-1 that the benefits of dapagliflozin use outweigh identified risks and support marketing of dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Media:
Bristol-Myers Squibb
Shelly Mittendorf, 609-480-2951
[email protected]
or
AstraZeneca
Kristin Rogers, 302-885-8922
[email protected]
or
Investors:
Bristol-Myers Squibb
Ranya Dajani, 609-252-5330
[email protected]
or
Bristol-Myers Squibb
Ryan Asay, 609-252-5020
[email protected]
or
AstraZeneca
Karl Hard, 44-20-7604-8123
[email protected]
Advisory Committee recommends metreleptin for the treatment of pediatric and adult patients with generalized lipodystrophy; does not recommend for the treatment of partial lipodystrophy for the indication currently proposed
WILMINGTON, Del. & PRINCETON, N.J.--(BUSINESS WIRE)--AstraZeneca (NYSE:AZN) and Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommends the investigational medicine metreleptin for the treatment of pediatric and adult patients with generalized lipodystrophy (LD).
Media:
Bristol-Myers Squibb
Shelly Mittendorf, 609-252-5799
[email protected]
or
AstraZeneca
Andrew Davis, 215-542-3378
[email protected]
or
Investors:
Bristol-Myers Squibb
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
or
AstraZeneca
Karl Hard, 44-20-7604-8123
[email protected]
76% of Sprycel patients vs.63% of imatinib patients achieved a major molecular response
84% of Sprycel patients vs. 64% of imatinib patients achieved an optimal molecular response at three months (BCR-ABL ≤10%) as defined by treatment guidelines; patients who achieved this response had improved overall survival vs. those who did not
With four years of follow-up, the Sprycel safety profile was consistent with previously observed findings in this patient population
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka America Pharmaceutical, Inc. today announced four-year follow-up data from the Phase 3 DASISION study of Sprycel® (dasatinib) 100 mg once daily vs. imatinib (400 mg daily) in the first-line treatment of adults with Philadelphia chromosome-positive (Ph+) chronic phase chronic myeloid leukemia (CP-CML).
Bristol-Myers Squibb
Media:
Melanie Brunner, 609-252-6338
[email protected]
or
Sarah Koenig, 609-252-4145
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
or
Otsuka America Pharmaceutical Inc.
Media:
Kevin Wiggins (US), 609-249-7292
[email protected]
or
Otsuka Pharmaceutical Co., Ltd.
Jeffrey Gilbert (Japan)
[email protected]
LONDON & PRINCETON, N.J.--(BUSINESS WIRE)--AstraZeneca (NYSE:AZN) and Bristol-Myers Squibb (NYSE:BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Xigduo™ (dapagliflozin and metformin hydrochloride) for adults aged 18 and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their current metformin-based treatment regimen o
Media:
Bristol-Myers Squibb
Carmel Hogan, 33-1588-38295
[email protected]
or
Bristol-Myers Squibb
Ken Dominski, 609-252-5251
[email protected]
or
AstraZeneca
Donna Huang, 302-885-6396
[email protected]
or
Investors:
AstraZeneca
Karl Hard, 44-20-7604-8123
[email protected]
or
Bristol-Myers Squibb
Ranya Dajani, 609-252-5330
[email protected]
or
Bristol-Myers Squibb
Ryan Asay, 609-252-5020
[email protected]
- All clazakizumab treatment arms, both as monotherapy as well as in combination with methotrexate (MTX), met the primary endpoint of ACR20 response at 12 weeks, compared to MTX alone.
- Clazakizumab demonstrated promising rates of low disease activity and remission based on DAS28, CDAI and SDAI criteria in the study which included MTX and anti-TNF comparator arms.
- Overall the safety profile was consistent with the known pharmacology of IL6 blockade. The most frequent AE for clazakizumab was dose-related injection site reactions and these were mostly mild with few leading to discontinuation.
- Clazakizumab is a humanized anti-IL-6 monoclonal antibody directed against the IL-6 cytokine rather than the receptor.
SAN DIEGO--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Alder Biopharmaceuticals today announced the presentation of efficacy and safety data from a Phase IIb dose-ranging study of subcutaneous (SC) clazakizumab in adults with moderate-to-severe rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX). Clazakizumab is a humanized anti-IL-6 monoclonal antibody that is directed against the IL-6 cytokine rather than its receptor.
Bristol-Myers Squibb Company
Media:
Chris Clark, 609-252-6269
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
or
Alder Biopharmaceuticals
Ian Stone, 619-308-6541
[email protected]
- Across dose cohorts, 42% and 24% of heavily pre-treated patients with non-small cell lung cancer were alive at one and two years, respectively, based on Kaplan-Meier estimates
- Spectrum, frequency and severity of treatment-related adverse events were consistent with those initially reported
- Development program consists of more than 25 studies in broad range of tumors, including seven potentially registrational trials in lung cancer, melanoma and renal cell carcinoma
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced long-term follow-up results (median follow up of 20.3 months) from the lung cancer cohort (n=129) of the expanded Phase 1 dose-ranging study (003) of nivolumab, an investigational PD-1 immune checkpoint inhibitor. Results showed sustained activity in heavily pre-treated patients with non-small-cell lung cancer (NSCLC) as defined by one- and two-year survival rates of 42% and 24%, respectively, across dose cohorts.
Bristol-Myers Squibb Company
Media:
Sarah Koenig, 609-252-4145
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
- Phase III SVR24 data on daclatasvir + asunaprevir, an investigational, interferon-free and ribavirin-free treatment regimen, in Japanese HCV patients with high unmet needs selected to lead off this year’s Presidential Plenary session
- Data presentations provide further insight on dosing, tolerability and safety of multiple daclatasvir-based investigational HCV regimens
- 16 accepted abstracts on HCV and HBV underscore the breadth of the company’s hepatitis portfolio
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that 16 abstracts have been accepted for presentation at The Liver Meeting® 2013, the 64th Annual Meeting of The American Association for the Study of Liver Diseases (AASLD), in Washington D.C., November 1 – 5. These abstracts include new data supporting the company’s broad pipeline of hepatitis C (HCV) compounds.
Key presentations include:
Bristol-Myers Squibb
Media:
Carrie Fernandez, 609-252-4831
[email protected]
Julie Ferguson, 609-252-5597
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
Ryan Asay, 609-252-5020
[email protected]
- In this pooled analysis of 12 studies, a plateau in the survival curve begins at approximately three years, with some patients followed for up to ten years
- Three-year estimated survival rate of 22% observed in patients treated with Yervoy
- Findings based on different doses and regimens and show consistency of long-term survival data for Yervoy in metastatic melanoma
- Data presented as a late-breaker at the 2013 European Cancer Congress and highlighted at Congress press briefing
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced results from a pooled analysis of survival data for 12 studies (n=1,861) in patients with metastatic or locally advanced or unresectable melanoma who were treated with Yervoy® (ipilimumab) at different doses and regimens. A plateau in the survival curve begins at approximately three years, with follow-up of up to ten years in some patients. Approximately 22% of patients were alive at three years.
Bristol-Myers Squibb
Media:
Melanie Brunner, 609-252-6338
[email protected]
or
Sarah Koenig, 609-252-4145
[email protected]
or
Investors:
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
- Dapagliflozin added to metformin plus sulfonylurea demonstrated significantly greater improvements in HbA1c from baseline compared to placebo
- Significantly more patients treated with dapagliflozin achieved goal HbA1c levels of less than 7%, a key secondary endpoint
- Among other key secondary endpoints, dapagliflozin showed significant reductions in fasting plasma glucose and body weight at 24 weeks, and systolic blood pressure at 8 weeks
- Overall rates of adverse events were similar between the two treatment groups, and most were reported as mild or moderate in intensity
WILMINGTON, Del. & PRINCETON, N.J.--(BUSINESS WIRE)--AstraZeneca (NYSE: AZN) and Bristol-Myers Squibb Company (NYSE: BMY) today announced results from a Phase III study evaluating dapagliflozin in adult patients with type 2 diabetes who were inadequately controlled on combination treatment with metformin plus sulfonylurea.
Media:
AstraZeneca
Kirsten Evraire, 302-885-0435
[email protected]
or
Bristol-Myers Squibb
Shelly Mittendorf, 609-480-2951
[email protected]
or
Investors:
AstraZeneca
Karl Hard, 44-20-7604-8123
[email protected]
or
Bristol-Myers Squibb
Ranya Dajani, 609-252-5330
[email protected]
or
Ryan Asay, 609-252-5020
[email protected]
- Primary endpoint of overall survival did not reach statistical significance in this advanced patient population (p=0.053); however, anti-tumor activity was observed in other efficacy endpoints, including progression-free survival
- Drug-related adverse events were mostly immune-related, consistent with those observed previously with Yervoy
- Phase 3 trial (Study 095) assessing overall survival of Yervoy in patients with less advanced castration-resistant prostate cancer who have received no prior cytotoxic treatment is ongoing
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today reported results from the Phase 3 randomized, double-blind clinical trial (Study 043) comparing Yervoy 10 mg/kg (ipilimumab) (n=399) to placebo (n=400) following radiation in patients with advanced metastatic castration-resistant prostate cancer (mCRPC) who have received prior treatment with docetaxel. The study’s primary endpoint of overall survival (OS) did not reach statistical significance (HR = 0.85; 95% CI = 0.72-1.00; p = 0.053).
Bristol-Myers Squibb Company
Media:
Melanie Brunner, 609-252-6338, [email protected]
Sarah Koenig, 609-252-4145, [email protected]
or
Investors:
Ranya Dajani, 609-252-5330, [email protected]
Ryan Asay, 609-252-5020, [email protected]
WILMINGTON, Del. & PRINCETON, N.J.--(BUSINESS WIRE)--AstraZeneca (NYSE: AZN) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission for investigational drug dapagliflozin for the treatment of adults with type 2 diabetes. The FDA assigned a new Prescription Drug User Fee Act (PDUFA) goal date of Jan. 11, 2014.
Media:
AstraZeneca
Kristin Rogers, 302-885-8922
[email protected]
or
Bristol-Myers Squibb
Ken Dominski, 609-252-5251
[email protected]
or
Investors:
AstraZeneca
Karl Hard, 44-20-7604-8123
[email protected]
or
Bristol-Myers Squibb
John Elicker, 609-252-4611
[email protected]
PRINCETON, N.J. & NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Supplemental New Drug Application (sNDA) for Eliquis® (apixaban), for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is March 15, 2014.
Bristol-Myers Squibb
Media:
Chrissy Trank, 609-252-3418, [email protected]
Investors:
Ranya Dajani, 609-252-5330, [email protected]
Ryan Asay, 609-252-5020, [email protected]
or
Pfizer Inc.
Media:
MacKay Jimeson, 212-733-2324, [email protected]
Investors:
Suzanne Harnett, 212-733-8009, [email protected]