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bristol-myers squibb co (BMY) Key Developments

Bristol-Myers Squibb Company and Pfizer Inc. Announce U.S. Food and Drug Administration Approval of New Drug Application for Eliquis

Bristol-Myers Squibb Company and Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. Combined, DVT and PE are known as VTE. The full Prescribing Information for Eliquis includes Boxed Warnings for the increased risk of thrombotic events in patients who prematurely discontinue Eliquis and for the increased risk of epidural or spinal hematoma, which may cause long-term or permanent paralysis, in patients using Eliquis and undergoing spinal epidural anesthesia or spinal puncture. The FDA approval of Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy, is based on data from the global AMPLIFY and AMPLIFY-EXT studies. The AMPLIFY study, a randomized, double-blind trial, was designed to demonstrate the efficacy and safety of Eliquis for the treatment of DVT and PE, and included patients with confirmed symptomatic DVT or PE (2,609 for Eliquis and 2,635 for standard of care, which was initial enoxaparin treatment for at least five days, overlapped by warfarin therapy [International Normalized Ratio (INR) range 2.0-3.0] orally for six months). In the AMPLIFY study, Eliquis 10 mg twice daily for one week followed by 5 mg twice daily for six months demonstrated efficacy comparable to standard of care in treating DVT and PE patients for the primary efficacy composite endpoint of recurrent, symptomatic VTE, or VTE-related death (2.3% vs. 2.7%, relative risk, 0.84; 95% confidence interval [CI], 0.60 to 1.18; P-value<0.0001 for noninferiority).

Bristol-Myers Squibb and Celgene to Collaborate on Cancer Treatment Study

Bristol-Myers Squibb Company (BMY) and Celgene Corporation (CELG) established a clinical trial collaboration to study a combination regimen of two cancer treatment therapies. The two companies announced a Phase 1 study to evaluate Bristol-Myers' immune checkpoint inhibitor OPDIVO and Celgene's technology-based chemotherapy ABRAXANE. OPDIVO is part of a new class of cancer treatments known as immunotherapies that are designed to harness the body's own immune system in fighting cancer. ABRAXANE works by interfering with the ability of cancer cells to divide. The study, which is expected to begin in the fourth quarter of 2014, will be conducted by Celgene.

Leica Biosystems and Bristol-Myers Squibb Enter Into a Development and Commercialization Collaboration for Companion Diagnostics that Support Targeted Therapies

Leica Biosystems announced an agreement with Bristol-Myers Squibb Company to collaborate on developing companion diagnostics on the Leica BOND system for use as an aid in selecting patients for treatment with certain pharmaceuticals developed, or to be developed, by Bristol-Myers Squibb. Other terms of the agreement were not disclosed.

Allied Minds and Bristol-Myers Squibb Company Announces Formation of Allied-Bristol Life Sciences LLC

Allied Minds and Bristol-Myers Squibb Company announced the formation of Allied-Bristol Life Sciences LLC, a new jointly owned enterprise created to identify and foster research and pre-clinical development of biopharmaceutical innovations from leading university research institutions across the U.S. Under the terms of the agreement, the companies have jointly formed and funded Allied-Bristol Life Sciences LLC, which will work with university researchers to identify discoveries it believes has promising therapeutic and commercial potential, and will support the research and development needed to take these early-stage opportunities from initial feasibility to pre-clinical candidacy. Allied Minds and Bristol-Myers Squibb together will form and fund new companies to conduct feasibility and full-phase discovery programs. Once a program succeeds in identifying a pre-clinical candidate, Bristol-Myers Squibb will have the option to acquire the company from Allied-Bristol Life Sciences LLC under pre-agreed terms.

European Commission Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and Prevention of Recurrent DVT and PE

Bristol-Myers Squibb Company and Pfizer Inc. announced that the European Commission has approved Eliquis for the treatment of DVT and PE, and the prevention of recurrent DVT and PE in adults. The European Commission approval applies to all European Union (EU) member states as well as Iceland and Norway. Eliquis is also approved in the EU for the prevention of venous thromboembolism (VTE) in adults who have undergone elective total hip or knee replacement surgery, and for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors. The marketing authorization for Eliquis follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, and is supported by two pivotal Phase 3 clinical trials, AMPLIFY and AMPLIFY-EXT. AMPLIFY (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY) was designed to demonstrate the efficacy and safety of Eliquis for the treatment of DVT and PE versus enoxaparin 1 mg/kg twice daily subcutaneously for at least 5 days (until INR>= 2) and warfarin (target INR range 2.0-3.0) orally for six months. AMPLIFY-EXT (Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY-EXTended treatment) was designed to demonstrate the efficacy and safety of Eliquis compared to placebo for the prevention of recurrent DVT and PE following six to 12 months of anticoagulant treatment for DVT and/or PE. As described in the SmPC, in the AMPLIFY study a total of 5,395 patients were randomized to treatment with Eliquis 10 mg twice daily orally for seven days followed by Eliquis 5 mg twice daily orally for six months, or enoxaparin 1 mg/kg twice daily subcutaneously for at least five days (until INR>= 2) and warfarin (target INR range 2.0-3.0) orally for six months. The mean age was 56.9 years and 89.8% of randomized patients had unprovoked VTE events. In the study, Eliquis was shown to be non-inferior to enoxaparin/warfarin in the combined primary endpoint of adjudicated recurrent symptomatic VTE (nonfatal DVT or nonfatal PE) or VTE-related death. Eliquis efficacy in initial treatment of VTE was consistent between patients who were treated for a PE [Relative Risk 0.9; 95% CI (0.5, 1.6)] or DVT [Relative Risk 0.8; 95% CI (0.5, 1.3)]. Efficacy across subgroups, including age, gender, body mass index (BMI), renal function, extent of index PE, location of DVT thrombus, and prior parenteral heparin use was generally consistent. For patients randomized to warfarin, the mean percentage of time in therapeutic range (TTR) (INR 2.0-3.0) was 60.9. The effect of Eliquis on recurrent symptomatic VTE or VTE- related death was consistent across the different levels of center TTR; within the higher quartile of TTR according to center, the relative risk for Eliquis vs enoxaparin/warfarin was 0.79 (95% CI, 0.39, 1.61). The primary safety endpoint was major bleeding. In the study, Eliquis was statistically superior to enoxaparin/warfarin in the primary safety endpoint [Relative Risk 0.31, 95% confidence interval (0.17, 0.55), P-value <0.0001]. The adjudicated major bleeding and clinically relevant non-major (CRNM) bleeding at any anatomical site were generally lower in the Eliquis group as compared to the enoxaparin/warfarin group. Adjudicated International Society on Thrombosis and Haemostasis (ISTH) major gastrointestinal bleeding occurred in 6 (0.2%) Eliquis-treated patients and 17 (0.6%) enoxaparin/warfarin-treated patients. As described in the SmPC, in the AMPLIFY-EXT study a total of 2,482 patients were randomized to treatment with Eliquis 2.5 mg twice daily orally, Eliquis 5 mg twice daily orally, or placebo for 12 months after completing six to 12 months of initial anticoagulant treatment. Of these, 836 patients (33.7%) participated in the AMPLIFY study prior to enrollment in the AMPLIFY-EXT study. The mean age was 56.7 years and 91.7% of randomized patients had unprovoked VTE events. In the study, both doses of Eliquis were statistically superior to placebo in the primary endpoint of symptomatic, recurrent VTE (nonfatal DVT or nonfatal PE) or all-cause death. Eliquis efficacy for prevention of a recurrence of a VTE was maintained across subgroups, including age, gender, BMI, and renal function. The primary safety endpoint was major bleeding during the treatment period. In the study, the incidence in major bleeding for both Eliquis doses was not statistically different from placebo. There was no statistically significant difference in the incidence of major, clinically relevant non-major, minor, and all bleeding between the Eliquis 2.5 mg twice daily and placebo treatment groups. The recommended dose of Eliquis for the prevention of recurrent DVT and PE is 2.5 mg taken orally twice daily. Adjudicated ISTH major gastrointestinal bleeding occurred in 1 (0.1%) Eliquis-treated patient at the 5 mg twice daily dose, no patients at the 2.5 mg twice daily dose, and 1 (0.1%) placebo-treated patient.

 

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