Key Developments: Bristol-Myers Squibb Co (BMY_p.N)
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Latest Key Developments (Source: Significant Developments)
Bristol-Myers Squibb Co Issues FY 2013 Guidance In Line With Analysts' Estimates
Bristol-Myers Squibb Co announced that for fiscal 2013, it expects GAAP EPS in the range of $1.54-$1.64 and non-GAAP EPS in the range of $1.78-$1.88. Fiscal 2013 worldwide sales is expected to be between $16.2 billion and $17.0 billion. According to I/B/E/S Estimates, analysts on an average are expecting the Company to report EPS of $1.83 and revenue of $16.6 billion for fiscal 2013. Full Article
Tranzyme Pharma Announces Completion Of Drug Discovery Collaboration With Bristol-Myers Squibb Co
Tranzyme Pharma announced the completion of chemistry-based drug discovery collaboration with Bristol-Myers Squibb. As a result of the joint research efforts, Tranzyme has transferred compounds to Bristol-Myers Squibb for further development across multiple drug targets. As part of this agreement, Tranzyme retains the option to further pursue select collaboration targets for internal development. The goal of the strategic collaboration, established in December 2009, was to deploy Tranzyme's chemistry technology, Macrocyclic Template Chemistry (MATCH), in the discovery of active macrocycles against a range of diverse biological targets that have historically been difficult to access with conventional small molecule chemistry. Under the terms of the agreement, Tranzyme had primary responsibility for early lead compound discovery. Bristol-Myers Squibb has primary responsibility for optimizing the identified lead compounds, and sole responsibility for completing preclinical and clinical development of all products arising from the collaboration, and for their commercialization globally. Full Article
Bristol-Myers Squibb Co And Pfizer Inc Receives FDA Approves ELIQUIS (apixaban) To Reduce Risk Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation
Bristol-Myers Squibb Co and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved ELIQUIS (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Atrial fibrillation, the most common type of irregular heartbeat, affects approximately 5.8 million people in the U.S., and results in a five times greater risk of stroke. In the U.S., 15% of strokes are attributable to atrial fibrillation. The ELIQUIS clinical trial program is the completed clinical development program designed to evaluate risk reduction of stroke or systemic embolism in nonvalvular atrial fibrillation patients; it included two Phase 3 studies ARISTOTLE and AVERROES in patients with nonvalvular atrial fibrillation and at least one additional risk factor for stroke. ARISTOTLE evaluated ELIQUIS versus warfarin in 18,201 patients with nonvalvular atrial fibrillation who were suitable for warfarin therapy, and AVERROES evaluated ELIQUIS versus aspirin in 5,598 patients with nonvalvular atrial fibrillation who were considered unsuitable for treatment with warfarin. The Full Prescribing Information for ELIQUIS includes a Boxed Warning for patients who discontinue treatment. Patients on ELIQUIS who discontinue treatment are at an increased risk of thrombotic events. An increased rate of stroke was observed following discontinuation of ELIQUIS in clinical trials in patients with nonvalvular atrial fibrillation. Full Article
Bristol-Myers Squibb Co Sues Dr Reddy's Laboratories For Patent Infringement In US-The Economic Times
The Economic Times reported that Bristol-Myers Squibb Co has filed patent infringement case against Dr Reddy's Laboratories over the cancer drug Ixempra. Bristol-Myers in its petition filed in the United States District Court of New Jersey alleged that the Indian drug maker has infringed the patents of its drug on three counts. According to the petition, by a letter dated November 13, 2012, DRL notified Bristol-Myers that the Indian drug had submitted Abbreviated New Drug Application (ANDA) concerning its proposed drug product of Ixabepilone for injection, as required by the FDA rules. DRL's letter further notified that Ixabepilone injection patents are invalid and or will not be infringed by the commercial manufacture, use, offer for sale, or sale of DRL's ANDA product, the petition said. Full Article
Medicines Co And Bristol-Myers Squibb Agree To Global Alliance for Recothrom
Medicines Co and Bristol-Myers Squibb Company announced that the companies have signed a global license and two year collaboration for Recothrom, a recombinant thrombin approved by the U.S. Food and Drug Administration for use as a topical hemostat to control non-arterial bleeding during surgical procedures. The transaction is expected to be accretive to earnings per share (EPS) for The Medicines Company in 2013. Under terms of the agreement, The Medicines Company will pay Bristol-Myers Squibb an upfront collaboration payment of $105 million and an upfront option fee of $10 million. The Medicines Company has also agreed to pay Bristol-Myers Squibb a tiered royalty on annual net revenues of Recothrom during the two-year collaboration term. Bristol-Myers Squibb will retain responsibility for the manufacturing of Recothrom and will be The Medicine Company's exclusive supplier of Recothrom during the term of the agreement. The option enables The Medicines Company to acquire the Recothrom assets for a purchase price based on average net sales during the two-year collaboration term. The transaction is expected to be minimally accretive to EPS for Bristol-Myers Squibb in 2013 and 2014. Full Article
Bristol-Myers Squibb Co and Abbott Laboratories Announce Elotuzumab Progression-Free Survival Data from Phase 2 Study of Patients with Previously-Treated Multiple Myeloma
Bristol-Myers Squibb Co and Abbott Laboratories announced results from a small, randomized Phase 2, open-label study in patients with previously-treated multiple myeloma that evaluated two doses of elotuzumab (10 mg/kg and 20 mg/kg) in combination with lenalidomide and low-dose dexamethasone. In the 10 mg/kg arm, median progression-free survival (PFS), or the time without disease progression or death, was not reached after 20.8 months of follow up (N=36) and the objective response rate (ORR) was 92%. Of patients who received elotuzumab at a dose of 20 mg/kg, median PFS was 18.6 months (N=37) and ORR was 76%. The safety data are consistent with previously-reported results for elotuzumab. Overall, 78% of patients experienced ≥1 treatment emergent grade ≥3 events. The most common were lymphopenia (19%), neutropenia (18%), thrombocytopenia (16%), anemia (12%), leukopenia (10%), hyperglycemia (10%), pneumonia (7%), diarrhea (7%), fatigue (7%), and hypokalemia (6%). Two deaths occurred on study (multiple adverse events [n=1; pneumonia, multiple organ failure and sepsis]; disease progression [n=1]). Infusion reactions (any grade) were reported in 14% of patients. Second primary malignancies were reported in four patients and were deemed as unrelated to elotuzumab. Full Article
Bristol-Myers Squibb Co and Pfizer Inc Announce Results Of Phase 3 AMPLIFY-EXT Trial
Bristol-Myers Squibb Co and Pfizer Inc announced the results of the Phase 3 AMPLIFY-EXT trial, which evaluated treatment with ELIQUIS (apixaban) over a one-year period compared to placebo for the prevention of recurrent venous thromboembolism (VTE) in 2,486 patients who had already completed 6 to 12 months of anticoagulation treatment for VTE, including deep vein thrombosis (DVT) or pulmonary embolism (PE). In the trial, extended treatment with ELIQUIS 2.5 mg and 5 mg twice daily, demonstrated superiority versus placebo in the reduction of the composite endpoint of symptomatic, recurrent VTE and death from any cause (11.6% in the placebo group, compared with 3.8% and 4.2% in the ELIQUIS 2.5 mg and 5 mg groups, respectively, P<0.001), the primary efficacy outcome of the trial. ELIQUIS also was superior to placebo for the predefined secondary efficacy outcome of recurrent VTE and VTE-related death (8.8% in the placebo group, compared with 1.7% in both the ELIQUIS 2.5 mg and 5 mg groups). Both of these endpoints, the primary and secondary efficacy outcomes, were statistically significant (p<0.001). The rate of the composite of major bleeding and clinically relevant non-major bleeding for the 5 mg treatment group (4.3%) was higher versus the placebo group (2.7%), while the rate for the 2.5 mg treatment group (3.2%) was similar to the placebo group. Full Article
Bristol-Myers Squibb Co Announces Dividend
Bristol-Myers Squibb Co announced that it has declared an increase of approximately 3 % in the Company`s quarterly dividend, beginning in the first quarter of 2013. The dividend increase will result in a quarterly dividend of thirty-five cents ($0.35) per share on the $0.10 par value Common Stock of the corporation for an indicative 2013 full-year dividend of $1.40 per share, subject to the normal quarterly review by the Board. The next quarterly dividend will be payable on February 1, 2013, to stockholders of record at the close of business on January 4, 2013. The Directors also declared a quarterly dividend of fifty cents ($0.50) per share on the $2.00 Convertible Preferred Stock of the corporation, payable March 1, 2013, to stockholders of record at the close of business on February 1, 2013. Full Article
Biocon Ltd Enters Into Option Agreement With Bristol-Myers Squibb Company For Biocon's IN-105
Biocon Ltd announced that it has entered into an option agreement with Bristol-Myers Squibb Company for Biocon's IN-105, a prandial oral insulin product candidate. Under the terms of the agreement, Bristol-Myers Squibb will have the right to exercise an option to obtain an exclusive worldwide license to the program. Biocon will conduct clinical studies to further characterize IN-105's clinical profile according to a pre-agreed development program up to the completion of Phase II. If Bristol-Myers Squibb exercises its option to license IN-105 following the successful completion of the Phase II trial, Bristol-Myers Squibb will assume full responsibility for the development program, including all development and commercialization activities outside India. Biocon will receive a license fee in addition to potential regulatory and commercial milestone payments and royalties on commercial sales of IN-105 outside India. Biocon will retain exclusive rights to IN-105 in India. Full Article
Bristol-Myers Squibb Co Announces New Head-To-Head Patient Reported Outcomes Data For Orencia Sc (Abatacept)
Bristol-Myers Squibb Co announced new clinical trial results showing the subcutaneous (SC) formulation of Orencia (abatacept) on a background of methotrexate (MTX) was similar to Humira (adalimumab) plus MTX in demonstrating clinical improvements in Patient Reported Outcomes (PROs) in adults with moderate to severe rheumatoid arthritis (RA),including patient pain, patient global assessment, fatigue, physical function and health related quality of life (HRQoL) that were sustained for one year. At one year, Orencia SC plus MTX was similar to Humira plus MTX in improving patient pain (53.0% and 39.2%), improving patient global assessment (46.1% and 41.2%) and decreasing fatigue (-23.2% and -21.4%). A normal physical function (measured by the Health Assessment Questionnaire Disability Index, HAQ-DI) was achieved by 60.4% of patients in the Orencia SC treatment group and 57.0% in the Humira treatment group, and the measure of Health Related Quality of Life (HRQoL) assessed using SF-36 was also similar between the two groups. The data comes from analysis of one-year results from AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naive RA Subjects With Background Methotrexate), an ongoing, investigator-blinded randomized, Phase IIIb, controlled study comparing the efficacy of Orencia SC vs. Humira on a background of MTX in adult, biologic naïve patients with moderate to severe RA. AMPLE is a two year study with a one year efficacy primary endpoint (non-inferiority for ACR20). Full Article
Bristol melanoma drug combo marks new advance in immunotherapy
CHICAGO - Melanoma patients treated with two Bristol-Myers Squibb drugs fared much better than those who received either of the medications individually, a new advance for treatments that harness the body's immune system to fight cancer.
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