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bristol-myers squibb co (BMY) Key Developments

Bristol-Myers Squibb Company, Five Prime Therapeutics to Evaluate Investigational Immunotherapies in Six Tumor Types

Bristol-Myers Squibb Company and Five Prime Therapeutics said they have agreed to evaluate Bristol's Opdivo in combination with Five Prime's FPA008 in five different tumor types. Under the terms of the agreement, Bristol-Myers Squibb will make a one-time payment of $30 million to Five Prime Therapeutics, and will be responsible for study costs. Five Prime will conduct the clinical trial, which is expected to begin in 2015. The clinical collaboration with evaluate the safety tolerability and preliminary efficacy of combining Opdivo (nivolumab), an investigational PD-1 (programmed death-1) immune checkpoint inhibitor, with FPA008, a monoclonal antibody that inhibits colony stimulating factor-1 receptor. The combination will be evaluated in patients with non-small cell lung cancer, melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma. Bristol-Myers Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trademark for nivolumab.

Bristol-Myers Announces Favorable Data from Hepatitis C Virus Trial

Bristol-Myers Squibb Company has announced favorable data from the UNITY Trial program investigating a 12-week regimen of its all-oral daclatasvir, or DCV, TRIO regimen, a fixed-dose combination of daclatasvir with asunaprevir, or ASV, and beclabuvir, or BCV, in patients with genotype 1 hepatitis C virus, or HCV. The primary endpoint for both studies was the percentage of patients who achieved cure, defined as HCV RNA. The open-label UNITY-1 study evaluated a 12-week regimen of the DCV-TRIO without ribavirin in treatment-naive and -experienced non-cirrhotic patients. Non-cirrhotic treatment-naive patients (n=312) and treatment-experienced patients (n=103) received the DCV-TRIO fixed-dose combination in one pill twice daily for 12 weeks, with 24 weeks of follow-up. The majority of the patients (73%) were genotype 1a, and 91% of all patients achieved SVR12. 92% of treatment-naive patients and 89% of treatment-experienced patients achieved cure, without the use of ribavirin. In the UNITY-2 study, both cirrhotic treatment-naive and treatment-experienced patients received the DCV-TRIO fixed-dose combination, one arm without ribavirin (n=102) and one with ribavirin (n=100). The study was double-blinded to ribavirin, and the majority of the patients (74%) were genotype 1a. The study showed 96% of all patients who received the DCV-TRIO with ribavirin achieved SVR12, and 90% of those who received the DCV-TRIO without ribavirin achieved SVR12.

Portola, Bristol-Myers Squibb and Pfizer Announce Statistically Significant Results From the First Part of the Phase 3 ANNEXA

Portola Pharmaceuticals, Inc., Bristol-Myers Squibb Company and Pfizer Inc. announced results from the first part of the Phase 3 ANNEXA(TM)-A (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXA Inhibitors -- Apixaban) studies. Andexanet alfa produced rapid and nearly complete reversal (by approximately 94%, p value < 0.0001) of the anticoagulant effect of Eliquis (apixaban) in healthy volunteers ages 50-75. This first part of the Phase 3 ANNEXA-A trial achieved all of its primary and secondary endpoints with statistical significance (p value < 0.0001). The trial included 33 subjects, with 24 randomized to andexanet alfa and nine to placebo. In the study, two to five minutes after completion of a bolus dose of andexanet alfa, the anticoagulant activity of Eliquis was reversed by approximately 94% (p value < 0.0001) compared with placebo as measured by anti-Factor Xa activity. Every subject treated with andexanet alfa had between 90 and 96% reversal of the anticoagulant activity of Eliquis. The reversal of anti-Factor Xa activity correlated with a significant reduction in the level of free, unbound Eliquis in the plasma, consistent with the mechanism of action of andexanet alfa. Additionally, andexanet alfa restored thrombin generation to baseline normal levels (prior to Eliquis therapy). In this study, no serious adverse events, thrombotic events, or antibodies to Factor X or Xa were reported following andexanet alfa administration. Mild infusion reaction was reported in three subjects.

Bristol-Myers Squibb to Invest Around €720 Million in New Plant in Dublin

Bristol-Myers Squibb has announced it is to invest around €720 million in a new plant in Dublin that will see the creation of 350-400 highly skilled jobs. The new 30,000 sq.m facility at Cruiserath near Blanchardstown will see the manufacture of a range of biologic drugs. The construction phase will see the creation of a further 1,000 temporary jobs. The new plant will be built on the grounds of the company's existing manufacturing site in the area.

Bristol-Myers Squibb to Construct A New Large-Scale Biologics Manufacturing Facility in Cruiserath, Ireland

Bristol-Myers Squibb Company announced plans to construct a new state-of-the-art, large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland, that will produce multiple therapies for the company's growing biologics portfolio. Once completed, the new facility will significantly increase Bristol-Myers Squibb's biologics manufacturing capacity and play a central role in its global manufacturing network. The 30,000-square meter project will house six 15,000-liter bioreactors and a purification area as well as office and laboratory space. The plant will be built on the grounds of the company's existing bulk pharmaceutical manufacturing plant. Approximately 350 to 400 scientists, engineers, bioprocess operators, quality specialists and other skilled professionals are expected to work at the facility when construction is completed, and the construction program is expected to create about 1,000 jobs. The completion of the facility, including commissioning and validation, is anticipated to take approximately four years and is estimated to be operational in 2019.


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