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February 3, 2014
08:11 EDTBAYRY, PTLAPortola Pharmaceuticals enters into clinical collaboration agreement with Bayer
Portola Pharmaceuticals (PTLA) announced that it has entered into a second clinical collaboration agreement with Bayer HealthCare (BAYRY) and Janssen Pharmaceuticals to evaluate its investigational Factor Xa inhibitor reversal agent, andexanet alfa, in Phase 3 registration studies with the FDA-approved oral Factor Xa inhibitor XARELTO. Portola's original collaboration agreement with Bayer and Janssen, announced in February 2013, covered the conduct of a Phase 2 proof-of-concept study. Interim results of that study were presented in December 2013 at the 55th American Society of Hematology Annual Meeting and demonstrated that andexanet alfa can produce an immediate and dose-dependent reversal of the anticoagulation activity of XARELTO. The new clinical collaboration agreement will be in effect through completion of Phase 3 studies with XARELTO and any potential U.S. and EU regulatory approval of andexanet alfa. The Phase 3 studies are expected to start in the first half of 2014. Under this non-exclusive collaboration agreement, Portola will receive an upfront payment and is eligible to receive additional development and regulatory milestone payments. Portola retains full, worldwide commercial rights to andexanet alfa, which was designated as a breakthrough therapy by the FDA in November 2013 and for which Portola is pursuing an Accelerated Approval pathway.
News For PTLA;BAYRY From The Last 14 Days
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March 3, 2015
07:08 EDTBAYRYAmerican Society for Clinical Pharmacology and Therapeutics holds meeting
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March 2, 2015
08:15 EDTPTLAPortola announces full results from positive Phase 3 ANNEXA-R study
Portola Pharmaceuticals announced full results from the first part of the Phase 3 ANNEXA-R study, which is evaluating the safety and efficacy of andexanet alfa with the Factor Xa inhibitor XARELTO in healthy volunteers. Results showed the first part of this registration-enabling study met all primary and secondary endpoints with high statistical significance. Andexanet alfa administered as an intravenous bolus produced rapid and significant reversal of the anticoagulant effect of XARELTO as measured by anti-Factor Xa activity. Additionally, there was a significant reduction in the level of free XARELTO in the plasma, and thrombin generation was rapidly restored to within the normal baseline range following administration of andexanet alfa. In the study, andexanet alfa was well tolerated. There were no serious or severe adverse events, no thrombotic events, and no antibodies to Factor X or Xa observed. Andexanet alfa, a FDA-designated breakthrough therapy, is a recombinant protein specifically designed to reverse the anticoagulant activity in patients treated with an oral or injectable Factor Xa inhibitor. Andexanet alfa has the potential to be a first-in-class antidote for anticoagulated patients who suffer a major bleeding episode or require emergency surgery. The randomized, double-blind, placebo-controlled Phase 3 ANNEXA-R study is evaluating the safety and efficacy of andexanet alfa in reversing XARELTO-induced anticoagulation in healthy volunteers ages 50-75 years. Efficacy is being evaluated using biomarker endpoints, with anti-Factor Xa levels as the primary endpoint. Secondary endpoints include plasma levels of free unbound XARELTO and endogenous thrombin potential, a measure of thrombin generation. In the first part of the ANNEXA-R study, 41 healthy volunteers were given XARELTO 20 mg once daily for four days to steady state. They were then randomized in a 2:1 ratio to receive at Cmax either andexanet alfa administered as an 800 mg IV bolus or placebo. Results showed that, for the primary endpoint, andexanet alfa reduced the anti-Factor Xa activity of rivaroxaban from baseline to nadir by >90 percent, a highly significant difference.
February 26, 2015
11:36 EDTBAYRYBayer sees FY15 sales EUR 46
The company expects positive currency effects on sales of about 3% compared with the previous year. Bayer plans to raise EBITDA before special items by a low- to mid-teens percentage, allowing for expected positive currency effects of about 2 percent. Bayer aims to increase core earnings per share by a low-teens percentage, allowing for expected positive currency effects of around 3%.
11:35 EDTBAYRYBayer reports FY14 net income EUR 3.43B vs. EUR 3.19B last year
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08:20 EDTPTLAPortola Pharmaceuticals receives FDA ODD for andexanet alfa
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06:30 EDTBAYRYBayer says flotation of MaterialScience 'proceeding on schedule'
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February 20, 2015
07:23 EDTBAYRYAbbVie replaces Pfizer as top global pharma pick at Jefferies
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06:29 EDTBAYRYBayer close to selling diabetes unit to Panasonic, Bloomberg says
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February 19, 2015
18:25 EDTBAYRYPiper Jaffray biotech analyst to hold analyst/industry conference call
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16:50 EDTBAYRYSanofi appoints Olivier Brandicourt CEO
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14:53 EDTBAYRYBayer near sale of diabetes unit to KKR backed venture, Bloomberg says
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14:01 EDTBAYRYBayer near sale of diabetes unit to KKR's Panasonic Healthcare, Bloomberg says
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