Corporate News Blog – US FDA Approves Portola’s Anticoagulant for High-risk Patients with Thromboembolic Complications

Research Desk Line-up: OncoSec Medical Post Earnings Coverage

LONDON, UK / ACCESSWIRE / June 27, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Portola Pharmaceuticals, Inc. (NASDAQ: PTLA), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=PTLA. On June 23, 2017, US Food and Drug Administration (FDA) approved Portola Pharma’s Bevyxxa, an anticoagulant for the treatment of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness and who are at risk for thromboembolic complications. For immediate access to our complimentary reports, including today’s coverage, register for free now at:

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Portola’s Bevyxxa also known as betrixaban, is an oral, once-daily Factor Xa inhibitor and was granted a Fast Track designation and approved by the FDA under Priority Review, a status given to drugs that may offer significant improvements in treatment or provide a treatment where no adequate therapy exists. Bevyxxa has been approved based on data from Portola’s pivotal Phase-3 APEX Study, which enrolled 7,513 patients at more than 450 clinical sites worldwide.

“Our goal as a company is to bring to market important medicines for the benefit of patients,” said Bill Lis, Portola’s Chief Executive Officer, “Today’s approval is the ultimate milestone for Portola. We are grateful to the patients who participated in our trials, the FDA, our academic collaborators and investigators, and, importantly, our dedicated employees who have worked tirelessly to achieve this goal.”

Study Results

Portola noted that the APEX study evaluated oral betrixaban for 35 to 42 days compared with injectable enoxaparin for 6 to 14 days followed by placebo in assessing the prevention of VTE in high-risk acutely ill medical patients. Bevyxxa efficacy was measured in the modified Intent-to-Treat (mITT) analysis, which includes 7,441 patients assessed by a composite outcome score comprising either the occurrence of asymptomatic proximal DVT or symptomatic DVT, non-fatal PE or VTE-related death. As per the results, Bevyxxa reduced the incidence of DVT and PE blood clots compared with those taking enoxaparin plus placebo with no significant increase in major bleeding. The most frequent reason for treatment discontinuation was bleeding, with an incidence rate of all bleeding episodes of 2.4% and 1.2% for betrixaban and enoxaparin, respectively.

Portola stated that results from the APEX study have been peer-reviewed and published in The New England Journal of Medicine, Circulation, and the American Heart Journal.

Moving Forward

Portola expects to launch Bevyxxa between August and November 2017. During this period, the Company plans to complete sales force hiring and training, drug manufacturing validation, and inventory buildup. Portola noted that in European Union, the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) is reviewing the Marketing Authorization Application for betrixaban under its standard review period.

Last Close Stock Review

On Monday, June 26, 2017, the stock closed the trading session at $56.91, rising 1.52% from its previous closing price of $56.06. A total volume of 5.59 million shares have exchanged hands, which was higher than the 3-month average volume of 851.49 thousand shares. Portola Pharma’s stock price skyrocketed 45.48% in the last three months, 203.84% in the past six months, and 145.83% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have soared 153.61%. At Monday’s closing price, the stock’s net capitalization stands at $3.35 billion.

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