Bay Area's Portola Rockets as the FDA Approves First and Only Anticoagulant for Hospitals

Published: Jun 27, 2017

Bay Area's Portola Rockets as the FDA Approves First and Only Anticoagulant for Hospitals June 26, 2017
By Mark Terry, BioSpace.com Breaking News Staff

South San Francisco – Portola Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) had approved Bevyxxa (betrixaban). The drug is the first and only anticoagulant for hospital and extended duration prophylaxis of 35 to 42 days of venous thromboembolism (VTE) in adult patients who have been hospitalized for an acute medical illness.

Portola skyrocketed from $35.46 on June 15 to a current price of $55.32.

The drug is aimed at patients in the hospital for heart failure, stroke, and pulmonary diseases who are immobile and bedridden for a lengthy period of time, which places them at high risk of venous thromboembolism (VTE), or blood clots.

Frank Vinluan, with Xconomy, writes, “While anticoagulants are readily available, bleeding and other safety concerns limit how long they can be used. The FDA based its approval decision on data from a Phase III clinical trial that randomized 7,513 patients to receive either betrixaban or enoxaparin (Lovenox), an injectable drug currently used to prevent blood clots. Patients in the betrixaban group received the Portola drug for 35 to 42 days. Patients in the comparator arm received enoxaparin for six to 14 days, followed by a placebo for 14 days. Portola enrolled the trial by looking for patients who had elevated levels of D-dimer, a protein fragment that is present after a blood clot has developed.”

“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, in a statement. “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.”

The company expects to launch Bevyxxa between August and November 2017. As part of that launch, it expects to finish salesforce hiring and training, drug manufacturing validation and inventory buildup.

The drug is also being evaluated by the European Medicines Agency’s Committee for Human Medicinal Products (CHMP).

Bevyxxa is a once-daily pill. It is designed for both hospital use and after post-hospitalization care. There is no competition in the home setting. Most VTEs occur at home.

In 2009, Portola licensed the drug to Merck for an upfront cash payment of $50 million. In 2011, Merck ended the deal after reviewing its drug portfolio.

“Bevyxxa represents a major advance for the field of thrombosis,” said C. Michael Gibson, APEX Executive Committee Member and Steering Committee Chairman, professor at Harvard Medical School and chairman of the PERFUSE Study Group, in a statement. “It is the first therapy to demonstrate a reduction in the incidence of VTE in these high-risk patients without a significant increase in major bleeding. With this approval, we are finally able to help protect these patients from this often fatal, yet preventable condition.”

Company stock has increased about 47.1 percent over the last three months. Over the same period, the S&P 500 SPX rose only about 4 percent.

Wall Street analysts project the drug as a potential blockbuster, with $1 billion in sales by 2023.

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