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Portola Pharmaceuticals Supports “World Thrombosis Day” Campaign to Increase Awareness of Risks of Blood Clots
According to the
Recent advances in the field of thrombosis have led to the development of novel oral anticoagulants (NOACs) to prevent and treat VTEs. NOACs are predominantly comprised of a class of drugs called Factor Xa inhibitors, which are indicated to prevent stroke and blood clots in people with atrial ﬁbrillation; to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE); and to prevent DVT, which may lead to PE, following hip or knee replacement surgery. In
Portola is unique in its dedication to helping patients with issues related to thrombosis. It is addressing two significant areas of unmet medical need with its two late-stage product candidates: betrixaban, a Factor Xa inhibitor to prevent blood clots in acute medically ill patients during hospitalization and after discharge, and AndexXaTM (andexanet alfa), a Factor Xa inhibitor antidote for patients with acute major bleeding.
Patients hospitalized for serious, common medical conditions (i.e., the acute medically ill) are at increased risk for VTE, which is a major cause of morbidity, mortality and re-hospitalization. An estimated 20 million acute medically ill patients in the G7 countries are at risk of developing VTE, either while in the hospital or following discharge. More than half of VTE events among the acute medically ill occur after the patient is discharged from the hospital. Despite the benefits provided by oral Factor Xa inhibitors, none is currently
While Factor Xa inhibitors are effective in preventing blood clots, they can be associated with potentially life-threatening acute major bleeding, including intracranial hemorrhage, in some patients. As the use of Factor Xa inhibitors increases, the number of patients hospitalized each year due to bleeding associated with these agents continues to grow. At this time, no
About the Need for an Oral Anticoagulant for Extended-Duration Prevention of VTE in Acute Medically Ill Patients
Acute medically ill patients are hospitalized for serious, common medical conditions, including heart failure, stroke, infection and pulmonary disease. Because of their underlying disorder or immobilization during hospitalization, they are at increased risk of serious and potentially life-threatening blood clots known as VTE. An estimated 20 million acute medically ill patients in the G7 countries are at risk of developing VTE, either while in the hospital or following discharge. Each year, more than 1 million VTE events and 150,000 VTE-related deaths occur in acute medically ill patients in the G7 countries, despite the standard use of injectable enoxaparin and other heparins in the hospital. More than half of VTE events occur after the patient is discharged from the hospital. However, no anticoagulant, including enoxaparin or any of the marketed oral Factor Xa inhibitors, is approved for extended VTE prophylaxis in the more than 24 million medically ill patients hospitalized in the G7 countries annually.
About the Need for a Factor Xa Inhibitor Antidote
Annually, 1 to 4 percent of patients treated with Factor Xa inhibitors may experience major bleeding, and an additional 1 percent may require emergency surgery. Commensurate with the increase in the use of Factor Xa inhibitors -- for stroke prevention in atrial fibrillation; treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism; and prevention of DVT following knee or hip replacement surgery -- the number of hospital admissions due to bleeding associated with these agents continues to grow. In
About Portola Pharmaceuticals, Inc.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding development of our product candidates and estimated timelines associated therewith. Risks that contribute to the uncertain nature of the forward-looking statements include the risk that we may be unable to satisfy regulatory requirements for product approvals, and the risk that the results from our APEX clinical trial may cause betrixaban regulatory approval to be delayed, more costly or not be obtained at all, we may be unable to manufacture andexanet alfa on a commercial scale, and we will need additional capital to fund our operations. These and other risks and uncertainties are described more fully in our most recent filings with the
Ana Kapor Portola Pharmaceuticalsir@portola.com Media Contact: Julie Normart W2O Groupjnormart@w2ogroup.com 415.946.1087