Portola Pharmaceuticals Announces Proactive Steps Supporting Public Health Efforts to Combat Coronavirus (COVID-19)
SOUTH SAN FRANCISCO, Calif., March 18, 2020 /PRNewswire/ -- Portola Pharmaceuticals, Inc.® (NASDAQ: PTLA) today announced proactive steps the Company is taking in support of public health efforts to prevent furtherspread of coronavirus (or COVID-19) around the globe.
As this global pandemic evolves rapidly, Portola's first priority is the health and safety of employees, patients and healthcare providers. To align with growing rigorous regulations at the global, federal and local level around the COVID-19 global pandemic, we have taken proactive steps to help hospitals focus efforts where they are needed most right now, and to ensure the health and safety of our employees.
Effective March 13, we suspended face-to-face field activity and instituted a mandatory work from home policy for all employees, including those in our South San Francisco and European headquarters. San Francisco and six surrounding counties have been asked to "Shelter in Place" until April 7, and we anticipate our offices being closed until that order is lifted. For our staff around the globe, we are monitoring local government recommendations and adapting plans accordingly.
While the coronavirus pandemic has led to suspended activities and business around the world, it will not stop patients who take rivaroxaban or apixaban from experiencing life-threatening bleeds. To address these enduring needs, we are shifting to a virtual field force to continue engaging customers with digital tools and remote meetings where possible. Our plan to present and publish data throughout the year remains intact. We were pleased to announce the latest results of real-world data demonstrating Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], was associated with the lowest rate of mortality in patients with multiple types of Factor Xa inhibitor-related bleeds. These data will be presented at the virtual American College of Cardiology's Annual Scientific Session together with the World Congress of Cardiology (ACC.20/WCC) later this month. We will be using virtual meetings to actively share these data and continue our education efforts to establish Andexxa as the standard of care for patients.
"These are unprecedented times that have changed all aspects of our daily lives and the way in which we conduct business. Now more than ever is the time for us to come together to support healthcare professionals working on the front line to prevent the further spread of coronavirus," said Scott Garland, Portola's president and chief executive officer. "We admire their dedication and believe our actions will support efforts to address this public health crisis."
Additionally, it is important that we are able to continue to supply hospitals with Andexxa. We have adequate supply of this important medicine on-hand for the next couple of years in the United States and Europe. At this time, the global Andexxa supply chain and distribution structure is intact for customers to continue to use and re-order Andexxa.
Portola will continue to closely monitor this global situation and work with suppliers, distributors, customers, clinical trial collaborators and our employees to adjust strategies as it evolves.
ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Important Safety Information
The most frequently reported adverse reactions in clinical trials in healthy subjects with Andexxa were mild or moderate infusion-related reactions comprising symptoms such as flushing and feeling hot (very common), and cough, dysgeusia, and dyspnea (common). Amongst bleeding patients, commonly reported side effects were ischemic stroke and pyrexia, with uncommon reported side effects of cerebral infarction, cerebrovascular accident, transient ischemic attack, acute myocardial infarction, cardiac arrest, myocardial infarction, deep vein thrombosis, iliac artery occlusion, pulmonary embolism.
Please refer to full Prescribing Information for more information, including Boxed Warning, at www.Andexxa.com.
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a global, commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics that could significantly advance the fields of thrombosis and other hematologic conditions. The Company's first two commercialized products are Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], marketed in Europe as Ondexxya® (andexanet alfa), and Bevyxxa® (betrixaban). The company also is advancing cerdulatinib, a SYK/JAK inhibitor being developed for the treatment of hematologic cancers. Founded in 2003 in South San Francisco, California, Portola has operations in the United States and Europe.
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 Portola's development plans, and the potential benefits of Andexxa. Risks that contribute to the uncertain nature of the forward-looking statements include: the risk that physicians, patients and payers may not see the benefits of utilizing Andexxa for the indications for which it is approved; the risk that the ongoing global COVID-19 pandemic may negatively affect our employees and business and our ability to serve patients; our ability to continue to manufacture our products and to expand approved manufacturing facilities; the possibility of unfavorable results from additional clinical trials or other studies involving Andexxa; our ability to grow our commercial operations in the EU and generate product revenue within projected timelines and budget; the risk that we may not obtain additional regulatory approvals necessary to expand approved indications for Andexxa; our expectation that we will incur losses for the foreseeable future and will need additional funds to finance our operations; the accuracy of our estimates regarding expenses and capital requirements; our ability to successfully build a hospital-based sales force and commercial infrastructure; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to retain key scientific or management personnel and general market conditions. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent annual report on Form 10-K. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
SOURCE Portola Pharmaceuticals, Inc.®
For further information: Investor Contact: Jennifer Zibuda, Portola Pharmaceuticals, IR@portola.com; Media Contact: Emily Faucette, Portola Pharmaceuticals, Media@portola.com