Portola Pharmaceuticals Inc (NASDAQ
Time to load up ?
More recently, Portola Pharmaceuticals reported that the CHMP of the European Medicines Agency has extended the assessment period for the firm’s marketing authorization application for Ondexxya™ and cancelled the Oral Explanation that was planned earlier this month. An opinion is now anticipated by February 28, 2019.
As per the update, the CHMP will give a list of outstanding questions linked to the data package the firm submitted for Ondexxya in last quarter, which will need additional responses from the firm. The initial timetable provided to the firm by the CHMP establishes a deadline of January 29, 2019 for answers to the questions and then a 30-day evaluation period for the CHMP to assess the firm’s responses. Ondexxya is under evaluation for the reversal of the anticoagulant impact of the Factor Xa inhibitors rivaroxaban and apixaban in people witnessing unmanaged or life-threatening bleeding.
The CEO and President of Portola expressed that they will work thoroughly to address the Committee’s queries as they evaluate and further deliberate the data package backing the MAA. They look forward to advancing the dialogue as they move toward a formal view and potential European nodl early next year.
Andexanet alfa was permitted by the U.S. FDA in this May and is commercialized by Portola in the United States under the trade name “Andexxa®”.
In 3Q2018, Portola posted revenue of $14.2 million versus $3.8 million for the same quarter of 2017. This comprises product revenue of $7.7 million for their initial full quarter of Andexxa sales and collaboration and license revenues of $7 million.
With the markets crashing all over the world, fortunes could very well turn around for this company. Stay tuned to more updates to follow shortly.