European market launch
On April 26, Portola Pharmaceuticals (PTLA) issued a press release announcing conditional marketing authorization granted by the European Commission to Andexxa, under the trade name Ondexxya, as an antidote to Factor Xa inhibitor apixaban or rivaroxaban. The company has now planned for the launch of the drug in wave one European countries including the United Kingdom, Austria, Germany, Netherlands, and some Nordic countries.
According to the first-quarter earnings conference call, Portola Pharmaceuticals has selected wave one countries based probability of higher access and reimbursement. The company is also working on dossiers to negotiate pricing with reimbursement authorities in the United Kingdom and Germany.
According to a first-quarter earnings investor presentation, these commercial launches are expected to add around 140,000 patients who are admitted for Factor Xa inhibitor-related bleeding in these European countries. The company expects this market opportunity to be equal to or even larger than the US market opportunity. Portola Pharmaceuticals expects to report the first European market sales in the second half of fiscal 2019. The company has forecasted the addition of 190,000 patients to the drug’s addressable patient pool after the launch of Ondexxya in the remaining European markets.
Portola Pharmaceuticals is working to add Factor Xa inhibitors, edoxaban and enoxaparin, to Andexxa’s label. This development is expected to expand the drug’s addressable market by 60,000–100,000 members. The company is also working to expand the label of Andexxa in urgent surgery setting, which will further increase the drug’s addressable market by 60,000–100,000 patients. Finally, according to the first-quarter earnings conference call, genericization of Factor Xa inhibitors, which will start in Europe in fiscal 2023 and in the US in fiscal 2024, is expected to increase the addressable market of Andexxa by 200,000–300,000 members. The company expects to benefit from the Andexxa opportunity in the US and Europe until fiscal 2025.