Portola Pharmaceuticals has struck a royalty deal with private investment firm HealthCare Royalty Partners (HRC), which could give the company the extra financial boost it needs to finish the regulatory requirements in order to get its anticoagulant antidote on the market.
Portola has developed the AndexXa, an antidote designed to reverse the blood thinning qualities of the novel new blood thinners Xarelto and Eliquis in the event of a bleeding emergency. Xarelto is the top selling anticoagulant in its class but sales of Eliquis are gaining. Together, the drugs generate billions in sales. Some analysis project Xarelto to become Europe’s top-selling drug by 2022.
The drugs are intended as a more convenient alternative to the long-used warfarin in the prevention of strokes for patients with atrial fibrillation. They are also used to treat and prevent deep vein thrombosis and pulmonary embolism as well as prevent blood clots in patients who have recently undergone hip or knee replacement.
But they also can cause major bleeding events, such as gastrointestinal bleeds and brain bleeds, which can be fatal. Unlike warfarin, there is not an antidote to stop major bleeding in patients taking Xarelto or Eliquis, which makes many doctors leery of prescribing the meds. The availability of an antidote would likely boost sales.
Portola’s AndexXa was expected to be approved by the Food and Drug Administration (FDA) last August, but the agency rejected the company’s application citing issues with manufacturing and requesting more data.
HCR’s investment into Portola is earmarked for clinical and regulatory activities and for marketing expenses for AndexXa. Portola says it plans to resubmit the drug for FDA approval sometime during the first half of 2017.
Source: BioPharma Dive