Royalty deal could help unclot Portola's AndexXa
- Portola Pharmaceuticals, which has struggled with regulatory delays for its closely watched anticoagulant antidote, last week secured new financing support through a royalty deal with private investment firm HealthCare Royalty Partners (HCR).
- Under the deal, Portola will receive $50 million at closing in return for giving HCR rights to a mid single-digit royalty on worldwide sales of Portola's AndexXa (andexanet alfa), which is designed to reverse the effects of Factor Xa inhibitors.
- Portola also stands to receive another $100 million if AndexXa secures U.S. approval. Royalty payments to HCR are capped at 195% of the $150 total, after which the deal expires.
Warfarin is the traditional anticoagulant for people at risk of stroke or blood clots. While widely used and trusted, warfarin has safety and efficacy issues that have led drugmakers to develop a new class of oral anticoagulants, including Factor Xa inhibitors like Bayer's Xarelto (rivaroxaban) and Bristol-Myers Squibb's Eliquis (apixaban).
But apart from Boehringer Ingelheim's slower selling Pradaxa (dabigatran), the new Factor Xa inhibitors have no universal reversal agent, which can put patients at risk of life-threatening or uncontrollable bleeding.
Approval of Portola's AndexXa, which is designed to work with both oral and injectable Factor Xa inhibitors, could therefore be a major catalyst to boost physician confidence in the new class of drugs.
The road to approval hasn't been easy for Portola, however.
Last August, the Food and Drug Administration rejected Portola's application for approval of AndexXa, citing issues with manufacturing and requesting additional data. Portola admitted that the Chemistry, Manufacturing and Controls (CMC) section of the application may not have been complete.
The new money from HCR is earmarked for funding continued clinical and regulatory activities and for the planned commercialization of AndexXa.
"We are looking forward to partnering with HealthCare Royalty Partners on this financing, which will provide us with capital to fund our operations in a non-dilutive manner and successfully launch this potentially life-saving agent for the benefit of tens of thousands of patients," said Bill Lis, CEO, Portola.
A Phase 3b/4 study, ANNEXA-4, is underway in patients with Factor Xa inhibitor-associated acute major bleeding, and interim results showed AndexXa stopped bleeding in 79% of patients with an acute major bleed while taking a Factor Xa inhibitor.
Portola is relying on this kind of data, and the injection of cash from HCR, to push the drug through resubmission of the biologics license application and into markets. A resubmission to the FDA is expected sometime in the first half of this year.
- Portola Pharmaceuticals Statement
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