Portola Pharmaceuticals Inc. (NASDAQ: PTLA) signed a $150 million royalty deal, selling the royalty rights to AndexXa to HealthCare Royalty Partners (HCR).
The terms of the deal
On the signing of the deal, HCR paid Portola $50 million. Portola will receive the remaining $100 million upon approval of AndexXa by the Foods and Drugs Administration (FDA). What HCR partners get from the deal is a tiered, mid-single-digit royalty factored from the worldwide sales of AndexXa. The deal expires once the total royalty payments hit 195% of the $150 million funded by the HCR partners.
From the proceeds of the deal, Portola hopes to continue developing and commercializing AndexXa, said Bill Lis, CEO of Portola.
AndexXa is a human Factor Xa molecule modified and designed to counter the anticoagulant effect in patients treated with Factor Xa inhibitors. In simpler terms, AndexXa is an antidote for Factor Xa Inhibitors and is the first of its kind, according to Portola. Currently, FDA designates it as Breakthrough Therapy.
FDA and European Medicines Agency (EMA) approval
After Portola submitted a Biologics License Application (BLA), FDA issued a Complete Response Letter (CLR) requesting Portola to add more information regarding the manufacture of the drug. FDA also asked Portola to support its inclusion of edoxaban and enoxaparin in the drug. Portola said it would resubmit the revised BLA to FDA in the first half of this year. AndexXa has been on clinical Hold since August 2016.
Portola has already submitted the AndexXa’s Marketing Authorization Application (MAA) to the EMA for review. The company is still waiting for a response from the European regulator.
The future of AndexXa is optimistic
Portola has signed some deals to support the clinical tests of AndexXa despite the drug being on clinical hold. Pfizer Inc. (NYSE: PFE) and Bristol-Myers Squibb Co. (NYSE: BMY) each loaned $25 million to Portola to support the development and clinical study of the drug.
HCR is a private financial investments company that buys royalties and invests in commercial life sciences assets, or prototype life sciences products and assets with a high commercial potential. Currently, the company has $3.4 billion in cumulative capital commitments, according to GEN.