AGC Biologics, a global contract development and manufacturing organization (CDMO), announced it will supply bulk drug substance for the launch of Portola Pharmaceuticals, Inc.’s Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo] antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Andexxa received U.S. Food and Drug Administration (FDA) Orphan Drug and Breakthrough Therapy designations, and recently was approved under the FDA’s Accelerated Approval pathway based on the change from baseline in anti-Factor Xa activity in healthy volunteers.
Continued approval for the indication may be contingent upon post-marketing study results to demonstrate an improvement in hemostasis in patients.
Meanwhile, Portola Pharmaceuticals announced Thursday that it has received a $100 million milestone payment from HealthCare Royalty Partners (HCR) following the FDA’s Andexxa approval earlier this month.
In February 2017, Portola entered into a $150 million royalty agreement with HCR, a private investment firm, in exchange for a tiered, mid-single-digit royalty based on worldwide sales of Andexxa. Portola received $50 million at closing, with an additional $100 million payment contingent upon the FDA approval of Andexxa.
The agreement is subject to a maximum total royalty payment of 195 percent of the $150 million funded by HCR, at which time the royalty obligation will expire. HCR purchases royalties and uses debt-like structures to invest in commercial or near-commercial stage life science assets.
“Our partnership with HCR provides us with non-dilutive capital to fund the further development and commercialization of Andexxa,” said Bill Lis, chief executive officer of Portola.
Portola is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics that could significantly advance the fields of thrombosis and other hematologic diseases. In addition to Andexxa, the company’s other FDA-approved medicine is Bevyxxa (betrixaban), an oral, once-daily Factor Xa inhibitor, and is in the process of advancing cerdulatinib, a SYK/JAK inhibitor for the treatment of hematologic cancers.
At present, AGC Biologics, which was formed through the convergence and integration of Asahi Glass Company (AGC) Bioscience, Biomeva GmbH, and CMC Biologics, is manufacturing bulk drug substance for Portola’s planned launch of Andexxa.
AGC currently employs more than 850 employees worldwide. Its network spans three continents, with cGMP-compliant facilities in Seattle, WA; Berkeley, CA; Copenhagen, Denmark; Heidelberg, Germany; Yokohama, Japan; and Chiba, Japan.