Portola Pharmaceuticals and Lonza announced a partnership to start a commercial supply of Portola’s recently approved, second generation Andexxa (andexanet alfa, recombinant coagulation factor Xa).
Portola’s Andexxa is an antidote for the medications Xarelto (rivaroxaban) and Eliquis (aprizaban), when the reversal of anticoagulation is needed for uncontrolled bleeding.
“Portola has just received US Food and Drug Administration (FDA) approval for the second gen process and also expects a positive CHMP opinion at the end of February, paving the way for supplying European markets,” a spokesperson for Lonza added.
The ‘generation 1’ version of the treatment had previously received a complete response letter (CRL) from the FDA due to the need for additional data to be provided regarding chemistry, manufacturing, and controls.
At the time of the CRL, Portola was working with CMC Biologics’ to manufacture the product in its reactor, as well as the company’s single-use bioreactor for the Changes Being Effect (CBE) supplementary FDA submission.
It was then, in 2016, that Lonza was contracted to undertake a higher yield process for the intended expansion of the drug once approved.
Lonza and Portola also worked closely in the development of the second generation manufacturing process for Andexxa and since its approval by the FDA the two companies will continue to work together through the commercial supply collaboration.
A spokesperson for Lonza told us, “We worked with Portola to design a path to market for this second generation Andexxa which includes our large-scale commercial assets in Porriño, Spain and IbexTM Solutions at our Visp, Switzerland facility.”
Production will occur at Lonza’s 10,000L mammalian facility in Porriño and be supplemented by additional large-scale capacity in IbexTm Dedicate at Lonza’s Switzerland facility when it comes online in 2020. The two sites will ensure flexible supply of Andexxa to patients.
In regard to the transition from one site to two, to ensure manufacturing capacity, the spokesperson stated, “Having two sites with the appropriate technology and capacity for Portola means they can ramp up or down as needed and ensures they can keep pace with the market needs in this critical first phase of commercialization.”