- Contract manufacturer Lonza has begun commercial supply of Portola Pharmaceutical's second-generation version of Andexxa, supporting a full launch of the Factor Xa inhibitor reversal agent in the U.S. following a recent supplementary approval for the Food and Drug Administration.
- Lonza will supply Andexxa out of its Porriño facility in Spain, where it has 10,000 liters of bioreactor capacity. The Swiss company will supplement that supply when additional large-scale capacity comes online at its Visp, Switzerland, site in 2020.
- Lonza and Portola worked together to develop the second-generation manufacturing process for Andexxa, which will permit the biotech to sell the drug more broadly than it has to date.
Portola won U.S. approval for Andexxa (andexanet alfa) last spring after years of setbacks in the drug's development.
Yet, while a major milestone, approval did not fully clear the path to broadly launching the reversal agent in the U.S. The FDA had approved Andexxa under its first-generation manufacturing process, which Portola judged inadequate to support wide commercial sale.
For most of last year, Portola rolled-out Andexxa on a limited basis to only a few dozen treatment centers. Now, following an FDA nod for its new manufacturing process in January, Portola is ramping up its commercial efforts.
Andexxa is used to reverse Factor Xa inhibition induced by anticoagulants like Eliquis (apixaban) and Xarelto (rivaroxaban). As such, its potential addressable market is large, encompassing roughly 140,000 U.S. hospital admissions per year.
Portola now has 78 salespeople behind its launch and is in the process of onboarding another 40 representatives. That salesforce will be backed by supply coming from Lonza, which indicated it plans to produce the drug across two sites by 2020.
Credit Suisse predicts modest Andexxa uptake in the first quarter of this year, with continued build throughout 2019. The investment bank estimates sales of the therapy to total roughly $110 million for 2019.
Portola is also awaiting an approval from the European Medicines Agency in the second quarter.