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Catalent signs on to produce Aurinia’s newly approved lupus nephritis drug

Just weeks after Aurinia Pharmaceuticals bagged its first FDA green light, the company is turning to one of its clinical manufacturing partners to help bring its drug to market. 

Aurinia enlisted Catalent to deliver commercial supply of its oral lupus nephritis drug Lupkynis (voclosporin), the CDMO said Thursday. The multiyear pact follows Lupkynis’ January green light and the companies’ successful team-up in the clinic. 

Catalent is set to manufacture the drug as a softgel capsule at its site in St. Petersburg, Florida. The 435,000-square-foot facility, chief among the CDMO’s North American softgel operations, boasts capacity to turn out 18 billion capsules per year, Catalent said in a release. 

Catalent helped develop the Lupkynis encapsulation process during its clinical trials in lupus nephritis, or kidney inflammation caused by systemic lupus erythematosus, an Aurinia spokesperson said via email. The drug’s active ingredient is made by Lonza in Switzerland.

Catalent’s commercial manufacturing work has kicked off already, the spokesman added. The companies didn’t specify how much money would be changing hands, and Catalent wasn’t immediately available for comment. 

Ahead of its Lupkynis launch, Aurinia spent 2020 bulking up its commercial operations. It raised its workforce of 50 to more than 300, primarily in the U.S., with about 100 to 150 of those new staffers customer-facing sales and medical team reps, Peter Greenleaf, president and CEO of Aurinia, told Fierce Pharma last month. 

In December, Aurinia enlisted Otsuka Pharmaceutical to market Lupkynis globally, starting in Europe and Japan. That same month, Lonza agreed to build out dedicated manufacturing capacity for the drug at its small-molecule ingredients factory in Visp, Switzerland. Lonza had first linked up with Aurinia on API production in 2016. 

As Lupyknis rolls onto the market, it faces competition from GlaxoSmithKline’s lupus treatment Benlysta, which bagged a new indication to treat lupus nephritis in December.