Aurinia and Lonza Announce Exclusive Dedicated Voclosporin Production Capability Agreement

businesswire | December 15, 2020

Aurinia and Lonza Announce Exclusive Dedicated Voclosporin Production Capability Agreement
Aurinia Pharmaceuticals Inc.  ("Aurinia") and Lonza Ltd. ("Lonza") today reported they have extended their select assembling relationship. The gatherings went into a community oriented consent to construct a devoted assembling limit inside Lonza's current little particle API office in Visp, Switzerland. The committed office (likewise alluded to as "monoplant") will be furnished with cutting edge fabricating gear to give cost and creation effectiveness to the assembling of voclosporin, while growing existing limit and giving stock security to fulfill future business need.

The new understanding expands on the gatherings' fruitful multi-year relationship. The arrangement, which is restrictive upon U.S. administrative endorsement of voclosporin, doesn't affect the dispatch supply for voclosporin as this is made sure about by existing stock. The monoplant is assessed to be operational in 2023.

“Lonza’s world-class expertise and partnership have helped Aurinia to cost-effectively optimize the unique and complex manufacturing process required for the synthesis of voclosporin,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals. “We are currently well-poised and ready with adequate product supply for launch and anticipated market demand. A dedicated production capability will help keep our manufacturing costs down and ensure long-term flexibility to meet future demand for years to come.”

“This collaboration is a great example of how we can support both early and commercial-stage biopharmaceutical companies through innovation in manufacturing technology and flexible business models,” said Gordon Bates, President Small Molecules Division, Lonza. “We are looking forward to further developing our relationship with Aurinia into a long and productive collaboration to supply this innovative medicine to patients across the globe.”

Following U.S. administrative endorsement of voclosporin, Aurinia will begin a few capital consumption installments. Endless supply of the monoplant, Aurinia will reserve the privilege to keep up unhindered utilization of the monoplant by paying a quarterly fixed office charge.

The U.S. Food and Drug Administration (FDA) acknowledged the documenting of Aurinia's NDA for voclosporin in the treatment of lupus nephritis (LN), conceded Priority Review, and alloted a Prescription Drug User Fee Act (PDUFA) target activity date of January 22, 2021.

About Voclosporin
Voclosporin is a novel therapy in development for patients with LN, an inflammation of the kidney which is one of the most serious complications of the autoimmune disease systemic lupus erythematosus (SLE). If left untreated, LN can lead to irreversible kidney damage, kidney failure or even death. Through an extensive clinical program, voclosporin has demonstrated superiority to the standard-of-care for LN. Voclosporin is now under review by the FDA with Fast Track status and Priority Review as a potential therapy for LN in the United States.

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