Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) recently signed an enduring alliance with Lonza for creating API, an active ingredient of voclosporin. The agreement can be seen as a successor of several other strategic moves to produce commercial or clinical voclosporin supplies. In the past, the companies have entered into multi-year relationships for clinical manufacturing of this product. Such alliances have fetched successful results.
The Terms of Agreement
As per the signed deal, Aurinia Pharmaceuticals Inc will receive the voclosporin drug substance of cGMP-grade. This will be produced by Lonza. The substance, or the active ingredient of the drug, shall be used in the clinical program that concerns Aurinia’s Phase III lupus nephritis (LN) test. Also, this will pertain to its commercial use in the times ahead. At one fell swoop, this agreement will give Lonza the exclusive rights of being a supplier of this ingredient for two decades.
Continuing with the high quality API production
Commenting on the deal, the VP Regulatory and Quality of Aurinia Pharmaceuticals, Lawrence Mandt stated that Lonza has been a partner to their company since a long time. This has allowed the two companies to maintain know-how in voclosporin manufacturing for the commercial scale. He added that the skill to produce this ingredient through joint agreement has opened further avenues for voclosporin’s exclusivity position as well as reliable and high quality production.
The company’s CEO, Charles Rowland stated their company’s collaboration with Lonza has been a result of “years of collaboration” wherein the complex manufacturing process of the drug has been mastered and optimized.
Aurinia Pharmaceuticals is now gearing up to take voclosporin to a transitional phase where it shall be put for LN Phase III program. The company is planning to position their drug for those patients who are suffering from “this devastating disease,” called lupus nephritis.
Both the companies aim at making the treatment, a successful one, for patents living with this disease. The aim is to make the drug available across the world.