Business
Aurinia and Lonza Announce Exclusive Agreement for Dedicated Voclosporin Manufacturing Capacity
- State-of-the-Art Monoplant Will Provide Cost and Production Efficiency and Secure Active Pharmaceutical Ingredient (API) Supply for Future Commercial
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\n- State-of-the-Art Monoplant Will Provide Cost and Production Efficiency and Secure Active Pharmaceutical Ingredient (API) Supply for Future Commercial Demand - \n\n VICTORIA, British Columbia--(BUSINESS WIRE)--\nAurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia”) and Lonza Ltd. (SIX: LONN) (\"Lonza\") today announced they have expanded their exclusive manufacturing relationship. The parties entered into a collaborative agreement to build a dedicated manufacturing capacity within Lonza’s existing small molecule API facility in Visp, Switzerland. The dedicated facility (also referred to as \"monoplant\") will be equipped with state-of-the-art manufacturing equipment to provide cost and production efficiency for the manufacture of voclosporin, while expanding existing capacity and providing supply security to meet future commercial demand.\n\nThe new agreement builds on the parties' successful multi-year relationship. The agreement, which is conditional upon U.S. regulatory approval of voclosporin, does not impact the launch supply for voclosporin as this is secured by existing inventory. The monoplant is estimated to be operational in 2023.\n\n“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.”\n\n“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.”\n\nFollowing U.S. regulatory approval of voclosporin, Aurinia will commence several capital expenditure payments. Upon completion of the monoplant, Aurinia will have the right to maintain unobstructed use of ...