Aurinia and Lonza enter long-term manufacturing collaboration for clinical supply of voclosporin

The agreement also provides an option to have Lonza exclusively supply API for up to 20 years.

This agreement follows a successful multi-year clinical manufacturing relationship where the companies have been refining the process and analytical methods to produce clinical and commercial supplies of voclosporin.

Under the terms of the agreement, Lonza agrees to produce cGMP-grade voclosporin drug substance for use in Aurinia’s Phase III lupus nephritis (LN) clinical program and for future commercial use. The agreement also provides an option to have Lonza exclusively supply API for up to 20 years.

“Throughout the company’s long relationship with Lonza, we have developed substantial proprietary know-how in manufacturing commercial-scale voclosporin. We believe this know-how has the potential to broaden our exclusivity position for voclosporin and ensure high quality, reliable production of the API,” said Lawrence Mandt, VP Regulatory and Quality at Aurinia.

“Our partnership with Lonza is the culmination of years of collaboration in which we have optimized the complex manufacturing process for voclosporin,” said Charles Rowland, CEO of Aurinia. “As we prepare to advance voclosporin into an LN Phase III program, we are investing in the infrastructure to deliver this important therapy to patients living with this devastating disease.”

“We’re looking forward to further developing our partnership with Aurinia to supply this innovative medicine to lupus nephritis patients around the world,” said Gordon Bates, Senior Vice President, Business Unit Head, Chemical and Microbial Manufacturing for Lonza.

“As voclosporin requires a complex manufacturing process, our expertise in scaling multi-step synthesis at clinical and commercial scale allows us to support Aurinia to and through Phase III clinical trials,” he added. “This latest agreement further demonstrates Lonza’s commitment to developing customized supply solutions for our customers as they meet some of the greatest challenges in patient treatment, in this case for lupus nephritis patients around the world.”