Aurinia announces long-term manufacturing collaboration agreement with Lonza for clinical and commercial supply of voclosporin.
Aurinia Pharmaceuticals Inc., a clinical stage biopharmaceutical company focused on the global immunology market, has entered into a long-term agreement with Lonza for the manufacture of voclosporin active pharmaceutical ingredient (API).
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,” Lawrence Mandt, VP regulatory and quality at Aurinia, said. “We believe this know-how has the potential to broaden our exclusivity position for voclosporin and ensure high quality, reliable production of the API.” Aurinia is investing in the infrastructure to deliver the therapy as the companies prepare to advance voclosporin into an LN Phase III program, according to Aurinia CEO Charles Rowland.
“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.
Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (CNI) with clinical data in over 2,000 patients across indications. It is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in LN when added to standard of care. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses. It is made by a modification of a single amino acid of the cyclosporine molecule which has shown a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency, an altered metabolic profile, and potential for flat dosing.
It is anticipated that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries, according to the companies.
(Source: Business Wire)