DrugName : voclosporin

Aurinia Pharmaceuticals Inc., a clinical stage biopharmaceutical company focused on the global immunology market, announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (“USPTO”) for U.S. patent application 15/835,219, entitled “PROTOCOL FOR TREATMENT OF LUPUS NEPHRITIS”. The allowed claims broadly cover the novel voclosporin dosing protocol adhered to and required in both the previously reported Phase II AURA-LV study and the ongoing Phase III confirmatory AURORA study. Notably, the allowed claims cover a method of modifying the dose of voclosporin in patients with lupus nephritis (LN) based on patient specific pharmacodynamic parameters.

This Notice of Allowance concludes a substantive examination of the patent application at the USPTO, and after administrative processes are completed and fees are paid, is expected to result in the issuance of a U.S. patent with a term extending to December 2037. Issuance of the patent will expand the scope of intellectual property protection for voclosporin, which already includes robust manufacturing, formulation, synthesis and composition of matter patents.

The Company has also filed for protection of this subject matter under the Patent Cooperation Treaty (PCT) and has the option of applying for similar protection in the member countries thereof. This may lead to the granting of corresponding claims in the treaty countries which include all the major global pharmaceutical markets. “These method of use claims allowed in the U.S. broadly cover the personalized voclosporin dosing protocol utilized across our LN program, which includes specific dose modification requirements that we anticipate being incorporated into any potential future label for voclosporin in LN,” said Michael R. Martin, Chief Operating Officer of Aurinia.

“This Notice of Allowance is a significant milestone for Aurinia as it enhances our current intellectual property portfolio and provides potential exclusivity for Aurinia’s protocol for the treatment of proteinuric kidney diseases, including LN, until late 2037. Importantly, these claims provide validation of some unique and differentiating features of voclosporin compared to the legacy CNIs.” stated Richard M. Glickman, Chairman and CEO of Aurinia. “Establishing a robust exclusivity platform is a critical part of our strategy as we work towards regulatory approvals in the United States and internationally.”

About Voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class CNI with clinical data in over 2,400 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (vs cyclosporin), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin’s composition of matter 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 and until April 2028 with anticipated pediatric extension. Voclosporin’s unique dosing protocol used in both the AURA-LV and the AURORA studies for LN has also been granted a Notice of Allowance from the USPTO, these allowed claims have the potential to provide additional coverage for voclosporin until late 2037.