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Aurinia Pharmaceuticals Inc
Symbol AUP
Shares Issued 85,500,228
Close 2019-02-22 C$ 8.13
Market Cap C$ 695,116,854
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Aurinia gets U.S. notice of allowance for lupus patent

2019-02-25 08:58 ET - News Release

Mr. Michael Martin reports

AURINIA RECEIVES NOTICE OF ALLOWANCE FROM THE US PATENT AND TRADEMARK OFFICE FOR CLAIMS DIRECTED TO ITS NOVEL VOCLOSPORIN DOSING PROTOCOL FOR LUPUS NEPHRITIS

Aurinia Pharmaceuticals Inc. 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 continuing 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 chief executive officer 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 Aurinia Pharmaceuticals Inc.

Aurinia Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the potential treatment of lupus nephritis (LN), focal segmental glomerulosclerosis (FSGS) and dry eye syndrome (DES). The company is headquartered in Victoria, B.C., and focuses its development efforts globally.

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 with 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.

About lupus nephritis (LN)

LN in an inflammation of the kidney caused by systemic lupus erythematosus (SLE) and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder. The disease is highly heterogeneous, affecting a wide range of organs and tissue systems. Unlike SLE, LN has straightforward disease outcomes (measuring proteinuria) where an early response correlates with long-term outcomes. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced estimated glomerular filtration rate (eGFR), and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease (ESRD), thus making LN a serious and potentially life-threatening condition.

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