Aurinia Pharmaceuticals Announces Approval of a New and Refined Use Patent for LUPKYNIS® for the Treatment of Lupus Nephritis by the US Patent and Trademark Office

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) announced today that the United States Patent and Trademark Office (USPTO) has granted a method patent application entitled IMPROVED PROTOCOL FOR THE TREATMENT OF LUPUS NEPHRITIS. Aurinia’s recently allowed US patent application (No. 17/713,140) reflects the unique and proprietary dosing regimen of its currently marketed product, LUPKYNIS. Specifically, this patent further refines the method of using LUPKYNIS in combination with mycophenolate mofetil (MMF) and corticosteroids using eGFR as a method for pharmacodynamic dosing of the product in patients with lupus nephritis. The newly allowed application provides patent coverage that complements Aurinia’s existing US Patent No. 10,286,036, which is listed in the Orange Book and claims an FDA-approved method of using LUPKYNIS. The claims of this additional patent add additional specificity for dosage consistent with the FDA-approved product label. This patent has the potential to provide an additional layer of patent protection for LUPKYNIS until 2037. The company intends to list this newly allowed patent in the Orange Book when issued.

In addition, Aurinia also announces that it has recently received a Notice of Intent to Grant from the European Patent Office (EPO) for a patent application that has similar claims to Aurinia’s existing method of use US Patent No. 10,286,036. This European patent application was pursued through the Patent Cooperation Treaty (PCT) process. Once this patent is issued, it can provide protection up to 2037 throughout Europe.

“This authorization from the USPTO and the accompanying news from the European Patent Office further strengthens our intellectual property portfolio as it relates to LUPKYNIS and its unique pharmacodynamic dosing protocol described in the FDA package insert. Once issued, these new patents will enhance the long-term potential of LUPKYNIS,” said Peter Greenleaf, CEO of Aurinia.

About Lupus Nephritis

LN is a severe manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the United States, and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. About 50 percent of all people with SLE may develop lupus nephritis. If poorly controlled, LN can lead to permanent and irreversible tissue damage in the kidney. Black and Asian individuals with SLE are four times more likely to develop LN, and individuals of Hispanic descent are approximately twice as likely to develop the disease compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes compared with Caucasian individuals.

About LUPKYNIS

LUPKYNIS® is the first US FDA and EC approved oral drug for the treatment of adult patients with active LN. LUPKYNIS is a novel structurally modified calcineurin inhibitor (CNI) with a dual mechanism of action that acts as an immunosuppressive agent through inhibition of T-cell activation and cytokine production and promotes podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily without the need for serum drug monitoring. Dose modifications can be made based on Aurinia’s proprietary personalized eGFR-based dosing protocol. Boxed warnings, warnings, and precautions for LUPKYNIS are consistent with other CNI immunosuppressive treatments.

About Aurinia

Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies for the treatment of targeted patient populations affected by serious diseases with a large unmet medical need. In January 2021, the company introduced LUPKYNIS ® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis (LN). The company’s headquarters are in Victoria, British Columbia, its US commercial hub is in Rockville, Maryland, and the company focuses its development efforts globally.

Forward-looking statements

Certain statements in this press release may constitute forward-looking information within the meaning of applicable Canadian securities laws and forward-looking statements within the meaning of applicable US securities laws. These forward-looking statements or information include, but are not limited to, statements or information regarding: Aurinia with patent protection until 2037; Aurinia’s intention to list the newly granted patent in the Orange Book once issued; and Aurinia’s estimate of the number of patients with SLE in the United States and the proportion of individuals who have developed LN at the time of SLE diagnosis. It is possible that such results or conclusions may change. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “goal”, “plan”, “goal”, “goal”, “may” and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including, but not limited to, assumptions about: the accuracy of reported data from third-party surveys and reports; and that Aurinia’s intellectual property rights are valid and do not infringe the intellectual property rights of third parties. Although the management of Aurinia believes that the assumptions made and the expectations represented by such statements or information are reasonable, no assurance can be given that the forward-looking information will prove to be accurate.

Forward-looking information is by its nature based on assumptions and involves known and unknown risks, uncertainties and other factors that could cause Aurinia’s actual results, performance or performance to differ materially from future results, performance or performance expressed or implied by such forward-looking information . Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results could differ materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: the market for the LN business may not be as estimated; results from Aurinia’s clinical studies and from third-party studies and reports may not be accurate; and Aurinia’s assets or business activities may be subject to disputes that may result in litigation or other legal claims. Although Aurinia has attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performance, achievements or events do not turn out as expected, estimated or intended. Also, many of the factors are beyond Aurinia’s control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events may differ materially from those anticipated in such statements. Therefore, you should not place undue reliance on forward-looking statements or information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia’s most recent Annual Report on Form 10-K and its other publicly available filings, available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the US Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar and on Aurinia’s website at www.auriniapharma . com .

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATIONS

LUPKYNIS is indicated in combination with a background immunosuppressive regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS in combination with cyclophosphamide have not been established. Use of LUPKYNIS is not recommended in this situation.

IMPORTANT SAFETY INFORMATION

WARNINGS WITH INSERTION: MALIGNANCY AND SERIOUS INFECTIONS

Increased risk of developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

CONTRAINDICATIONS

LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors due to the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a severe/severe hypersensitivity reaction to LUPKYNIS or its excipients.

WARNINGS AND PRECAUTIONS

Lymphoma and other malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, especially of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of a specific agent.

Serious infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoan infections (including opportunistic infections), which can lead to serious, including fatal, outcomes.

Nephrotoxicity: LUPKYNIS, like other CNIs, may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are co-administered with drugs associated with nephrotoxicity.

Hypertension: Hypertension is a common side effect of LUPKYNIS treatment and may require antihypertensive therapy.

Neurotoxicity: LUPKYNIS, like other CNIs, can cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizures, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.

Hyperkalemia: Hyperkalemia, which may be severe and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of substances associated with hyperkalemia may increase the risk of hyperkalemia.

QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed above the recommended therapeutic dose for lupus nephritis. The use of LUPKYNIS in combination with other drugs known to prolong QTc may result in clinically significant QT prolongation.

Vaccinations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines considered safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

Pure Red Cell Aplasia: Cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuing LUPKYNIS.

Drug-Drug Interactions: Avoid coadministration of LUPKYNIS with strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dose when co-administered with moderate CYP3A4 inhibitors. Reduce the dose of certain P-gp substrates with narrow therapeutic windows when coadministered.

SIDE EFFECTS

The most common adverse reactions (>3%) were decreased glomerular filtration rate, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, upper abdominal pain, dyspepsia, alopecia, decreased renal function, abdominal pain, mouth ulcers, fatigue, tremor, acute kidney injury, and decreased appetite.

SPECIFIC POPULATIONS

Pregnancy/breastfeeding: May cause birth defects. Advise breastfeeding.

Renal impairment: Not recommended in patients with baseline eGFR ≤45 ml/min/1.73 m2 unless benefit outweighs risk. Severe renal impairment: Reduce the dose of LUPKYNIS.

Mild and moderate hepatic impairment: Reduce LUPKYNIS dose. Severely impaired liver function: Avoid using LUPKYNIS.

Please see prescribing information including warning boxes and medication guide for LUPKYNIS.

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Aurinia Pharmaceuticals Announces Approval of a New and Refined Use Patent for LUPKYNIS® for the Treatment of Lupus Nephritis by the US Patent and Trademark Office

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