Mr. Peter Greenleaf reports

FDA APPROVES AURINIA PHARMACEUTICALS' LUPKYNIS (VOCLOSPORIN) FOR ADULT PATIENTS WITH ACTIVE LUPUS NEPHRITIS

The U.S. Food and Drug Administration (FDA) has approved Aurinia Pharmaceuticals Inc.'s Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). Lupkynis is the first FDA-approved oral therapy for LN. LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). Lupkynis is now available to patients in the United States.

In pivotal trials, patients treated with Lupkynis in combination with standard of care (SoC) were more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio (UPCR) twice as fast as patients on typical SoC alone. UPCR is a standard measurement used to monitor protein levels in the kidney. Early intervention and kidney response are linked to better long-term outcomes and prevent irreversible kidney damage. Patients treated with Lupkynis showed improved response rates at all levels across the immunologically active classes of LN studied.

"The Lupkynis approval marks a turning point for the lupus nephritis community -- patients, caregivers, families and health care professionals -- all of whom we thank for their partnership in the development of this innovative novel treatment. We are thrilled to bring Lupkynis to the people impacted by this devastating condition," said Peter Greenleaf, president and chief executive officer of Aurinia Pharmaceuticals. "The approved label supports the efficacy and safety of Lupkynis, as well as Aurinia's proprietary and patented eGFR pharmacodynamic dosing protocol. We have worked tirelessly to put the correct team and infrastructure in place to ensure we are ready for swift commercial adoption of Lupkynis."

"For years, treating patients with lupus nephritis has been challenging. We have had a very limited number of therapeutic options, and these have been only modestly effective, but highly toxic," said Brad H. Rovin, MD, professor of medicine, director of the division of nephrology, Ohio State University Wexler Medical Center, and Aurora clinical trial investigator. "The FDA approval of Lupkynis allows us to treat patients safely and more effectively with a rapid acting therapy, which requires far less steroids, something our patients will appreciate."

To assist Lupkynis patients and the health care providers (HCPs) who prescribe the treatment, Aurinia has developed and launched Aurinia Alliance, a patient support program featuring dedicated nurse case managers who provide personalized educational resources and assistance in navigating insurance and Aurinia medication costs throughout each patient's Lupkynis treatment journey.

"People with lupus nephritis have desperately needed approved treatments to help them avoid irreversible kidney damage and the eventual need for kidney transplant," said Stevan W. Gibson, president and chief executive officer, Lupus Foundation of America. "The approval of a tailored therapy represents a significant step forward in treating lupus nephritis and is excellent news for the lupus community."

"Despite strong efforts in research to find solutions for SLE and LN, options to date have been limited. Once patients progress to LN, they face inevitable life-altering effects," said Kenneth M. Farber, president and CEO, Lupus Research Alliance. "We have long supported Aurinia Pharmaceuticals and are encouraged by the U.S. FDA approval of voclosporin, a much needed oral treatment option to address the challenges faced by people living with LN."

"New treatments indicated specifically for lupus nephritis will contribute to our quest for health equity in kidney diseases," commented National Kidney Foundation's chief medical officer Joseph Vassalotti, MD. "Interventions that are effective to manage and potentially prevent irreversible kidney damage are exciting for people living with lupus nephritis and their clinicians in nephrology and rheumatology."

"As a patient-led organization who understands all too well the urgent need for more efficacious treatments for people struggling to live with diseases of unmet need like lupus nephritis, we are thrilled with the approval of Lupkynis," said Kathleen A. Arntsen, president and CEO of Lupus and Allied Diseases Association. "There is now a new treatment for this debilitating and life-diminishing condition that is four times higher for people of African descent and Asians and two times higher for Hispanics/Latinos and native Americans. At a time when our nation faces extreme challenges such as addressing and overcoming social inequities and health disparities, this is welcome and promising news, especially since both lupus nephritis and COVID-19 disproportionately impact communities of colour."

Lupkynis was approved by the FDA under priority review and was previously granted fast-track designation from the agency in 2016.

Multimedia components and conference call information

Multimedia components are available with this press release. Aurinia will host a conference call and webcast to discuss the approval of Lupkynis on Jan. 25, 2021, at 8:30 a.m. ET. The webcast can be accessed on the investor section of the Aurinia website. To participate in the teleconference, please dial 1-877-407-9170 (toll-free United States and Canada).

Clinical trial overview of Lupkynis (voclosporin)

The approval of Lupkynis is based on data from Aurinia's pioneering late-stage global clinical studies in LN -- the pivotal Aurora phase 3 study and the Aura-LV phase 2 study. These studies together demonstrated the ability of Lupkynis treatment to significantly improve outcomes as reported up to 52 weeks for patients on several levels when added to the typical SoC, mycophenolate mofetil (MMF) and low-dose steroids.

In both studies, a total of 533 patients with LN were randomized to receive either Lupkynis 23.7 milligrams or placebo twice daily used with SoC. All patients were dosed with concurrent MMF at a target dose of two grams per day. In both studies, initial treatment with intravenous (IV) methylprednisolone up to a cumulative dose of one gram was administered on days one and two, and all patients received a subsequent taper of oral corticosteroids. The starting dose of oral prednisone was 20 milligrams per day for patients with a body weight of 45 millilitres per minute per 1.73 square metres.

In the phase 3 study, at one year, Lupkynis plus SoC was more than two times as effective at achieving a complete renal response than the SoC alone. Patients in the study taking Lupkynis also achieved a 50-per-cent reduction in UPCR twice as fast as SoC, and a higher portion of Lupkynis-treated patients achieved a complete renal response at 24 weeks compared with patients receiving SoC. The study results were achieved using a protocol-defined steroid taper. Patients treated with Lupkynis showed improved response rates at all levels across immunologically active classes of LN studied.

The most common adverse reactions were: glomerular filtration rate decrease, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury and decreased appetite.

About lupus nephritis

Lupus nephritis (LN) is a serious progression of SLE, a chronic, complex and autoimmune disease. About 200,000 to 300,000 people live with SLE in the United States, and approximately one out of three of these individuals has already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN, and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared with Caucasian individuals.

About Aurinia Pharmaceuticals Inc.

Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The company has introduced Lupkynis (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). The company's head office is in Victoria, B.C., its U.S. commercial hub is in Rockville, Md., and the company focuses its development efforts globally.

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