Peter Greenleaf leads autoimmune disease drug maker Aurinia
Credit: Aurinia Pharmaceuticals

Peter Greenleaf leads autoimmune disease drug maker Aurinia

With FDA approval in hand, the Victoria company plans to bring its drug to market

In the U.S. alone, as many as 135,000 people suffer from lupus nephritis (LN), a complication of the autoimmune disease lupus. Helping that group manage LN, which leads to chronic and potentially life-threatening inflammation of the kidneys, could be just the start for Aurinia Pharmaceuticals.

Victoria-based Aurinia got some good news in late January when the U.S. Food and Drug Administration approved its medication Lupyknis (voclosporin) for adult patients. In the first successful global Phase 3 clinical trials for a new LN drug, this oral treatment proved significantly more effective than mycophenolate, or CellCept, the unapproved U.S. standard of care.

“We recently joined the rarefied ranks of Canadian companies who have successfully ushered a drug from the lab through to a U.S. FDA approval, ultimately into the hands of patients,” says co-founder and chief business officer Michael Martin. “Our company’s future rests on the foundation that this team has built over the last decade in Victoria. We have the tools and resources in place to continue to bring meaningful treatments to people living with serious autoimmune diseases, and we have no plans of slowing down.”

Martin and chief medical officer Neil Solomons previously worked at Victoria’s Aspreva Pharmaceuticals, where they played a role in developing CellCept. In 2012, four years after Swiss pharma giant Galenica bought Aspreva for $915 million, they and colleague Larry Mandt spun off Aurinia. “We saw an opportunity to find a drug that we could layer on top of that therapy,” Martin recalls. Their addition: voclosporin, commonly used in renal transplants.

Through a reverse merger with Edmonton-based Isotechnika Pharma the following year, Aurinia secured the worldwide rights to voclosporin and a listing on the Toronto Stock Exchange. Since that deal, the company, which now trades on the Nasdaq Stock Exchange as well as the TSX, has raised about US$640 million.

LN is called an orphan disease because it affects fewer than 200,000 Americans. Aurinia president and CEO Peter Greenleaf, a pharmaceuticals industry veteran who took the helm in early 2019 and usually splits his time between Victoria and Maryland, says the company plans to start with the U.S. market.

To that end, Aurinia has been hiring stateside as it makes the Washington, D.C., area its commercial hub. In December, it announced an agreement with Tokyo-headquartered Otsuka Pharmaceutical Co. to bring voclosporin to Japan and Europe. But as Greenleaf stresses, 265-employee Aurinia is still very much a Canadian business, with its entire R&D team in Victoria.

As part of its mission to combat autoimmune disease, the company also launched trials of a voclosporin ophthalmic solution for dry eye, which afflicts millions of people worldwide. After suspending work on that treatment last fall, though, Aurinia is focused on lupus nephritis. “Our goal is going to be to get this drug launched successfully, become a fully integrated pharma company, not just a development-stage pharma company, and then alongside of that, to continue to build our pipeline,” Greenleaf says.