A man in a suit is holding a document in his office.

Locally developed drug secures FDA approval

Health and Life Sciences
Published On
February 23, 2021

Aurinia becomes one of only nine Canadian companies to secure this approval

Earlier this month, Aurinia Pharmaceuticals Inc. announced that their drug, LUPKYNIS, has been approved by the U.S. Food and Drug Administration to treat patients with active lupus nephritis. Aurinia is one of only nine Canadian companies that have successfully taken a novel drug to market through the FDA.

It’s an exciting announcement with an interesting story that originates in the Edmonton region and is a great example of what’s possible for the pharmaceutical sector here. 

Dr. Robert Fraser first discovered the drug voclosporin in 1993. Today it is valued at $3 billion CAD

LUPKYNIS was originally called voclosporin, a drug that Dr. Robert Foster first discovered 28 years ago, after leaving his position at the University of Alberta to found Isotechnika Pharma Inc.. Dr. Foster believed voclosporin could be an improvement to the drug Cylosporin, the standard of care drug for organ transplantation that had some problems from a safety perspective. Through the course of his work, he discovered that voclosporin also had the capacity to treat autoimmune diseases like arthritis, psoriasis and lupus. 

That’s when Aurinia Pharmaceuticals stepped in and purchased the licencing for the indication of voclosporin for lupus. They rebranded the drug as LUPKYNIS.

During the financial crisis in 2008, Aurinia found themselves struggling to secure financing, so Dr. Foster bought the molecule back in company stock in 2013, merging Aurinia with Isotechnika. He served as the company’s CEO and, later, its Chief Scientific Officer. 

Today, that voclosporin molecule is worth nearly $3 billion CAD and the development of the drug has created hundreds of jobs both here in the Edmonton region and in Victoria where Aurinia is headquartered. This recent announcement will certainly expand the drug’s economic impact. 

But beyond its economic impact, Dr Foster points to the fact that this drug will ultimately save lives. 

“Developing the drug and getting it FDA approved was truly a village effort,” said Dr. Foster.

Local non-profit Applied Pharmaceutical Innovation (API), played a part in the effort.  API is a not-for-profit institution hosted by the University of Alberta’s Faculty of Pharmacy and Pharmaceutical Sciences that helps innovators in the pharmaceutical space in the Edmonton region launch their ideas into the real world. They connect industry to the services they need for commercial success, and help accelerate the drug development process. They provide expertise, services, and infrastructure to drug developers and they recently worked with Aurinia on its clinical trial data prior to approval. 

“It’s incredibly exciting,” said API CEO, Andrew MacIsaac, “From our perspective, this approval is as exciting as a Nobel prize. It demonstrates what our pharmaceutical sector is capable of.”

Dr. Foster credits the research capabilities and expertise that exists in the Edmonton region for much of the success that LUPKYNIS is seeing.

“I can say with 100 percent certainty that the education at the Faculty of Pharmacy and Pharmaceutical Sciences at the University of Alberta is world class,” says Dr. Foster. “Everywhere I went around the world in my pre-COVID travels, I bumped into people from the University of Alberta—medical directors, senior executives, global heads of pharmaceutical companies—it’s just top notch people all over the world.”

“People look at me and see I’ve come from this place called Edmonton that they’d never heard of, and ask ‘how do you create a drug from such a place?’ Usually, they expect to hear about Stanford, Yale, Harvard, the Ivy Leagues. But no, not at all. You can easily get an education at the University of Alberta that is second to none. It’s really an absolutely world class school.”

Dr. Foster is currently working as the CEO of another biotechnology company that he founded in 2014 called Hepion Pharmaceuticals. Hepion bought all the early-stage molecules from Aurinia that Dr. Foster and his team originally discovered.

“Today, Hepion is doing the whole process over again, but with the benefit in each one of our cases, almost 30 years of experience,” says Dr. Foster. 

“We’re working closely with Hepion and are very excited to see what they bring forward. Having another blockbuster drug launch from our region in the near future is very likely,” says MacIsaac. “That’s thanks to the expertise of Dr. Foster and the hundreds of folks who started their careers at Isotechnika pursuing ventures across the life sciences, not to mention the thousands of others working from successful ventures and cutting edge research institutions.”