What Does it Take to Make a Life-Changing Drug?

For scientist and businessman Robert Foster, developing and funding a new life-changing drug has been a 25-year high-wire act.

When he was young, Robert Foster taught himself how to ride a unicycle. It took patience, persistence and skill to learn how to balance and move on a single wheel.

Since 1997, when he left a tenured professor’s post at the University of Alberta’s Faculty of Pharmacy and Pharmaceutical Sciences, Dr. Foster has been performing a different sort of balancing act — he’s part scientist, part businessman. He’s been in the lab, working to create a unique molecule that’s become the foundation for a new drug that could benefit lupus nephritis sufferers around the world. He’s also put on more frequent flier miles than a traveling circus, working to woo potential investors and present at medical and banking conferences.

But the drug that Foster first imagined in 1993 — Voclosporin — is in the final stages towards approval by the American Food and Drug Administration (FDA). And, he’s at the head of a new company, Hepion Pharmaceuticals, which is working to have a new anti-fibrotic drug in front of regulators by 2025 or ’26.

“For me it’s a vindication,” says Foster, sitting at his desk in an office at the Edmonton Research Park. Behind him, hanging on the wall, is a replica of the stick that Bobby Orr used to score the famous 1970 Stanley Cup-winning goal. “A lot of people were naysayers. Nobody believed that we could make a drug here, that we should leave something like that up to the big pharma companies.”

When Foster left a tenured professor post at the University of Alberta a little more than 25 years ago, he had a vision of creating an immunosuppressant drug that would improve the odds for patients receiving organ transplants. When a patient receives a new organ, the immune system wants to reject it. It creates antibodies to fight the new organ. So, in order to facilitate a successful transplant, the patient is given drugs that suppress the immune system.

Voclosporin, based on a molecule that Foster helped create, would be touted as a better alternative to the medications out there. It’s easier for clinicians to use and safer for patients. And, as a kinder, gentler drug, the patient’s outcome is more predictable.

“There’s a wider window of opportunity,” Foster says.

But developing a drug costs money. And even though Foster points out that the University of Alberta produces some of the best pharmaceutical minds in the world — he regularly meets U of A grads at conferences and in high-ranking positions at drug companies far away from this province — Edmonton doesn’t have the investment community that’s willing to make the required high-stakes investment risks. So, his fledgling company, Isotechnika Pharma, had to search far and wide for dollars. And it led to a hell of a unicycle high-wire act — doctors working to develop the drug in Edmonton, while Foster had to meet investors from around the world.

In the end, Foster thinks that it took close to $1 billion to transform Voclosporin from vision to reality.

“There is really no comparison between Canada and the United States. The truth is, a lot of cool drugs were first discovered in Canada, and that goes right back to the discovery of insulin. But they are often not developed here. Canadians are more risk averse with things they aren’t well versed in, like drug development, and, therefore, there are fewer dollars.”

It is 2002. Foster is the CEO of Isotechnika, the Edmonton-based company working to develop Voclosporin.

Then comes the big deal. Roche, the Swiss pharmaceutical giant, announces it is acquiring the rights to Voclosporin, a deal worth somewhere in the neighbourhood of $200 million.

But, in the summer of 2008, comes the worst news possible for Foster. Roche announces it is pulling the plug on the partnership. And this gets into the harsh reality of the pharma business. Roche didn’t pull out because the drug wasn’t promising. It pulled out because it no longer saw a massive market in transplant drugs. It wasn’t about Voclosporin’s medicinal potential, it was about what Big Pharma saw as the lack of commercial potential.

“We were left at the altar,” says Foster.

Foster made a number of what he calls “Band-Aid deals” to keep the lights on.

Lupus nephritis affects mainly women, who can suffer from a variety of symptoms — pain, inflammation, rashes — because their immune systems attack healthy tissues. So, why not use a better kind of immunosuppressant to battle lupus nephritis?

Jilted by Roche, Foster found a new willing dance partner — Aurinia Pharmaceuticals, based out of Victoria, B.C. By 2013, Isotechnika acquired Aurinia in an all-shares deal. Then, the Istotechnika name was jettisoned — after the Roche rejection and flirting with bankruptcy, the name had been dragged through the mud.

“It didn’t have the right smell to it,” says Foster.

Now, Voclosporin has completed its clinical trials and is awaiting approval. Doctors could be prescribing it within several months.

Of course, creating the new company meant that Voclosporin moved out of Alberta, as well. Aurinia’s offices are in Victoria and Maryland. And Foster says the lack of hue and cry when the company left this province showed a lot of the issues pharmaceutical researchers have in this province. Foster looks at the stock ticker in his office; he estimates Aurinia, which is traded on NASDAQ, is now worth between $1 and $2 billion US.

“If an oil and gas company worth more than a billion moved out of Alberta, how much of an outcry would there have been?” he asks.

Foster is now part of a new company, Hepion Pharmaceuticals, which is working to develop an anti-fibrotic drug that could be up for approval by the middle of the decade. Foster splits time between the research lab in Edmonton and the company’s corporate offices in Edison, New Jersey, on the outskirts of New York City.

Fibrosis in the liver is often the precursor to cancer or the need for an organ transplant. If there’s a drug that can battle fibrosis, there are many long-term benefits for patients and for health care systems in countries around the world. Not having to treat cancers or perform liver transplants opens up surgical suites and saves money.

While it took more than 25 years to develop Voclosporin, the timetable is much shorter for Foster’s new project.

“With Voclosporin, it was like learning how to ride the unicycle. But, with Hepion, we’re now a bunch of circus bears.”

 

Birth of a drug

1993 – Dr. Foster first conceptualizes his vision for an autoimmune drug.

1997 – He leaves his professor’s job at the University of Alberta to pursue drug development full-time.

2002 – Roche acquires the rights to Isotechnika and the rights to develop Voclosporin for $200 million.

2008 – Roche ends the partnership, leaving Isotechnika on life support.

2013 – After finding a new Canadian partner, Isotechnika eventually acquires Aurinia.

2020 – Clinical trials for Voclosporin are complete, and the drug is awaiting final approval.

This article appears in the June 2020 issue of Avenue Edmonton.

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