Your product Aggrastat is the most used glycoprotein IIb/IIIa-inhibitor in the US; what does its journey look like?
We bought Aggrastat, which was originally developed by Merck and later sold to MGI who abandoned it, so we got it relatively cheap. At first, I hired someone in sales and he told me to contract a sales organization on the condition that the product would be out in one year. After several hit and miss attempts at commercializing the product throughout the country, I hired one salesperson in Winnipeg and a chemist, whom I knew quite well. We started this initiative with the motto "never lie, never cheat" which turned into the success that Aggrastat is today. Our team went out to convince the doctors, explaining why the product was better than the others, in addition to its competitive price. Soon our team grew to 50 people who were on the road two weeks out of four, and then the product’s own success followed it.
In what way has the Covid-19 pandemic altered the biopharma industry, and the way Medicure specifically does business?
The pharmaceutical industry did an incredible job and developed the vaccine quicker than any of us predicted. I personally thought it would take two years, but they did it in a year. The FDA bent over backwards to accommodate this, for the better interest of the population.
Remember, the FDA's role is to protect the public, but to also provide an opportunity for better treatments - the pandemic re-emphasized the identity of the FDA as an enabler of life saving medicine, and not only as a gatekeeper.
Another thing that also happened is that one of the breakthroughs in the development of the vaccine was the use of messenger RNA. In my research, back when I was doing my PhD, I was involved in mRNA studies, basic research which is older than most people realize, namely back in the 1960s. The way technology often is translated to commercial use is in response to a pressing need, like COVID-19. The technology itself might be decades old, as it was in the Manhattan project, suddenly a technological golden grail for modern issues.
Looking back at your rich experience in the industry, what is the achievement you are proudest of?
I led the development of a drug called WinRho at a time when Rh diseases were a major medical concern. If a woman is Rh negative and her husband is Rh positive, there is a risk that the woman will give birth to a "blue baby" or an "Rh disease baby", which used to be a devastating disease that affected 2-3% of global pregnancies. We treated 1,200 women during our clinical trials, and my wife was one of the candidates. Of the 1,200 women, there was one failure in protection, and this was a cross-candidate. As a matter of fact, this person was my sister, so we could easily track her wellbeing, finding that she did not report a miscarriage, so it was a 100% success rate at the end of the day. In my wife’s case, all of my three daughters were protected, they all are Rh+, as a result they each received the drug, WinRho, that we developed. I still get emails from mothers that say that "your work contributed to saving our baby" and I find it all immensely rewarding to have been intimately involved in the protection and transformation of a previously devastating ailment.
What are your plans for Medicure for the near term future?
Medicure turned 25 in 2022 and I am very proud of where our team in Winnipeg was able to bring the company. Aggrastat is an ongoing success. We are currently focused on growing sales for our statin product, Zypitamag (pitavastatin) which we acquired in 2018, as well as our online pharmacy, Marley Drug, which we acquired in 2020. Marley Drug aims to disrupt traditional pharmacy channels by bypassing insurance companies and PBMs and selling medications, like Zypitamag, directly to patients. The industry has been suffering from a lack of trust, and our goal remains to earn and keep patients’ trust.
Lastly, most of our R&D spend is going towards a product called MC-1, which is now in Phase 3 clinical trials to treat a rare pediatric disease that causes seizures in children and is fatal if left untreated. We have received orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration for MC-1 for this disease. Assuming positive results from that study and FDA-approval, Medicure will be eligible to be awarded a priority review voucher, which typically sells for USD $100-200 million.
How is Medicure’s strategic approach at commercializing primary care products different from the traditional PBM/insurance route?
At Medicure we try to find unmet needs in the healthcare space. Through our relationships that have taken years to develop, we work with key opinion leaders in the U.S. healthcare space to find their ‘pain-points’. Most recently, one of those pain points was with getting patients access to a third-generation statin, pitavastatin. Not only was this medication extremely difficult to get insurance approval, but it was also overpriced. Nearly $1000 for a 90-day supply. We launched Zypitamag (pitavastatin) in 2018 and later bought Marley Drug, a pharmacy licensed to ship medications in all 50 states, in 2020. This allowed us to offer pitavastatin directly to patients without the need for any insurance or pharmacy benefit manager middlemen. This strategy also made us the first manufacturer to sell its medications directly to patients cutting out nearly all of the middlemen. This keeps our margins high and the cost to patients low. We feel this model will be the future of primary care products.
