Robert DeLuca: I’ve been in the pharmaceutical industry for well over thirty-five years. I started out as a pharmacist in retail pharmacy, and I really didn’t like standing on my feet all day. I got into being a sales rep for a pharmaceutical company, Hoffmann-La Roche, back in the day. It was great, and I really enjoyed it, and I use my pharmacy background more as a sales rep and as a marketer and a global operations and market access person and president than I did standing behind a counter counting pills every day. It’s been an incredibly rewarding journey for me, and I look forward to it continuing for quite some period of time.
And yes, I’ve had the opportunity to work at very large and small companies, but Orexo has been the pinnacle of what I like to say has been a pretty good career. Because not only do we get to work with great people nationally and internationally, but I get to work on solving a major problem with my colleagues that is unmet in need and is so desperately needed from a community perspective and from a family perspective. And it’s just very satisfying, but we’ve got a heck of a lot of work to do.
M. Marin: Thank you. So, if you watch the news, unless you’re living under a rock, I think we’ve all been hearing a lot about tariffs. Orexo is a non-US-headquartered company; I’m not sure where your manufacturing potentially will be. Can you talk a little bit about what you’re thinking in terms of potential tariff impact?
Robert DeLuca: Yeah, so obviously, you can imagine the board of directors had some significant questions for me to answer when Mr. Trump came up with his tariffs. One of the positive things from a ZUBSOLV perspective is: it is 100% manufactured and packaged here in the United States. There is only one ingredient that we buy ex-US, it’s the naloxone portion, but it’s from a US-based company. Based on what we know right now, the impact will be zero to ZUBSOLV’s bottom line.
With regard to our AmorphOX platform, that’s a bit of a different story because while we have the manufacturing capabilities and we have run commercial batches and we know we can do it, some of it is in Canada, that’s where it’s manufactured, and it’s sourced from various other parts outside the United States. So, it’s something we’re going to have to address financially. How we deal with it today, versus how we deal with it next month or in six months or in a year, that’s probably going to change over time. And we just have to stay ahead of it, at least stay with it, so that we can understand what implications it could have to bringing these products to market.
M. Marin: That makes sense. So, let’s switch topics a little bit and talk more specifically about the opioid crisis because I think we all understand there is a crisis. You said during your prepared remarks that we’re making some progress, and yet, it seems like there are more and different ways for people to get certain drugs. Can you give us a little bit of color on where we are today versus where we were five years ago, and whether you think we’re moving in the right direction, and at what pace?
Robert DeLuca: That’s a big question. I’ll give you my perspective. I think we are curbing the opioid epidemic to a degree. I think, unfortunately, we’re seeing other adulterants, illicit adulterants, and even legal adulterants being used more regularly by more people. You’re seeing an increase. Well, you’re reading about a decrease in the use of alcohol, right? At least I have been reading about it. You’re seeing an increase in use of marijuana, right? Being sold legally on the streets here in New York, New Jersey, and in many states. I’m not going to get into the gateway thing, but we’re also seeing things like xylazine, medetomidine, dexmedetomidine, more cocaine use, and other things coming into the country.
So, while fentanyl is still being abused and while the death rates are coming down because there’s more availability in naloxone, I also think there are more people in treatment. I also think more people have died from fentanyl. So, there are less people using it. You’re still having more people illicitly use drugs to get high and to feel different than where they are, and a lot of that is trauma-based. So, I still think we have a huge amount of work to do from a prevention perspective. Treatment is prevention. From an educational perspective and from a legal perspective, law enforcement perspective, we’ve got to cut down the supply.
M. Marin: Ok, would it be fair to say that, based on your remarks, you think the numbers you do see are probably underreported?
Robert DeLuca: I can tell you the numbers are under-reported. Just in the state of New Jersey alone, there are 26 counties. According to the former governor, each medical examiner in those 26 counties looks at and does examinations after death differently. So, you know they’re missing or not following the same protocols across the board.
M. Marin: So now I want to switch gears a little bit, talk a little bit more about AmorphOX, the delivery technology. You mentioned the potential to deliver to Africa, American markets, where it’s more difficult to get a liquid vaccine.
Robert DeLuca: To get a vaccine that would require refrigeration or temperature control, yes. And our hypothesis is that with this very stable AmorphOX technology, we’re testing various, different viruses in this technology. And therefore, when we understand the heat excursions, we can then figure out: can we get vaccine X to this country through the supply chain safely so that it’s still live, right? And it’ll still have the interglobular effect associated that’s required for them to be able to build antibodies to fight off the disease. That’s where we’re trying to go with this from a vaccine perspective.
But that’s just one aspect of it. When you look, there are so many other compounds where this product can be used and keep it more stable, and maybe make it even more patient-friendly, depending on the disease or the compound.
M. Marin: That makes sense. In terms of BARDA, obviously, that was a big announcement for you. You said before that you’re, I’m guessing, in the early stages of thinking about and or approaching larger partners for potential commercialization partnerships.
Robert DeLuca: Well, the partnership strategy is not new. It’s something that we’ve had the entire time that I’ve been at Orexo. And, with AmorphOX, it’s a significant part. While we’re generating good revenue, with all those projects we would like to do, we’re going to need some people to come on board and invest with us so that we can develop these compounds and bring them to market with them, or they can buy them, or we can do it in partnership.
I think partnership is always something companies, large and small, have to look at. But I think because of the nature of this AmorphOX delivery platform, we have to be very strategic because that is a big list. But how much can Orexo handle and do responsibly and do well so that we can meet the needs of our partners, meet our own internal needs and timelines, and also meet the needs of the marketplace?
I think that’s an incredibly important conversation we have on a very regular basis, not only as a management team, but in conjunction with our board of directors. And it’s a privilege to be a part of it. It’s mostly the scientists and the others, but it’s nice to sit there as the commercial guy and say, well, take a look at this or take a look at that. It’s a privilege to do that.
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