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Monkeypox: There are 1.7 million treatment courses in the national stockpile, SIGA BioArmor CEO says

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SIGA BioArmor CEO Phil Gomez joins Yahoo Finance Live to discuss the latest on the global monkeypox outbreak and what resources the U.S. currently has available to fight it, including treatments.

Video Transcript

RACHELLE AKUFFO: Of course, monkeypox, we're keeping an eye on that. New York State, along with San Francisco, have declared the monkeypox outbreak a public health emergency.

And with vaccine demand outpacing supply, meeting this threat could prove challenging in the weeks to come. Companies like Siga Technology CEO Phillip Gomez have antivirals to treat the disease that are awaiting FDA approval. Their CEO, Phil Gomez, joins us now with more. So thank you for joining us. So, Phil, where are we in this process? And how far behind the curve are we on really getting a handle on monkey pox right now?

PHIL GOMEZ: So certainly, it's a concern. It's a concern that many have planned for and thought about for a long time. So our drug is approved by the US FDA for the treatment of smallpox. It's not approved for the treatment of monkeypox. But I'd be happy to give you background because it's approved in Europe and the United Kingdom for the treatment of monkey pox and smallpox. So we do have an approval in Europe, and we have the FDA approval for smallpox here in the US.

ANJALEE KHEMLANI: Phil, I'm so glad you brought that up because I did want to ask you where we are on that label expansion. I know that you have been working with the FDA on looking in tandem with Junius, the vaccine, but also looking for the monkeypox as well. Where are we with this regulatory scenario?

PHIL GOMEZ: Yeah, it's a great question, and it's a complex area, but it's an important one that was developed by the US government. So we were developed under the animal rule, which means our monkey pox efficacy was in a lethal challenge model of monkey pox in non-human primates. So with an outbreak of whether it be smallpox or monkey pox, the plan was always to do randomized controlled trials, placebo controlled to verify that efficacy data in animals. That's the case in Europe. That's the case here.

And we have collaborations in Europe with Oxford University and a number of clinical sites in Canada. And as reported in "The New York Times" today, NIAID at the NIH is getting ready to launch this fall placebo controlled trials with T pox to treat patients with monkeypox. But I'd also like to remind viewers that the product is available. There are 1.7 million courses in the strategic national stockpile.

And the CDC and FDA are working to streamline the access to that drug, like COVID vaccines and Paxlovid. It's provided free through the US government. And the CDC and FDA are working to streamline the protocols used to gather data so that we can continue to gather safety and efficacy data while people are treated with the drug.

ANJALEE KHEMLANI: Right, I know that that has led to a little bit of delays and a little bit of struggle to get access to the treatment for patients. I also know that you've sealed some deals with new regions of the world, 56 million in total for this year in terms of orders. And you've got some of that plan to be delivered by September. Talk to me about manufacturing for this right now. Where are you? Do you have partners in place? And do you plan to ramp up?

PHIL GOMEZ: Yeah, absolutely. So the good news is we are manufacturing this product in a US-based supply chain. So we're a US company manufactured here in the US through partnerships with contract manufacturing organizations we've had now going back almost 10 years. So we, in the past two years, in 2020 and 2021, delivered over 360,000 courses of drug to the US government to help resupply the stockpile.

Unfortunately, before this outbreak, really, only Canada and the US pre-positioned our drug for an outbreak. So we do have a lot of inquiries coming in from dozens of countries that are now trying to catch up and establish stockpiles and be able to treat monkeypox. We're certainly working with our network to expand manufacturing. But we were anticipating a large number of orders over the next few years. So we had product available and in our supply chain to advance in response to these orders.

SEANA SMITH: Phil, are you in touch with the Biden administration? I guess, what can you tell us about what those talks have been like? And what's your response or take on how they have responded to the monkeypox outbreak so far?

PHIL GOMEZ: Yeah, I would say there's two parts to that answer. One is pre-positioning product with our partnership with BARDA, which is the agency that we work with that developed this drug. In the strategic national stockpile, we were well positioned to have 1.7 million courses there. When there's an outbreak, there's obviously a lot of discussion of how severe is it going to be.

And unfortunately, I think the original perception that this was going to be a self-limiting infection with not a lot of morbidity and mortality just hasn't played out. We've seen now from WHO 80 cases in children that they're reporting. We saw death reported in Brazil today. And we've also seen the incredible pain and difficulty that patients are seeing.

And so that's presented a challenge. I don't think we were as fast to get vaccines and drugs out there as I think we could have been and should have been in retrospect, now that we know how severe this disease is.

RACHELLE AKUFFO: And obviously, the WHO declaring this a global emergency, but just individual states at the moment in the US, how important is it to have that classification as a public health emergency in the US for unlocking things like funding and access to vaccines and to really get the momentum going on this?

PHIL GOMEZ: I think it's important. I've been working in pandemics for over 20 years in things like Ebola, SARS response, and the like. And it's important because those declarations allow the administration and coordination to happen, to identify funding for the next phase, to make sure we resupply products, to make sure we're ready for the long-term.

So I think it would be very helpful to raise awareness in the public about the disease. We know this is going to get into additional populations. And so I think that declaration would be helpful in making sure we build our preparedness and we respond in the way that really needs to happen.

ANJALEE KHEMLANI: Phil, I'm glad you mentioned your experience with pandemics, obviously, also with the NIH. So you're very well aware of also the global efforts that need to come as a result of the public health emergency declaration.

As it stands right now, I know you've already worked with Oxford to get treatment courses into Africa and to African countries. What can you tell us about right now, the global equity efforts? Because we already know that has been such a topic of conversation with COVID. Tell us about your efforts right now to get doses everywhere.

PHIL GOMEZ: Yeah, so certainly, we're working with countries around the world. And we knew early on a number of years ago with our approval that monkeypox, unfortunately, has become very endemic in Africa. So as you highlighted, we started a collaboration with Oxford a number of years ago. And last year, we donated drug. We donated the financial support to do observational studies, where we do compassionate use work in the Central African Republic. And that data is going to be very informative as the outbreak goes as it gets published.

We also worked with NIAID, who is launching a study in the Democratic Republic of Congo, another area highly impacted by this virus. And unfortunately, in the CAR and the DRC, the strain or clade of monkeypox there has shown a 10% fatality rate. So we always worried that monkeypox might become endemic outside Africa. There are two major clades. One has a fatality rate about 1% or less, one 10%.

We're fortunate what's circulating right now is the less virulent one or the less lethal one. But unfortunately, there's no reason that the other clade couldn't come out. And I think you make a really good point. There's been the comment that a case anywhere can be a case everywhere. And as a globe, we need to work very hard on making sure we have equitable access to drugs and vaccines. And certainly, as Siga, we've been talking with WHO, talking with NGOs, thinking about the best way to make this equitably available.

RACHELLE AKUFFO: And Philip, what do you see as the biggest challenges in ramping that up? Obviously, we saw with the different kinds of vaccines for COVID issues with refrigeration. It took a while to sort of get that momentum going. Any challenges that you see in terms of not just perhaps accessing and logistics, but also the potential for new strains or variants of monkeypox?

PHIL GOMEZ: Yeah, with any infectious disease, I think this is a call to continue to develop therapies. Any agent, you want to make sure you have multiple tools. We have a product in pre-clinical testing that's also active against smallpox and monkeypox that we have been developing. So I think it is a call to the scientific community to make sure we have vaccines and therapeutics.

Monkeypox is different. It's a DNA virus. It's typically very stable over time. It's not an RNA virus like influenza or coronavirus. So we're fortunate that as we saw with smallpox eradication, there was one vaccine that was used very effectively to ultimately eradicate the disease. So orthopox viruses are different. And I think we have a good toolset, but we need to continue to build our toolbox.

SEANA SMITH: All right, Philip Gomez, CEO of Siga Technologies, thanks so much. And of course, our thanks to Anjalee Khemlani as well.