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FIREBRICK PHARMA (FRE) - Combating the Common Cold: Firebrick Pharma's Executive Chairman Dr. Peter Molloy on Nasodine's Revolutionary Nasal Spray and Global Market Strategy

• Andrew Musgrave

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What if you could finally treat the common cold with a simple nasal spray? Join us on ASX Briefs as we sit down with Dr. Peter Molloy, Executive Chairman of Firebrick Pharma Limited, to uncover the groundbreaking journey of Nasodine, a povidone iodine-based nasal spray aimed at combating the common cold. Dr. Molloy takes us through the development, challenges, and triumphs of Nasodine, inspired by the success of Betadine sore throat gargle. From the inception of the idea in 2012, through rigorous clinical trials, to the strategic international launches in the United States and Singapore, Dr. Molloy offers a detailed account of what it takes to bring an innovative pharmaceutical product to market.

Despite facing significant regulatory hurdles in Australia, Firebrick Pharma has demonstrated resilience and strategic adaptability. Dr. Molloy shares how the company pivoted its focus to international markets after spending millions on trials and legal battles with the TGA. Learn how Firebrick Pharma's new strategy aims to make Nasodine available worldwide, ensuring it is in the hands of healthcare professionals for future pandemics. This episode is a must-listen for anyone interested in pharmaceutical innovation, regulatory challenges, and the relentless pursuit of effective treatments for common ailments.

Andrew Musgrave:

Welcome to another episode of ASX Briefs, and today we are speaking with Dr Peter Molloy, the Executive Chairman of Firebrick Pharma Limited, a company dedicated to the development and commercialisation of innovative pharmaceuticals, particularly their povidone iodine-based nasal spray, Nasodine. In April, fibric made headlines with the launch of Nasodine in the United States, marking the first step in their global commercialisation plans, and last week they also announced they were launching in Singapore, providing a future hub for supply of their product throughout Southeast Asia.

Andrew Musgrave:

Peter, thanks for joining us today and welcome to the ASX Briefs podcast.

Andrew Musgrave:

Now, if we'll just kick things off, if you can give us an overview of Firebrick Pharma and the core focus of your product development.

Peter Molloy:

Absolutely early in my career, I launched Betadine sore throat gargle in Australia and, as most Australians know, it's been a very successful product commercially, and I think the reason for that is that the active ingredient, povidone iodine, is a broad spectrum antimicrobial that kills all bacteria and viruses that can cause sore throats.

Peter Molloy:

Now, a lot of those bugs also cause the common cold, and that was the genesis of the idea of a povidone iodine based nasal spray a nasal spray that kills all viruses and it was also the chance, frankly, to pursue the holy grail of drug development, which has always been to come up with an effective treatment for the common cold, something that has eluded the pharmaceutical industry for decades.

Peter Molloy:

So in 2012, Stephen Goodall and I launched the company with the mission to develop this povidone iodine nasal spray, which we called Nasodine, and it took us another six years to fully develop the product and get it ready for clinical trials, which started in 2018. Our goal was to get it on the market in Australia because we knew that Australian consumers, pharmacists and doctors would support it on the back of the very strong Betadine franchise that exists in Australia, and our goal was that, once we had shown success in Australia, we could partner it worldwide. That was the plan. So between 2018 and 2023, we spent goodness around $10 million on clinical trials that confirmed its safety and showed that it could reduce symptoms of the common cold if used early enough.

Andrew Musgrave:

And, as you said, it's been launched in the US and Singapore. But if we can talk about the Australian side of things, what happened when you were going down the path of getting TGA approval?

Peter Molloy:

We completed our first phase three trial for the common cold in 2019. And shortly thereafter around mid-2020, we filed for approval with TGA. Our goal was to get it approved as an OTC treatment for the common cold. Unfortunately, this also coincided with the height of the COVID pandemic panic and, paradoxically, a nasal spray that kills viruses was not seen as a positive thing. Clearly, the focus was on vaccines. TGA did agree that the product was safe and in fact, it met all their high hurdles for pharmaceutical manufacturing and quality, but they said they weren't convinced it was effective enough, clinically effective enough. Discussions with them and appeals dragged on for another three years and eventually we gave up, having spent way too much on legal costs fighting for a fair go.

Peter Molloy:

In parallel, we had completed a second phase three trial in 2023 that we hoped would push TGA across the line in terms of the clinical efficacy question, but it delivered scientifically inexplicable results which, frankly, didn't support our case for approval in Australia. So in November 2023, we had a bit of a hard reset Firebrick version 2.0, if you like and our goal became to make Nasodine available anyway and anywhere we can, just so people can buy it, because this is a product that is safe and needs to be available in people's hands, particularly in the hands of healthcare professionals, when the next pandemic comes along. So our new strategy is one that in effect liberates us from the risk-averse regulatory system that was stopping this product becoming available. So we set about launching Nasodine internationally. With that, Australia is the springboard.

Andrew Musgrave:

Okay, and if we look at the launch of the product in the US, that was an important milestone for Firebrick. So can you walk us through what this launch entails and the strategic importance of entering the US market?

Peter Molloy:

Well, it's the first example of our new strategy in action and I guess that's an important proof of principle. It was also really our first ability to get the product manufactured at commercial scale, so that was very important. The issue with the US for us is that the FDA regulations only allow us to promote it as a nasal cleanser, which doesn't allow us to tell the full story of the product, and we're selling it online only and without a pharmaceutical partner. So this means that sales in the US are going to be relatively modest, but it does get the product available so that people can experience it, and our experience in Australia has been when people use the product, they become devoted to it and they become advocates of it.

Peter Molloy:

Word of mouth is critical for a product like this, so for the first time, Australian shareholders have been able to buy it from somewhere. So that's a major development, a major breakthrough. It's been transformative, frankly, for Australian shareholders who've been buying the product from the US site, and if you just look at the reviews on Nasodine. com, you'll see what they think of it. It's extremely positive. So I'm very optimistic about the word-of-mouth potential from the use and advocacy of Nasodine that will come from our US sales. Our main goal, of course, was to make Nasodine commercially available for the next pandemic, and when that happens, every frontline healthcare worker in the US, I think, will want this product on hand and it will be available.

Andrew Musgrave:

And last week the announcement came out that you were launching in Singapore, so can you talk about that?

Peter Molloy:

We can actually describe it as a nasal spray that kills germs and talk about situations where people are exposed to airborne germs and highlight the potential risk that goes with that. So that's what's important about Singapore. Singapore allows Nasodine to be sold as a nasal antiseptic and it's also providing us with a hub for sales throughout the region and for sales into Australia, so I expect that we'll see a lot of Australians buying the product from the Singapore site. Frankly, it's cheaper than buying it from the US site and doesn't involve the same delivery issues that come with delivery from the US. So we'll be looking at other countries as well. I've said from the outset of the presentation of a new strategy that we'll be looking for multiple countries where we can make Nasodine available as a nasal antiseptic slash disinfectant in preparation for the next pandemic and to make it available for people's use to treat colds or for whatever purpose they want to use it for. And we've now achieved that in two countries, but it will not be the last.

Andrew Musgrave:

And if we look at the clinical trials, you've had a total of six clinical trials on Nasodine over the last six years. What have been the key findings from these trials and how do they support your commercial strategies?

Peter Molloy:

The key findings from these trials and how do they support your commercial strategies? The phase one trial was the first trial we did back in 2018 and it showed that the product was safe even when used at the maximum usable dose and four times daily over five days. It's important because it addressed the main safety concern with any povidone or iodine-based nasal spray, which is the potential for iodine uptake. Now that's not a problem in normal healthy people, but it can be a problem in people who have thyroid conditions. Today we announced that the results of that study had been published for the first time. Now that's important because it now puts the detailed results of that study into the hands of healthcare professionals who can make decisions about whether or not a patient who has perhaps a thyroid condition or some other condition that would impair their usage of the product, they can make decisions about whether or not that patient should use it. So that's why it's important. It's also part of our overall strategy to publish information about Nasodine wherever possible to get the message out there to healthcare professionals about the value of this product.

Peter Molloy:

Subsequent to that Phase 1 trial, we had one phase two and two phase three trials of Nasodine as a treatment for the common cold and, as I mentioned earlier, the first phase three trial was completed in 2019, which showed that if you use the product early enough, it was worked very effectively as a treatment for the common cold. It's got to be used very early in the condition. The second phase three trial, as I said earlier, was a little strange for the results and we found them scientifically inexplicable and invalid. We then had two phase two trials in COVID-19 patients. The second was recently published and it showed that it cleared 100% of the virus from the nasal passages, which was a very impressive outcome.

Andrew Musgrave:

And if

Peter Molloy:

Well, Nasodine nasal spray is the forerunner of an entire range of povidone iodine-based antiseptic products that we intend to develop and market, many of which will be novel product forms that the world hasn't seen before. I don't want to spoil the surprise, but I can tell you that one of them will be an antimicrobial body cleanser to eliminate problem body odour. So we will be developing a whole portfolio of products under the Nasodine brand and rolling those out over the next several years.

Andrew Musgrave:

And just to close off, looking forward, what are Firebrick Pharmas long-term goals and where do you see the company in the next five to 10 years?

Peter Molloy:

Well, I think our path is now quite clear. We're going to build a portfolio of proprietary Nasodine products, supported by a valuable brand, nasodine and offering a portfolio of marketing opportunities. We'll use the US as a platform to build substantial sales over the longer term and create a valuable business there in its own right. For Singapore, I see that as a hub for growth in Southeast Asia and potentially repeating the Singapore model in other countries where the nasal disinfectant positioning works, and we're exploring the potential for this in Europe as well. In five years. I see Firebrick as a valuable, internationally facing company that is delivering high shareholder returns and should become very attractive to a partner for acquisition or licensing.

Andrew Musgrave:

All right. Well, Peter, it's been great to chat Plenty going on at the company. So thanks for your time today and we look forward to further updates from Firebrick in the coming months.

Peter Molloy:

Thank you very much, Andrew.

Andrew Musgrave:

That concludes this episode of ASX Briefs. Don't forget to subscribe and we look forward to catching you on our next episode.