SUDA Pharmaceuticals (ASX:SUD) adapting drugs for oral dosing


by Rachael Jones

SUDA Pharmaceuticals Limited (ASX:SUD) Managing Director Dr Michael Baker discusses the company's technology to convert solid dose drugs into oral sprays and the outlook for the year ahead.

Rachael Jones:
Hello. I'm Rachael Jones for the Finance News Network. Joining me from SUDA Pharmaceuticals (ASX:SUD) is Managing Director Dr Michael Baker. Michael, welcome to FNN. 

Dr Michael Baker: Thank you, Rachael. Thank you for having me.

Rachael Jones: Now, SUDA Pharmaceuticals is a drug delivery company focused on oral mucosal administration for more effective dose delivery. Can you tell us more about this?

Dr Michael Baker: Absolutely. So as you rightly pointed out, we focus on our mucosal delivery of drugs. And to do that, we take drugs that exist as solid dose forms and convert them into oral sprays so they can be sprayed directly into the mouth and then cross the lining of the cheek. And the reason we do that is that when we're able to do that successfully, we get more of the drug into the bloodstream, which means we can potentially lower the dose of drug given and potentially have safer products. We also know that the drugs can enter the bloodstream faster. So we do often see a faster onset of action for particular drugs, which is important for areas like insomnia, which is one of our drugs and also for pain. And it also opens up access to other patient groups. So there's a significant portion of the population that can't actually swallow and in the case of paediatrics and for people having seizures and so forth.

Rachael Jones: And what can you tell me about your lead product and what stage is that at?

Dr Michael Baker: So our lead product is a product called Zolpimist. So it's an oral spray version of what was Sanofi's former blockbuster drug, Ambien, better known in Australia as Stilnox. And so we were delighted to receive TGA approval for that product, earlier in the year in July. And it's a really important milestone for a company like SUDA. It represents the first part that we have had approved. Really importantly, we've already got license and supply agreements in place with the world's largest generics manufacturer, Teva and a top 10 Japanese pharmaceutical company, Mitsubishi. And so that approval feeds into their regulatory submissions and will assist with commercialisation of the product. And once they commercialise in their respective territories, SUDA we'll take royalties off those net sales. And just for those territories where we've got those agreements in place, the populations total more than 550 million people.

Rachael Jones: Thanks, Michael. And you were developing a drug called Anagrelide and repurposing it for the use in cancer. Can you tell me about the study for that?

Dr Michael Baker: That's right. So we are developing Anagrelide for use in metastatic disease. It was formally approved to treat a condition where patients had increased platelet levels. And what limited sales of that product and uptake was the pill form, as it goes through the digestive track actually gets converted into something that's bad for the heart. And so what we're doing is re-purposing the drug into an oral spray, so that as it crosses the lining of the mouth and enters the bloodstream, we had the theory that we would see less of that intermediate being produced. And so that study you referred to, was a study we completed only recently. And demonstrated that when we have an oral form of the drug, we do get more into the blood stream. We do see an increase in the unwanted intermediate that's bad for the heart, but we know that we could lower the dose back down to get patients to the required level, to lower their platelets. And that would likely reduce exposure to that intermediate. So we're very pleased with the outcome from that study.

Rachael Jones: And what can you tell me about the patent that was granted?

Dr Michael Baker: Yeah, so the patents are very important part of these types of programs. They're essentially the currency for biotechnology firm because it protects the position or blocks competitors from coming into your particular area of interest. And so we are the only company worldwide that has patents protecting the use of this molecule for the treatment of metastatic disease. And only last quarter, we had the patent granted in Australia. And that adds to the patents that we've already got granted in Japan and also Europe. And we're continuing to prosecute the patents for additional territories, including North America, but also using the data that we produce to generate more patents along the way.

Rachael Jones: Excellent. And you recently announced that you're looking for additional assets to enhance the product portfolio. What does this mean for the business and what areas are you focusing on?

Dr Michael Baker: That's right. So our senior management and board have a lot of experience in, not just biotech and pharma but specifically also in the venture capital side of things. So that means sourcing, evaluating, acquiring, or investing into novel technologies. And so that's a key skill of the senior management group that we're looking to make the most of. And so we'll look actively to bring new technologies into the business that supplement our portfolio. So we've already got a focus on oncology in the central nervous system. And so we'll be actively looking to bring new technologies to strengthen the portfolio, to create value for SUDA and ultimately for shareholders

Rachael Jones: To the last question now, Michael, is there anything else you would like to add?

Dr Michael Baker: Yeah, it was very pleasing earlier in the year. We completed an entitlement offer with Becky Young and we're looking to raise just over three and a half million and we had offers of five point two. So very pleased with the level of support we've got from our current shareholders. And we certainly look forward to having their continued support, but also prioritising them as we move forward. So we are excited for 2021 as we move through the regulatory submissions with our partners for Zolpimist and into commercialisation, as well as pushing a lot further towards clinical trials. And I'm looking forward to bringing new assets into the business.

Rachael Jones: Dr Michael Baker, thanks so much for the update.

Dr Michael Baker: Thanks very much for having me, Rachael.


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