SUDA Pharmaceuticals Limited (ASX:SUD) CEO, Dr Michael Baker talks 1H20 results progress with the company's lead product Zolpimist, the spay version of Sanofi’s blockbuster insomnia drug Ambien and focus for 2020.
Katrina Bullock: Hello. Katrina Bullock for the Finance News Network. And joining me today from SUDA Pharmaceuticals (ASX:SUD) is CEO Dr Michael Baker. Michael, welcome back to the network.
Dr Michael Baker: Hi Katrina. Thanks for having me.
Katrina Bullock: Can you remind the audience about SUDA Pharmaceuticals? What's the company's focus? And what stage is the company?
Dr Michael Baker: So, SUDA Pharmaceuticals is a Perth-based biotechnology company. And we specialise in taking solid dose forms of drugs and converting them into an oral spray. We do have a range of products in our portfolio, and they range from projects that are still quite early in their development stages, through to our product Zolpimist, which is currently undergoing regulatory submissions in Australia.
Katrina Bullock: Now turning to the first half 2020 results, what were the highlights?
Dr Michael Baker: We had a share consolidation at 25 to one, which was good to clean out the capitalisation structure. Stephen Carter resigned, and I joined on as the CEO at the beginning of January, 2020. In addition, we created three really exciting partnerships, the first with Cann Pharma, to reformulate one of their products for the medical-grade cannabis space. And also a well-known Spanish pharmaceutical company, Ordesa, for a product that we are unfortunately unable to name due to confidentiality reasons on their side. But also we created a partnership with a large pharmaceutical company, Sanofi, which we're very excited about. Unfortunately for SUDA, the denial by the TGA for the Artemis program for the treatment of paediatric malaria was upheld. And this was a disappointing outcome, but something we're continuing to take legal and regulatory advice around.
Katrina Bullock: And how are the partnerships progressing?
Dr Michael Baker: They're still all very early stage, given we've just entered into the partnerships. But for Cann Pharma, particularly exciting. It's a product in the medical-grade cannabis space. And we're essentially taking that to reformulate into an oral spray for use in patients that have drug-resistant epilepsy, as well as those that suffer from melanoma and even motion sickness. For Ordesa and Sanofi, unfortunately we are unable to disclose the products, just given the confidential nature of those details on behalf of our clients. But nevertheless, certainly very excited to have the projects underway.
Katrina Bullock: Thanks Michael. Now turning to the portfolio, when we last spoke, you mentioned Zolpimist and Anagrelide. How are they tracking?
Dr Michael Baker: So, for Zolpimist, we're still continuing the strategy of creating new partnerships across the globe -- in addition to the partnerships we already got with Teva, the largest generic drug maker worldwide, as well as Mitsubishi, a top-five Japanese pharmaceutical company. So we are still continuing to create new partnerships across different territories worldwide. In addition, Zolpimist is still currently undergoing submission at the Therapeutic Goods Administration in Australia, for which we're expecting to hear an outcome in 2020.
For Anagrelide the program is still at the reformulation stage. So we're working very hard to get a suitable formulation, in terms of an oral spray. Important to note, we had Dr Richard Franklin come on board as the project director for the program, towards the end of 2019. And he is a gentleman that was involved in the early development and registration, while he was at Shire, of Anagrelide. So he's got a wealth of information, and understands the molecule very well. In addition, he has great connections across the industry as well.
Katrina Bullock: And how is the rest of the portfolio progressing?
Dr Michael Baker: So, we still have a number of other projects ongoing, So, we're continuing to work with Strides for our Sumatriptan, which is for the treatment of migraine, as well as Zelda, with whom we also have an agreement and a partnership, working with their medical-grade cannabis products. So, both still ongoing.
Katrina Bullock: Now, Michael, what's the focus for 2020 now that you've settled into the new role?
Dr Michael Baker: Certainly. So, for Zolpimist, we're really looking to roll that out globally, creating new partnerships in territories worldwide, in addition to Teva and Mitsubishi. Also, we've got the TGA submission underway. So we're very excited to hear the outcome of that, and we're expecting that to take place in 2020.
For Anagrelide, it is still in the reformulation stages, but we're excited about continuing the development through that phase, before we embark upon the preclinical phases before getting that program into clinical trials.
Also, as I said, we've got a number of earlier stage feasibility studies underway. And I think a key focus for 2020 is to make sure that we're producing the highest quality data to satisfy our clients, to get those products moving into the later development stages.
In addition, we'll be looking in 2020 to continue to opportunistically scan the landscape, to assess if there are additional assets that we can bring into SUDA.
Katrina Bullock: Michael, before we let you go, any other messages for current or potential investors out there?
Dr Michael Baker: Yeah, absolutely. I'd just like to reiterate that I'm very excited about the new partnerships that we have created with, particularly, a company like Sanofi, which is a billion-dollar pharmaceutical company. In addition to building Zolpimist globally, and certainly for hearing about the outcome from the TGA during 2020. In addition, driving the Anagrelide program through the formulation stages, and towards a phase one clinical trial, is quite exciting.
Katrina Bullock: Dr Michael Baker, thanks for the update.
Dr Michael Baker: My pleasure, Katrina. Thank you for having me.