How SUDA Ltd is reinventing the wheel
Having established a broad technology platform for its oromucosal drug OroMist, SUDA Ltd is...
Having established a broad technology platform for its oromucosal drug OroMist, SUDA Ltd is now constructing a pharmaceutical business based on reformulated products that demonstrate major cost, functional and effectual advantages over the competition to corner demand.
SUDA holds over 70 patents related to OroMist, covering approximately 300 active pharmaceutical ingredients formulated into patented oral sprays. Using this technology, SUDA is developing low-risk, innovative products that improve both patient’s health and lifestyle.
It’s a two-pronged business strategy: Either SUDA formulates a market-leading drug in the therapeutic category into a spray, taking it through clinical development to a stage at which the SUDA will out-license the spray; or other companies come directly to SUDA with their molecules and ideas to develop them into spray applications.
“We have what we believe is world-leading technology, expertise and know-how of how to formulate oromucosal sprays,” said SUDA Chief Business Officer Nick Woolf.
With its home office based in Perth, SUDA has other subsidiaries throughout Western Australia and Europe. Its subsidiary business, called West Coast Surgical and Medical Supplies, provides everything from pharmaceuticals to vaccines for a range of customers.
West Coast’s four divisions include aged care, pharmacies, hospitals and supplying mining sites in Western Australia. The company reported revenue of $5.7 million in the 2014-15 financial year, with underlying revenue growth of about 20 per cent, excluding activities related to Detention Centres.
“Westcoast is growing very nicely,” said Woolf. “It’s a nice ‘add-on’, non-core business for us.”
Better sprays mean better results
SUDA often takes existing tablet form drugs with either expired or close to expirated patents and reformats them into oral sprays.
There are several advantages to delivering drugs through the oral mucosa, including ease of use, lower dosages, less side effects and a quicker onset of action.
“Because the lining of the mouth is highly vascularized, the drug is absorbed directly into the blood system, avoiding hepatic first metabolism and the gastrointestinal tract,” said Woolf. “This can provide enhanced bioavailability — meaning you need less of the drug to get the same amount absorbed into the blood system and with quicker onset of action.”
“We also avoid the need for patients to have to swallow — which is important for pediatrics and geriatrics, as well as when nausea or vomiting is involved. We formulate our sprays with flavours and tastes for a pleasant patient experience, which gives better compliance and convenience.”
SUDA’s pipeline of sprays include ZolpiMist® — the same active that is administered in tablet form as Ambien® or Stilnox® — which is used to treat insomnia. The product is registered in the U.S. and is expected to be launched in 2016, and SUDA is currently speaking with pharmaceutical companies in other parts of the world to license the drug.
In addition, a sublingual spray for treating pediatric malaria called ArTiMist™ has completed a Phase III study, where it was compared to intravenous quinine. The results from this study confirmed that SUDA’s spray was superior.
SUDA is in dialogue with The World Health Organisation (WHO) and other philanthropic groups to make the drug accessible in malaria epidemic countries, as well as expanding the use of the product to include early interventional treatment in the pre-referral setting.
Other key products in SUDA’s pipeline include first-in-class sprays of market-leading drugs for treating migraine (SUD-001), nausea & vomiting (SUD-002) and erectile dysfunction (SUD-003, DuroMist™). The active drug in DuroMist™ is the same as Pfizer’s Viagra® tablet, which is world’s top selling treatment for this condition.
Ahead of the rest
While it isn’t the only company formulating oral sprays, no one is doing it quite like SUDA.
Although there isn’t a single type of technology SUDA uses, there are several different approaches the company takes depending on the molecule to be formulated into an oromucosal spray. Moreover, SUDA has established a first-rate team of chemists, which Woolf believes separates the company from its competitors.
“None to our knowledge have the breadth of intellectual property (IP) and experience that we have,” said Woolf. “Our approximate 300 molecules span many different drug classes and size of molecules as well. We work with different solvents, different types of excipients, different flavours and taste masking.”
That being said, there are several obstacles to clear when translating drugs into sprays.
“The challenges of formulating a tablet into a spray are solubility, stability and permeation. With solubility, we have to get the dose drug dissolved in a certain amount of liquid.”
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“With stability, there are a lot of drugs that are stable in dry powder, but will degrade immediately in a solution, so we have techniques and know-how to overcome stability issues. “
“With permeation, the question is how you formulate it so the drug is rapidly absorbed. We have know-how and access to proprietary permeation enhancers. That’s what differentiates us.”
Through its in-house pipeline, SUDA specialises in formulating products and developing them through clinical studies to a stage that creates added value for investors.
SUDA’s business model doesn’t involve sales and marketing, but instead revolves primarily around out-licensing to pharmaceutical companies around the world to complete the clinical developments to the extent required, as well as oversee the registration and commercialization of SUDA’s pipeline of sprays.
In these licensing agreements, SUDA seeks up-front payments for the license, milestone payments associated with the successful registration of the products, commercial milestones associated with hitting sales targets and royalties on sales.
“Ultimately we will create value through the up-front and milestone payments, and the sustainable income that comes with royalty flows,” said Woolf. “In our co-development collaborations where companies are coming to us, they will pay for us to do the formulation work, and if it was formulated in our lab, we will seek to have a royalty income stream from it.”
SUDA also works with manufacturers, such as IDT in Australia, who operate to the standards of good manufacturing practice (GMP). IDT is currently manufacturing SUDA’s clinical batches of its first-in-class anti-migraine spray in preparation for its pivotal upcoming trial.
“We’re a deliberately lean company, so we outsource where appropriate,” said Woolf. “We work with a number of contract manufacturers around the world. We work with regulatory consultants around the world, but particularly in the U.S. to ensure everything we do in relation to the FDA is up to the highest standard.”
Way of the future
With several clear advantages, Woolf predicts oral sprays will become even more common in the future.
“For diseases or patient groups where a spray offers advantages, it can become the market leader,” said Woolf. “Technology has advanced to the extent that we can overcome the challenges of formatting drugs into sprays. We envision many more sprays coming into the market in the future.”
SUDA established its laboratories in Perth in 2014, but continues to add staff and equipment to the facilities as the company expands and works on more projects.
“At some point we will outgrow our current facilities and will be looking for new facilities,” said Woolf. “And I envision that happening within the next 24 months.”
“We have an exciting 12 months ahead of us,” said Woolf.
How UiPath robots are helping with the NHS backlog
The COVID-19 pandemic has caused many hospitals to have logistical nightmares, as backlogs of surgeries built up as a result of cancellations. The BMJ has estimated it will take the UK's National Health Service (NHS) a year and a half to recover.
However software robots can help, by automating computer-based processes such as replenishing inventory, managing patient bookings, and digitising patient files. Mark O’Connor, Public Sector Director for Ireland at UiPath, tells us how they deployed robots at Mater Hospital in Dublin, saving clinicians valuable time.
When Did Mater Hospital implement the software robots - was it specifically to address the challenges of the pandemic?
The need for automation at Mater Hospital pre-existed the pandemic but it was the onset of COVID-19 that got the team to turn to the technology and start introducing software robots into the workflow of doctors and nurses.
The pandemic placed an increased administrative strain on the Infection Prevention and Control (IPC) department at Mater Hospital in Dublin. To combat the problem and ensure that nurses could spend more time with their patients and less time on admin, the IPC deployed its first software robots in March 2020.
The IPC at Mater plans to continue using robots to manage data around drug resistant microbes such as MRSA once the COVID-19 crisis subsides.
What tasks do they perform?
In the IPC at Mater Hospital, software robots have taken the task of reporting COVID-19 test results. Pre-automation, the process created during the 2003 SARS outbreak required a clinician to log into the laboratory system, extract a disease code and then manually enter the results into a data platform. This was hugely time consuming, taking up to three hours of a nurse’s day.
UiPath software robots are now responsible for this task. They process the data in a fraction of the time, distributing patient results in minutes and consequently freeing up to 18 hours of each IPC nurse’s time each week, and up to 936 hours over the course of a year. As a result, the healthcare professionals can spend more time caring for their patients and less time on repetitive tasks and admin work.
Is there any possibility of error with software robots, compared to humans?
By nature, humans are prone to make mistakes, especially when working under pressure, under strict deadlines and while handling a large volume of data while performing repetitive tasks.
Once taught the process, software robots, on the other hand, will follow the same steps every time without the risk of the inevitable human error. Simply speaking, robots can perform data-intensive tasks more quickly and accurately than humans can.
Which members of staff benefit the most, and what can they do with the time saved?
In the case of Mater Hospital, the IPC unit has adopted a robot for every nurse approach. This means that every nurse in the department has access to a robot to help reduce the burden of their admin work. Rather than spending time entering test results, they can focus on the work that requires their human ingenuity, empathy and skill – taking care of their patients.
In other sectors, the story is no different. Every job will have some repetitive nature to it. Whether that be a finance department processing thousands of invoices a day or simply having to send one daily email. If a task is repetitive and data-intensive, the chances are that a software robot can help. Just like with the nurses in the IPC, these employees can then focus on handling exceptions and on work that requires decision making or creativity - the work that people enjoy doing.
How can software robots most benefit healthcare providers both during a pandemic and beyond?
When the COVID-19 outbreak hit, software robots were deployed to lessen the administrative strain healthcare professionals were facing and give them more time to care for an increased number of patients. With hospitals around the world at capacity, every moment with a patient counted.
Now, the NHS and other healthcare providers face a huge backlog of routine surgeries and procedures following cancellations during the pandemic. In the UK alone, 5 million people are waiting for treatment and it’s estimated that this could cause 6,400 excess deaths by the end of next year if the problem isn’t rectified.
Many healthcare organisations have now acquired the skills needed to deploy automation, therefore it will be easier for them to build more robots to respond to the backlog going forwards. Software robots that had been processing registrations at COVID test sites, for example, could now be taught how to schedule procedures, process patient details or even manage procurement and recruitment to help streamline the processes associated with the backlog. The possibilities are vast.
The technology, however, should not be considered a short-term, tactical and reactive solution that can be deployed in times of crisis. Automation has the power to solve systematic problems that healthcare providers face year-round. Hospital managers should consider the wider challenge of dealing with endless repetitive work that saps the energy of professionals and turns attention away from patient care and discuss how investing in a long-term automation project could help alleviate these issues.
How widely adopted is this technology in healthcare at the moment?
Automation was being used in healthcare around the world before the pandemic, but the COVID-19 outbreak has certainly accelerated the trend.
Automation’s reach is wide. From the NHS Shared Business Service in the UK to the Cleveland Clinic in the US and healthcare organisations in the likes of Norway, India and Canada, we see a huge range of healthcare providers deploying automation technology.
Many healthcare providers, however, are still in the early stages of their journeys or are just discovering automation’s potential because of the pandemic. I expect to see the deployment of software robots in healthcare grow over the coming years as its benefits continue to be realised globally.
How do you see this technology evolving in the future?
If one thing is certain, it’s that the technology will continue to evolve and grow over time – and I believe there will come a point in time when all processes that can be automated, will be automated. This is known as the fully automated enterprise.
By joining all automation projects into one enterprise-wide effort, the healthcare industry can tap into the full benefits of the technology. This will involve software robots becoming increasingly intelligent in order to reach and improve more processes. Integrating the capabilities of Artificial Intelligence and Machine Learning into automation, for example, will allow providers to reach non-rule-based processes too.
We are already seeing steps towards this being taken by NHS Shared Business Service, for example. The organisation, which provides non-clinical services to around two-thirds of all NHS provider trusts and every clinical commissioning organisation in the UK, is working to create an entire eco-system of robots. It believes that no automation should be looked at in isolation, but rather the technology should stretch across departments and functions. As such, inefficiencies in the care pathway can be significantly reduced, saving healthcare providers a substantial amount of time and money.