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.”
“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.